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Intramuscular 17-hydroxyprogesterone caproate to prevent preterm birth among HIV-infected women in Zambia: study protocol of the IPOP randomized trial
- Source :
- BMC Pregnancy and Childbirth, Vol 19, Iss 1, Pp 1-9 (2019), BMC Pregnancy and Childbirth
- Publication Year :
- 2019
- Publisher :
- BMC, 2019.
-
Abstract
- Each year, an estimated 15 million babies are born preterm, a global burden borne disproportionately by families in lower-income countries. Maternal HIV infection increases a woman’s risk of delivering prematurely, and antiretroviral therapy (ART) may compound this risk. While prenatal progesterone prophylaxis prevents preterm birth among some high-risk women, it is unknown whether HIV-infected women could benefit from this therapy. We are studying the efficacy of progesterone supplementation to reduce the risk of preterm birth among pregnant women with HIV in Lusaka, Zambia. The Improving Pregnancy Outcomes with Progesterone (IPOP) study is a Phase III double-masked, placebo-controlled, randomized trial of intramuscular 17-alpha hydroxprogesterone caproate (17P) to prevent preterm birth in HIV-infected women. A total of 800 women will be recruited prior to 24 weeks of gestation and randomly allocated to 17P or placebo administered by weekly intramuscular injection. The primary outcome will be a composite of live birth prior to 37 completed gestational weeks or stillbirth at any gestational age. Secondary outcomes will include very preterm birth (
- Subjects :
- medicine.medical_specialty
Anti-HIV Agents
Zambia
17-alpha hydroxyprogesterone caproate
Gestational Age
HIV Infections
Prenatal care
Injections, Intramuscular
lcsh:Gynecology and obstetrics
03 medical and health sciences
Study Protocol
0302 clinical medicine
Pregnancy
17 alpha-Hydroxyprogesterone Caproate
Medicine
Very Preterm Birth
Humans
030212 general & internal medicine
Extreme Preterm Birth
Pregnancy Complications, Infectious
Developing Countries
Progesterone
lcsh:RG1-991
Randomized Controlled Trials as Topic
030219 obstetrics & reproductive medicine
Sub-Saharan Africa
business.industry
Obstetrics
Obstetrics and Gynecology
Gestational age
HIV
Preterm birth
Stillbirth
medicine.disease
3. Good health
Antiretroviral therapy
Low birth weight
Clinical Trials, Phase III as Topic
Small for gestational age
Premature Birth
Female
medicine.symptom
Progestins
Live birth
business
Hydroxyprogesterone caproate
Live Birth
medicine.drug
Subjects
Details
- Language :
- English
- ISSN :
- 14712393
- Volume :
- 19
- Issue :
- 1
- Database :
- OpenAIRE
- Journal :
- BMC Pregnancy and Childbirth
- Accession number :
- edsair.doi.dedup.....99e7ec696026ac03584c2c6719539674