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Does Thiamine Help Vomiting and Nausea in Pregnancy?

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

Status
Terminated
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00861523
Enrollment
50
Registered
2009-03-13
Start date
2009-02-28
Completion date
2012-01-31
Last updated
2015-06-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hyperemesis Gravidarum

Keywords

nausea, vomiting, pregnancy, thiamine, promethazine, nausea and vomiting in pregnancy

Brief 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.

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

DRUGthiamine & promethazine

thiamine 100 mg IV promethazine 25 mg IV

Sponsors

HaEmek Medical Center, Israel
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
the improvement in nausea and/or vomiting after treatment2 months after first visit in ER (until 14 week of pregnancy)

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026