Does Thiamine Help Vomiting and Nausea in Pregnancy?

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StatusTerminated

Keywords

gerstmann-straussler-scheinker disease

Abstract

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.

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.

Dates

Last Verified:	05/31/2015
First Submitted:	02/17/2009
Estimated Enrollment Submitted:	03/11/2009
First Posted:	03/12/2009
Last Update Submitted:	06/20/2015
Last Update Posted:	06/22/2015
Actual Study Start Date:	01/31/2009
Estimated Primary Completion Date:	12/31/2011
Estimated Study Completion Date:	12/31/2011

Condition or disease

Hyperemesis Gravidarum

Intervention/treatment

Drug: thiamine & promethazine

Phase

Phase 3

Arm Groups

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
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

Eligibility Criteria

Ages Eligible for Study	18 Years To 18 Years
Sexes Eligible for Study	Female
Accepts Healthy Volunteers	Yes
Criteria	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

Outcome

Primary Outcome Measures

1. the improvement in nausea and/or vomiting after treatment [2 months after first visit in ER (until 14 week of pregnancy)]