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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2011 by Kermanshah University of Medical Sciences.
Recruitment status was  Not yet recruiting
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
  Purpose

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.

  Eligibility

Ages Eligible for Study:   15 Years to 44 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01477840

Contacts
Contact: Anisodowleh Nankali, MD 98 831 4276310 anankali@kums.ac.ir

Locations
Iran, Islamic Republic of
KUMS Obstetrics & Gynecology Department, Imam Reza Hospital Recruiting
Kermanshah, Iran, Islamic Republic of, 67144-15333
Contact: Anisodowleh Nankali, MD    98 831 4276310    anankali@kums.ac.ir   
Principal Investigator: Soudabeh Eshghi Ali, MD         
Sponsors and Collaborators
Soudabeh Eshghi ali
Kermanshah University of Medical Sciences
Investigators
Study Chair: Anisodowleh Nankali, MD Kermanshah University of Medical Sciences
  More Information

Additional Information:
Publications:
Responsible Party: Soudabeh Eshghi ali, Obstetrics & Gynecology Department, Kermanshah University of Medical Sciences
ClinicalTrials.gov 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:
Misoprostol
Oxytocin
Cesarean Delivery
Blood Loss

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
Misoprostol
Oxytocin
Abortifacient Agents
Abortifacient Agents, Nonsteroidal
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 20, 2014