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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01HD087119 | 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 |
| AMAG Pharmaceuticals, Inc. | INDUSTRY |
| Bill and Melinda Gates Foundation | OTHER |
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This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.
Weekly intramuscular injections of 250mg 17-alpha hydroxyprogesterone caproate (17P) or indistinguishable placebo will be randomly allocated in a 1:1 ratio started between 16-24 weeks gestation and administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner.
Individual participants will be followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 250 mg 17P | Active Comparator | weekly intramuscular injection of 250mg 17P |
|
| Placebo | Placebo Comparator | weekly intramuscular injection of indistinguishable placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 17P | Drug | Synthetic progestin |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Preterm Births or Stillbirths | A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age | At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Experiencing Preterm Birth <37 Weeks | Delivery prior to 37 gestational weeks | At delivery, up to 37 weeks of gestation |
| Number of Participants Experiencing Preterm Birth <34 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeff Stringer, MD, FACOG | University of North Carolina, Chapel Hill | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kamwala District Clinic | Lusaka | Zambia | ||||
| University Teaching Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34509197 | Derived | Price JT, Vwalika B, Freeman BL, Cole SR, Saha PT, Mbewe FM, Phiri WM, Peterson M, Muyangwa D, Sindano N, Mwape H, Smithmyer ME, Kasaro MP, Rouse DJ, Goldenberg RL, Chomba E, Stringer JSA. Weekly 17 alpha-hydroxyprogesterone caproate to prevent preterm birth among women living with HIV: a randomised, double-blind, placebo-controlled trial. Lancet HIV. 2021 Oct;8(10):e605-e613. doi: 10.1016/S2352-3018(21)00150-8. Epub 2021 Sep 9. | |
| 30813934 | Derived |
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| ID | Title | Description |
|---|---|---|
| FG000 | 250 mg 17P | The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin |
| FG001 | Placebo | The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Mothers: 250 mg 17P | Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | 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 Experiencing Preterm Births or Stillbirths | A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age | Participants who received at least one injection of study product | Posted | Count of Participants | Participants | At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths |
|
From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks
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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 | Mothers: 250 mg 17P | Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Abdominal Pain | General disorders | Systematic Assessment | Pain in the abdomen not necessarily associated with a specific diagnosis or etiology |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Product Issues | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Joan Price, MD, MPH | University of North Carolina at Chapel Hill | 919-962-4717 | joan_price@med.unc.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 | Mar 26, 2020 | Apr 9, 2021 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| D019326 | 17-alpha-Hydroxyprogesterone |
| ID | Term |
|---|---|
| D006908 | Hydroxyprogesterones |
| D011374 | Progesterone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
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Phase III, double-masked, placebo-controlled, randomized controlled trial
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| Placebo | Other | Non-active placebo comparator |
|
Delivery prior to 34 gestational weeks
| At delivery, up to 34 weeks of gestation |
| Number of Participants Experiencing Preterm Birth <28 Weeks | Delivery prior to 28 gestational weeks | At delivery, up to 28 weeks of gestation |
| Number of Participants Experiencing Stillbirth | Participants who had a fetus born without signs of life at any gestational age | At delivery, up to approximately 40 weeks of gestation |
| Number of Participants Experiencing Spontaneous Delivery <37 Weeks | Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention | At delivery, up to 37 weeks of gestation |
| Number of Participants Experiencing Spontaneous Delivery <34 Weeks | Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention | At delivery, up to 34 weeks of gestation |
| Number of Participants Experiencing Spontaneous Delivery <28 Weeks | Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention | At delivery, up to 28 weeks of gestation |
| Number of Infants With Birth Weight <10th Percentile for Gestational Age | Infant born with a weight below the 10th percentile for gestational age | Birth |
| Number of Infants With Birth Weight <3rd Percentile for Gestational Age | Infant born with a weight below the 3rd percentile for gestational age | Birth |
| Number of Infants Who Experienced Maternal-to-Child HIV Transmission | Confirmed HIV infection in an infant | At 6 weeks of life |
| Number of Neonatal Deaths | Death of an infant following live birth | Birth through 28 days postpartum |
| Number of Infants With 1-minute Apgar Score <7 | Apgar score of less than 7 at 1 minute of life. Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and is a quick test rated on a scale of 1-10 performed on a baby at one minute of life to determine how well the baby tolerated the birth process. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low. | 1 minute of life |
| Number of Infants With 5-minute Apgar Score <7 | Apgar score of less than 7 at 5 minutes of life. Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and is a quick test rated on a scale of 1-10 performed on a baby at five minutes of life to assess how well the baby is doing following delivery. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low. | 5 minutes of life |
| Lusaka |
| Zambia |
| Price JT, Vwalika B, Freeman BL, Cole SR, Mulenga HB, Winston J, Mbewe FM, Chomba E, Mofenson LM, Rouse DJ, Goldenberg RL, Stringer JSA. Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial. BMC Pregnancy Childbirth. 2019 Feb 27;19(1):81. doi: 10.1186/s12884-019-2224-8. |
| Lost to Follow-up |
|
| BG001 |
| Mothers: Placebo |
Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Placebo |
The study intervention started between 16-24 weeks gestation and was administered weekly thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever was sooner. Participants were followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator |
|
|
| Secondary | Number of Participants Experiencing Preterm Birth <37 Weeks | Delivery prior to 37 gestational weeks | Participants who received at least one injection of study product | Posted | Count of Participants | Participants | At delivery, up to 37 weeks of gestation |
|
|
|
| Secondary | Number of Participants Experiencing Preterm Birth <34 Weeks | Delivery prior to 34 gestational weeks | Participants who received at least one injection of study product | Posted | Count of Participants | Participants | At delivery, up to 34 weeks of gestation |
|
|
|
| Secondary | Number of Participants Experiencing Preterm Birth <28 Weeks | Delivery prior to 28 gestational weeks | Participants who received at least one injection of study product | Posted | Count of Participants | Participants | At delivery, up to 28 weeks of gestation |
|
|
|
| Secondary | Number of Participants Experiencing Stillbirth | Participants who had a fetus born without signs of life at any gestational age | Participants who received at least one injection of study product | Posted | Count of Participants | Participants | At delivery, up to approximately 40 weeks of gestation |
|
|
|
| Secondary | Number of Participants Experiencing Spontaneous Delivery <37 Weeks | Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention | Participants who received at least one injection of study product | Posted | Count of Participants | Participants | At delivery, up to 37 weeks of gestation |
|
|
|
| Secondary | Number of Participants Experiencing Spontaneous Delivery <34 Weeks | Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention | Participants who received at least one injection of study product | Posted | Count of Participants | Participants | At delivery, up to 34 weeks of gestation |
|
|
|
| Secondary | Number of Participants Experiencing Spontaneous Delivery <28 Weeks | Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention | Participants who received at least one injection of study product | Posted | Count of Participants | Participants | At delivery, up to 28 weeks of gestation |
|
|
|
| Secondary | Number of Infants With Birth Weight <10th Percentile for Gestational Age | Infant born with a weight below the 10th percentile for gestational age | Liveborn or stillborn infants weighed at birth | Posted | Count of Participants | Participants | Birth |
|
|
|
| Secondary | Number of Infants With Birth Weight <3rd Percentile for Gestational Age | Infant born with a weight below the 3rd percentile for gestational age | Live born or stillborn infants weighed at birth | Posted | Count of Participants | Participants | Birth |
|
|
|
| Secondary | Number of Infants Who Experienced Maternal-to-Child HIV Transmission | Confirmed HIV infection in an infant | Infants receiving a test for early infant diagnosis at approximately 6 weeks postpartum | Posted | Count of Participants | Participants | At 6 weeks of life |
|
|
|
| Secondary | Number of Neonatal Deaths | Death of an infant following live birth | Live born infants for whom follow-up information is available | Posted | Count of Participants | Participants | Birth through 28 days postpartum |
|
|
|
