Control of Blood Loss During Caesarean Section

Complications; Cesarean Section Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01412073
• Other study ID #: 582011
• Status: Completed
• Phase: Phase 3
• First received: August 5, 2011
• Last updated: October 4, 2014
• Start date: September 2011
• Est. completion date: October 2014

Study information

• Verified date: October 2014
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: October 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Complications; Cesarean Section

Intervention

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

Locations

Country	Name	City	State
Egypt	faculty of medicine , Cairo University	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	amount of blood loss		12 month	Yes
Secondary	Haemoglobin % and haematocrit value		12 month	Yes