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

Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Postpartum Hemorrhage
• Intervention / Treatment: Drug: oxytocin; Drug: oxytocin plus misoprostol; Drug: Carbetocin

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 Type: Interventional
• Enrollment (Actual): 135
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • Aswan, Egypt, 81528
    • Aswan university hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: oxytocin; The patient will be received oxytocin 20 IU by intravenous infusion	Drug: oxytocin; The patient will be received oxytocin 20 IU by intravenous infusion; Other Names: Active comparator
Active Comparator: oxytocin plus misoprostol; The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol	Drug: oxytocin; The patient will be received oxytocin 20 IU by intravenous infusion; Other Names: Active comparator; Drug: oxytocin plus misoprostol; The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol; Other Names: Active Comparator
Active Comparator: Carbetocin; The patient will be received Carbetocin 100 mic gm IV	Drug: Carbetocin; The patient received Carbetocin 100 mic gm; Other Names: Active Comparator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of blood loss	calculation of the amount of blood loss by weighing the swabs and using pictorial charts	6 hours post delivery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The number of patients develop blood loss more than 1000 ml	Calculation of the number of patients develop blood loss more than 1000 ml	24 hours post delivery
The number of patient need blood transfusion	Calculation of number of patient need blood transfusion	24 hours post delivery

Collaborators and Investigators

• Sponsor: Aswan University Hospital
• Investigators: Principal Investigator: hany f allam, md, Aswan university hospital

Publications and helpful links

General Publications

• Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2019
• Primary Completion (Actual): June 30, 2021
• Study Completion (Actual): August 1, 2021

Study Registration Dates

• First Submitted: March 9, 2019
• First Submitted That Met QC Criteria: March 9, 2019
• First Posted (Actual): March 12, 2019

Study Record Updates

• Last Update Posted (Actual): September 29, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: oxytocin; Postpartum Hemorrhage; misoprostol; vaginal delivery; carbetocin
• Additional Relevant MeSH Terms: Pathologic Processes; Pregnancy Complications; Obstetric Labor Complications; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Postpartum Hemorrhage; Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Oxytocin; Misoprostol; Carbetocin
• Other Study ID Numbers: aswu/201/19

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No