| Secondary | Number of Infants With 1-minute Apgar Score <7 | Apgar score of less than 7 at 1 minute of life. Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and is a quick test rated on a scale of 1-10 performed on a baby at one minute of life to determine how well the baby tolerated the birth process. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low. | Live born infants for whom an Apgar score was measured at 1 minute of life | Posted | Count of Participants | Participants | 1 minute of life |
|
|
|
| Secondary | Number of Infants With 5-minute Apgar Score <7 | Apgar score of less than 7 at 5 minutes of life. Apgar stands for "Appearance, Pulse, Grimace, Activity, and Respiration" and is a quick test rated on a scale of 1-10 performed on a baby at five minutes of life to assess how well the baby is doing following delivery. Scores 7 and above are generally normal, 4 to 6 fairly low, and 3 and below are generally regarded as critically low. | Live born infants for whom an Apgar score was measured at 5 minutes of life | Posted | Count of Participants | Participants | 5 minutes of life |
|
|
|
| 0 |
| 399 |
| 56 |
| 399 |
| 43 |
| 399 |
| EG001 | Mothers: Placebo | Mothers started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator | 1 | 401 | 55 | 401 | 27 | 401 |
| EG002 | Infants Born to Mothers Receiving 250 mg 17P | Infants born to mothers who started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. 17P: Synthetic progestin | 14 | 399 | 33 | 399 | 0 | 399 |
| EG003 | Infants Born to Mothers Receiving Placebo | Infants born to mothers who started study intervention between 16-24 weeks gestation and were administered weekly injections thereafter until 36 6/7 gestational weeks, stillbirth, or delivery, whichever is sooner. Participants followed from enrollment (prior to 24 weeks gestation) through 42 days postpartum. Placebo: Non-active placebo comparator | 7 | 401 | 22 | 401 | 0 | 401 |
|
| Anemia | Blood and lymphatic system disorders | Systematic Assessment | Low hemoglobin |
|
| Diabetes | Metabolism and nutrition disorders | Systematic Assessment |
|
| Eclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Edema | Blood and lymphatic system disorders | Systematic Assessment | Swelling in lower legs |
|
| Fever | General disorders | Systematic Assessment |
|
| Hemorrhage | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Antepartum or postpartum |
|
| Hypertension | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Pregnancy induced and postpartum hypertension |
|
| Neonatal Hypothermia | General disorders | Systematic Assessment |
|
| Neonatal Intestinal Obstruction | Gastrointestinal disorders | Systematic Assessment |
|
| Neonatal Jaundice | Hepatobiliary disorders | Systematic Assessment |
|
| Malaria | Infections and infestations | Systematic Assessment |
|
| Neonatal Death of Unknown Cause | General disorders | Systematic Assessment |
|
| Presumed Neonatal Sepsis | Infections and infestations | Systematic Assessment |
|
| Nose Bleed / Laceration | General disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Premature Rupture of Membranes | Pregnancy, puerperium and perinatal conditions | Systematic Assessment | Preterm or Term |
|
| Preeclampsia | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Neonatal Encephelopathy | Nervous system disorders | Systematic Assessment |
|
| Presumed Psychosis | Psychiatric disorders | Systematic Assessment |
|
| Preterm labor | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Puerperal Sepsis | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Neonatal Respiratory Distress Syndrome | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Stillbirth | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Syncope | General disorders | Systematic Assessment |
|
| Respiratory Tract Infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Urinary Tract Infection | Renal and urinary disorders | Systematic Assessment |
|
| Bowel Perforation | Gastrointestinal disorders | Systematic Assessment |
|
| Left Side Pain | General disorders | Systematic Assessment |
|
| Cesarean Scar Tenderness | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Abdominal Trauma | General disorders | Systematic Assessment |
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| Gastroenteritis | Gastrointestinal disorders | Systematic Assessment |
|
| Neonatal Hypoglecemia | Metabolism and nutrition disorders | Systematic Assessment |
|
| General Malaise | General disorders | Systematic Assessment |
|
| Neonatal Dehydration | General disorders | Systematic Assessment |
|
| Placental Abruption | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Pulmonary Tuberculosis | Infections and infestations | Systematic Assessment |
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| Prematurity | Pregnancy, puerperium and perinatal conditions | Systematic Assessment |
|
| Kidney Infection | Renal and urinary disorders | Systematic Assessment |
|
| Bladder Injury | Renal and urinary disorders | Systematic Assessment |
|
| Diarrhea | Product Issues | Systematic Assessment |
|
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| D000091642 | Urogenital Diseases |
| D011278 |
| Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D045167 | Progesterone Congeners |
| D012739 | Gonadal Steroid Hormones |
| D042341 | Gonadal Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |