Control of Blood Loss During Caesarean Section

NCT01412073 | Completed Phase 3 DMC

• 1 other identifier: 582011
• Study Type: interventional
• Target: 600
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Complications; Cesarean Section

Keywords

caesarean section, intrapartum haemorrhage

Outcome Measures

Primary Outcomes (1)

• amount of blood loss

  12 month

Secondary Outcomes (1)

• Haemoglobin % and haematocrit value

  12 month

Study Arms (3)

oxytocin bolus

ACTIVE COMPARATOR

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.

Drug: oxytocin

oxytocin bolus & oxytocin infusion

ACTIVE COMPARATOR

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

Drug: oxytocin

misoprostol intrauterine

ACTIVE COMPARATOR

misoprostol 800 micrograms intrauterine, placed manually on the bottom of the uterine cavity after delivery of the placenta and cleaning of the cavity

Drug: Misoprostol

Interventions

oxytocin DRUG

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

Also known as: syntocinon

oxytocin bolus; oxytocin bolus & oxytocin infusion

Misoprostol DRUG

misoprostol intrauterine 800 microgram placed intrauterine after delivery of the baby \& the placenta

Also known as: cytotec

misoprostol intrauterine

Eligibility Criteria

• Age: 25 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

faculty of medicine , Cairo University

Cairo, Cairo Governorate, 12211, Egypt

Location

MeSH Terms

Interventions

Oxytocin; Misoprostol

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins; Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Waleed M El-khayat, M.D.

  Lecturer of Obstetrics & Gynecology , Faculty of medicine, Cairo University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Study Record Dates

• First Submitted: August 5, 2011
• First Posted: August 8, 2011
• Study Start: September 1, 2011
• Primary Completion: September 1, 2014
• Study Completion: October 1, 2014
• Last Updated: October 7, 2014

Record last verified: 2014-10

Locations

EG (1)