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| ID | Type | Description | Link |
|---|---|---|---|
| R01HD098186 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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The purpose of this randomized controlled trial is to examine the impact of a remotely-delivered antenatal milk expression (AME) intervention versus an attention control condition on breastfeeding outcomes among a sample of 280 nulliparous, non-diabetic women with pre-pregnancy body mass indices ≥ 25. AME involves milk expression and collection in the third pregnancy trimester and is theorized to address multiple barriers to breastfeeding among women with higher BMI, including impaired breastfeeding self-efficacy, insufficient milk supply (critical period endocrine modulation of milk volume), and early formula supplementation in the context of a medically complex birth (availability of banked antenatal milk).
Participants will be enrolled in their third trimester of pregnancy and allocated into one of two study arms: 1) AME instruction delivered by remote, live International Board Certified Lactation Consultants via an innovative app-based telelactation platform; or 2) an attention control condition (video-based infant care education unrelated to infant feeding). Video-based education for both groups will occur in weekly study visits from 37 to 40 weeks gestation, with women in the intervention group continuing AME 1-2 times per day at home.
Measured outcomes of interest will include short and long-term breastfeeding practices (e.g., breastfeeding duration, exclusivity) and participants' experiences with and perceptions of AME.
The purpose of the PREPARE Trial is to examine the impact of an antenatal milk expression (AME) intervention among women with pre-pregnancy BMI 25 or more on breastfeeding outcomes, including breastfeeding self-efficacy, breastfeeding duration and exclusivity, and perception of insufficient milk supply. Specifically, the investigators will:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Antenatal Milk Expression (AME) Intervention Group | Experimental | Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk. |
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| Video-based Infant Care Education Control Group | Active Comparator | Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AME | Behavioral | Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Breastfeeding Exclusivity | Whether participant is feeding 100% breast milk at 2 weeks postpartum | 2 weeks postpartum |
| Breastfeeding Self-efficacy | Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome) | 2 weeks postpartum |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization | This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). |
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Inclusion Criteria:
Pregnant women who:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jill Demirci, PhD | University of Pittsburgh | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15213 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36927811 | Derived | Demirci JR, Glasser M, Bogen DL, Sereika SM, Ren D, Ray K, Bodnar LM, O'Sullivan TA, Himes K. Effect of antenatal milk expression education on lactation outcomes in birthing people with pre-pregnancy body mass index >/=25: protocol for a randomized, controlled trial. Int Breastfeed J. 2023 Mar 16;18(1):16. doi: 10.1186/s13006-023-00552-6. |
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Raw (subject level) and/or aggregate data will be shared with other investigators as requested after: 1) publication of main findings; 2) removal of identifiers that would permit linkages to individual research participants; and 3) removal of variables that could lead to deductive disclosure of the identity of individuals. Any individual requests for data sharing will be executed in collaboration with the University of Pittsburgh Institutional Review Board to ensure strict adherence to policies for protections of human subjects. In addition, at the conclusion of the study, de-identified data will be submitted to the National Institute of Child Health and Development (NICHD) Data Repository to ensure public availability.
At the conclusion of the study, after publication of main findings.
Contact study investigator or NICHD for access to data repository.
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Of 539 participants assessed for eligibility, 280 met eligibility criteria, agreed to participate, and were randomized to an interventionist group.
Participants were enrolled between September 23, 2020 and October 23, 2023. Recruitment occurred via electronic health record scans of prenatal practices involved in the study for patients who met basic eligibility criteria, who then received study advertisements, health system portal messages, and/or approaches by study staff at a prenatal visit. Other recruitment strategies included social media ads, a university research registry, study flyers at clinical sites, and magazine advertisements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Antenatal Milk Expression (AME) Intervention Group | Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk. AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video. |
| FG001 | Video-based Infant Care Education Control Group | Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.). Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Measures with numbers analyzed less than the overall baseline numbers include all participants with data collected.
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| ID | Title | Description |
|---|---|---|
| BG000 | Antenatal Milk Expression (AME) Intervention Group | Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk. AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Breastfeeding Exclusivity | Whether participant is feeding 100% breast milk at 2 weeks postpartum | Only includes participants with breastfeeding data available at 2 weeks postpartum (i.e., participants who completed breastfeeding survey item(s) at 2 weeks); note that some participants do not have 2 week breastfeeding data or 2 week survey data, but went on to complete the study by completing subsequent study timepoints | Posted | Count of Participants | Participants | 2 weeks postpartum |
|
From study enrollment at 34-36 weeks of gestation until conclusion of the intervention and conclusion of primary aims data collection at 2 weeks postpartum. Please note that no adverse events were measured after the 2 week postpartum timepoint.
