Clinical trial NCT02101567: Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Haemorrhage Following Caesarean Section
Official title: A Comparison Between Carbetocin, Oxytocin and Ergometrine in Prevention of Postpartum Haemorrhage Following Caesarean Section
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Bleeding
Anemia
Keywords: Postpartum hemorrhage, Cesarean section, Uterotonics
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2014-04-02
Enrollment: 200
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 30
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The investigators compare the effectiveness and adverse effects of I.V carbetocin versus oxytocin \& ergometrine I.V for prevention of postpartum haemorrhage following cesarean section.

Detailed description: * Postpartum hemorrhage (PPH) accounts for nearly one quarter of all maternal deaths worldwide 1 and was the second most frequent cause of maternal death in the UK for the 2000-2002 triennium.
* Caesarean section is a recognized risk factor for PPH and the worldwide caesarean delivery rate is increasing .2
* A combination of oxytocin and ergometrine is effective in preventing postpartum hemorrhage but is frequently associated with side effects such as retained placenta and hypertension.
* A recent guideline on PPH prevention developed by the World Health Organization recommended the use of oxytocin for prevention of PPH in settings in which active management of labor is not practiced.
* Ergometrine is an ergot alkaloid and hypertension and cardiac disease are contraindications due to the possible development of severe hypertension and myocardial ischemia.
* Carbetocin is a newly developed uterotonics and it may represent a promising choice as reported in the literature. It is a synthetic analogue of human oxytocin with structural modifications that increase its half-life thereby prolonging its pharmacological effects .
* A prospective double blinded randomized study . The study population will include 200 patients. The study will take place in Beni_suef University Hospitals.
* Inclusion criteria:

  • Women with a singleton pregnancy undergoing elective caesarean section after 37 weeks of gestation.
* Exclusion criteria

  * Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
  * women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
  * Hypertension with pregnancy.
  * Cardiac and coronary diseases with pregnancy
* Women included in the study were divided into 2 groups:

.Group (A): including 100 patients who will receive carbetocin 100 µg I.V after delivery of the fetal head.

.Group (B): including 100 patients who will receive a combination of intraoperative oxytocin 5 I.U \& ergometrine 0.2 mg.

Eligibility criteria: Inclusion Criteria:

* • Women with a singleton pregnancy undergoing elective cesarean section after 37 weeks of gestation.

Exclusion Criteria:

* Women undergoing cesarean section with general anesthesia will be excluded, because carbetocin is licensed for use with regional anaesthesia only.
* women undergoing cesarean section at less than 37 weeks of gestation (likely to be emergency cesarean sections; a different smaller group from term pregnancies)
* Hypertension with pregnancy.
* Cardiac and coronary diseases with pregnancy

Primary outcomes:
measure: Uterine tone and size
timeFrame: One hour after the cesarean section
Secondary outcomes:
measure: Blood loss
timeFrame: One hour after cesarean section
Other outcomes:
measure: Hemoglobin concentration
timeFrame: Before and 24 hours after the operation
Locations:
city: Cairo
country: Egypt
facility: Nesreen Abdel Fattah Abdullah Shehata
Study officials:
affiliation: Beni-Suef University
name: Nesreen A Shehata, MD
role: PRINCIPAL_INVESTIGATOR
References: