Does Thiamine Help Vomiting and Nausea in Pregnancy?

NCT ID: NCT00861523

Last Updated: 2015-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2012-01-31

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.

Conditions

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Hyperemesis Gravidarum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

thiamine & promethazine

Intervention Type DRUG

thiamine 100 mg IV promethazine 25 mg IV

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

Group Type ACTIVE_COMPARATOR

thiamine & promethazine

Intervention Type DRUG

thiamine 100 mg IV promethazine 25 mg IV

Interventions

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thiamine & promethazine

thiamine 100 mg IV promethazine 25 mg IV

Intervention Type DRUG

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
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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HaEmek Medical Center, Israel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yfat Kadan

Role: PRINCIPAL_INVESTIGATOR

haemek medical center

Locations

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Gynecologic department, Haemek medical center

Afula, , Israel

Site Status

Countries

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Israel

Other Identifiers

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0101-08-EMC

Identifier Type: -

Identifier Source: org_study_id

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