Does Thiamine Help Vomiting and Nausea in Pregnancy? | NCT00861523

Studies
Does Thiamine Help Vomiting and Nausea in Pregnancy?

NCT00861523

Sponsor

HaEmek Medical Center, Israel

Status

Terminated

Last Update Posted

Jun 23, 2015Estimated

Enrollment

50Actual

Phase

Phase 3

Conditions

Hyperemesis Gravidarum

Interventions

thiamine & promethazine

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2015

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Difficulties in recruiting patients

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Jan 2012Actual

Completion Date

Jan 2012Actual

First Submitted Date

Feb 18, 2009

First Submission Date that Met QC Criteria

Mar 12, 2009

First Posted Date

Mar 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 21, 2015

Last Update Posted Date

Jun 23, 2015Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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
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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
thiamine & promethazine	Drug	thiamine 100 mg IV promethazine 25 mg IV	1. thiamine 2. promethazine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
the improvement in nausea and/or vomiting after treatment		2 months after first visit in ER (until 14 week of pregnancy)

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Yfat Kadan	haemek medical center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Gynecologic department, Haemek medical center		Afula			Israel

Condition Browse Module

MeSH Terms

ID	Term
D006939	Hyperemesis Gravidarum
D009325	Nausea
D014839	Vomiting

Ancestor Terms

ID	Term
D048968	Morning Sickness
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D013831	Thiamine
D011398	Promethazine

Ancestor Terms

ID	Term
D013844	Thiazoles
D013457	Sulfur Compounds
D009930	Organic Chemicals
D001393	Azoles

Browse Leaves

Not provided

Browse Branches

Not provided