Control of Blood Loss During Caesarean Section

Cairo University (CU)

Status and phase: Completed; Phase 3

Conditions: Complications; Cesarean Section

Treatments: Drug: Misoprostol; Drug: oxytocin

Study type: Interventional

Funder types: Other

Identifiers

NCT01412073

582011

Details and patient eligibility

About

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

Full 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.

Enrollment: 600 patients

Sex: Female

Ages: 25 to 40 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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600 participants in 3 patient groups

oxytocin bolus

Active Comparator group

Description:

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.

Treatment:

Drug: oxytocin

oxytocin bolus & oxytocin infusion

Active Comparator group

Description:

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

Treatment:

Drug: oxytocin

misoprostol intrauterine

Active Comparator group

Description:

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

Treatment:

Drug: Misoprostol