MedTrace Logo

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

NCT01571323 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 150

Last updated 2012-10-11

No results posted yet for this study

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.

Conditions

  • Post Partum Haemorrhage

Interventions

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 .

Sponsors & Collaborators

  • Qazvin University Of Medical Sciences

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
42 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-02-29
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • Iran

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01571323 on ClinicalTrials.gov