Does Thiamine Help Vomiting and Nausea in Pregnancy?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by HaEmek Medical Center, Israel.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
HaEmek Medical Center, Israel
ClinicalTrials.gov Identifier:
NCT00861523
First received: February 18, 2009
Last updated: May 31, 2010
Last verified: May 2010
  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 3

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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Thiamine
Vomiting
Hyperemesis Gravidarum
Signs and Symptoms, Digestive
Signs and Symptoms
Morning Sickness
Pregnancy Complications
Promethazine
Diphenhydramine
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Antipruritics
Dermatologic Agents
Therapeutic Uses
Histamine H1 Antagonists
Histamine Antagonists
Histamine Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Allergic Agents
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014