Misoprostol+Oxytocin vs. Carbetocin in CS

Cesarean Section Clinical Trial

— CS  

Official title:

Adjuvant Use of Misoprostol and Oxytocin vs. Carbetocin for the Prevention of Post-partum Hemorrhage in Elective Cesarian Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02786992
• Other study ID #: AS1301
• Status: Completed
• Phase: Phase 2/Phase 3
• Start date: May 2016
• Est. completion date: January 2020

Study information

• Verified date: July 2020
• Source: Ain Shams University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This prospective randomized double-blind clinical trial will be conducted at Ain-Shams University Maternity Hospital, Cairo, Egypt. Patients eligible for elective lower segment cesarean section will be randomized to 2 groups. Group 1: will receive 400 ug misoprostol following + 10 IU oxytocin intravenous slowly after cord clamping. Group 2: will receive 100 ug carbetocin intravenous after cord clamping.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 600
• Est. completion date: January 2020
• Est. primary completion date: January 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Women with singleton pregnancy Women scheduled for elective CS full term (gestational age =37 weeks).

Exclusion Criteria:

• hypersensitivity to oxytocin, carbetocin or prostaglandins

• contraindication to prostaglandins (e.g. glaucoma)

• history of significant heart disease

• severe asthma

• epilepsy

• history or evidence of liver

• renal or vascular disease

• history of coagulopathy

• thrombocytopenia or anticoagulant therapy

• women with HELLP syndrome

• eclampsia

• women presenting by placental abruption

• contraindication to spinal anesthesia as carbetocin is licensed for use with regional anesthesia only.

Related Conditions & MeSH terms

• Cesarean Section
• Postpartum Hemorrhage

Intervention

Drug:
• Misoprostol

• Oxytocin

• Carbetocin

• Placebo

Locations

Country	Name	City	State
Egypt	Ain Shams University Maternity Hospital	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	incidence of post-partum hemorrhage		24 hours
Primary	amount of blood loss		24 hours
Secondary	Number of participants needing extra uterotonic drug (10 IU oxytocin IVI)	An experienced attendant (principal investigator) will assess the need of extra uterotonic drug (10 IU oxytocin IVI) if the uterus is atonic or if blood loss is more than 1000 ml.	24 hours
Secondary	Number of participants needing hemostatic surgical interventions		intra-operative
Secondary	Hemoglobin deficit in gm/dl	difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl	24 hours
Secondary	APGAR score at 1 minute and 5 minutes		1 minute and 5 minutes
Secondary	Number of participants with NICU admission		24 hours
Secondary	Drug side effects		24 hours
Secondary	Time till resuming bowel habits	Time of passing gas will be recorded how many hours post-operative	24 hours
Secondary	hematocrit deficit in %	difference between pre-operative and 24 hours post-operative hematocrit in %	24 hours