Improving Pregnancy Outcomes With Progesterone (IPOP)

July 21, 2021 updated by: University of North Carolina, Chapel Hill

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
800

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
      • Lusaka, Zambia
        • University Teaching Hospital
      • Lusaka, Zambia
        • Kamwala District Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: 250 mg 17P
weekly intramuscular injection of 250mg 17P
Drug: 17P
Synthetic progestin
Other Names:
  • 17-alpha hydroxyprogesterone caproate
PLACEBO_COMPARATOR: Placebo
weekly intramuscular injection of indistinguishable placebo
Other: Placebo
Non-active placebo comparator

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
At delivery, up to 37 weeks of gestation for live births and up to approximately 40 weeks of gestation for stillbirths

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing Preterm Birth <37 Weeks
Time Frame: At delivery, up to 37 weeks of gestation
Delivery prior to 37 gestational weeks
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
Delivery prior to 34 gestational weeks
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
Delivery prior to 28 gestational weeks
At delivery, up to 28 weeks of gestation
Number of Participants Experiencing Stillbirth
Time Frame: At delivery, up to approximately 40 weeks of gestation
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
Time Frame: At delivery, up to 37 weeks of gestation
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
Time Frame: At delivery, up to 34 weeks of gestation
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
Time Frame: At delivery, up to 28 weeks of gestation
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
Time Frame: Birth
Infant born with a weight below the 10th percentile for gestational age
Birth
Number of Infants With Birth Weight <3rd Percentile for Gestational Age
Time Frame: Birth
Infant born with a weight below the 3rd percentile for gestational age
Birth
Number of Infants Who Experienced Maternal-to-Child HIV Transmission
Time Frame: At 6 weeks of life
Confirmed HIV infection in an infant
At 6 weeks of life
Number of Neonatal Deaths
Time Frame: Birth through 28 days postpartum
Death of an infant following live birth
Birth through 28 days postpartum
Number of Infants With 1-minute Apgar Score <7
Time Frame: 1 minute of life
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
Time Frame: 5 minutes of life
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of North Carolina, Chapel Hill

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Bill and Melinda Gates Foundation
AMAG Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 7, 2018

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 25, 2020

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 6, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 15, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2017

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 29, 2017

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 22, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 21, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 17-1173
  • 1R01HD087119 (NIH)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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