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| Name | Class |
|---|---|
| Abdul Latif Jameel Poverty Action Lab | OTHER |
| University of Chicago | OTHER |
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This study evaluates the effects of the Nurse Family Partnership (NFP), an established home-visiting program, using a scientifically rigorous individual-level randomized controlled trial. The study will be based in South Carolina, where a Medicaid waiver in combination with a pay-for-success contract will allow expansion of the program to women on Medicaid. The study plans to enroll 4000 low-income, first time mothers and their children into the intervention group, and another 2000 into the control group. The study will evaluate the program's impacts on outcomes using administrative records. This study aims to yield new evidence on the effect of NFP in a modern context, applied to a new population, across a broad range of outcomes, and financed by a novel public-private partnership based on accountability for outcomes.
This study is an individual-level randomized controlled trial, with randomization post-consent. The study will enroll pregnant women who are income-eligible for Medicaid, less than 28 weeks pregnant, and have not had a previous live birth. All eligible applicants who provide written consent will be randomly assigned either to a treatment group that is offered access to NFP or to a control group that is not. Two-thirds of those recruited will be randomized to the treatment group and one-third to the control group. Control group members will have access to the standard of care and whatever other programs and services are available in the community.
The investigators will assess the effect of NFP on a range of short- and long-run maternal and child outcomes using administrative data that will be available for all members of both treatment and control groups. Several of the outcomes the investigators will evaluate are required as part of the Medicaid waiver and pay-for-success financing model.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment-NFP | Experimental | NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old. |
|
| Control | No Intervention | Control group members have access to the standard of care and whatever other programs and services are available in the community. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-Family Partnership | Behavioral |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With a Composite Birth Outcome | Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life). | 0-7 days after index birth; vital records, mortality records, and fetal death records |
| Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren). | within 24 months after index birth; Medicaid claims or hospital discharge data |
| Number of Participants With an Inter-birth Interval of < 21 Months | Having a subsequent birth within the first 21 months of the index birth | within 21 months after index birth; vital records |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With an Infant Born Small for Gestational Age (SGA) | Infant birth weight below the 10th percentile for infants of the same gestational age | At index birth; vital records |
| Number of Participants With an Infant Born Large for Gestational Age (LGA) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Margaret McConnell, PhD | Harvard School of Public Health (HSPH) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nurse-Family Partnership of Anderson County | Anderson | South Carolina | 29625 | United States | ||
| NFP of Berkeley/Charleston/Dorchester Counties |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40522648 | Derived | Swanson K, Ayers S, Oviedo D, Zhou RA, Bates MA, Baicker K, Chien AT, McConnell M. Intensive Nurse Home Visiting and Early Childhood Outcomes: A Randomized Clinical Trial. JAMA Pediatr. 2025 Aug 1;179(8):857-866. doi: 10.1001/jamapediatrics.2025.1600. | |
| 40177469 | Derived | Rokicki S, Oviedo D, Perreault N, Bates MA, Zhou RA, Baicker K, McConnell MA. Impact of nurse home visiting on take-up of social safety net programs in a Medicaid population. Health Aff Sch. 2025 Apr 2;3(4):qxaf038. doi: 10.1093/haschl/qxaf038. eCollection 2025 Apr. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Treatment - Participation in Nurse Family Partnership | NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old. |
| FG001 | Control | Control group members have access to the standard of care and whatever other programs and services are available in the community. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
The total number of participants in the baseline analysis includes randomized participants who were successfully matched to an index birth or fetal death and excludes those who were not. This sample also excludes participants who withdrew from the study, experienced a pregnancy loss/miscarriage, or who did not receive the treatment as assigned.
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| ID | Title | Description |
|---|---|---|
| BG000 | Treatment - Participation in Nurse Family Partnership | NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With a Composite Birth Outcome | Composite of at least one of: small for gestational (SGA), or low birth weight (LBW) less than 2500 grams, preterm birth (PTB) less than 37 weeks' gestation (obstetric estimate), or perinatal mortality (fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life). | Differs from randomized sample as it excludes participants who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | 0-7 days after index birth; vital records, mortality records, and fetal death records |
|
From enrollment until end of follow-up (3 years)
We define adverse events in accordance with the Harvard Institutional Review Board (IRB) guidelines as any physical, psychological, social, or economic harms associated with participation in the research. This definition is distinct from that of the National Institutes of Health, which includes all untoward medical occurrences regardless of their relationship to the research. By using the Harvard IRB definition, we report adverse events related to the research or the conduct of the study.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Treatment - Participation in Nurse Family Partnership | NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old. |
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The study ended enrollment earlier than planned on March 17, 2020, due to safety concerns arising from the Coronavirus disease 2019 (COVID-19) pandemic. The original plan was to enroll 6,000 mothers (4,000 in the treatment group and 2,000 in the control group) over a four-year period (April 2016-2020), with NFP services provided through the children's second birthday (2016-2022). At the close of enrollment, a total of 5,670 participants had been enrolled.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Margaret McConnell | Harvard University | 6174321232 | mmcconne@hsph.harvard.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Aug 4, 2022 | Nov 3, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Feb 5, 2025 | Nov 3, 2025 | SAP_002.pdf |
| ICF | No | No | Yes | Informed Consent Form | Jun 20, 2017 | Dec 17, 2020 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| D014947 | Wounds and Injuries |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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The Nurse-Family Partnership (NFP) was launched by pediatrician David Olds in the early 1970s in response to the observation that low-income mothers are less likely to engage in positive health and parenting behaviors that are associated with better child development outcomes (Olds et al. 1986). NFP is a prenatal and infancy home visiting program for low-income, first-time mothers and their families. Registered nurses begin visiting their clients as early in the pregnancy as possible, helping the mother-to-be make informed choices. The nurses continue visiting regularly until the child is two years old.
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Infant birth weight above the 90th percentile for infants of the same gestational age |
| At index birth birth; vital records |
| Number of Participants With an Infant Born With Low Birth Weight (LBW) | Number of participants with an infant born with a birth weight of less than 2500 grams. | At index birth; vital records |
| Number of Participants With an Infant With Very Low Birth Weight | Number of participants with an infant born with a birth weight of less than 1500 grams. | At index birth; vital records |
| Birth Weight (Continuous) | A continuous measure of infant birth weight (grams) | At index birth; vital records |
| Number of Participants With a Preterm Birth | Infant born before 37 weeks' gestation (obstetric estimate) | At index birth; vital records |
| Number of Participants With an Extremely Preterm Birth | Number of participants with an infant born before 28 weeks' gestation. | At index birth; vital records |
| Gestational Age at Birth | Gestational age at birth in weeks (continuous) | At index birth; vital records |
| Number of Participants Experiencing Perinatal Mortality | Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life | Within 1 week after index birth; mortality records and fetal death records |
| Number of Participants With a NICU Admission of at Least Overnight | Infant admitted to the neonatal intensive care unit (NICU) for at least one night | At index birth; hospital discharge |
| Number of Participants Experiencing Neonatal Morbidity | Assisted ventilation immediately after delivery, assisted ventilation for more than six hours, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis. | At index birth; hospital discharge |
| Number of Participants Experiencing Cesarean Delivery | Number of participants experiencing a cesarean delivery for their index birth. | At index birth; vital records |
| Number of Participants Experiencing Severe Acute Maternal Morbidity | Severe acute maternal morbidity as defined by the Centers for Disease Control and Prevention (CDC). | At index birth; hospital discharge |
| Number of Participants Experiencing Maternal Mortality | Number of participants experiencing all-cause mortality within one year postpartum. | Within one year after index birth; mortality records |
| Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse | Number of participants experiencing neonatal abstinence disorder (NAS) or maternal drug/substance abuse in the first two years postpartum. | Within two years after index birth; Medicaid claims, hospital discharge |
