Oxytocin Administration During Cesarean Section

Phase 4

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: Oxytocin

• Registration Number: NCT03344302
• Lead Sponsor: Assiut University

Brief Summary

Cesarean delivery is defined as fetal birth through incisions in the abdominal wall and the uterine wall. This definition does not include removal of the fetus from the abdominal cavity in the case of uterine rupture or in the case of an abdominal pregnancy The guidelines of the Royal College of Obstetricians and Gynaecologists on caesarean section recommend a slow intravenous bolus dose of 5 IU of oxytocin after delivery of the infant. Intravenous oxytocin has a short half life (4-10 minutes); therefore the potential advantage of an oxytocin infusion at caesarean section is in maintaining uterine contractility throughout the surgical procedure and immediate postpartum period, when most primary haemorrhage occurs

Detailed Description

Not available

Study Timeline

• Study Start: 2016-10
• Primary Completion: 2017-08
• Study Completion: 2017-09
• Study First Submitted: 2017-11-13
• Study First Submitted QC: 2017-11-13
• Study First Posted: 2017-11-17
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-20
• Last Update Posted: 2018-04-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

• Primigravida or multigravida
• Term (37 - 42 weeks),
• Singleton pregnancies
• Booked for elective caesarean section.
• Accepting to participate in the study.

Exclusion Criteria

• • Medical disorders involving the heart, liver, kidney or brain.

  • Diabetes mellitus and hypertension.
  • Blood disorders (e.g. coagulopathies, thrombocytopenia)
  • Patients requiring blood transfusion due to anemia.
  • Risk factors for uterine atony e.g. macrosomia, polyhydramnios and multiple pregnancy.
  • Previous 2 or more cesarean section
  • Placenta previa or placental abruption
  • Previous major obstetric haemorrhage (>1000 ml) in previous deliveries.
  • Known fibroid or adenomyosis.
  • Women who received anticoagulant therapy.
  • Severe preeclampsis.
  • Uterine anomalies.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
study group	Oxytocin	100 women were assigned to receive an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour minutes diluted into 500 mL of normal 0.9% sodium chloride) immediately after opening the visceral peritoneum just before incising the uterine wall during Cesarean section
Control group	Oxytocin	100 women were assigned to an intravenous infusion of oxytocin 30 units in a rate 125 mL/hour diluted into 500 mL of normal 0.9% sodium chloride) immediately after clamping the umbilical cord during cesarean section

Primary Outcome Measures

Name	Time	Method
rate of blood loss	4 hours	collection of the blood in the drape below the patient

Trial Locations

Locations (1)

Assiut Faculty of Medicine; 🇪🇬 Assiut, Egypt