The unit of measurement here is the maternal participant, where a fetal adverse event was noted, it will be included under the maternal participant.
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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 | Antenatal Milk Expression (AME) Intervention Group | Weekly video interactions (weeks 37-40 of pregnancy) with International Board Certified Lactation Consultants (IBCLCs) to teach and reinforce antenatal milk expression. At-home practice of hand expression and collection of any expressed milk. AME: Participants receive education on AME and feedback on technique with a remotely-based IBCLC via live streaming video. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Pre-eclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Oversupply at 2 weeks postpartum | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 4 participants (2 from each group) were withdrawn prior to the 2 week survey, either by self (n=1) or by staff (n=3) and thus were not followed to the 2 week timepoint |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jill Demirci | University of Pittsburgh | 412-648-9236 | JVR5@pitt.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Apr 27, 2023 | Feb 21, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 21, 2024 | Feb 21, 2025 | ICF_002.pdf |
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| ID | Term |
|---|---|
| D001942 | Breast Feeding |
| ID | Term |
|---|---|
| D005247 | Feeding Behavior |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| C017501 | methylamphotericin B |
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Statistician completing final analysis of data will be blinded to group assignment. An unbiased, third party will conduct qualitative interviews.
Participants, obstetric providers in recruitment clinics, and lactation consultant interventionists will be blinded to outcomes of interest.
| Video-based infant care education | Behavioral | Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding. |
|
| Postpartum hospitalization (0-4 days postpartum) |
| Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum | This variable derived from participant self-report survey emailed at 2 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). | 2 weeks postpartum |
| Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum | This variable derived from participant self-report survey emailed at 6 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). | 6 weeks postpartum |
| Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum | This variable derived from participant self-report survey emailed at 12 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). | 12 weeks postpartum |
| Number of Participants Exclusively Breastfeeding at 6 Months Postpartum | This variable derived from participant self-report survey emailed at 6 months postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). | 6 months postpartum |
| Breastfeeding Exclusivity (Categorical) | Categorical outcome indicating proportional range of breast milk feeds during postpartum/birth hospitalization (0-4 days postpartum) | 0-4 days postpartum |
| Breastfeeding Exclusivity (Categorical) | Categorical outcome indicating proportional range of breast milk feeds since infant was born | 2 weeks |
| Breastfeeding Exclusivity (Categorical) | Categorical outcome indicating proportional range of breast milk feeds in past week | 6 weeks postpartum |
| Breastfeeding Exclusivity (Categorical) | Categorical outcome indicating proportional range of breast milk feeds in past week | 12 weeks postpartum |
| Breastfeeding Exclusivity (Categorical) | Categorical outcome indicating proportional range of breast milk feeds in past week | 6 months postpartum |
| Breastfeeding Self-efficacy | Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome) | 6 weeks postpartrum |
| Breastfeeding Self-efficacy | Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome) | 12 weeks postpartum |
| Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum) | This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | Postpartum hospitalization (0-4 days postpartum) |
| Number of Participants Breastfeeding at 2 Weeks Postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | 2 weeks postpartum |
| Number of Participants Breastfeeding at 6 Weeks Postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | 6 weeks postpartum |
| Number of Participants Breastfeeding at 12 Weeks Postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | 12 weeks postpartum |
| Number of Participants Breastfeeding at 6 Months Postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | 6 months postpartum |
| Number of Participants Breastfeeding at 12 Months Postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | 12 months postpartum |
| Onset of Lactogenesis II | Recall of lactogenesis II in post-birth days | 2 weeks postpartum |
| Perceived Milk Supply (Continuous) | Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome) | 2 weeks postpartum |
| Perceived Milk Supply (Continuous) | Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome) | 6 weeks postpartum |
| Perceived Milk Supply (Continuous) | Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome) | 12 weeks postpartum |
| Perceived Milk Supply (Dichotomous) | Endorsement of insufficient milk supply via investigator created item (dichotomous outcome) | 2 weeks postpartum |
| Perceived Milk Supply (Dichotomous) | Endorsement of insufficient milk supply via investigator created item (dichotomous outcome) | 6 weeks postpartum |
| Perceived Milk Supply (Dichotomous) | Endorsement of insufficient milk supply via investigator created item (dichotomous outcome) | 12 weeks postpartum |
| Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period | A subset of participants took place in a qualitative assessment via semi-structured interview. Numbers below represent the number of participants who endorsed each of the following categories during their interview: 1) discussing the impact of the study on their pregnancy/postpartum experience, 2) integration of AME into their daily life, and 3) utilization of antenatal milk during the postpartum period | 6 weeks postpartum |
| Fetal demise |
|
| Protocol Violation |
|
