Control of Blood Loss During Caesarean Section

Phase 3

Completed

• Conditions: Complications; Cesarean Section
• Interventions: Drug: Misoprostol; Drug: oxytocin

• Registration Number: NCT01412073
• Lead Sponsor: Cairo University

Brief 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.

Study Timeline

• Study First Submitted: 2011-08-05
• Study First Submitted QC: 2011-08-05
• Study First Posted: 2011-08-08
• Study Start: 2011-09
• Primary Completion: 2014-09
• Status Verified: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2014-10-04
• Last Update Posted: 2014-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 600

Inclusion Criteria

• Patients booked for elective cesarean section.
• Singleton pregnancies.
• Primigravida or multipara ,first cesarean section or previous .

Exclusion Criteria

• Patients with obstetric hemorrhage.
• Uterine laceration.
• Placenta previa.
• Blood dyscrasias.
• Large fibroids.
• Multiple pregnancy.
• Pre-eclampsia.
• Marked maternal anemia.
• Previous history of PPH.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
misoprostol intrauterine	Misoprostol	misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity
oxytocin bolus & oxytocin infusion	oxytocin	5 IU oxytoxin bolus over 3 minutes and 30 IU oxytocin infusion in 500 ml 0.9% saline over 4 hours after delivery of the baby
oxytocin bolus	oxytocin	5 IU bolus iv over 3 minutes after delivery of the baby 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.

Primary Outcome Measures

Name	Time	Method
amount of blood loss	12 month

Secondary Outcome Measures

Name	Time	Method
Haemoglobin % and haematocrit value	12 month

Trial Locations

Locations (1)

faculty of medicine , Cairo University; 🇪🇬 Cairo, Egypt