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Hyperemesis Gravidarum | Does Thiamine Help Vomiting and Nausea in Pregnancy?

Hyperemesis Gravidarum research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Hyperemesis Gravidarum

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:thiamine 100 mg IV promethazine 25 mg IV

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

1. thiaminePregnant 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

2. promethazinePregnant 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

Study Status

Terminated

Start Date: February 2009

Completed Date: January 2012

Phase: Phase 3

Type: Interventional

Design:

Primary Outcome: the improvement in nausea and/or vomiting after treatment

Secondary Outcome:

Study sponsors, principal investigator, and references

Principal Investigator: Yfat Kadan

Lead Sponsor: HaEmek Medical Center, Israel

Collaborator:

More information:https://clinicaltrials.gov/show/NCT00861523

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