Pre-term BirthPhase 3IPOPNCT03297216
Improving Pregnancy Outcomes With Progesterone
A Phase 3 study testing 17P in people with Pre-term Birth and HIV-1-infection, run by University of North Carolina, Chapel Hill at 2 sites in Zambia.
Trial summary
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pre-term Birth, HIV-1-infection
- What is being tested?
- 17P
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 800 participants
- Where
- 2 sitesZambia
- Study dates
- 7 Feb 2018to 6 Aug 2020
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years of age or older
- less than 24 0/7 weeks of gestation
- viable intrauterine singleton pregnancy confirmed by ultrasound
- antibody-confirmed HIV-1 infection
- currently receiving antiretroviral l therapy (ART) or intending to commence ART in pregnancy
- ability and willingness to provide written informed consent
- intent to remain in current geographical area of residence for the duration of study
- willing to adhere to weekly study visit schedule
Who cannot join
- confirmed prior spontaneous preterm birth
- multiple gestation
- known uterine anomaly
- planned or in situ cervical cerclage
- major fetal anomaly detected on screening ultrasound
- indication for planned delivery prior to 37 weeks (e.g., prior classical cesarean)
Show all 10Show fewer
- threatened abortion, preterm labor, or ruptured membranes at time of enrollment
- known allergy or medical comorbidity listed as a contraindication to 17P in the prescribing information
- prior participation in the trial
- any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.
Trial locations and contacts
2 sites in 1 country.
Zambia2 sites
Kamwala District Clinic
Lusaka
University Teaching Hospital
Lusaka
About this study
Official title: Z 31702 - Improving Pregnancy Outcomes With Progesterone (IPOP): a Trial of 17-Hydroxyprogesterone Caproate to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.
Read the detailed description
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.
- Conditions
- Pre-term Birth, HIV-1-infection
- Being tested
- 17P, Placebo
- Keywords
- PreTerm Birth, HIV-1-infection, Antiretroviral Treatment
- Medical subject headings
- Premature Birth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
17PDrug
Also called 17-alpha hydroxyprogesterone caproate
Synthetic progestin
PlaceboOther
Non-active placebo comparator
| Study group | Role | What they receive |
|---|---|---|
| 250 mg 17P | Active comparator | weekly intramuscular injection of 250mg 17P Receives: Drug: 17P |
| Placebo | Placebo comparator | weekly intramuscular injection of indistinguishable placebo Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths
Secondary outcomes (13)
Number of Participants Experiencing Preterm Birth <37 Weeks
Delivery prior to 37 gestational weeks
Measured: At delivery, up to 37 weeks of gestation
Number of Participants Experiencing Preterm Birth <34 Weeks
Delivery prior to 34 gestational weeks
Measured: At delivery, up to 34 weeks of gestation
Number of Participants Experiencing Preterm Birth <28 Weeks
Delivery prior to 28 gestational weeks
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Birth
Number of Infants With Birth Weight <3rd Percentile for Gestational Age
Infant born with a weight below the 3rd percentile for gestational age
Measured: Birth
Number of Infants Who Experienced Maternal-to-Child HIV Transmission
Confirmed HIV infection in an infant
Measured: At 6 weeks of life
Number of Neonatal Deaths
Death of an infant following live birth
Measured: 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.
Measured: 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.
Measured: 5 minutes of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Sep 2017
- Study start7 Feb 2018
- Primary completion25 Jun 2020
- Study completion6 Aug 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Pre-term BirthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase III, double-masked, placebo-controlled, randomized controlled trial
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 800 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), AMAG Pharmaceuticals, Inc., Bill and Melinda Gates Foundation
- Responsible party
- Sponsor
- Investigators
- Jeff Stringer, MD, FACOG, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03297216
- Sponsor's protocol ID
- 17-1173
- Other IDs
- 1R01HD087119
- Acronym
- IPOP
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2017
- Last updated
- 22 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34509197Price 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.
PubMed 30813934
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Z 31702 - Improving Pregnancy Outcomes With Progesterone (IPOP): a Trial of 17-Hydroxyprogesterone Caproate to Reduce Preterm Birth Among Women Receiving Antiretroviral Therapy in Pregnancy
- ClinicalTrials.gov ID
- NCT03297216
- Acronym / sponsor ID
- IPOP / 17-1173
- Conditions
- Pre-term Birth, HIV-1-infection
- Keywords
- PreTerm Birth, HIV-1-infection, Antiretroviral Treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 800 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), AMAG Pharmaceuticals, Inc., Bill and Melinda Gates Foundation
- Study start
- 7 Feb 2018 (actual)
- Primary completion
- 25 Jun 2020 (actual)
- Study completion
- 6 Aug 2020 (actual)
- First posted
- 29 Sep 2017 (actual)
- Results
- Posted 9 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Phase III, double-masked, placebo-controlled, randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| 250 mg 17P | Active comparator | Drug: 17Pweekly intramuscular injection of 250mg 17P |
| Placebo | Placebo comparator | Other: Placeboweekly intramuscular injection of indistinguishable placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 18 years of age or older
- less than 24 0/7 weeks of gestation
- viable intrauterine singleton pregnancy confirmed by ultrasound
- antibody-confirmed HIV-1 infection
- currently receiving antiretroviral l therapy (ART) or intending to commence ART in pregnancy
Key exclusion criteria (10 listed)
- confirmed prior spontaneous preterm birth
- multiple gestation
- known uterine anomaly
- planned or in situ cervical cerclage
- major fetal anomaly detected on screening ultrasound
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 17PAlso: 17-alpha hydroxyprogesterone caproateSynthetic progestin | Drug | 250 mg 17P |
| PlaceboNon-active placebo comparator | Other | Placebo |
Primary outcome
Number of Participants Experiencing Preterm Births or Stillbirths
Time frame: At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths
A composite of live births prior to 37 weeks of gestation or stillbirth occurring at any gestational age
13 secondary outcomes
Number of Participants Experiencing Preterm Birth <37 Weeks
Time frame: At delivery, up to 37 weeks of gestation
Number of Participants Experiencing Preterm Birth <34 Weeks
Time frame: At delivery, up to 34 weeks of gestation
Number of Participants Experiencing Preterm Birth <28 Weeks
Time frame: At delivery, up to 28 weeks of gestation
Number of Participants Experiencing Stillbirth
Time frame: At delivery, up to approximately 40 weeks of gestation
Number of Participants Experiencing Spontaneous Delivery <37 Weeks
Time frame: At delivery, up to 37 weeks of gestation
Number of Participants Experiencing Spontaneous Delivery <34 Weeks
Time frame: At delivery, up to 34 weeks of gestation
Number of Participants Experiencing Spontaneous Delivery <28 Weeks
Time frame: At delivery, up to 28 weeks of gestation
Number of Infants With Birth Weight <10th Percentile for Gestational Age
Time frame: Birth
Number of Infants With Birth Weight <3rd Percentile for Gestational Age
Time frame: Birth
Number of Infants Who Experienced Maternal-to-Child HIV Transmission
Time frame: At 6 weeks of life
Number of Neonatal Deaths
Time frame: Birth through 28 days postpartum
Number of Infants With 1-minute Apgar Score <7
Time frame: 1 minute of life
Number of Infants With 5-minute Apgar Score <7
Time frame: 5 minutes of life
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34509197Price 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.
- Derived from this study: PubMed 30813934Price 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeff Stringer, MD, FACOG principal investigator
University of North Carolina, Chapel Hill
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing 17P in people with Pre-term Birth and HIV-1-infection, run by University of North Carolina, Chapel Hill at 2 sites in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jul 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Experiencing Preterm Births or Stillbirths (time frame: At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03297216, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2021.