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BMC Pregnancy and Childbirth
Published in: BMC Pregnancy and Childbirth 1/2015

Open Access 01-12-2015 | Research article

Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial

Authors: Gideon Koren, Shannon Clark, Gary D V Hankins, Steve N Caritis, Jason G Umans, Menachem Miodovnik, Donald R Mattison, Ilan Matok

Published in: BMC Pregnancy and Childbirth | Issue 1/2015

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Abstract

Background

Nausea and vomiting of pregnancy (NVP) is the most common medical condition in pregnancy, affecting up to 80% of expecting mothers. In April 2013 the FDA approved the delayed release combination of doxylamine succinate and -pyridoxine hydrochloride (Diclegis®) for NVP, following a phase 3 randomized trial in pregnant women. The fetal safety of this medication has been proven by numerous studies. However, because it is the only FDA-approved medication for NVP that is likely to be used by a large number of pregnant women, its maternal safety is an important public health question. The Objective is to evaluate the maternal safety of doxylamine succinate -pyridoxine hydrochloride delayed-release preparation (Diclegis® as compared to placebo.

Methods

We randomized women suffering from NVP to receive Diclegis® (n = 131) or placebo (n = 125) for 14 days at doses ranging from 2–4 tablets a day, based on a pre-specified titration protocol response to symptoms. Adverse events were collected through patient diaries, clinical examination and laboratory testing.

Results

Doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg use was not associated with an increased rate of any adverse event over placebo, including CNS depression, gastrointestinal or cardiovascular involvement.

Conclusions

Doxylamine succinate–pyridoxine hydrochloride delayed release combination is safe and well tolerated by pregnant women when used in the recommended dose of up to 4 tablets daily in treating nausea and vomiting of pregnancy.

Trial Registration

Clinical Trial Registration No: NCT00614445.
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Metadata
Title
Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial
Authors
Gideon Koren
Shannon Clark
Gary D V Hankins
Steve N Caritis
Jason G Umans
Menachem Miodovnik
Donald R Mattison
Ilan Matok
Publication date
01-12-2015
Publisher
BioMed Central
Published in
BMC Pregnancy and Childbirth / Issue 1/2015
Electronic ISSN: 1471-2393
DOI
https://doi.org/10.1186/s12884-015-0488-1

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