Does Thiamine Help Vomiting and Nausea in Pregnancy? - Full Text View

Sponsor:	HaEmek Medical Center, Israel
Information provided by:	HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:	NCT00861523

Purpose

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	Intervention	Phase
Hyperemesis Gravidarum	Drug: thiamine & promethazine	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Crossover Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy

Resource links provided by NLM:

MedlinePlus related topics: Nausea and Vomiting

Drug Information available for: Promethazine hydrochloride Diphenhydramine Thiamine Promethazine Thiamine hydrochloride Diphenhydramine citrate Diphenhydramine hydrochloride Thiamine nitrate

U.S. FDA Resources

Further study details as provided by HaEmek Medical Center, Israel:

Primary Outcome Measures:

the improvement in nausea and/or vomiting after treatment [ Time Frame: 2 months after first visit in ER (until 14 week of pregnancy) ] [ Designated as safety issue: No ]

Estimated Enrollment:	280
Study Start Date:	February 2009
Estimated Primary Completion Date:	April 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00861523

Contacts

Contact: Yfat Kadan, MD

972-4-6494331

yfat_ka@bclalit.org.il; kadana@bezeqint.net

Locations

Israel
Gynecologic department, Haemek medical center	Recruiting
Afula, Israel

Sponsors and Collaborators

HaEmek Medical Center, Israel

Investigators

Principal Investigator:

Yfat Kadan

Haemek medical center

More Information

No publications provided

Responsible Party:	Dep. of OB/GYN, HaEmek Medical Center, yfat kadan
ClinicalTrials.gov Identifier:	NCT00861523 History of Changes
Other Study ID Numbers:	0101-08-EMC
Study First Received:	February 18, 2009
Last Updated:	May 31, 2010
Health Authority:	israel: helsinky comittee

Keywords provided by HaEmek Medical Center, Israel:

nausea
vomiting
pregnancy

thiamine
promethazine
nausea and vomiting in pregnancy

Additional relevant MeSH terms:

Hyperemesis Gravidarum
Nausea
Vomiting
Morning Sickness
Pregnancy Complications
Signs and Symptoms, Digestive
Signs and Symptoms
Promethazine
Diphenhydramine
Thiamine
Antipruritics
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Histamine H1 Antagonists

Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Anti-Allergic Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Gastrointestinal Agents
Hypnotics and Sedatives
Central Nervous System Depressants
Anesthetics, Local
Anesthetics

ClinicalTrials.gov processed this record on February 09, 2012