Misoprostol+Oxytocin vs. Carbetocin in CS

Sponsor

Ain Shams University (Other)

Overall Status

Completed

CT.gov ID

NCT02786992

Collaborator

(none)

600

Enrollment

Location

Arms

Duration (Months)

13.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Cesarean Section	Drug: Misoprostol Drug: Oxytocin Drug: Carbetocin Drug: Placebo	Phase 2/Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

600 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Prevention

Official Title:

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

Study Start Date :

May 1, 2016

Actual Primary Completion Date :

Jan 1, 2020

Actual Study Completion Date :

Jan 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Misoprostol + Oxytocin 400 ug sublingual misoprostol + 10 IU Oxytocin IVI	Drug: Misoprostol Other Names: Mesotec Mesotac Drug: Oxytocin Other Names: Syntocinon Drug: Placebo
Active Comparator: Carbetocin 100 ug Carbetocin IV	Drug: Carbetocin Other Names: Pabal Drug: Placebo

Arm

Intervention/Treatment

Active Comparator: Misoprostol + Oxytocin

400 ug sublingual misoprostol + 10 IU Oxytocin IVI

Drug: Misoprostol

Other Names:

Mesotec

Mesotac

Drug: Oxytocin

Other Names:

Syntocinon

Drug: Placebo

Active Comparator: Carbetocin

100 ug Carbetocin IV

Drug: Carbetocin

Other Names:

Pabal

Drug: Placebo

Outcome Measures

Primary Outcome Measures

incidence of post-partum hemorrhage [24 hours]
amount of blood loss [24 hours]

Secondary Outcome Measures

Number of participants needing extra uterotonic drug (10 IU oxytocin IVI) [24 hours]
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.
Number of participants needing hemostatic surgical interventions [intra-operative]
Hemoglobin deficit in gm/dl [24 hours]
difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl
APGAR score at 1 minute and 5 minutes [1 minute and 5 minutes]
Number of participants with NICU admission [24 hours]
Drug side effects [24 hours]
Time till resuming bowel habits [24 hours]
Time of passing gas will be recorded how many hours post-operative
hematocrit deficit in % [24 hours]
difference between pre-operative and 24 hours post-operative hematocrit in %

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 40 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.