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

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.

Study Overview

• Status: Completed
• Conditions: Post Partum Haemorrhage
• Intervention / Treatment: Drug: Misoprostol; Drug: Oxytocin; Drug: Oxytocin and Misoprostol

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Iran, Islamic Republic of
  • Qazvin, Iran, Islamic Republic of, 3419759811
    • Qazvin Medical University Science

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 42 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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 .

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
changes in hemoglobin levels after delivery	Hemoglobin values will be determined both before surgery and 24 h following surgery

Secondary Outcome Measures

Outcome Measure	Time Frame
Hemodynamic variables	every 5 minutes during surgery

Collaborators and Investigators

• Sponsor: Qazvin University Of Medical Sciences

Study record dates

Study Major Dates

• Study Start: February 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: April 3, 2012
• First Submitted That Met QC Criteria: April 4, 2012
• First Posted (Estimate): April 5, 2012

Study Record Updates

• Last Update Posted (Estimate): October 11, 2012
• Last Update Submitted That Met QC Criteria: October 10, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: post partum haemorrhage at cesarean section
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Oxytocin; Misoprostol
• Other Study ID Numbers: ACTRN12612000095864