DRUG
Misoprostol+Oxytocin vs. Carbetocin in CS
Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
600
Locations
1
Results
Not posted
Publications
0
Study summary
What the protocol is testing.
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.
Interventions
Treatment arms and agents.
DRUG
Oxytocin
DRUG
Carbetocin
DRUG
Placebo
Timeline
From registration to results.
First posted
Jun 1, 2016
Study start
May 2016
Primary completion
Jan 2020
Study completion
Jan 2020
Results posted
Not reported
Registry updated
Jul 8, 2020
Outcomes
What the study measures.
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)
Time frame · 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
Time frame · intra-operative
Hemoglobin deficit in gm/dl
Time frame · 24 hours
difference between pre-operative and 24 hours post-operative hemoglobin in gm/dl
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 frame · 24 hours
Time of passing gas will be recorded how many hours post-operative
hematocrit deficit in %
Time frame · 24 hours
difference between pre-operative and 24 hours post-operative hematocrit in %
Eligibility
Who can take part.
- Minimum age
- 18 Years
- Maximum age
- 40 Years
- Sex
- FEMALE
- Healthy volunteers
- No
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.
Study locations
1 registered sites.
Egypt. Showing up to 24 locations stored in the fast local snapshot.
Ain Shams University Maternity Hospital
Cairo, Egypt
Publications
Results and literature.
No PMID-linked publications were present in this registry snapshot.
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More studies on Carbetocin.
NCT IDStudyPhase / statusEnrollmentUpdated
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Not applicable
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