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

History of Changes

Tracking Information
First Received Date ^ICMJE	April 3, 2012
Last Updated Date	October 10, 2012
Start Date ^ICMJE	February 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: April 4, 2012)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01571323 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: April 4, 2012)	Hemodynamic variables [ Time Frame: every 5 minutes during surgery ] [ Designated as safety issue: Yes ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Combined Use of Oxytocin and Misoprostol Versus Oxytocin Infusion and Misoprostol Alone to Reduce Blood Loss at Cesarean Section
Official Title ^ICMJE	Not Provided
Brief Summary	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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 1 Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention
Condition ^ICMJE	Post Partum Haemorrhage
Intervention ^ICMJE	Drug: Misoprostol The misoprostol group (groupM) received 400 µg sublingually and infusion of lactated Ringer ( which one ampoule placebo dissolved it) 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 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 .
Study Arm (s)	Active Comparator: Misoprostol Intervention: Drug: Misoprostol Active Comparator: Oxytocin Intervention: Drug: Oxytocin Active Comparator: Oxytocin and Misoprostol Intervention: Drug: Oxytocin and Misoprostol
Publications *	Not Provided
* 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	Completed
Enrollment ^ICMJE	150
Completion Date	September 2012
Primary Completion Date	August 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Female
Ages	18 Years to 42 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Iran, Islamic Republic of

Administrative Information
NCT Number ^ICMJE	NCT01571323
Other Study ID Numbers ^ICMJE	ACTRN12612000095864
Has Data Monitoring Committee	Yes
Responsible Party	marzieh beigom khezri, Qazvin University Of Medical Sciences
Study Sponsor ^ICMJE	Qazvin University Of Medical Sciences
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Qazvin University Of Medical Sciences
Verification Date	October 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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