8-Way Randomized Controlled Trial of Doxylamine, Pyridoxine and Dicyclomine for Nausea and Vomiting during Pregnancy: Restoration of Unpublished Information.

ABSTRACT:

Objectives

We report information about an unpublished 1970s study ("8-way" Bendectin Study) that aimed to evaluate the relative therapeutic efficacy of doxylamine, pyridoxine, and dicyclomine in the management of nausea and vomiting during pregnancy. We are publishing the trial's findings according to the restoring invisible and abandoned trials (RIAT) initiative because the trial was never published.

Design

Double blinded, multi-centred, randomized placebo-controlled study.

Setting

14 clinics in the United States.

Participants

2308 patients in the first 12 weeks of pregnancy with complaints of nausea or vomiting were enrolled.

Interventions

Each patient was randomized to one of eight arms: placebo, doxylamine/pyridoxine/dicylcomine, doxylamine/pyridoxin

SUBMITTER: Zhang R 

PROVIDER: S-EPMC5215753 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature