Does Thiamine Help Vomiting and Nausea in Pregnancy?

Phase 3

Terminated

• Conditions: Hyperemesis Gravidarum
• Interventions: Drug: thiamine & promethazine

• Registration Number: NCT00861523
• Lead Sponsor: HaEmek Medical Center, Israel

Brief Summary

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.

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 Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-18
• Study First Submitted QC: 2009-03-12
• Study First Posted: 2009-03-13
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Status Verified: 2015-06
• Last Update Submitted: 2015-06-21
• Last Update Posted: 2015-06-23

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
1. thiamine	thiamine & 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 thiamine IV
2. promethazine	thiamine & 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

Primary Outcome Measures

Name	Time	Method
the improvement in nausea and/or vomiting after treatment	2 months after first visit in ER (until 14 week of pregnancy)

Trial Locations

Locations (1)

Gynecologic department, Haemek medical center; 🇮🇱 Afula, Israel