| Number of Participants Experiencing Violence or Homicide | Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code | Within 2 years after index birth; Medicaid claims, mortality records |
| Number of Participants With a Postpartum Visit | Number of participants with a postpartum visit in first 12 weeks after an index birth. | Within 12 weeks after index birth; Medicaid claims |
| Number of Participants Who Received Adequate Prenatal Care | With adequacy defined using the Adequacy of Prenatal Care Utilization Index (APNCU), where prenatal care began by the 4th month and at least 80% of recommended visits were attended | At index birth; vital records |
| Number of Emergency Department Visits During Pregnancy | Number of emergency department visits during pregnancy. | At index birth; hospital discharge |
| Number of Participants With a Dental Visit During Pregnancy | Number of participants with a dental visit during pregnancy (preventive or treatment). | At index birth; Medicaid claims and dental records |
| Number of Participants With an Ultrasound at 18-22 Weeks | Number of participants with an ultrasound (anatomy scan) at 18-22 weeks. | 18-22 weeks gestation during index pregnancy. Assessed at index birth using Medicaid claims. |
| Number of Participants Who Received Prenatal Screens | Our original prenatal screening outcome variable included the obstetric panel: Rhesus-D (DRh), red blood cell (RBC) antibody screen, complete blood count (CBC), urine culture, urinalysis; sexually transmitted infection (STI) screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25); Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers. | At index birth; Medicaid claims |
| Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks) | Received a glucose screen at 24-28 weeks' gestation. Note: Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers. | At 24-28 weeks' gestation of index pregnancy; Medicaid claims |
| Number of Participants With a Tdap Vaccination (27-36 Weeks) | Received Tdap vaccination at 27-36 weeks' gestation. Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers. | At 27-36 weeks' gestation of index pregnancy; Medicaid claims |
| Number of Participants With a Group B Streptococcus Test (35-37 Weeks) | Received Group B streptococcus test at 35-37 weeks' gestation. Note: Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers. | At 35-37 weeks' gestation of index pregnancy; Medicaid claims |
| Number of Participants With a Mental Health Diagnosis or Outpatient Treatment | Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit | During index pregnancy or 60 days postpartum; Medicaid claims |
| Number of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction | Number of participants with a diagnosis of depression/anxiety/stress reaction. | During index pregnancy or 60 days postpartum; Medicaid claims |
| Number of Participants With an Antidepressant Prescription | Number of participants with an antidepressant prescription. | During index pregnancy or 60 days postpartum; Medicaid claims |
| Number of Participants With an Outpatient Mental Health Visit | Number of participants with at least one outpatient mental health visit. | During index pregnancy or 60 days postpartum; Medicaid claims |
| Number of Participants With a Mental Health Treatment Follow up | Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation ("acute phase") | Within 120 days of treatment initiation; Medicaid claims |
| Number of Participants With a Mental Health Related Emergency/Inpatient Visit | Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction | During index pregnancy or 12 months postpartum; Hospital discharge |
| Number of Mental Health Related Emergency/Inpatient Visits | Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction | During index pregnancy or 12 months postpartum; Hospital discharge |
| Number of Participants Whose Child Experienced a Major Injury | Health care encounter or mortality associated with ICD codes indicating major injury | Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records |
| Number of Participants Whose Child Experienced Concern for Abuse or Neglect | Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect | Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records |
| Number of Injuries | Number of injuries for child | Within 24 months after index birth; hospital discharge |
| Number of Participants Whose Child Had an Emergency Department Visit | Number of participants whose child had at least one visit to the emergency department. | Within 24 months after index birth; hospital discharge |
| Number of Child Emergency Department Visits | Total number of child visits to the emergency department (without admission) | Within 24 months after index birth; hospital discharge |
| Number of Participants Experiencing Child Mortality | All-cause child mortality in first 24 months of life | Within 24 months after index birth; Mortality records |
| Number of Participants With Recommended Number of Well-child Visits | Number of participants that received the recommended number of well-child visits. | At 15 months after index birth; Medicaid claims |
| Number of Participants With Lead Screening | Number of participants whose child received at least one lead screening. | At 15 months after index birth; Medicaid claims |
| Number of Participants With Developmental Screening | Number of participants whose child received at least one developmental screening. | At 12 months after index birth; Medicaid claims |
| Number of Participants With a Dental Visit | Child receives a dental screen at least once in first 24 months | Within 24 months after index birth; Medicaid claims and dental records |
| Number of Participants With Fluoride Treatment | Share with recommended fluoride treatments received by child | Within 24 months after index birth; Medicaid claims and dental records |
| Number of Participants With an Inter-birth Interval of < 24 Months | Having a subsequent birth within the first 24 months of the index birth | Within 24 months after index birth; vital records |
| Number of Participants With an Inter-birth Interval of < 15 Months | Having a subsequent birth within the first 15 months of the index birth | Within 15 months after index birth; vital records |
| Inter-birth Interval | Continuous measure of inter-birth interval | 60 months after index birth; vital records |
| Number of Participants With a Family Planning Visit (6 Weeks) | Number of participants who received any family planning-related counseling or service. | Within 6 weeks after index birth; Medicaid claims, hospital discharge |
| Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks) | Received implant, immediate postpartum long-acting reversible contraception (IPP-LARC), long-acting reversible contraception (LARC), or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills | Within 6 weeks after index birth; Medicaid claims, hospital discharge |
| Number of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks) | Number of participants who received immediate postpartum long-acting reversible contraception in first 6 weeks postpartum. | Within 6 weeks after index birth; Medicaid claims, hospital discharge |
| Number of Participants With a Family Planning Visit (1 Year) | Number of participants who received any family planning-related counseling or service in the first year postpartum. | Within 12 months after index birth; Medicaid claims, hospital discharge |
| Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year) | Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills | Within 12 months after index birth; Medicaid claims, hospital discharge |
| Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year) | Number of participants who received a postpartum intrauterine device insertion in first 12 months postpartum. | Within 12 months after index birth; Medicaid claims, hospital discharge |
| Time to First Take-up of Family Planning Counseling or Service | Months from pregnancy to first take up of family planning counseling or service | Within 24 months after index birth; Medicaid claims, hospital discharge |
| Time to First Take-up of Highly Effective Contraceptive Method | Months from discharge to first take up of highly effective contraceptive method (include implant, IPP-LARC, LARC, or sterilization) | Within 24 months after index birth; Medicaid claims, hospital discharge |
| Number of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits | Number of participants who received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits during pregnancy. | During index pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively |
| Number of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits | Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families | Within 24 months after index birth; South Carolina Department of Social Services data |
| Number of Participants With SNAP or TANF Benefit Churn | Receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families at any time during a given year and having experienced at least one break in participation of four months or less that started and/or ended during the year | Within 24 months after index birth; South Carolina Department of Social Services data |
| Charleston |
| South Carolina |
| 29405 |
| United States |
| Nurse-Family Partnership of Lexington-Richland Co. | Columbia | South Carolina | 29204 | United States |
| Nurse-Family Partnership of Horry County | Conway | South Carolina | 29526 | United States |
| McLeod Health NFP | Florence | South Carolina | 29506 | United States |
| Nurse-Family Partnership of Greenville County | Greenville | South Carolina | 29605 | United States |
| Carolina Health Centers NFP | Greenwood | South Carolina | 29646 | United States |
| Family Solutions of the Lowcountry NFP | Orangeburg | South Carolina | 29118 | United States |
| Spartanburg Regional Hospital NFP | Spartanburg | South Carolina | 29303 | United States |
| 39714843 | Derived | Rokicki S, Oviedo D, Perreault N, Zera C, McGregor AJ, Bates MA, Zhou RA, Baicker K, McConnell MA. Home Visits and the Use of Routine and Emergency Postpartum Care Among Low-Income People: A Secondary Analysis of a Randomized Clinical Trial. JAMA Netw Open. 2024 Dec 2;7(12):e2451605. doi: 10.1001/jamanetworkopen.2024.51605. |
| 39671266 | Derived | Steenland MW, Oviedo D, Bates MA, Zhou A, Zera C, Baicker K, McConnell MA. Effect of an Intensive Nurse Home Visiting Program on Postpartum Contraceptive Use and Birth Spacing: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jan 1;145(1):3-12. doi: 10.1097/AOG.0000000000005786. Epub 2024 Nov 14. |
| 35788794 | Derived | McConnell MA, Rokicki S, Ayers S, Allouch F, Perreault N, Gourevitch RA, Martin MW, Zhou RA, Zera C, Hacker MR, Chien A, Bates MA, Baicker K. Effect of an Intensive Nurse Home Visiting Program on Adverse Birth Outcomes in a Medicaid-Eligible Population: A Randomized Clinical Trial. JAMA. 2022 Jul 5;328(1):27-37. doi: 10.1001/jama.2022.9703. |
| 33276816 | Derived | McConnell MA, Zhou RA, Martin MW, Gourevitch RA, Steenland M, Bates MA, Zera C, Hacker M, Chien A, Baicker K. Protocol for a randomized controlled trial evaluating the impact of the Nurse-Family Partnership's home visiting program in South Carolina on maternal and child health outcomes. Trials. 2020 Dec 4;21(1):997. doi: 10.1186/s13063-020-04916-9. |
| BG001 |
| Control |
Control group members have access to the standard of care and whatever other programs and services are available in the community. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Row population differs due to missing/non-reported values. | Count of Participants | Participants | No |
