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

NCT06217354 | Completed Phase 1

• 1 other identifier: Postpartum hemorrhage, Obesity
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity, Maternal; Post Partum Hemorrhage

Outcome Measures

Primary Outcomes (1)

• Estimated Blood loss (ml) at cesarean section

  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.

  3 months

Secondary Outcomes (2)

• Uterine contractility and the need for more doses of carbetocin

  3 months

• Estimated Blood loss by weighing gauze towel

  3 months

Study Arms (2)

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

ACTIVE COMPARATOR

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

Drug: Carbetocin 100 Microgram/mL Solution for Injection

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

OTHER

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

Drug: Carbetocin 100 Microgram/mL Solution for Injection

Interventions

Carbetocin 100 Microgram/mL Solution for Injection 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 A: Parturient with BMI ≥ 30 kg/m2.; Group B: Parturients with BMI < 30kg/m2 (control group)

Eligibility Criteria

• Age: 18 Years - 39 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Shaimaa El Shemy

Giza, Cairo Governorate, 11562, Egypt

Location

MeSH Terms

Conditions

Pregnancy in Obesity; Postpartum Hemorrhage

Interventions

Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer at Obstetrics and Gynecology department

Study Record Dates

• First Submitted: December 10, 2023
• First Posted: January 22, 2024
• Study Start: July 6, 2023
• Primary Completion: October 25, 2023
• Study Completion: November 25, 2023
• Last Updated: January 22, 2024

Record last verified: 2024-01

Locations

EG (1)