Pregnancy incidence and risk factors among women participating in vaginal microbicide trials for HIV prevention: systematic review and meta-analysis

Pregnancy is contraindicated in vaginal microbicide trials for the prevention of HIV infection in women due to the unknown maternal and fetal safety of the microbicides. Women who become pregnant are taken off the microbicide during pregnancy period but this result in reduction of the power of the t...

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Bibliographic Details
Published in:PloS one 2013-10, Vol.8 (10), p.e77014-e77014
Main Authors: Musekiwa, Alfred, Muchiri, Evans, Manda, Samuel O M, Mwambi, Henry G
Format: Article
Language:English
Subjects:
Acquired immune deficiency syndrome
AIDS
Anti-infective agents
Anti-Infective Agents - pharmacology
Circumcision
Clinical Trials as Topic - methods
Condoms
Disease transmission
Female
Fetuses
Health aspects
Health risk assessment
HIV
HIV infections
HIV Infections - prevention & control
HIV Infections - transmission
Human immunodeficiency virus
Humans
Identification methods
Implants
Incidence
Infection
Intrauterine devices
IUD
Medical research
Meta-analysis
Microbicides
Oral contraceptives
Pregnancy
Pregnancy - statistics & numerical data
Pregnant women
Prevention
Reduction
Reviews
Risk analysis
Risk Factors
Sexually transmitted disease prevention
Sexually transmitted diseases
STD
Sterilization
Systematic review
Uterus
Vagina
Vagina - drug effects
Vagina - virology
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Summary:Pregnancy is contraindicated in vaginal microbicide trials for the prevention of HIV infection in women due to the unknown maternal and fetal safety of the microbicides. Women who become pregnant are taken off the microbicide during pregnancy period but this result in reduction of the power of the trials. Strategies to reduce the pregnancy rates require an understanding of the incidence and associated risk factors of pregnancy in microbicide trials. This systematic review estimates the overall incidence rate of pregnancy in microbicide trials and describes the associated risk factors. A comprehensive literature search was carried out to identify eligible studies from electronic databases and other sources. Two review authors independently selected studies and extracted relevant data from included studies. Meta-analysis of incidence rates of pregnancy was carried out and risk factors of pregnancy were reported narratively. Fifteen studies reporting data from 10 microbicide trials (N=27,384 participants) were included. A total of 4,107 participants (15.0%) fell pregnant and a meta-analysis of incidence rates of pregnancy from 8 microbicide trials (N=25,551) yielded an overall incidence rate of 23.37 (95%CI: 17.78 to 28.96) pregnancies per 100 woman-years. However, significant heterogeneity was detected. Hormonal injectable, intra-uterine device (IUD) or implants or sterilization, older age, more years of education and condom use were associated with lower pregnancy. On the other hand, living with a man, history of pregnancy, self and partner desire for future baby, oral contraceptive use, increased number of unprotected sexual acts and inconsistent use of condoms were associated with higher pregnancy. The incidence rate of pregnancy in microbicide trials is high and strategies for its reduction are urgently required in order to improve the sample size and power of these trials.
ISSN:1932-6203
1932-6203
DOI:10.1371/journal.pone.0077014