Carbetocin in the Prevention of Primary Postpartum Haemorrhage

Carbetocin in the Prevention of Primary Postpartum Haemorrhage in Obese Versus Non-obese Women Undergoing Elective Cesarean Section

Postpartum haemorrhage (PPH) ranks as the first cause of maternal mortality in developing countries and it is the cause of 25% of maternal deaths worldwide.

Carbetocin is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions and increased uterine tone.

Study Overview

• Status: Completed
• Conditions: Post Partum Hemorrhage
• Intervention / Treatment: Drug: Carbetocin

Detailed Description

Postpartum hemorrhage is defined as a blood loss more than 500 ml, and serious PPH as a blood loss more than 1,000 ml.

It is a common maternal morbidity in high-resource countries and is trending upward and prevention of postpartum haemorrhage is, therefore, of great importance for improved maternal health care.

Although two-thirds of the PPH cases occur in women without predisposing factors, there are several risk factors for PPH. The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases .

Studies investigating effect of increased BMI on birth outcomes in a general obstetric population revealed an association between obesity and PPH. The overall increased risk of postpartum hemorrhage among obese women was 8-13%, depending on obesity class.

The risk of postpartum haemorrhage is much higher for women undergoing Cesarean section, particularly in developing countries, where the majority of operations are carried out as an emergency procedure.

Maternal obesity is associated with an elevated risk of intrapartum cesarean section, mainly due to reduced uterine contractility culminating in failure to progress in labor .

Up to date, which uterotonic agent suitable for prophylactic use is being debated and literature lacks of clear endpoints on this item .

The most routinely and widely used uterotonic agent for preventing postpartum haemorrhage is oxytocin, but it only has a half-life of 4-10 min. So, it must be administered as a continuous intravenous infusion to achieve sustained uterotonic activity, which is inconvenient and makes dosing errors a possibility.

• Study Type: Observational
• Enrollment (Actual): 244

Contacts and Locations

Study Locations

• Egypt
  • Cairo, Egypt
    • Kasr- Alainy Hospitals

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

To assess the effectiveness of single IV bolus dose of carbetocin in the prevention of primary PPH in obese versus non obese women undergoing elective cesarean section.

Description

Inclusion Criteria:

• Age: 20-40years.
• Body mass index (BMI): Obese ≥30 kg/m2 and non-obese women <30 kg/m2 calculated using maternal height and weight measured to the nearest centimeter and kilogram, respectively, at time of admission to labor word.
• Gestational age: Gestational age ≥37 weeks (gestational age will be recorded according to the last menstrual period and confirmed by ultrasound). In case of discrepancy, a 1st trimesteric ultrasound will be taken as the actual gestational age.
• Singleton pregnancy.

Exclusion Criteria:

Patients who have any factors that might increase the risk of postpartum haemorrhage will be excluded as anemic patients (Hb<10.5g%), antepartum haemorrhage ( placenta previa, placental abruption ), uterine myomata, multiple gestation, polyhydramnios.

• Patients with pre-existing bleeding or thromboembolic disorder.
• Patients with chronic medical diseases (cardiac, hepatic, renal)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A: Obese Pregnant Females; About 122 Pregnant women candidate for elective cesarean section suffering from obesity where as Body mass index (BMI) is ≥30 kg/m2	Drug: Carbetocin; To assess the effectiveness of single IV bolus dose of carbetocin in the prevention of primary PPH in obese versus non obese women undergoing elective cesarean section.; Other Names: Oxytocin
Group B: Non-Obese Pregnant Females; About 122 Pregnant women candidate for elective cesarean section and not obese obesity where as Body mass index (BMI) is < 30 kg/m2	Drug: Carbetocin; To assess the effectiveness of single IV bolus dose of carbetocin in the prevention of primary PPH in obese versus non obese women undergoing elective cesarean section.; Other Names: Oxytocin

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post postpartum bleeding	To compare the incidence of primary postpartum hemorrhage in both groups receiving carbetocin	first 6 hours after the Cesarean Section

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Sever PPH as bleeding is >1000 cc	Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.	first 24 hours after Cesarean Section

Collaborators and Investigators

• Sponsor: Ministry of Health and Population, Egypt
• Investigators: Study Chair: Abdallah Y Elkateb, Professor, Cairo University

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2023
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 30, 2023

Study Registration Dates

• First Submitted: November 25, 2023
• First Submitted That Met QC Criteria: December 5, 2023
• First Posted (Estimated): December 7, 2023

Study Record Updates

• Last Update Posted (Estimated): December 7, 2023
• Last Update Submitted That Met QC Criteria: December 5, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: Obesity; Oxytocin; BMI; PPH; Carbetocin; Uterotonic
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Reproductive Control Agents; Oxytocics; Oxytocin; Carbetocin
• Other Study ID Numbers: Dina Sanad Tawfik

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No