Does Thiamine Help Vomiting and Nausea in Pregnancy?

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy

Conditions
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Hyperemesis Gravidarum

Intervention / Treatment
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* Drug: thiamine & promethazine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1. thiamine<br>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<br>* thiamine 100 mg IV promethazine 25 mg IV<br>|
| Active Comparator: 2. promethazine<br>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<br>* thiamine 100 mg IV promethazine 25 mg IV<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the improvement in nausea and/or vomiting after treatment |  | 2 months after first visit in ER (until 14 week of pregnancy) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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nausea, vomiting, pregnancy, thiamine, promethazine, nausea and vomiting in pregnancy