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

Anemia Clinical Trial

Official title:

A Comparison Between Carbetocin, Oxytocin and Ergometrine in Prevention of Postpartum Haemorrhage Following Caesarean Section

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02101567
• Other study ID #: Beni-Suef 3
• Status: Completed
• Phase: Phase 4
• First received: March 29, 2014
• Last updated: April 9, 2015
• Start date: May 2014
• Est. completion date: April 2015

Study information

• Verified date: April 2015
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Egypt: Ministry of Higher Education
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 30 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Anemia
• Bleeding
• Hemorrhage
• Postpartum Hemorrhage

Intervention

Drug:
• Pabal 100 mcg iv infusion over 1 minute given after delivery of fetal head
In the first group of patients, carbitocin 100 mcg will be given iv infusion over one minute after delivery of the head in cesarean section.
• Oxytocin 5 IU iv infusion and Methtergine 0.2 mg iv
In the second group of patients oxytocin 5 IU will be given iv infusion and Methergine 0.2 mg iv

Locations

Country	Name	City	State
Egypt	Nesreen Abdel Fattah Abdullah Shehata	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Hemoglobin concentration	Changes in hemoglobin concentrations before and 24 hours postoperative. Using a 10% fall in hematocrit value to define post-partum hemorrhage.	Before and 24 hours after the operation	No
Primary	Uterine tone and size	The uterine tone and size will be assessed by using a hand resting on the fundus and palpating the anterior wall of the uterus one hour after the operation. The presence of a boggy uterus with either heavy vaginal bleeding or increasing uterine size can suspect diagnosis of uterine atony.	One hour after the cesarean section	No
Secondary	Blood loss	Blood loss will be estimated postoperatively by giving each woman of each group standard 2 dressings (standard weight of dressing is 25 gm) for one hour postoperative and recording weight of blood soaked dressings and volume of lost blood.	One hour after cesarean section	No

External Links

•   • Villar J, Valladares E, Wojdyla D, Zavaleta N, Carroli G, Velazco A, et al. Caesarean delivery rates and pregnancy outcomes: the 2005 WHO global survey on maternal and perinatal health in Latin America. Lancet 2006; 367:1819-29.
•   Epidemiology of postpartum haemorrhage: a systematic review. Carroli G1, Cuesta C,2008 Dec;22(6):999-1012. doi: 10.1016/j.bpobgyn.2008.08.004. Epub 2008 Sep 25. Abalos E, Gulmezoglu AM.