Improving Pregnancy Outcomes With Progesterone

HIV-1-infection Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03297216
• Other study ID #: 17-1173
• Secondary ID: 1R01HD087119
• Status: Completed
• Phase: Phase 3
• Start date: February 7, 2018
• Est. completion date: August 6, 2020

Study information

• Verified date: September 2020
• Source: University of North Carolina, Chapel Hill
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 800
• Est. completion date: August 6, 2020
• Est. primary completion date: June 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• HIV-1-infection
• Pre-term Birth
• Premature Birth

Intervention

Drug:
• 17P
Synthetic progestin

Other:
• Placebo
Non-active placebo comparator

Locations

Country	Name	City	State
Zambia	Kamwala District Clinic	Lusaka
Zambia	University Teaching Hospital	Lusaka

Sponsors (4)

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

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants Experiencing Preterm Birth <37 Weeks	Delivery prior to 37 gestational weeks	At delivery, up to 37 weeks of gestation
Secondary	Number of Participants Experiencing Preterm Birth <34 Weeks	Delivery prior to 34 gestational weeks	At delivery, up to 34 weeks of gestation
Secondary	Number of Participants Experiencing Preterm Birth <28 Weeks	Delivery prior to 28 gestational weeks	At delivery, up to 28 weeks of gestation
Secondary	Number of Participants Experiencing Stillbirth	Participants who had a fetus born without signs of life at any gestational age	At delivery, up to approximately 40 weeks of gestation
Secondary	Number of Participants Experiencing Spontaneous Delivery <37 Weeks	Delivery prior to 37 weeks of gestation that was initiated spontaneously, without provider intervention	At delivery, up to 37 weeks of gestation
Secondary	Number of Participants Experiencing Spontaneous Delivery <34 Weeks	Delivery prior to 34 weeks of gestation that was initiated spontaneously, without provider intervention	At delivery, up to 34 weeks of gestation
Secondary	Number of Participants Experiencing Spontaneous Delivery <28 Weeks	Delivery prior to 28 weeks of gestation that was initiated spontaneously, without provider intervention	At delivery, up to 28 weeks of gestation
Secondary	Number of Infants With Birth Weight <10th Percentile for Gestational Age	Infant born with a weight below the 10th percentile for gestational age	Birth
Secondary	Number of Infants With Birth Weight <3rd Percentile for Gestational Age	Infant born with a weight below the 3rd percentile for gestational age	Birth
Secondary	Number of Infants Who Experienced Maternal-to-Child HIV Transmission	Confirmed HIV infection in an infant	At 6 weeks of life
Secondary	Number of Neonatal Deaths	Death of an infant following live birth	Birth through 28 days postpartum
Secondary	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.	1 minute of life
Secondary	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.	5 minutes of life