Carbetocin Versus Oxytocin and Ergometrine for the Prevention of Postpartum Haemorrhage Following Caesarean Section

Beni-Suef University

Status and phase: Completed; Phase 4

Conditions: Anemia; Bleeding

Treatments: Drug: Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head; Drug: Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv

Study type: Interventional

Funder types: Other

Identifiers

NCT02101567

Beni-Suef 3

Details and patient eligibility

About

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.

Full 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.

Enrollment: 200 patients

Sex: Female

Ages: 20 to 30 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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200 participants in 2 patient groups

Pabal ( carbetocin)

Active Comparator group

Description:

Pabal (carbetocin which is a long acting oxytocin ) given as 100 mcg slow i.v. injection over 1 minute ( Draxis/Multiph). It will be given to the patients included in the study after delivery of the fetal head.

Treatment:

Drug: Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head

Oxytocin and Methergine (methyl ergometrine)

Active Comparator group

Description:

The second group of patients included in the study will be given Oxytocin 5 IU ampoule by intravenous infusion and Methergine 0.2 mg IV after delivery of fetal head.

Treatment:

Drug: Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv