Oxytocin Administration During Cesarean Section

Postpartum Hemorrhage Clinical Trial

Official title:

Oxytocin Administration During Cesarean Section Before Versus After Fetal Delivery Randomized Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03344302
• Other study ID #: OACS
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2017
• Last updated: April 20, 2018
• Start date: October 2016
• Est. completion date: September 2017

Study information

• Verified date: April 2018
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: September 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 40 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Oxytocin
intravenous infusion of oxytocin 30 units over 5 minutes diluted into 500 mL of normal 0.9% sodium chloride

Locations

Country	Name	City	State
Egypt	Assiut Faculty of Medicine	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of blood loss	collection of the blood in the drape below the patient	4 hours