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Improving Pregnancy Outcomes With Progesterone (IPOP)

Primary Purpose

Pre-term Birth, HIV-1-infection

Status
Completed
Phase
Phase 3
Locations
Zambia
Study Type
Interventional
Intervention
17P
Placebo
Sponsored by
University of North Carolina, Chapel Hill
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pre-term Birth focused on measuring PreTerm Birth, HIV-1-infection, Antiretroviral Treatment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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)
  • 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.

Sites / Locations

  • Kamwala District Clinic
  • University Teaching Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

250 mg 17P

Placebo

Arm Description

weekly intramuscular injection of 250mg 17P

weekly intramuscular injection of indistinguishable placebo

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Number of Participants Experiencing Preterm Birth <37 Weeks
Delivery prior to 37 gestational weeks
Number of Participants Experiencing Preterm Birth <34 Weeks
Delivery prior to 34 gestational weeks
Number of Participants Experiencing Preterm Birth <28 Weeks
Delivery prior to 28 gestational weeks
Number of Participants Experiencing Stillbirth
Participants who had a fetus born without signs of life at any gestational age
Number of Participants Experiencing Spontaneous Delivery <37 Weeks
Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention
Number of Participants Experiencing Spontaneous Delivery <34 Weeks
Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention
Number of Participants Experiencing Spontaneous Delivery <28 Weeks
Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention
Number of Infants With Birth Weight <10th Percentile for Gestational Age
Infant born with a weight below the 10th percentile for gestational age
Number of Infants With Birth Weight <3rd Percentile for Gestational Age
Infant born with a weight below the 3rd percentile for gestational age
Number of Infants Who Experienced Maternal-to-Child HIV Transmission
Confirmed HIV infection in an infant
Number of Neonatal Deaths
Death of an infant following live birth
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.
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.

Full Information

First Posted
September 15, 2017
Last Updated
July 21, 2021
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), AMAG Pharmaceuticals, Inc., Bill and Melinda Gates Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT03297216
Brief Title
Improving Pregnancy Outcomes With Progesterone
Acronym
IPOP
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
February 7, 2018 (Actual)
Primary Completion Date
June 25, 2020 (Actual)
Study Completion Date
August 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD), AMAG Pharmaceuticals, Inc., Bill and Melinda Gates Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pre-term Birth, HIV-1-infection
Keywords
PreTerm Birth, HIV-1-infection, Antiretroviral Treatment

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Phase III, double-masked, placebo-controlled, randomized controlled trial
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
800 (Actual)

8. Arms, Groups, and Interventions

Arm Title
250 mg 17P
Arm Type
Active Comparator
Arm Description
weekly intramuscular injection of 250mg 17P
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
weekly intramuscular injection of indistinguishable placebo
Intervention Type
Drug
Intervention Name(s)
17P
Other Intervention Name(s)
17-alpha hydroxyprogesterone caproate
Intervention Description
Synthetic progestin
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Non-active placebo comparator
Primary Outcome Measure Information:
Title
Number of Participants Experiencing Preterm Births or Stillbirths
Description
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
Secondary Outcome Measure Information:
Title
Number of Participants Experiencing Preterm Birth <37 Weeks
Description
Delivery prior to 37 gestational weeks
Time Frame
At delivery, up to 37 weeks of gestation
Title
Number of Participants Experiencing Preterm Birth <34 Weeks
Description
Delivery prior to 34 gestational weeks
Time Frame
At delivery, up to 34 weeks of gestation
Title
Number of Participants Experiencing Preterm Birth <28 Weeks
Description
Delivery prior to 28 gestational weeks
Time Frame
At delivery, up to 28 weeks of gestation
Title
Number of Participants Experiencing Stillbirth
Description
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
Title
Number of Participants Experiencing Spontaneous Delivery <37 Weeks
Description
Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention
Time Frame
At delivery, up to 37 weeks of gestation
Title
Number of Participants Experiencing Spontaneous Delivery <34 Weeks
Description
Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention
Time Frame
At delivery, up to 34 weeks of gestation
Title
Number of Participants Experiencing Spontaneous Delivery <28 Weeks
Description
Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention
Time Frame
At delivery, up to 28 weeks of gestation
Title
Number of Infants With Birth Weight <10th Percentile for Gestational Age
Description
Infant born with a weight below the 10th percentile for gestational age
Time Frame
Birth
Title
Number of Infants With Birth Weight <3rd Percentile for Gestational Age
Description
Infant born with a weight below the 3rd percentile for gestational age
Time Frame
Birth
Title
Number of Infants Who Experienced Maternal-to-Child HIV Transmission
Description
Confirmed HIV infection in an infant
Time Frame
At 6 weeks of life
Title
Number of Neonatal Deaths
Description
Death of an infant following live birth
Time Frame
Birth through 28 days postpartum
Title
Number of Infants With 1-minute Apgar Score <7
Description
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
Title
Number of Infants With 5-minute Apgar Score <7
Description
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jeff Stringer, MD, FACOG
Organizational Affiliation
University of North Carolina, Chapel Hill
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kamwala District Clinic
City
Lusaka
Country
Zambia
Facility Name
University Teaching Hospital
City
Lusaka
Country
Zambia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34509197
Citation
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.
Results Reference
derived
PubMed Identifier
30813934
Citation
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.
Results Reference
derived

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Improving Pregnancy Outcomes With Progesterone

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