Efficacy of Carbetocin in Prevention of Postpartum Hemorrhage in Obese Versus Non Obese Women

NCT ID: NCT06217354

Last Updated: 2024-01-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-07-06
• Study Completion Date: 2023-11-25

Brief Summary

Postpartum hemorrhage [PPH] can have serious consequences and is the leading cause of maternal mortality globally. Uterine contractility plays an important role in post-delivery uterine involution; impaired contractility can contribute to PPH. Should contractility be impaired among obese women, there would be implications for management. Therefore, the investigators sought to investigate whether obese women would also experience a need for more uterine agents during the management of an obstetric hemorrhage.

Detailed Description

The American College of Obstetricians and Gynecologists (ACOG) updated their definition of postpartum hemorrhage (PPH) to be "blood loss greater than or equal to 1000 ml or blood loss accompanied by signs or symptoms of hypovolemia" .

Recent clinical and translational studies have suggested a decrease in uterine contractility among obese and morbidly obese women as a primary cause of obstetric hemorrhage.

In the United States, the prevalence of maternal obesity has been steadily rising, with more than half of pregnant women classified as overweight or obese. A panel of obstetric experts has speculated that the rising prevalence of maternal obesity in developed countries may explain the increase in postpartum hemorrhage incidence.

Uterotonic drugs are recommended to reduce blood loss and the risk of postpartum hemorrhage (PPH) after Cesarean delivery.

There are several prophylactic uterotonic agents available for use, including oxytocin, oxytocin/ergometrine, and carbetocin. Carbetocin is a synthetic analog of oxytocin which provides a longer duration of action than oxytocin (half-life 85-100 min versus 3-4 min).

The investigators aim to investigate the impact of carbetocin on uterine contractility in obese versus non-obese pregnant women undergoing elective cesarean delivery following carbetocin 100 mcg bolus IV administration as a prophylaxis of postpartum hemorrhage in a randomized controlled trial. The incestigators hypothesize that increased volume of distribution reduces the bioavailability of carbetocin and may be an explanation for reduced efficacy. Also the investigators will examine uterine tone as a surrogate marker for the bioavailability of carbetocin.

Conditions

Obesity, Maternal; Post Partum Hemorrhage

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Group A: Parturient with BMI ≥ 30 kg/m2.

All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. \[PabalVR, Ferring AG, Baar, Switzerland\]).

Group Type: ACTIVE_COMPARATOR

Carbetocin 100 Microgram/mL Solution for Injection

Intervention Type: DRUG

All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. \[PabalVR, Ferring AG, Baar, Switzerland\]).then assess uterine contractility and postpartum bleeding measuring

Group B: Parturients with BMI < 30kg/m2 (control group)

All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. \[Pabal, Ferring , Baar, Switzerland\]).

Group Type: OTHER

Carbetocin 100 Microgram/mL Solution for Injection

Intervention Type: DRUG

All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. \[PabalVR, Ferring AG, Baar, Switzerland\]).then assess uterine contractility and postpartum bleeding measuring

Interventions

Carbetocin 100 Microgram/mL Solution for Injection

All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. \[PabalVR, Ferring AG, Baar, Switzerland\]).then assess uterine contractility and postpartum bleeding measuring

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Healthy women with a singleton pregnancy undergoing a Cesarean delivery after at least 37 completed weeks of gestation under regional anesthesia.
• Aged (18-39) years and with signed informed consent.

Exclusion Criteria

• Emergency Cesarean Section due to fetal distress.
• Maternal comorbidities such as severe cardiovascular disorders, kidney or liver disorders, coagulopathies, as well as epilepsy.
• Uterine malformation.
• Fetal malformation.
• Known hypersensitivity to carbetocin or oxytocin.
• Uterine overdistention (as in polyhydramnios, twins, and fetal macrosomia)
• Injury of uterine vessels during CS.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 39 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Cairo University

OTHER

Sponsor Role: lead

Responsible Party

Shaimaa Mostafa Mohammed Refaay El shemy

Lecturer at Obstetrics and Gynecology department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shaimaa El Shemy

Giza, Cairo Governorate, Egypt

Countries

Egypt

Other Identifiers

Postpartum hemorrhage, Obesity

Identifier Type: -

Identifier Source: org_study_id