Improving Pregnancy Outcomes With Progesterone

NCT03297216 | Completed Phase 3 Results DMC FDA Drug

• 2 other identifiers: 17-11731R01HD087119
• Study Type: interventional
• Target: 800
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Pre-term Birth; HIV-1-infection

Keywords

PreTerm Birth; HIV-1-infection; Antiretroviral Treatment

Outcome Measures

Primary Outcomes (1)

• 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

  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

  At delivery, up to 37 weeks of gestation

• Number of Participants Experiencing Preterm Birth <34 Weeks

  At delivery, up to 34 weeks of gestation

• Number of Participants Experiencing Preterm Birth <28 Weeks

  At delivery, up to 28 weeks of gestation

• Number of Participants Experiencing Stillbirth

  At delivery, up to approximately 40 weeks of gestation

• Number of Participants Experiencing Spontaneous Delivery <37 Weeks

  At delivery, up to 37 weeks of gestation

Study Arms (2)

250 mg 17P

ACTIVE COMPARATOR

weekly intramuscular injection of 250mg 17P

Drug: 17P

Placebo

PLACEBO COMPARATOR

weekly intramuscular injection of indistinguishable placebo

Other: Placebo

Interventions

17P DRUG

Synthetic progestin

Also known as: 17-alpha hydroxyprogesterone caproate

250 mg 17P

Placebo OTHER

Non-active placebo comparator

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead
• Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD): collaborator
• AMAG Pharmaceuticals, Inc.: collaborator
• Bill and Melinda Gates Foundation: collaborator

Study Sites (2)

Kamwala District Clinic

Lusaka, Zambia

Location

University Teaching Hospital

Lusaka, Zambia

Location

Related Publications (2)

• 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.

  PMID: 34509197 DERIVED

• 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.

  PMID: 30813934 DERIVED

MeSH Terms

Conditions

Premature Birth

Interventions

17-alpha-Hydroxyprogesterone

Condition Hierarchy (Ancestors)

Obstetric Labor, Premature; Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Hydroxyprogesterones; Progesterone; Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Progesterone Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists

Results Point of Contact

• Title: Joan Price, MD, MPH
• Organization: University of North Carolina at Chapel Hill

joan_price@med.unc.edu

919-962-4717

Study Officials

• Jeff Stringer, MD, FACOG

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Phase III, double-masked, placebo-controlled, randomized controlled trial

Study Record Dates

• First Submitted: September 15, 2017
• First Posted: September 29, 2017
• Study Start: February 7, 2018
• Primary Completion: June 25, 2020
• Study Completion: August 6, 2020
• Last Updated: July 22, 2021
• Results First Posted: July 9, 2021

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

ZA (2)