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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2011 by Kermanshah University of Medical Sciences.
Recruitment status was:  Not yet recruiting
Kermanshah University of Medical Sciences
Information provided by (Responsible Party):
Soudabeh Eshghi ali, Kermanshah University of Medical Sciences Identifier:
First received: October 31, 2011
Last updated: December 12, 2011
Last verified: December 2011
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.

Condition Intervention Phase
Bleeding Intraoperative
Drug: Misoprostol
Phase 2
Phase 3

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries

Resource links provided by NLM:

Further study details as provided by Kermanshah University of Medical Sciences:

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

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 180
Study Start Date: August 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Misoprostol Drug: Misoprostol
Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia
Other Name: Brand Name: Cytotec, Cyotec, Serial 022-00 , Code A02BB01

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.

Ages Eligible for Study:   15 Years to 44 Years   (Child, Adult)
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01477840

Iran, Islamic Republic of
KUMS Obstetrics & Gynecology Department, Imam Reza Hospital
Kermanshah, Iran, Islamic Republic of, 67144-15333
Sponsors and Collaborators
Soudabeh Eshghi ali
Kermanshah University of Medical Sciences
Study Chair: Anisodowleh Nankali, MD Kermanshah University of Medical Sciences
  More Information

Additional Information:
Responsible Party: Soudabeh Eshghi ali, Obstetrics & Gynecology Department, Kermanshah University of Medical Sciences Identifier: NCT01477840     History of Changes
Other Study ID Numbers: Kermanshah University 
Study First Received: October 31, 2011
Last Updated: December 12, 2011
Health Authority: Iran: Ethics Committee

Keywords provided by Kermanshah University of Medical Sciences:
Cesarean Delivery
Blood Loss

Additional relevant MeSH terms:
Pathologic Processes
Reproductive Control Agents
Physiological Effects of Drugs
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents processed this record on January 14, 2017