Does Thiamine Help Vomiting and Nausea in Pregnancy?
Information source: HaEmek Medical Center, Israel
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Hyperemesis Gravidarum
Intervention: thiamine & promethazine (Drug)
Phase: Phase 3
Status: Terminated
Sponsored by: HaEmek Medical Center, Israel Official(s) and/or principal investigator(s):
Yfat Kadan, Principal Investigator, Affiliation: haemek medical center
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.
Clinical Details
Official title: Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy
Study design: Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: the improvement in nausea and/or vomiting after treatment
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
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Female.
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
Locations and Contacts
Gynecologic department, Haemek medical center, Afula, Israel
Additional Information
Starting date: February 2009
Last updated: June 21, 2015
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