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| Sponsored by: |
HaEmek Medical Center, Israel |
|---|---|
| Information provided by: | HaEmek Medical Center, Israel |
| ClinicalTrials.gov Identifier: | NCT00861523 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Hyperemesis Gravidarum |
Drug: thiamine & promethazine |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Active Control, Crossover Assignment |
| Official Title: | Comparison Between the Treatment of Thiamine and Promethazine for Improving Vomiting and Nausea in Pregnancy |
| Estimated Enrollment: | 280 |
| Study Start Date: | February 2009 |
| Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1. thiamine: Active Comparator
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
thiamine 100 mg IV promethazine 25 mg IV
|
|
2. promethazine: Active Comparator
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
thiamine 100 mg IV promethazine 25 mg IV
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Yfat Kadan, MD | 972-4-6494331 | yfat_ka@bclalit.org.il; kadana@bezeqint.net |
| Israel | |
| Gynecologic department, Haemek medical center | Recruiting |
| Afula, Israel | |
| Principal Investigator: | Yfat Kadan | Haemek medical center |
More Information
| Responsible Party: | yfat kadan ( Dep. of OB/GYN, HaEmek Medical Center ) |
| Study ID Numbers: | 0101-08-EMC |
| Study First Received: | February 18, 2009 |
| Last Updated: | March 12, 2009 |
| ClinicalTrials.gov Identifier: | NCT00861523 History of Changes |
| Health Authority: | israel: helsinky comittee |
|
nausea vomiting pregnancy |
thiamine promethazine nausea and vomiting in pregnancy |
|
Neurotransmitter Agents Pregnancy Complications Vomiting Signs and Symptoms, Digestive Antiemetics Anesthetics Signs and Symptoms Promethazine Vitamins Hypnotics and Sedatives Thiamin Antipruritics Nausea Micronutrients |
Vitamin B Complex Thiamine Central Nervous System Depressants Trace Elements Anti-Allergic Agents Anesthetics, Local Histamine Hyperemesis Gravidarum Vitamin B1 Histamine Antagonists Histamine phosphate Histamine H1 Antagonists Peripheral Nervous System Agents Diphenhydramine |
|
Neurotransmitter Agents Pregnancy Complications Vomiting Signs and Symptoms, Digestive Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Anesthetics Antiemetics Signs and Symptoms Promethazine Sensory System Agents Vitamins Therapeutic Uses Hypnotics and Sedatives Antipruritics |
Micronutrients Dermatologic Agents Vitamin B Complex Growth Substances Thiamine Gastrointestinal Agents Central Nervous System Depressants Histamine Agents Anti-Allergic Agents Anesthetics, Local Pharmacologic Actions Hyperemesis Gravidarum Histamine Antagonists Autonomic Agents Histamine H1 Antagonists |
