Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage

Not Applicable

Completed

• Conditions: Postpartum Hemorrhage
• Interventions: Drug: oxytocin; Drug: Carbetocin; Drug: oxytocin plus misoprostol

• Registration Number: NCT03870503
• Lead Sponsor: Aswan University Hospital

Brief Summary

The objective of this study is to compare the effectiveness and safety of carbetocin vs. oxytocin plus sublingual misoprostol in the management of atonic postpartum hemorrhage (PPH)after vaginal delivery.

Detailed Description

The first cause of hemorrhage at the time of delivery is uterine atony; therefore, there is general agreement that active management of the third stage of labor is recommended.

Oxytocin is the most widely used uterotonic agent but has a half-life of only 4-10 min, that is why it is better administered as a continuous intravenous infusion to achieve sustained uterotonic activity. Carbetocin is a synthetic long-acting oxytocin agonistic analog with prolonged half-life prolonging its pharmacological effects. Its prolonged uterine activity may theoretically offer advantages over oxytocin in the management of the third stage of labor. The side-effect profile of carbetocin was not found to be different from that of Oxytocin but may prove to be advantageous when compared to Syntometrine.

Study Timeline

• Study First Submitted: 2019-03-09
• Study First Submitted QC: 2019-03-09
• Study First Posted: 2019-03-12
• Study Start: 2019-04-01
• Primary Completion: 2021-06-30
• Study Completion: 2021-08-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-27
• Last Update Posted: 2021-09-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 135

Inclusion Criteria

• All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation

Exclusion Criteria

• gestational age<37 weeks,
• genital tract trauma,
• coagulation defect,
• women with hypertension, preeclampsia, cardiac, renal or liver diseases, epilepsy
• known hypersensitivity to carbetocin or oxytocin.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
oxytocin	oxytocin	The patient will be received oxytocin 20 IU by intravenous infusion
oxytocin plus misoprostol	oxytocin plus misoprostol	The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol
Carbetocin	Carbetocin	The patient will be received Carbetocin 100 mic gm IV
oxytocin plus misoprostol	oxytocin	The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol

Primary Outcome Measures

Name	Time	Method
The amount of blood loss	6 hours post delivery	calculation of the amount of blood loss by weighing the swabs and using pictorial charts

Secondary Outcome Measures

Name	Time	Method
The number of patients develop blood loss more than 1000 ml	24 hours post delivery	Calculation of the number of patients develop blood loss more than 1000 ml
The number of patient need blood transfusion	24 hours post delivery	Calculation of number of patient need blood transfusion

Trial Locations

Locations (1)

Aswan University Hospital; 🇪🇬 Aswan, Egypt