Combined Use of Oxytocin and Misoprostol Versus Oxytocin Infusion and Misoprostol Alone to Reduce Blood Loss at Cesarean Section

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
marzieh beigom khezri, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier:
NCT01571323
First received: April 3, 2012
Last updated: October 10, 2012
Last verified: October 2012
  Purpose

The purpose of this study is to demonstrate that the combined used of low dose of oxytocin and misoprostol prevent from post partum haemorrhage better than oxytocin or misoprostol alone at cesarean sectionOne hundred fifty women with singleton term pregnancy undergoing elective or emergency lower segment cesarean section under spinal anesthesia were included in this study. The patients were randomly allocated to one of three groups of 50 each. The oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period, immediately after delivery of the neonate ,The misoprostol group (groupM) received 400 µg sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it) and the combined misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously immediately after delivery of the neonate . The main outcome measures were blood loss at cesarean section, change in hemoglobin levels, need for additional oxytocics and drug related side effects.The volume of blood in the suction bottle was measured, blood soaked sponges and added to volume from suction bottle. Hemoglobin values were determined both before surgery and 24 h following surgery. Hemodynamic variables were recorded every 5 minutes during surgery .The need for additional oxytocic therapy, operating time, infusion volume given intraoperatively, need for blood transfusion, side effects of study drug and any significant puerperal morbidity were also recorded.


Condition Intervention Phase
Post Partum Haemorrhage
Drug: Misoprostol
Drug: Oxytocin
Drug: Oxytocin and Misoprostol
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention

Resource links provided by NLM:


Further study details as provided by Qazvin University Of Medical Sciences:

Primary Outcome Measures:
  • changes in hemoglobin levels after delivery [ Time Frame: Hemoglobin values will be determined both before surgery and 24 h following surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Hemodynamic variables [ Time Frame: every 5 minutes during surgery ] [ Designated as safety issue: Yes ]

Enrollment: 150
Study Start Date: February 2012
Study Completion Date: September 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Misoprostol Drug: Misoprostol
The misoprostol group (groupM) received 400 µg sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it)
Active Comparator: Oxytocin Drug: Oxytocin
The oxytocin group(group O) received intravenous infusion of 20 units of oxytocin soon after delivery of the neonate and one tablet of placebo sublingually. (20 IU syntocinon dissolved in 1liter of lactated Ringer's solution) at the rate of 1000 ml over a 1h period, immediately after delivery of the neonate
Active Comparator: Oxytocin and Misoprostol Drug: Oxytocin and Misoprostol
The combined misoprostol-oxytocin group(group MO) received 200 µg and 5 iu oxytocin bolus intravenously immediately after delivery of the neonate .

  Eligibility

Ages Eligible for Study:   18 Years to 42 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • pregnant women at term (37—40 wks) gestation scheduled for either elective or emergency lower segment cesarean section

Exclusion Criteria:

  • women with any risk factor
  • associated with an increased risk of postpartum
  • hemorrhage were excluded i.e. anemia (Hb8 g%), multiple gestation, antepartum hemorrhage,poly-hydramnios, two or more previous cesarean sections and/or a history of previous rupture uterus.
  • current or previous history of significant disease including heart disease, liver, renal disorders or known coagulopathy
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01571323

Locations
Iran, Islamic Republic of
Qazvin Medical University Science
Qazvin, Iran, Islamic Republic of, 3419759811
Sponsors and Collaborators
Qazvin University Of Medical Sciences
  More Information

No publications provided

Responsible Party: marzieh beigom khezri, assistant professor, Qazvin University Of Medical Sciences
ClinicalTrials.gov Identifier: NCT01571323     History of Changes
Other Study ID Numbers: ACTRN12612000095864
Study First Received: April 3, 2012
Last Updated: October 10, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Qazvin University Of Medical Sciences:
post partum haemorrhage at cesarean section

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Anti-Ulcer Agents
Gastrointestinal Agents

ClinicalTrials.gov processed this record on September 18, 2014