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

Phase 1

Completed

• Conditions: Obesity, Maternal; Post Partum Hemorrhage
• Interventions: Drug: Carbetocin 100 Microgram/mL Solution for Injection

• Registration Number: NCT06217354
• Lead Sponsor: Cairo University

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.

Study Timeline

• Study Start: 2023-07-06
• Primary Completion: 2023-10-25
• Study Completion: 2023-11-25
• Study First Submitted: 2023-12-10
• Status Verified: 2024-01
• Study First Submitted QC: 2024-01-11
• Last Update Submitted: 2024-01-11
• Study First Posted: 2024-01-22
• Last Update Posted: 2024-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 150

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group A: Parturient with BMI ≥ 30 kg/m2.	Carbetocin 100 Microgram/mL Solution for Injection	All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. \[PabalVR, Ferring AG, Baar, Switzerland\]).
Group B: Parturients with BMI < 30kg/m2 (control group)	Carbetocin 100 Microgram/mL Solution for Injection	All patients will receive a bolus of carbetocin 100mcg IV over one minute after cord clamping. \[Pabal, Ferring , Baar, Switzerland\]).

Primary Outcome Measures

Name	Time	Method
Estimated Blood loss (ml) at cesarean section	3 months	Estimation of blood loss will be by assessing difference between pre -operative hemoglobin and a 24 hours after delivery hemoglobin and pre and 24h after delivery hematocrit according to the following formula: Estimated blood volume (pre-operative Hct-postoperative Hct)/pre-operative Hct.

Secondary Outcome Measures

Name	Time	Method
Uterine contractility and the need for more doses of carbetocin	3 months	Uterine contractility, the proportion of women receiving additional uterotonics after administration of single dose of carbetocin, transfusion of blood products and use of non-drug measures to treat PPH.
Estimated Blood loss by weighing gauze towel	3 months	weighing gauze towels (grams)pre and postoperative. Using suction when amniotic fluid membranes rupture up to delivery of the placenta. Gauze towels will be used exclusively to mop up the blood until closure of the abdomen

Trial Locations

Locations (1)

Shaimaa El Shemy; 🇪🇬 Giza, Cairo, Egypt