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

Bleeding Intraoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01477840
• Other study ID #: Kermanshah University
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• First received: October 31, 2011
• Last updated: December 12, 2011
• Start date: August 2012
• Est. completion date: August 2012

Study information

• Verified date: December 2011
• Source: Kermanshah University of Medical Sciences
• Contact: Anisodowleh Nankali, MD
• Phone: 98 831 4276310
• Email: anankali[@]kums.ac.ir
• Is FDA regulated: No
• Health authority: Iran: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 180
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 15 Years to 44 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Bleeding Intraoperative

Intervention

Drug:
• Misoprostol
Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia

Locations

Country	Name	City	State
Iran, Islamic Republic of	KUMS Obstetrics & Gynecology Department, Imam Reza Hospital	Kermanshah

Sponsors (2)

Lead Sponsor	Collaborator
Soudabeh Eshghi ali	Kermanshah University of Medical Sciences

Country where clinical trial is conducted

Iran, Islamic Republic of, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative bleeding		At the time of surgery	Yes
Secondary	Fever		During 48 hours after surgery measured every 3 hours	Yes
Secondary	Changing of pulse rate from base		Before surgery & intraoperative & 6 hours after surgery	Yes
Secondary	Changing of blood pressure		Before surgery & intraoperative & 6 hours after surgery	Yes
Secondary	Diarrhea		Before & 6 hours after surgery	Yes
Secondary	Vomiting		Before & 6 hours after surgery	Yes

External Links

•   http://www.ncbi.nlm.nih.gov/pubmed?term=eftekhari%20n%2C%20doroodian%20m%2C%20lashkarizadeh%20r.