Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

April 3, 2012
October 10, 2012
February 2012
August 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01571323 on ClinicalTrials.gov Archive Site
Hemodynamic variables [ Time Frame: every 5 minutes during surgery ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Combined Use of Oxytocin and Misoprostol Versus Oxytocin Infusion and Misoprostol Alone to Reduce Blood Loss at Cesarean Section
Not Provided

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Post Partum Haemorrhage
  • 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 .
  • Active Comparator: Misoprostol
    Intervention: Drug: Misoprostol
  • Active Comparator: Oxytocin
    Intervention: Drug: Oxytocin
  • Active Comparator: Oxytocin and Misoprostol
    Intervention: Drug: Oxytocin and Misoprostol
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
150
September 2012
August 2012   (final data collection date for primary outcome measure)

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
Female
18 Years to 42 Years
No
Contact information is only displayed when the study is recruiting subjects
Iran, Islamic Republic of
 
NCT01571323
ACTRN12612000095864
Yes
marzieh beigom khezri, Qazvin University Of Medical Sciences
Qazvin University Of Medical Sciences
Not Provided
Not Provided
Qazvin University Of Medical Sciences
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP