Comparison of Sublingual Misoprostol and Intravenous Oxyt... | NCT01612390

Studies
Comparison of Sublingual Misoprostol and Intravenous Oxytocin in Active Management of the Third Stage of Labor

NCT01612390

Sponsor

Rasha Mohammed Mohammed Badawi

Status

Unknown status

Last Update Posted

Jun 5, 2012Estimated

Enrollment

180Estimated

Phase

Not provided

Conditions

Postpartum Hemorrhage Prevention by Using Oxytocin Verses Misoprostol

Interventions

Not provided

Countries

Egypt

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 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2012

Primary Completion Date

Aug 2013Estimated

Completion Date

Dec 2013Estimated

First Submitted Date

Jun 2, 2012

First Submission Date that Met QC Criteria

Jun 4, 2012

First Posted Date

Jun 5, 2012Estimated

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 4, 2012

Last Update Posted Date

Jun 5, 2012Estimated

Name	Class
Ain Shams University	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor

Detailed Description

Sublingual misoprostol is superior to oxytocin in reduction of blood loss during the third and fourth stages of labor as The data from a pharmacokinetics study suggested that the bioavaiblitiy of misoprostol after sub-lingual administration was higher than those after oral or vaginal administration

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

180Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
group 1		receive 400 Mg sublingual misoprostol.
group 2		receive 600 Mg sublingual misoprostol.
group 3		receive 5IU of intravenous oxytocin.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
reduce blood loss during third and fourth stages of labor.	reduce blood loss during third and fourth stages of labor by using misopristol is better than using oxytocin	1 year

Secondary Outcomes

Measure	Description	Time Frame
the duration of the third stage of labor ,need for oxytocics ,blood transfusion and any adverse effects of the drugs	the duration of the third stage of labor ,needed for oxytocics ,blood transfusion and any adverse effects of the drug will be reduced with mesopristol	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Women with aheathy singleton pregnancy in spontaneous or induced labor at term .

Exclusion Criteria:

Hypersensitivity/Contraindication to prostaglandins Antepartum hemorrhage Multiple pregnancy Cardiac disease Malpresentation Rhesus- negative mother hypersensitive disorders Severe anaemia(hemoglobin<7g/dl)

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

The study will include (180)randomly allocated

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Rasha mohamed, M.B;B.CH	Contact			abosalma_82@yahoo.com

Overall Officials

Name	Affiliation	Role
RBadawi mohamed, M.B;B.CH	Ain Shams University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
AinShamsU		Cairo		44511	Egypt

Condition Browse Module

MeSH Terms

ID	Term
D006473	Postpartum Hemorrhage

Ancestor Terms

ID	Term
D007744	Obstetric Labor Complications
D011248	Pregnancy Complications
D005261	Female Urogenital Diseases and Pregnancy Complications
D000091642	Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided