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Completed

NCT Number: NCT03297216

Improving Pregnancy Outcomes With Progesterone

This is a phase III, double-masked, placebo-controlled, randomized controlled trial taking place in Zambia.

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Key information

Conditions

Pre-term Birth Female Urogenital Diseases and Pregnancy Complications HIV-1-infection Obstetric Labor Complications Obstetric Labor, Premature Pregnancy Complications Premature Birth Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Kamwala District Clinic, Lusaka, Zambia

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

17P

Drug

Synthetic progestin

Other names: 17-alpha hydroxyprogesterone caproate

Placebo

Other

Non-active placebo comparator

Primary outcomes

  1. 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

Secondary outcomes

  1. Number of Participants Experiencing Preterm Birth <37 Weeks

    Time frame: At delivery, up to 37 weeks of gestation

    Delivery prior to 37 gestational weeks

  2. Number of Participants Experiencing Preterm Birth <34 Weeks

    Time frame: At delivery, up to 34 weeks of gestation

    Delivery prior to 34 gestational weeks

  3. Number of Participants Experiencing Preterm Birth <28 Weeks

    Time frame: At delivery, up to 28 weeks of gestation

    Delivery prior to 28 gestational weeks

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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

  10. Number of Infants Who Experienced Maternal-to-Child HIV Transmission

    Time frame: At 6 weeks of life

    Confirmed HIV infection in an infant

  11. Number of Neonatal Deaths

    Time frame: Birth through 28 days postpartum

    Death of an infant following live birth

  12. 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.

  13. 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.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • AMAG Pharmaceuticals, Inc.
  • Bill and Melinda Gates Foundation
  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Registry information

Official study 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

Acronym: IPOP

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
Sep 29, 2017
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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