Does Thiamine Help Vomiting and Nausea in Pregnancy?

HaEmek Medical Center, Israel

Status and phase: Terminated; Phase 3

Conditions: Hyperemesis Gravidarum

Treatments: Drug: thiamine & promethazine

Study type: Interventional

Funder types: Other

Identifiers

NCT00861523

0101-08-EMC

Details and patient eligibility

About

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 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.

Enrollment: 50 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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50 participants in 2 patient groups

1. thiamine

Active Comparator group

Description:

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

Treatment:

Drug: thiamine & promethazine

2. promethazine

Active Comparator group

Description:

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

Treatment:

Drug: thiamine & promethazine