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Reproductive Health
Published in: Reproductive Health 1/2017

Open Access 01-12-2017 | Research

Effect of suppressive acyclovir administered to HSV-2 positive mothers from week 28 to 36 weeks of pregnancy on adverse obstetric outcomes: a double-blind randomised placebo-controlled trial

Authors: Sarah Nakubulwa, Dan K. Kaye, Freddie Bwanga, Nazarius Mbona Tumwesigye, Edith Nakku-Joloba, Florence Mirembe

Published in: Reproductive Health | Issue 1/2017

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Abstract

Background

Acyclovir (ACV) given to HSV-2 positive women after 36 weeks reduces adverse outcomes but its benefit at lower gestation was undocumented. We determined the effect of oral acyclovir administered from 28 to 36 weeks on premature rupture of membranes (PROM) primarily and preterm delivery risk.

Methods

This was a randomized, double-blind placebo-controlled trial among 200 HSV-2 positive pregnant women at 28 weeks of gestation at Mulago Hospital, Uganda. Participants were assigned randomly (1:1) to take either acyclovir 400 mg orally twice daily (intervention) or placebo (control) from 28 to 36 weeks. Both arms received acyclovir after 36 weeks until delivery. Development of Pre-PROM by 36 weeks and preterm delivery were outcomes.

Results

One hundred women were randomised to acyclovir and 100 to placebo arms between January 2014 and February 2015. There was tendency towards reduction of incidence of PROM at 36 weeks but this was not statistically significant (4.0% versus 10.0%; RR 0.35; 95% 0.11–1.10) in the acyclovir and placebo arms respectively. However, there was a significant reduction in the incidence of preterm delivery (11.1% versus 23.5%; RR 0.41; 95% 0.20–0.85) in the acyclovir and placebo arms respectively.

Conclusions

Oral acyclovir given to HSV-2 positive pregnant women from 28 to 36 weeks reduced incidence of preterm delivery but did not significantly reduce incidence of pre-PROM.

Trial registration

www.pactr.org, PACTR20131100055​8197.
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Metadata
Title
Effect of suppressive acyclovir administered to HSV-2 positive mothers from week 28 to 36 weeks of pregnancy on adverse obstetric outcomes: a double-blind randomised placebo-controlled trial
Authors
Sarah Nakubulwa
Dan K. Kaye
Freddie Bwanga
Nazarius Mbona Tumwesigye
Edith Nakku-Joloba
Florence Mirembe
Publication date
01-12-2017
Publisher
BioMed Central
Published in
Reproductive Health / Issue 1/2017
Electronic ISSN: 1742-4755
DOI
https://doi.org/10.1186/s12978-017-0292-7

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