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Improving Pregnancy Outcomes With Progesterone (IPOP)

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ClinicalTrials.gov Identifier: NCT03297216
Recruitment Status : Recruiting
First Posted : September 29, 2017
Last Update Posted : February 18, 2019
Sponsor:
Collaborators:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
AMAG Pharmaceuticals, Inc.
Bill and Melinda Gates Foundation
Information provided by (Responsible Party):
University of North Carolina, Chapel Hill

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

Condition or disease Intervention/treatment Phase
Pre-term Birth HIV-1-infection Drug: 17P Other: Placebo Phase 3

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 800 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Phase III, double-masked, placebo-controlled, randomized controlled trial
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : February 7, 2018
Estimated Primary Completion Date : January 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: 250 mg 17P
weekly intramuscular injection of 250mg 17P
Drug: 17P
Synthetic progestin
Other Name: 17-alpha hydroxyprogesterone caproate

Placebo Comparator: Placebo
weekly intramuscular injection of indistinguishable placebo
Other: Placebo
Non-active placebo comparator




Primary Outcome Measures :
  1. Deliveries or stillbirths before 37 weeks gestation [ Time Frame: From date of randomization (between 16 and 24 weeks gestation) until delivery or stillbirth, up to a total of approximately 20 weeks, 6 days ]
    Composite outcome of delivery and stillbirth before 37 weeks gestation



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. 18 years of age or older
  2. less than 24 0/7 weeks of gestation
  3. viable intrauterine singleton pregnancy confirmed by ultrasound
  4. antibody-confirmed HIV-1 infection
  5. currently receiving ART or intending to commence ART in pregnancy
  6. ability and willingness to provide written informed consent
  7. intent to remain in current geographical area of residence for the duration of study
  8. willing to adhere to weekly study visit schedule

Exclusion Criteria:

  1. confirmed prior spontaneous preterm birth
  2. multiple gestation
  3. known uterine anomaly
  4. planned or in situ cervical cerclage
  5. major fetal anomaly detected on screening ultrasound
  6. indication for planned delivery prior to 37 weeks (e.g. prior classical cesarean)
  7. threatened abortion, preterm labor, or ruptured membranes at time of enrollment
  8. known allergy or medical comorbidity listed as a contraindication to 17P in the prescribing information
  9. prior participation in the trial
  10. any other condition (social or medical) which, in the opinion of the study staff, would make trial participation unsafe or complicate data interpretation.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03297216


Contacts
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Contact: Bellington Vwalika, MBChB, MMed +260 966 668 312 vwalikab@gmail.com

Locations
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Zambia
Kamwala District Clinic Recruiting
Lusaka, Zambia
Contact: Joan Price, MD    260 966 668 312    joan_price@med.unc.edu   
University Teaching Hospital Recruiting
Lusaka, Zambia
Contact: Joan Price, MD    +260 966 668 312      
Sponsors and Collaborators
University of North Carolina, Chapel Hill
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
AMAG Pharmaceuticals, Inc.
Bill and Melinda Gates Foundation
Investigators
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Principal Investigator: Jeff Stringer, MD, FACOG University of North Carolina, Chapel Hill

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of North Carolina, Chapel Hill
ClinicalTrials.gov Identifier: NCT03297216     History of Changes
Other Study ID Numbers: 17-1173
1R01HD087119 ( U.S. NIH Grant/Contract )
First Posted: September 29, 2017    Key Record Dates
Last Update Posted: February 18, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Keywords provided by University of North Carolina, Chapel Hill:
PreTerm Birth
HIV-1-infection
Antiretroviral Treatment

Additional relevant MeSH terms:
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17 alpha-Hydroxyprogesterone Caproate
11-hydroxyprogesterone
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Progesterone
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Estrogen Antagonists
Hormone Antagonists