Misoprostol+Oxytocin vs. Carbetocin in CS

Ain Shams University600 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

QUADRUPLE

Enrollment

600

Conditions

Cesarean Section

Interventions

MisoprostolDRUG

OxytocinDRUG

CarbetocinDRUG

PlaceboDRUG

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 40 Years

Medical Language ↔ Plain English

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.

Locations (1)

Ain Shams University Maternity Hospital

Cairo, Egypt

Outcomes

Primary Outcomes

incidence of post-partum hemorrhage

Time frame: 24 hours

amount of blood loss

Time frame: 24 hours

Secondary Outcomes

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.

Time frame: 24 hours

Number of participants needing hemostatic surgical interventions

Time frame: intra-operative

Hemoglobin deficit in gm/dl

difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl

Time frame: 24 hours

APGAR score at 1 minute and 5 minutes

Time frame: 1 minute and 5 minutes

Number of participants with NICU admission

Time frame: 24 hours

Drug side effects

Time frame: 24 hours

Time till resuming bowel habits

Time of passing gas will be recorded how many hours post-operative

Time frame: 24 hours

hematocrit deficit in %

difference between pre-operative and 24 hours post-operative hematocrit in %

Data from ClinicalTrials.gov

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