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

This study is not yet open for participant recruitment.

Verified December 2011 by Kermanshah University of Medical Sciences

Sponsor:

Collaborator:

Kermanshah University of Medical Sciences

Information provided by (Responsible Party):

Soudabeh Eshghi ali, Kermanshah University of Medical Sciences

ClinicalTrials.gov Identifier:

NCT01477840

First received: October 31, 2011

Last updated: December 12, 2011

Last verified: December 2011

History of Changes

Tracking Information

First Received Date ^ICMJE

October 31, 2011

Last Updated Date

December 12, 2011

Start Date ^ICMJE

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Intraoperative bleeding [ Time Frame: At the time of surgery ] [ Designated as safety issue: Yes ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01477840 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Fever [ Time Frame: During 48 hours after surgery measured every 3 hours ] [ Designated as safety issue: Yes ]
Changing of pulse rate from base [ Time Frame: Before surgery & intraoperative & 6 hours after surgery ] [ Designated as safety issue: Yes ]
Changing of blood pressure [ Time Frame: Before surgery & intraoperative & 6 hours after surgery ] [ Designated as safety issue: Yes ]
Diarrhea [ Time Frame: Before & 6 hours after surgery ] [ Designated as safety issue: Yes ]
Vomiting [ Time Frame: Before & 6 hours after surgery ] [ Designated as safety issue: Yes ]

Original Secondary Outcome Measures ^ICMJE

Fever [ Time Frame: During 48 hrs after surgery measured every 3 hours ] [ Designated as safety issue: Yes ]
Changing of pulse rate from basment [ Time Frame: Before surgery & intraoperative & 6 hrs after surgery ] [ Designated as safety issue: Yes ]
Changing of blood pressure [ Time Frame: Before surgery & intraoperative & 6 hrs after surgery ] [ Designated as safety issue: Yes ]
Diarrehea [ Time Frame: Before & 6 hrs after surgery ] [ Designated as safety issue: Yes ]
Vomiting [ Time Frame: Before & 6 hrs after surgery ] [ Designated as safety issue: Yes ]

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 2
Phase 3

Study Design ^ICMJE

Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention

Condition ^ICMJE

Bleeding Intraoperative

Intervention ^ICMJE

Drug: Misoprostol

Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia

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

Study Arm (s)

Experimental: Misoprostol

Intervention: Drug: Misoprostol

Publications *

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.

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

180

Estimated Completion Date

August 2012

Estimated Primary Completion Date

August 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Female

Ages

15 Years to 44 Years

Accepts Healthy Volunteers

Yes

Contacts ^ICMJE

Contact: Anisodowleh Nankali, MD

98 831 4276310

anankali@kums.ac.ir

Location Countries ^ICMJE

Iran, Islamic Republic of

Administrative Information

NCT Number ^ICMJE

NCT01477840

Other Study ID Numbers ^ICMJE

Kermanshah University

Has Data Monitoring Committee

Yes

Responsible Party

Soudabeh Eshghi ali, Kermanshah University of Medical Sciences

Study Sponsor ^ICMJE

Soudabeh Eshghi ali

Collaborators ^ICMJE

Kermanshah University of Medical Sciences

Investigators ^ICMJE

Study Chair:

Anisodowleh Nankali, MD

Kermanshah University of Medical Sciences

Information Provided By

Kermanshah University of Medical Sciences

Verification Date

December 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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