Does Thiamine Help Vomiting and Nausea in Pregnancy?

Hyperemesis Gravidarum Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00861523
• Other study ID #: 0101-08-EMC
• Status: Terminated
• Phase: Phase 3
• First received: February 18, 2009
• Last updated: June 21, 2015
• Start date: February 2009
• Est. completion date: January 2012

Study information

• Verified date: June 2015
• Source: HaEmek Medical Center, Israel
• Contact: n/a
• Is FDA regulated: No
• Health authority: israel: helsinky comittee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 50
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperemesis Gravidarum
• Vomiting

Intervention

Drug:
• thiamine & promethazine
thiamine 100 mg IV promethazine 25 mg IV

Locations

Country	Name	City	State
Israel	Gynecologic department, Haemek medical center	Afula

Sponsors (1)

Lead Sponsor	Collaborator
HaEmek Medical Center, Israel

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	the improvement in nausea and/or vomiting after treatment		2 months after first visit in ER (until 14 week of pregnancy)	No