Current partner codePEPTIDESDE
NCT03693599·Phase 4·INTERVENTIONAL

Carbetocin Versus Syntometrine in Obese Women Undergoing Elective Cesarean

Status

Completed

Phase

Phase 4

Enrollment

1,200

Locations

1

Results

Not posted

Publications

0

Study summary

What the protocol is testing.

to compare effectiveness and tolerability of carbetocin versus syntometrine in prevention of Postpartum hemorrhage after cesarean section

Full detailed description

A double-blind randomized study conducted on 1200 obese pregnant subjected randomly either to single 100 μg IV dose of carbetocin (600 women) or combination of 5 IU oxytocin and 0.5 mg ergometrine (600 women) after fetal extraction and before placental removal. Prevention of postpartum haemorrhage (PPH) after cesarean section (CS) had been evaluated by measurement of drop of Hemoglobin and hematocrit, incidence of PPH and number of subjects needed additional oxytocic

Interventions

Treatment arms and agents.

DRUG

carbetocin

single 100 µg IV dose of carbetocin diluted in 10 ml of Ringer's lactate solution (Pabal, Ferring Pharmaceuticals Ltd, West Drayton, UK).

DRUG

Syntometrine

one ampoule of syntometrine (Novartis, Basel, Switzerland), which consisted of 5 IU of oxytocin and 500 microgram of ergometrine diluted in 10 ml of Ringer's lactate solution and was administered intravenously over 2 minutes

Timeline

From registration to results.

  1. First posted

    Oct 3, 2018

  2. Study start

    Oct 1, 2018

  3. Primary completion

    Sep 15, 2019

  4. Study completion

    Sep 30, 2019

  5. Results posted

    Not reported

  6. Registry updated

    Jan 3, 2020

Outcomes

What the study measures.

Primary outcomes

incidence of postpartum hemorrhage after CS

Time frame · 24 hours

Number of participants experienced massive postpartum hemorrhage

Secondary outcomes

side effects of drugs used

Time frame · 24 hours

GIT side effects as nausea , vomiting

Eligibility

Who can take part.

Minimum age
Not reported
Maximum age
Not reported
Sex
FEMALE
Healthy volunteers
Yes

Inclusion Criteria: * All participants are at 37 - 40 weeks of gestational age * Noncomplicated pregnancy. * obese women with BMI \> 30. Exclusion Criteria: * Participants with placenta previa, * coagulopathy, * preeclamptic * known sensitivity to carbetocin,oxytocin or methergine were excluded

Study locations

1 registered sites.

Egypt. Showing up to 24 locations stored in the fast local snapshot.

faculty of medicine Cairo university

Giza, Egypt

Publications

Results and literature.

No PMID-linked publications were present in this registry snapshot.

Primary links

Continue at the source.

Related trials

More studies on Carbetocin.

Related PeptideStat pages

Put the record in context.

Research pages describe evidence. Vendor pages, where available, describe independently tracked research-product listings and are not clinical recommendations.