Vaginal progesterone to reduce preterm birth among HIV-infected pregnant women in Zambia: a feasibility study protocol.

ABSTRACT:

Background

Women infected with HIV have a risk of preterm birth (PTB) that is twice that among uninfected women, and treatment with antiretroviral therapy (ART) may further increase this risk. Progesterone supplementation reduces the risk of preterm delivery in women who have a shortened cervix in the midtrimester. We propose to study the feasibility of a trial of vaginal progesterone (VP) to prevent PTB among HIV-infected women receiving ART in pregnancy. Given low adherence among women self-administering vaginal study product in recent microbicide trials, we plan to investigate whether adequate adherence to VP can be achieved prior to launching a full-scale efficacy trial.

Methods and design

One hundred forty HIV-infected pregnant women in Lusaka, Zambia, will be randomly

SUBMITTER: Price JT 

PROVIDER: S-EPMC5516378 | biostudies-literature | 2018

REPOSITORIES: biostudies-literature