Comparative of Effects of Sublingual Misoprostol and Infu... | NCT01477840

Studies
Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean

NCT01477840

Sponsor

Soudabeh Eshghi ali

Status

Unknown status

Last Update Posted

Dec 13, 2011Estimated

Enrollment

180Estimated

Phase

Phase 2Phase 3

Conditions

Bleeding Intraoperative

Interventions

Misoprostol

Countries

Iran

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

Dec 2011

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 2012Estimated

Completion Date

Aug 2012Estimated

First Submitted Date

Oct 31, 2011

First Submission Date that Met QC Criteria

Nov 19, 2011

First Posted Date

Nov 23, 2011Estimated

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

Dec 12, 2011

Last Update Posted Date

Dec 13, 2011Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soudabeh Eshghi ali, Obstetrics & Gynecology Department, Kermanshah University of Medical SciencesSponsor-Investigator

Lead Sponsor

Soudabeh Eshghi aliOTHER

Collaborators

Name	Class
Kermanshah University of Medical Sciences	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

The purpose of this study is to determine whether the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries.

Detailed Description

A total of 180 pregnant women with gestational age 37 weeks and over who underwent cesarean operation in Imam Reza hospital had elective or emergency procedure with incision in lower segment during one year recruitment. The patients were randomly assigned to undergo 200 micrograms misoprostol sublingual or 400 micrograms and infusion 20 unit oxytocin after spinal anesthesia. Main outcome measures: The length of surgery, bleeding volume, the need for transfusion, fever, tachycardia, and hypotension.

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 2Phase 3

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
Misoprostol	Experimental		Drug: Misoprostol

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Misoprostol	Drug	Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia	Misoprostol

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraoperative bleeding		At the time of surgery

Secondary Outcomes

Measure	Description	Time Frame
Fever		During 48 hours after surgery measured every 3 hours
Changing of pulse rate from base		Before surgery & intraoperative & 6 hours after surgery
Changing of blood pressure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Indication of Cesarean Deliveries
Elective or Emergency with Incision in Lower Segment in Women with
Gestational Age more than 37 Weeks.

Exclusion Criteria:

Anemia
Multiple Pregnancy
Polyhydraminus
Prolonged Labor
Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus
Hypertension
Cardiovascular Disease
Coagulopathy Disease

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

15 Years

Maximum Age

44 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Anisodowleh Nankali, MD	Contact	98 831 4276310		anankali@kums.ac.ir

Overall Officials

Name	Affiliation	Role
Anisodowleh Nankali, MD	Kermanshah University of Medical Sciences	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
KUMS Obstetrics & Gynecology Department, Imam Reza Hospital		Kermanshah	Kermanshah Province	67144-15333	Iran

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19757270	Result	Eftekhari N, Doroodian M, Lashkarizadeh R. The effect of sublingual misoprostol versus intravenous oxytocin in reducing bleeding after caesarean section. J Obstet Gynaecol. 2009 Oct;29(7):633-6. doi: 10.1080/01443610903061744.

ID	Term
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

ID	Term
D011459	Prostaglandins E, Synthetic
D011465	Prostaglandins, Synthetic
D011453	Prostaglandins
D015777	Eicosanoids