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

NCT ID: NCT01477840

Last Updated: 2011-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2/PHASE3

Total Enrollment

180 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2012-08-31

Brief Summary

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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

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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.

Conditions

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Bleeding Intraoperative

Keywords

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Misoprostol Oxytocin Cesarean Delivery Blood Loss

Study Design

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Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Misoprostol

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia

Interventions

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Misoprostol

Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia

Intervention Type DRUG

Other Intervention Names

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Brand Name: Cytotec, Cyotec, Serial 022-00 , Code A02BB01

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Maximum Eligible Age

44 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Kermanshah University of Medical Sciences

OTHER

Sponsor Role collaborator

Soudabeh Eshghi ali

OTHER

Sponsor Role lead

Responsible Party

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Soudabeh Eshghi ali

Obstetrics & Gynecology Department

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Anisodowleh Nankali, MD

Role: STUDY_CHAIR

Kermanshah University of Medical Sciences

Locations

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KUMS Obstetrics & Gynecology Department, Imam Reza Hospital

Kermanshah, Kermanshah Province, Iran

Site Status

Countries

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Iran

Central Contacts

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Anisodowleh Nankali, MD

Role: CONTACT

Phone: 98 831 4276310

Email: [email protected]

Facility Contacts

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Anisodowleh Nankali, MD

Role: primary

References

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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.

Reference Type RESULT
PMID: 19757270 (View on PubMed)

Other Identifiers

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Kermanshah University

Identifier Type: -

Identifier Source: org_study_id