| BG001 | Video-based Infant Care Education Control Group | Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.). Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Ethnicity assessed at baseline with n=279 participants' data available | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race assessed at baseline with n=279 participants' data available | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Married | Marital status assessed at baseline with n=279 participants' data available | Count of Participants | Participants |
|
| Education level | Education level assessed at baseline with n=279 participants' data available | Count of Participants | Participants |
|
| Employed at enrollment | Employment status at enrollment assessed at baseline with n=279 participants' data available | Count of Participants | Participants |
|
| Special Supplemental Program for Women, Infants, and Children (WIC) recipient | WIC status assessed at baseline with n=279 participants' data available | Count of Participants | Participants |
|
| Infant Feeding Intentions Scale Score at enrollment | Only items 3-5 included from Infant Feeding Intentions (IFI) Scale, as items 1-2 part of study eligibility (score range 0-12, with higher score indicative of stronger intention to exclusively breastfeed up to 6 months postpartum) | Scale administered at baseline with n=276 participants' data available | Mean | Standard Deviation | units on a scale |
|
| Breastfeeding Self-Efficacy Scale (Short Form) Score Baseline | Score range 14-70, with higher scores indicative of higher breastfeeding self-efficacy | Scale administered at baseline with n=276 participants' data available | Mean | Standard Deviation | units on a scale |
|
| Iowa Infant Feeding Attitude Scale | Score range 17-85, with higher scores indicative of more positive breastfeeding attitude | Scale administered at baseline with n=276 participants' data available | Mean | Standard Deviation | units on a scale |
|
| Pre-pregnancy BMI | BMI at enrollment assessed at baseline with n=279 participants' data available | Count of Participants | Participants |
|
| Pre-pregnancy BMI (Continuous) | BMI at enrollment assessed at baseline with n=279 participants' data available | Mean | Standard Deviation | lbs/in^2 |
|
| OG001 | Video-based Infant Care Education Control Group | Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.). Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding. |
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| Primary | Breastfeeding Self-efficacy | Score on Breastfeeding Self-Efficacy Scale-SF (score range 14-70, with higher score represents better outcome) | Please note that this indicates the number of participants who completed the BSES-SF in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experiences. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks postpartum |
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| Secondary | Number of Participants Exclusively Breastfeeding During Postpartum Hospitalization | This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff). | Posted | Count of Participants | Participants | Postpartum hospitalization (0-4 days postpartum) |
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| Secondary | Number of Participants Exclusively Breastfeeding at 2 Weeks Postpartum | This variable derived from participant self-report survey emailed at 2 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint. | Posted | Count of Participants | Participants | 2 weeks postpartum |
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| Secondary | Number of Participants Exclusively Breastfeeding at 6 Weeks Postpartum | This variable derived from participant self-report survey emailed at 6 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 6 weeks postpartum |
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| Secondary | Number of Participants Exclusively Breastfeeding at 12 Weeks Postpartum | This variable derived from participant self-report survey emailed at 12 weeks postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 12 weeks postpartum |
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| Secondary | Number of Participants Exclusively Breastfeeding at 6 Months Postpartum | This variable derived from participant self-report survey emailed at 6 months postpartum. Responses for Breastfeeding Exclusivity were categorized as YES if the infant had been fed only their mother's own breast milk. Responses were categorized as NO if they had received anything other than only their mother's own breast milk (e.g., formula + their own milk, formula only). | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 6 months postpartum |
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| Secondary | Breastfeeding Exclusivity (Categorical) | Categorical outcome indicating proportional range of breast milk feeds during postpartum/birth hospitalization (0-4 days postpartum) | Data not collected from the EHR for the study due to reliability concerns | Posted | 0-4 days postpartum |
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| Secondary | Breastfeeding Exclusivity (Categorical) | Categorical outcome indicating proportional range of breast milk feeds since infant was born | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint. | Posted | Count of Participants | Participants | 2 weeks |
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| Secondary | Breastfeeding Exclusivity (Categorical) | Categorical outcome indicating proportional range of breast milk feeds in past week | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 6 weeks postpartum |
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| Secondary | Breastfeeding Exclusivity (Categorical) | Categorical outcome indicating proportional range of breast milk feeds in past week | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 12 weeks postpartum |
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| Secondary | Breastfeeding Exclusivity (Categorical) | Categorical outcome indicating proportional range of breast milk feeds in past week | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 6 months postpartum |
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| Secondary | Breastfeeding Self-efficacy | Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome) | Please note that this indicates the number of participants who completed the BSES-SF in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks postpartrum |
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| Secondary | Breastfeeding Self-efficacy | Scores on Breastfeeding Self-Efficacy Scale-SF(score range 14-70, with higher score represents better outcome) | Please note that this indicates the number of participants who completed the BSES-SF in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks postpartum |
