Does Thiamine Help Vomiting and Nausea in Pregnancy?

Overview

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.

Full Title of Study: “Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Crossover Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2012

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.

Interventions

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

Arms, Groups and Cohorts

  • 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
  • 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

Clinical Trial Outcome Measures

Primary Measures

  • the improvement in nausea and/or vomiting after treatment
    • Time Frame: 2 months after first visit in ER (until 14 week of pregnancy)

Participating in This Clinical Trial

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

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • HaEmek Medical Center, Israel
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Yfat Kadan, Principal Investigator, haemek medical center

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