Does Thiamine Help Vomiting and Nausea in Pregnancy?

NCT00861523 | Terminated Phase 3

• 1 other identifier: 0101-08-EMC
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperemesis Gravidarum

Keywords

nausea; vomiting; pregnancy; thiamine; promethazine; nausea and vomiting in pregnancy

Outcome Measures

Primary Outcomes (1)

• the improvement in nausea and/or vomiting after treatment

  2 months after first visit in ER (until 14 week of pregnancy)

Study Arms (2)

1. thiamine

ACTIVE COMPARATOR

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

2. promethazine

ACTIVE COMPARATOR

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

Interventions

thiamine & promethazine DRUG

thiamine 100 mg IV promethazine 25 mg IV

1. thiamine; 2. promethazine

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• HaEmek Medical Center, Israel: lead

Study Sites (1)

Gynecologic department, Haemek medical center

Afula, Israel

Location

MeSH Terms

Conditions

Hyperemesis Gravidarum; Nausea; Vomiting

Interventions

Thiamine; Promethazine

Condition Hierarchy (Ancestors)

Morning Sickness; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Propylamines; Amines; Phenothiazines; Heterocyclic Compounds, 3-Ring; Heterocyclic Compounds, Fused-Ring

Study Officials

• Yfat Kadan

  haemek medical center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2009
• First Posted: March 13, 2009
• Study Start: February 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

IL (1)