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| Secondary | Number of Participants Breastfeeding at Postpartum Hospitalization (0-4 Days Postpartum) | This variable was derived from the infant's feeding documentation via Electronic Medical Record. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff). | Posted | Count of Participants | Participants | Postpartum hospitalization (0-4 days postpartum) |
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| Secondary | Number of Participants Breastfeeding at 2 Weeks Postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint. | Posted | Count of Participants | Participants | 2 weeks postpartum |
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| Secondary | Number of Participants Breastfeeding at 6 Weeks Postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 6 weeks postpartum |
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| Secondary | Number of Participants Breastfeeding at 12 Weeks Postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 12 weeks postpartum |
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| Secondary | Number of Participants Breastfeeding at 6 Months Postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 6 months postpartum |
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| Secondary | Number of Participants Breastfeeding at 12 Months Postpartum | Participants were asked what their infant was currently being fed. Responses were categorized as YES for Breastfeeding Duration if they answered that they were still feeding their own breast milk to their infant at each respective timepoint. Please note that responses were still classified as a YES if they were combination feeding (e.g., using their own breast milk along with formula, solids, etc.). Responses were categorized as NO if they had ceased to provide any of their own breast milk to their infant. | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 12 months postpartum |
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| Secondary | Onset of Lactogenesis II | Recall of lactogenesis II in post-birth days | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint. | Posted | Count of Participants | Participants | 2 weeks postpartum |
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| Secondary | Perceived Milk Supply (Continuous) | Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome) | Please note that this indicates the number of participants who completed the H&H Lactation Scale in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience. | Posted | Mean | Standard Deviation | score on a scale | 2 weeks postpartum |
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| Secondary | Perceived Milk Supply (Continuous) | Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome) | Please note that this indicates the number of participants who completed the H&H Lactation Scale in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience. | Posted | Mean | Standard Deviation | score on a scale | 6 weeks postpartum |
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| Secondary | Perceived Milk Supply (Continuous) | Score on PIBBS subscale of H & H Lactation Scale measuring perceived infant satisfaction with breast milk received (score range: 5-35, higher score is better outcome) | Please note that this indicates the number of participants who completed the H&H Lactation Scale in its entirety at this timepoint. Some participants may not have completed this portion of the survey due to 1) not completing a survey at this timepoint, or 2) reporting breastfeeding discontinuation at this timepoint, rendering this survey not applicable to their current experience. | Posted | Mean | Standard Deviation | score on a scale | 12 weeks postpartum |
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| Secondary | Perceived Milk Supply (Dichotomous) | Endorsement of insufficient milk supply via investigator created item (dichotomous outcome) | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint. | Posted | Count of Participants | Participants | 2 weeks postpartum |
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| Secondary | Perceived Milk Supply (Dichotomous) | Endorsement of insufficient milk supply via investigator created item (dichotomous outcome) | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 6 weeks postpartum |
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| Secondary | Perceived Milk Supply (Dichotomous) | Endorsement of insufficient milk supply via investigator created item (dichotomous outcome) | Please note that this indicates the number of participants who are represented here reflect only those who had still been active in the study at this point, exclusive of participants that had withdrawn (either by self or study staff) or did not complete a survey at this timepoint (either due to breastfeeding cessation at a prior timepoint or failure to complete the survey). | Posted | Count of Participants | Participants | 12 weeks postpartum |
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| Secondary | Number of Participants Commenting on the Impact/Integration of AME During Pregnancy and Utilization of Antenatally Collected Milk During the Postpartum Period | A subset of participants took place in a qualitative assessment via semi-structured interview. Numbers below represent the number of participants who endorsed each of the following categories during their interview: 1) discussing the impact of the study on their pregnancy/postpartum experience, 2) integration of AME into their daily life, and 3) utilization of antenatal milk during the postpartum period | Please note that this indicates the number of participants who were invited, agreed to participate, and completed a qualitative interview at 6 weeks postpartum. | Posted | Count of Participants | Participants | 6 weeks postpartum |
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|
|
| 0 |
| 139 |
| 71 |
| 139 |
| 113 |
| 139 |
| EG001 | Video-based Infant Care Education Control Group | Weekly video education (weeks 37-40 of pregnancy) on various topics related to infant care (e.g., safe sleep, car seat safety, etc.). Video-based infant care education: Participants view a standard set of web-based streamed videos addressing evidence-based infant care, unrelated to feeding/breastfeeding. | 0 | 139 | 66 | 139 | 74 | 139 |
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| Fetal distress as indication for delivery via caesarean section | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
|
| Fetal demise | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
|
| NICU admission during postpartum hospitalization | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
|
| Hyperbilirubinemia requiring phototherapy | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
|
| Reduced fetal movement during/after AME in past week | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 1 AME group participant was withdrawn by study staff after enrollment due to exclusion criteria upon EHR review. This adverse event was only collected in the AME Intervention Group since IC group participants did not receive AME |
|
| Rupture of membranes during AME | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 1 AME group participant was withdrawn by study staff after enrollment due to exclusion criteria upon EHR review. This adverse event was only collected in the AME Intervention Group since IC group participants did not receive AME |
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| Gestational hypertension | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Polyhydramnios | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Oligohydramnios | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Iron transfusion required during postpartum hospitalization | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Partial placental abruption | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Postpartum hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Infant participant requiring resuscitation beyond SDS after delivery | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Infant with hyperbilirubinemia requiring monitoring only | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Infant with hypoglycemia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Infant with clavicle fracture | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Infant with NAS and prolonged hospitalization | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Infant with hip dysplasia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| In-patient hospitalization (unrelated to AME) | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Participant admitted to hospital due to motor vehicle accident; 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| IUGR | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Postpartum pre-E with SF | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 2 participants (1 from each the AME and infant care group) were withdrawn from the study by study staff immediately after enrollment due to exclusion criteria being met upon EHR review. |
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| Delivery prior to 39 weeks | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 4 participants (2 from each group) were withdrawn prior to 39 weeks gestation, either by self (n=1) or by staff (n=3) |
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| Lactogenesis II onset < 2 days or > 4 days postpartum or no onset | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Please note that 4 participants (2 from each group) were withdrawn prior to the 2 week survey, either by self (n=1) or by staff (n=3) and thus were not followed to the 2 week timepoint |
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| Participant reported emotional discomfort or anxiety with AME while on AME interventionist call | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME |
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| Participant reported hand fatigue/pain/discomfort with AME while on AME interventionist call | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME |
|
| Participant reported breast/nipple discomfort associated with AME while on AME interventionist call | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME |
|
| Participant reported breast or nipple pain or soreness via daily text diaries | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME |
|
| Participant reported hand fatigue/hand cramping via daily text message diaries | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME |
|
| Participant reported anxiety/uneasiness/embarrassment via daily text message diaries | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME |
|
| Participant reported cramping via daily text message diary | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME |
|
| Participant reported pelvic pain during daily text message diaries | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME |
|
| Participant reported lightheadedness/nausea during expression via daily text message diary | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME |
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| Participant reported no/little milk output via daily text message diaries | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | 2 AME participants were withdrawn prior to 37 week interventionist call, either by self or staff and received no intervention. These adverse events were only collected in the AME Intervention Group since IC group participants did not receive AME |
|
Not provided
Not provided
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Single or separated |
|
| Completed occupational or vocational program |
|
| Graduated from high school/GED |
|
| Master's or doctoral degree |
|
| Some college, no degree |
|
| Unknown |
|
| Yes, with reduced hours |
|
| Yes, with the same number of hours as before pregnancy |
|
| Unknown/unreported |
|
| Unreported/unknown |
|
| .1399 |
| 2-Sided |
| 95 |
| -2.5299 |
| 2.8098 |
| Superiority |
| 1.0763 |
| 2-Sided |
| 95 |
| .6364 |
| 1.8216 |
| Superiority |
| 1.0307 |
| 2-Sided |
| 95 |
| .603 |
| 1.7067 |
| Superiority |
| 75-99% breast milk |
|
| 100% breast milk |
|
| .8882 |
| 2-Sided |
| 95 |
| .5523 |
| 1.4283 |
| Superiority |
| 75-99% breast milk |
|
| 100% breast milk |
|
| .7157 |
| 2-Sided |
| 95 |
| .4206 |
| 1.2178 |
| Superiority |
| 75-99% breast milk |
|
| 100% breast milk |
|
| 1.1955 |
| 2-Sided |
| 95 |
| .8745 |
| 1.3931 |
| Superiority |
| 75-99% breast milk |
|
| 100% breast milk. |
|
| 1.0233 |
| 2-Sided |
| 95 |
| .7751 |
| 1.2084 |
| Superiority |
| .9508 |
| 2-Sided |
| 95 |
| .3669 |
| 2.4621 |
| Superiority |
| 3 days |
|
| 4 days |
|
| More than 4 days |
|
| Never |
|
| Utilization of milk collected antenatally |
|