Trial reportBMC pregnancy and childbirth2015
Maternal safety of the delayed-release doxylamine and pyridoxine combination for nausea and vomiting of pregnancy; a randomized placebo controlled trial.
Trial report in BMC pregnancy and childbirth, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00614445 (A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy), which is not on this map. Cited by 10 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Of The Efficacy Of Diclectin® For Nausea And Vomiting Of Pregnancy
Who cites it
10 citing papers in PubMed, 1 synthesis or guideline pooled it, 42 citations in OpenAlex.
- Interventions for treating hyperemesis gravidarum.The Cochrane database of systematic reviews · 2016Pooled it
- Doxylamine-pyridoxine for nausea and vomiting of pregnancy randomized placebo controlled trial: Prespecified analyses and reanalysis.PloS one · 2018Trial
- Demonstration of early efficacy results of the delayed-release combination of doxylamine-pyridoxine for the treatment of nausea and vomiting of pregnancy.BMC pregnancy and childbirth · 2016Trial
- Vitamin B6 in nausea and vomiting of pregnancy: metabolism, mechanisms, and clinical implications-a narrative review.Frontiers in nutrition · 2026Review
- Resolution of Fetal Arrhythmia Following Maternal Discontinuation of Doxylamine (Unisom): A Case Report and Review.Cureus · 2025Article
- Bioavailability of CaribanDrugs in R&D · 2023Article
- News in pharmacology for the main medical pathologies of gestation.Frontiers in pharmacology · 2023Review
- Observational
- A Deep Learning-Based Approach for Identifying the Medicinal Uses of Plant-Derived Natural Compounds.Frontiers in pharmacology · 2020Article
- Nausea and vomiting of pregnancy - What's new?Autonomic neuroscience : basic & clinical · 2017Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
8 authors at 7 institutions in 2 countries.
Funding
Abstract
backgroundNausea 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.
methodsWe 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.
resultsDoxylamine 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.
conclusionsDoxylamine 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 registrationClinical Trial Registration No: NCT00614445 .
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Registered trials
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