|
| Region of Enrollment | Number | participants |
|
| Highest education level | Row population differs due to missing/non-reported values. | Count of Participants | Participants |
|
| Economic conditions at time of enrollment | Row population differs due to missing/non-reported values. | Count of Participants | Participants | No |
|
| Received mental health treatment in last year | Row population differs due to missing/non-reported values. | Count of Participants | Participants | No |
|
| High stress | Defined as a Perceived Stress Scale 4 (PSS-4) score ≥ 4. Based on the total score, which ranges from 0-16, with higher values indicating more severe stress. | Row population differs due to missing/non-reported values. | Count of Participants | Participants |
|
| Depressive symptoms | Defined as a Patient Health Questionnaire-2 score ≥ 3. Based on the total score, which ranges from 0-6, with higher values indicating more severe symptoms of depression. | Row population differs due to missing/non-reported values. | Count of Participants | Participants |
|
| OG001 | Control | Control group members have access to the standard of care and whatever other programs and services are available in the community. |
|
|
|
| Primary | Number of Participants Whose Child Experienced a Major Injury or Concern for Abuse or Neglect | Composite of at least one health care encounter or mortality associated with International Classification of Diseases (ICD) codes indicating either major injury, or, concern for abuse or neglect for the participant's index child(ren). | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | within 24 months after index birth; Medicaid claims or hospital discharge data |
|
|
|
|
| Primary | Number of Participants With an Inter-birth Interval of < 21 Months | Having a subsequent birth within the first 21 months of the index birth | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | within 21 months after index birth; vital records |
|
|
|
|
| Secondary | Number of Participants With an Infant Born Small for Gestational Age (SGA) | Infant birth weight below the 10th percentile for infants of the same gestational age | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth; vital records |
|
|
|
|
| Secondary | Number of Participants With an Infant Born Large for Gestational Age (LGA) | Infant birth weight above the 90th percentile for infants of the same gestational age | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth birth; vital records |
|
|
|
|
| Secondary | Number of Participants With an Infant Born With Low Birth Weight (LBW) | Number of participants with an infant born with a birth weight of less than 2500 grams. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth; vital records |
|
|
|
|
| Secondary | Number of Participants With an Infant With Very Low Birth Weight | Number of participants with an infant born with a birth weight of less than 1500 grams. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth; vital records |
|
|
|
|
| Secondary | Birth Weight (Continuous) | A continuous measure of infant birth weight (grams) | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Mean | Standard Deviation | grams | At index birth; vital records |
|
|
|
|
| Secondary | Number of Participants With a Preterm Birth | Infant born before 37 weeks' gestation (obstetric estimate) | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth; vital records |
|
|
|
|
| Secondary | Number of Participants With an Extremely Preterm Birth | Number of participants with an infant born before 28 weeks' gestation. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth; vital records |
|
|
|
|
| Secondary | Gestational Age at Birth | Gestational age at birth in weeks (continuous) | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Mean | Standard Deviation | weeks | At index birth; vital records |
|
|
|
|
| Secondary | Number of Participants Experiencing Perinatal Mortality | Fetal death at or after 20 weeks of gestation or mortality in the first 7 days of life | Differs from randomized sample as it excludes participants who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 1 week after index birth; mortality records and fetal death records |
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| Secondary | Number of Participants With a NICU Admission of at Least Overnight | Infant admitted to the neonatal intensive care unit (NICU) for at least one night | Differs from randomized sample as it excludes participants with missing outcome data, those who experienced an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth; hospital discharge |
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| Secondary | Number of Participants Experiencing Neonatal Morbidity | Assisted ventilation immediately after delivery, assisted ventilation for more than six hours, seizure, receipt of surfactant replacement therapy, and receipt of antibiotics for suspected sepsis. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth; hospital discharge |
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| Secondary | Number of Participants Experiencing Cesarean Delivery | Number of participants experiencing a cesarean delivery for their index birth. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth; vital records |
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| Secondary | Number of Participants Experiencing Severe Acute Maternal Morbidity | Severe acute maternal morbidity as defined by the Centers for Disease Control and Prevention (CDC). | The analysis population for this outcome includes participants who matched to an index birth in claims data. | Posted | Count of Participants | Participants | At index birth; hospital discharge |
