Does Thiamine Help Vomiting and Nausea in Pregnancy?

Sponsor

HaEmek Medical Center, Israel (Other)

Overall Status

Terminated

CT.gov ID

NCT00861523

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hyperemesis Gravidarum	Drug: thiamine & promethazine	Phase 3

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 Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Feb 1, 2009

Actual Primary Completion Date :

Jan 1, 2012

Actual Study Completion Date :

Jan 1, 2012

Arms and Interventions

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

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