NCT01412073

Control of Blood Loss During Caesarean Section

A Randomized Trial to Determine the Best Strategy for the Control of Blood Loss at Elective Caesarean Section

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 600 (actual)
• Sponsor: Cairo University · Academic / Other
• Sex: Female
• Age: 25 Years – 40 Years
• Healthy volunteers: Accepted

Summary

trial of 3 protocols to determine the best one to control blood loss during caesarean section

Detailed description

The study population will be divided into 3 groups each containing 200 women: Group (A): 200 patients will receive 5-IU oxytocin bolus over 3 minutes after delivery of the baby. Group (B): 200 patients will receive 5-IU oxytocin bolus over 3 minutes and 30-IU oxytocin infusion in 500 ml 0.9 % saline over 4 hours after delivery of the baby. Group (C): 200 patients will receive misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity. Operative blood loss will be estimated in theatre based on the volume in the suction bottle and the weight of swabs used. We will record blood loss up until the time the woman will be discharged from the theatre recovery ward. Hemoglobin level and haematocrit value will be done as follow:- 1. After admission of each case in the pre-operative period. 2. Immediately post- operative. 3. 24 hours post- operative.

Conditions

• Complications; Cesarean Section

Interventions

Type	Name	Description
DRUG	oxytocin	group I : oxytocin 5 IU bolus over 3 minutes after delivery of the baby group II : oxytocin 5 IU bolus over 3 minutes after delivery of the baby and oxytocin infusion in 500 ml 0.9% saline over 4 hours
DRUG	Misoprostol	misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby \& the placenta

Timeline

• Start date: 2011-09-01
• Primary completion: 2014-09-01
• Completion: 2014-10-01
• First posted: 2011-08-08
• Last updated: 2014-10-07

Locations

1 site across 1 country: Egypt