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| Secondary | Number of Participants Experiencing Maternal Mortality | Number of participants experiencing all-cause mortality within one year postpartum. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within one year after index birth; mortality records |
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| Secondary | Number of Participants Experiencing Neonatal Abstinence Disorder (NAS) or Maternal Drug/Substance Abuse | Number of participants experiencing neonatal abstinence disorder (NAS) or maternal drug/substance abuse in the first two years postpartum. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within two years after index birth; Medicaid claims, hospital discharge |
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| Secondary | Number of Participants Experiencing Violence or Homicide | Includes any ICD code for healthcare encounter associated with experiencing violence or mortality associated with homicide based on ICD code | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 2 years after index birth; Medicaid claims, mortality records |
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| Secondary | Number of Participants With a Postpartum Visit | Number of participants with a postpartum visit in first 12 weeks after an index birth. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 12 weeks after index birth; Medicaid claims |
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| Secondary | Number of Participants Who Received Adequate Prenatal Care | With adequacy defined using the Adequacy of Prenatal Care Utilization Index (APNCU), where prenatal care began by the 4th month and at least 80% of recommended visits were attended | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth; vital records |
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| Secondary | Number of Emergency Department Visits During Pregnancy | Number of emergency department visits during pregnancy. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Mean | Standard Deviation | number of visits | At index birth; hospital discharge |
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| Secondary | Number of Participants With a Dental Visit During Pregnancy | Number of participants with a dental visit during pregnancy (preventive or treatment). | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At index birth; Medicaid claims and dental records |
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| Secondary | Number of Participants With an Ultrasound at 18-22 Weeks | Number of participants with an ultrasound (anatomy scan) at 18-22 weeks. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | 18-22 weeks gestation during index pregnancy. Assessed at index birth using Medicaid claims. |
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| Secondary | Number of Participants Who Received Prenatal Screens | Our original prenatal screening outcome variable included the obstetric panel: Rhesus-D (DRh), red blood cell (RBC) antibody screen, complete blood count (CBC), urine culture, urinalysis; sexually transmitted infection (STI) screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25); Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers. | Not Posted | At index birth; Medicaid claims | Participants |
| Secondary | Number of Participants Who Received a Gestational Diabetes Test (24-28 Weeks) | Received a glucose screen at 24-28 weeks' gestation. Note: Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At 24-28 weeks' gestation of index pregnancy; Medicaid claims |
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| Secondary | Number of Participants With a Tdap Vaccination (27-36 Weeks) | Received Tdap vaccination at 27-36 weeks' gestation. Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At 27-36 weeks' gestation of index pregnancy; Medicaid claims |
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| Secondary | Number of Participants With a Group B Streptococcus Test (35-37 Weeks) | Received Group B streptococcus test at 35-37 weeks' gestation. Note: Our original prenatal screening outcome variable included the obstetric panel (D [Rh], RBC antibody screen, CBC, urine culture, urinalysis), STI screenings (HIV, syphilis, hepatitis B, chlamydia if <25, gonorrhea if <25), Group B strep screening, and glucose screening. However, since most participants had already completed their first prenatal visit prior to enrolling in the trial (when many of these tests are performed), it was not appropriate to include first-visit tests as outcomes. We therefore modified the outcome to instead use three clinically relevant measures that could occur after enrollment: glucose screening, Group B strep screening, and Tdap vaccination. These outcomes are reported as they appear in the published papers. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At 35-37 weeks' gestation of index pregnancy; Medicaid claims |
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| Secondary | Number of Participants With a Mental Health Diagnosis or Outpatient Treatment | Diagnosis for depression/anxiety/stress reaction or antidepressant prescription or outpatient mental health visit | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | During index pregnancy or 60 days postpartum; Medicaid claims |
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| Secondary | Number of Participants With a Diagnosis of Depression/Anxiety/Stress Reaction | Number of participants with a diagnosis of depression/anxiety/stress reaction. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | During index pregnancy or 60 days postpartum; Medicaid claims |
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| Secondary | Number of Participants With an Antidepressant Prescription | Number of participants with an antidepressant prescription. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | During index pregnancy or 60 days postpartum; Medicaid claims |
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| Secondary | Number of Participants With an Outpatient Mental Health Visit | Number of participants with at least one outpatient mental health visit. | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | During index pregnancy or 60 days postpartum; Medicaid claims |
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| Secondary | Number of Participants With a Mental Health Treatment Follow up | Second antidepressant prescription or outpatient mental health visit within 120 days of treatment initiation ("acute phase") | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 120 days of treatment initiation; Medicaid claims |
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| Secondary | Number of Participants With a Mental Health Related Emergency/Inpatient Visit | Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | During index pregnancy or 12 months postpartum; Hospital discharge |
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| Secondary | Number of Mental Health Related Emergency/Inpatient Visits | Based on all-listed diagnoses (i.e. primary or secondary) for depression/anxiety/stress reaction | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Mean | Standard Deviation | number of visits | During index pregnancy or 12 months postpartum; Hospital discharge |
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| Secondary | Number of Participants Whose Child Experienced a Major Injury | Health care encounter or mortality associated with ICD codes indicating major injury | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records |
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| Secondary | Number of Participants Whose Child Experienced Concern for Abuse or Neglect | Health care encounter or mortality associated with ICD codes indicating concern for abuse or neglect | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 24 months after index birth; Medicaid claims, hospital discharge, mortality records |
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| Secondary | Number of Injuries | Number of injuries for child | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Mean | Standard Deviation | number of injuries | Within 24 months after index birth; hospital discharge |
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| Secondary | Number of Participants Whose Child Had an Emergency Department Visit | Number of participants whose child had at least one visit to the emergency department. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 24 months after index birth; hospital discharge |
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| Secondary | Number of Child Emergency Department Visits | Total number of child visits to the emergency department (without admission) | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Mean | Standard Deviation | number of visits | Within 24 months after index birth; hospital discharge |
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| Secondary | Number of Participants Experiencing Child Mortality | All-cause child mortality in first 24 months of life | Differs from randomized sample as it excludes participants who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 24 months after index birth; Mortality records |
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| Secondary | Number of Participants With Recommended Number of Well-child Visits | Number of participants that received the recommended number of well-child visits. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At 15 months after index birth; Medicaid claims |
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| Secondary | Number of Participants With Lead Screening | Number of participants whose child received at least one lead screening. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At 15 months after index birth; Medicaid claims |
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| Secondary | Number of Participants With Developmental Screening | Number of participants whose child received at least one developmental screening. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | At 12 months after index birth; Medicaid claims |
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| Secondary | Number of Participants With a Dental Visit | Child receives a dental screen at least once in first 24 months | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 24 months after index birth; Medicaid claims and dental records |
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| Secondary | Number of Participants With Fluoride Treatment | Share with recommended fluoride treatments received by child | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 24 months after index birth; Medicaid claims and dental records |
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| Secondary | Number of Participants With an Inter-birth Interval of < 24 Months | Having a subsequent birth within the first 24 months of the index birth | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 24 months after index birth; vital records |
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| Secondary | Number of Participants With an Inter-birth Interval of < 15 Months | Having a subsequent birth within the first 15 months of the index birth | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 15 months after index birth; vital records |
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| Secondary | Inter-birth Interval | Continuous measure of inter-birth interval | Not Posted | Jun 2027 | 60 months after index birth; vital records | Participants |
| Secondary | Number of Participants With a Family Planning Visit (6 Weeks) | Number of participants who received any family planning-related counseling or service. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 6 weeks after index birth; Medicaid claims, hospital discharge |
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| Secondary | Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (6 Weeks) | Received implant, immediate postpartum long-acting reversible contraception (IPP-LARC), long-acting reversible contraception (LARC), or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 6 weeks after index birth; Medicaid claims, hospital discharge |
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| Secondary | Number of Participants Who Received Immediate Postpartum Long-acting Reversible Contraception (6 Weeks) | Number of participants who received immediate postpartum long-acting reversible contraception in first 6 weeks postpartum. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 6 weeks after index birth; Medicaid claims, hospital discharge |
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| Secondary | Number of Participants With a Family Planning Visit (1 Year) | Number of participants who received any family planning-related counseling or service in the first year postpartum. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 12 months after index birth; Medicaid claims, hospital discharge |
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| Secondary | Number of Participants Who Received a Highly or Moderately Effective Method of Contraception (1 Year) | Received implant, IPP-LARC, LARC, or sterilization and moderately effective contraception to include path, ring, diaphragm, injectables and contraceptive pills | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 12 months after index birth; Medicaid claims, hospital discharge |
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| Secondary | Number of Participants Who Received a Postpartum Intrauterine Device Insertion (1 Year) | Number of participants who received a postpartum intrauterine device insertion in first 12 months postpartum. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 12 months after index birth; Medicaid claims, hospital discharge |
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| Secondary | Time to First Take-up of Family Planning Counseling or Service | Months from pregnancy to first take up of family planning counseling or service | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Mean | Standard Error | months | Within 24 months after index birth; Medicaid claims, hospital discharge |
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| Secondary | Time to First Take-up of Highly Effective Contraceptive Method | Months from discharge to first take up of highly effective contraceptive method (include implant, IPP-LARC, LARC, or sterilization) | Differs from randomized sample as it excludes participants with missing outcome data, an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Mean | Standard Deviation | months | Within 24 months after index birth; Medicaid claims, hospital discharge |
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| Secondary | Number of Participants Who Received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) Benefits | Number of participants who received Supplemental Nutrition Assistance Program (SNAP) or Special Supplemental Nutrition Program for Women, Infants, and Children (WIC) benefits during pregnancy. | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | During index pregnancy, assessed up to 42 weeks; South Carolina Department of Social Services data and birth certificate data respectively |
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| Secondary | Number of Months Receiving SNAP or Temporary Assistance for Needy Families (TANF) Benefits | Total months receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Mean | Standard Deviation | number of months | Within 24 months after index birth; South Carolina Department of Social Services data |
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| Secondary | Number of Participants With SNAP or TANF Benefit Churn | Receiving Supplemental Nutrition Assistance Program or Temporary Assistance for Needy Families at any time during a given year and having experienced at least one break in participation of four months or less that started and/or ended during the year | Differs from randomized sample as it excludes participants with an index fetal death, who withdrew, who experienced a pregnancy loss, and who could not be matched to an index pregnancy. | Posted | Count of Participants | Participants | Within 24 months after index birth; South Carolina Department of Social Services data |
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| 5 |
| 3,319 |
| 0 |
| 3,319 |
| 0 |
| 3,319 |
| EG001 | Control | Control group members have access to the standard of care and whatever other programs and services are available in the community. | 2 | 1,647 | 0 | 1,647 | 0 | 1,647 |
Not provided
Not provided
| D000091642 | Urogenital Diseases |
| More than once race reported, non-Hispanic |
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| Non-Hispanic Black |
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| Non-Hispanic White |
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| Some college, less than bachelor's degree |
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| Bachelor's degree or higher |
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