Does Thiamine Help Vomiting and Nausea in Pregnancy?

June 21, 2015 updated by: HaEmek Medical Center, Israel

Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy

There are different treatments for nausea and vomiting in pregnancy. According to the ACOG recommendations, promethazine is the first line of parenteral treatment after oral treatment had failed. Thiamine is given to prevent wernicke encephalopathy. This research try to find out whether thiamine helps the vomiting and nausea as well, by comparing the response to thiamine and promethazine in women who suffer from nausea and vomiting in pregnancy.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

  • Research groups: pregnant women eho visit the emergency room for nausea and vomiting in pregnancy, pregnancy age 12 weeks or less
  • After basic examinations and hydration, the women will randomized to thiamine or promethazine treatment.
  • If no improvement is shown, the patient will be treated with the other drug
  • The patients will be interviewed on their current visit and every two weeks until 14th week of gestation
  • The interview includes medical history and details about their illness, other treatments, hospitalization etc.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Afula, Israel
        • Gynecologic department, Haemek medical center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women until 12th week of gestation
  • The women visit the ER because of nausea and vomiting
  • The women didn't received thiamine yet

Exclusion Criteria:

  • Pregnant women over 12th week of gestation
  • Women that received thiamine before
  • women that allergic to the studied drugs

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 1. thiamine
Pregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive thiamine IV
Drug: thiamine & promethazine
thiamine 100 mg IV promethazine 25 mg IV
Active Comparator: 2. promethazine
Pregnant women until 12 week of gestation who refer to the ER because of nausea and vomiting and didn't improve after hydration, will receive promethazine IV
Drug: thiamine & promethazine
thiamine 100 mg IV promethazine 25 mg IV

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the improvement in nausea and/or vomiting after treatment
Time Frame: 2 months after first visit in ER (until 14 week of pregnancy)
2 months after first visit in ER (until 14 week of pregnancy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HaEmek Medical Center, Israel

Investigators

  • Principal Investigator: Yfat Kadan, Haemek Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

February 18, 2009

First Submitted That Met QC Criteria

March 12, 2009

First Posted (Estimate)

March 13, 2009

Study Record Updates

Last Update Posted (Estimate)

June 23, 2015

Last Update Submitted That Met QC Criteria

June 21, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0101-08-EMC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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