Misoprostol+Oxytocin vs. Carbetocin in CS

NCT ID: NCT02786992

Last Updated: 2020-07-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

600 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2020-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Misoprostol + Oxytocin

400 ug sublingual misoprostol + 10 IU Oxytocin IVI

Group Type ACTIVE_COMPARATOR

Misoprostol

Intervention Type DRUG

Oxytocin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Carbetocin

100 ug Carbetocin IV

Group Type ACTIVE_COMPARATOR

Carbetocin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Interventions

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Misoprostol

Intervention Type DRUG

Oxytocin

Intervention Type DRUG

Carbetocin

Intervention Type DRUG

Placebo

Intervention Type DRUG

Other Intervention Names

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Mesotec Mesotac Syntocinon Pabal

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Ain Shams University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed S Sweed, MD

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Ain Shams University Maternity Hospital

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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AS1301

Identifier Type: -

Identifier Source: org_study_id

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