Carbetocin in the Prevention of Primary Postpartum Haemorrhage

NCT06159959 | Completed DMC

• 1 other identifier: Dina Sanad Tawfik
• Study Type: observational
• Target: 244
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Partum Hemorrhage

Keywords

Obesity; PPH; BMI; Carbetocin; Oxytocin; Uterotonic

Outcome Measures

Primary Outcomes (1)

• Post postpartum bleeding

  To compare the incidence of primary postpartum hemorrhage in both groups receiving carbetocin

  first 6 hours after the Cesarean Section

Secondary Outcomes (1)

• Sever PPH as bleeding is >1000 cc

  first 24 hours after Cesarean Section

Study Arms (2)

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

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

Interventions

Carbetocin DRUG

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.

Also known as: Oxytocin

Group A: Obese Pregnant Females; Group B: Non-Obese Pregnant Females

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ministry of Health and Population, Egypt: lead

Study Sites (1)

Kasr- Alainy Hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Postpartum Hemorrhage; Obesity

Interventions

carbetocin; Oxytocin

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pituitary Hormones, Posterior; Pituitary Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Abdallah Y Elkateb, Professor

  Cairo University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Specialist of Obstetrics and Gynecology at AlSahelTeaching Hospital

Study Record Dates

• First Submitted: November 25, 2023
• First Posted: December 7, 2023
• Study Start: January 1, 2023
• Primary Completion: October 1, 2023
• Study Completion: October 30, 2023
• Last Updated: December 7, 2023

Record last verified: 2023-12

Locations

EG (1)