A Phase 3 interventional study of 17P and Placebo in Pre-term Birth and HIV-1-infection, sponsored by University of North Carolina, Chapel Hill. Completed at 2 sites in Zambia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-22.
Sponsored by University of North Carolina, Chapel Hill · Phase 3, Interventional, and Prevention
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.
2,550 studies on the registry are indexed under Premature Birth; 500 are open to participants now.
This study's enrollment of 800 is above the median of 84 across 1,666 interventional studies indexed under Premature Birth.
Browse Premature Birth studies →University of North Carolina, Chapel Hill is the lead sponsor of 1,372 studies on the registry; 133 are open to participants now.
Of its 161 completed or terminated interventional studies of FDA-regulated products, 139 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
weekly intramuscular injection of 250mg 17P
Drug: 17P
weekly intramuscular injection of indistinguishable placebo
Other: Placebo
Synthetic progestin
Also known as: 17-alpha hydroxyprogesterone caproate
Non-active placebo comparator
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
Time frame: At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths
Number of Participants Experiencing Preterm Birth <37 Weeks
Delivery prior to 37 gestational weeks
Time frame: At delivery, up to 37 weeks of gestation
Number of Participants Experiencing Preterm Birth <34 Weeks
Delivery prior to 34 gestational weeks
Time frame: At delivery, up to 34 weeks of gestation
Number of Participants Experiencing Preterm Birth <28 Weeks
Delivery prior to 28 gestational weeks
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Birth
Number of Infants With Birth Weight <3rd Percentile for Gestational Age
Infant born with a weight below the 3rd percentile for gestational age
Time frame: Birth
Number of Infants Who Experienced Maternal-to-Child HIV Transmission
Confirmed HIV infection in an infant
Time frame: At 6 weeks of life
Number of Neonatal Deaths
Death of an infant following live birth
Time frame: 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.
Time frame: 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.
Time frame: 5 minutes of life
| Milestone | 250 mg 17P | Placebo |
|---|---|---|
| Started | 399 | 401 |
| Discontinued intervention | 5 | 4 |
| Infants born during study | 399 | 401 |
| Completed | 396 | 396 |
| Not completed | 3 | 5 |
| Withdrew: Death | 0 | 1 |
| Withdrew: Miscarriage | 0 | 2 |
| Withdrew: Lost to follow-up | 3 | 2 |
A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Participants Experiencing Preterm Births or Stillbirths | 36 | 36 |
Delivery prior to 37 gestational weeks
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Participants Experiencing Preterm Birth <37 Weeks | 31 | 35 |
Delivery prior to 34 gestational weeks
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Participants Experiencing Preterm Birth <34 Weeks | 14 | 16 |
Delivery prior to 28 gestational weeks
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Participants Experiencing Preterm Birth <28 Weeks | 3 | 5 |
Participants who had a fetus born without signs of life at any gestational age
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Participants Experiencing Stillbirth | 10 | 11 |
Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Participants Experiencing Spontaneous Delivery <37 Weeks | 25 | 26 |
Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Participants Experiencing Spontaneous Delivery <34 Weeks | 10 | 11 |
Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Participants Experiencing Spontaneous Delivery <28 Weeks | 3 | 4 |
Infant born with a weight below the 10th percentile for gestational age
| Participants | 250mg 17P | Placebo |
|---|---|---|
| Number of Infants With Birth Weight <10th Percentile for Gestational Age | 95 | 93 |
Infant born with a weight below the 3rd percentile for gestational age
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Infants With Birth Weight <3rd Percentile for Gestational Age | 28 | 47 |
Confirmed HIV infection in an infant
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Infants Who Experienced Maternal-to-Child HIV Transmission | 1 | 1 |
Death of an infant following live birth
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Neonatal Deaths | 14 | 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.
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Infants With 1-minute Apgar Score <7 | 12 | 9 |
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.
| Participants | 250 mg 17P | Placebo |
|---|---|---|
| Number of Infants With 5-minute Apgar Score <7 | 7 | 2 |
Collected over From the time of enrollment through 6 weeks postpartum, a total of up to 32 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Mothers: 250 mg 17P | 0/399 (0%) | 56/399 (14%) | 43/399 (10.8%) |
| Mothers: Placebo | 1/401 (0.2%) | 55/401 (13.7%) | 27/401 (6.7%) |
| Infants Born to Mothers Receiving 250 mg 17P | 14/399 (3.5%) | 33/399 (8.3%) | 0/399 (0%) |
| Infants Born to Mothers Receiving Placebo | 7/401 (1.7%) | 22/401 (5.5%) | 0/401 (0%) |
| Event | Mothers: 250 mg 17P | Mothers: Placebo | Infants Born to Mothers Receiving 250 mg 17P | Infants Born to Mothers Receiving Placebo |
|---|---|---|---|---|
| Neonatal Respiratory Distress SyndromeRespiratory, thoracic and mediastinal disorders | 0/399 | 0/401 | 14/399 | 10/401 |
| Urinary Tract InfectionRenal and urinary disorders | 8/399 | 11/401 | 0/399 | 0/401 |
| StillbirthPregnancy, puerperium and perinatal conditions | 10/399 | 9/401 | 0/399 | 0/401 |
| Abdominal PainGeneral disorders | 6/399 | 7/401 | 0/399 | 0/401 |
| Presumed Neonatal SepsisInfections and infestations | 0/399 | 0/401 | 6/399 | 2/401 |
| Neonatal EncephelopathyNervous system disorders | 0/399 | 0/401 | 6/399 | 2/401 |
| HemorrhagePregnancy, puerperium and perinatal conditions | 5/399 | 4/401 | 0/399 | 0/401 |
| PreeclampsiaPregnancy, puerperium and perinatal conditions | 5/399 | 4/401 | 0/399 | 0/401 |
| AnemiaBlood and lymphatic system disorders | 2/399 | 3/401 | 1/399 | 1/401 |
| HypertensionPregnancy, puerperium and perinatal conditions | 2/399 | 2/401 | 0/399 | 0/401 |
| Event | Mothers: 250 mg 17P | Mothers: Placebo | Infants Born to Mothers Receiving 250 mg 17P | Infants Born to Mothers Receiving Placebo |
|---|---|---|---|---|
| HeadacheProduct Issues | 25/399 | 17/401 | 0/399 | 0/401 |
| DiarrheaProduct Issues | 18/399 | 10/401 | 0/399 | 0/401 |
| Age, Categorical(Participants) | Mothers: 250 mg 17P | Mothers: Placebo | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 399 | 401 | 800 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Mothers: 250 mg 17P | Mothers: Placebo | Total |
|---|---|---|---|
| Median | 29 (25 to 33) | 30 (25 to 34) | 29 (25 to 34) |
| Sex: Female, Male(Participants) | Mothers: 250 mg 17P | Mothers: Placebo | Total |
|---|---|---|---|
| Female | 399 | 401 | 800 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Mothers: 250 mg 17P | Mothers: Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 |
| Not Hispanic or Latino | 399 | 401 | 800 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Mothers: 250 mg 17P | Mothers: Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 399 | 401 | 800 |
| White | 0 | 0 | 0 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Region of Enrollment(Participants) | Mothers: 250 mg 17P | Mothers: Placebo | Total |
|---|---|---|---|
| Zambia | 399 | 401 | 800 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Feb 2018 to primary completion in Jun 2020, 28 months.
Results were first posted in Jul 2021, 1 year after primary completion.
Of 35 non-industry phase 3 interventional studies under Premature Birth, half reached primary completion within 53 months of starting (the median), counting those still running; a quarter within 28 and three quarters within 89. This study's 28 months is below that.
Counting every sponsor, half of 40 studies reached it within 51 months; a quarter within 28 and three quarters within 89.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: 17 alpha-Hydroxyprogesterone Caproate
University of North Carolina, Chapel Hill →