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

Primary Purpose

Postpartum Hemorrhage

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
oxytocin
oxytocin plus misoprostol
Carbetocin
Sponsored by
Aswan University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postpartum Hemorrhage focused on measuring Postpartum Hemorrhage, vaginal delivery, carbetocin, misoprostol, oxytocin

Eligibility Criteria

20 Years - 40 Years (Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • Aswan University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

oxytocin

oxytocin plus misoprostol

Carbetocin

Arm Description

The patient will be received oxytocin 20 IU by intravenous infusion

The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol

The patient will be received Carbetocin 100 mic gm IV

Outcomes

Primary Outcome Measures

The amount of blood loss
calculation of the amount of blood loss by weighing the swabs and using pictorial charts

Secondary Outcome Measures

The number of patients develop blood loss more than 1000 ml
Calculation of the number of patients develop blood loss more than 1000 ml
The number of patient need blood transfusion
Calculation of number of patient need blood transfusion

Full Information

First Posted
March 9, 2019
Last Updated
September 27, 2021
Sponsor
Aswan University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03870503
Brief Title
Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Postpartum Hemorrhage
Official Title
Carbetocin Versus Oxytocin Plus Sublingual Misoprostol in the Management of Atonic Post-partum Hemorrhage (PPH) After Vaginal Delivery: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
April 1, 2019 (Actual)
Primary Completion Date
June 30, 2021 (Actual)
Study Completion Date
August 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aswan University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postpartum Hemorrhage
Keywords
Postpartum Hemorrhage, vaginal delivery, carbetocin, misoprostol, oxytocin

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This study will be a prospective double-blind randomized study
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
This study will be a prospective double-blind randomized study
Allocation
Randomized
Enrollment
135 (Actual)

8. Arms, Groups, and Interventions

Arm Title
oxytocin
Arm Type
Active Comparator
Arm Description
The patient will be received oxytocin 20 IU by intravenous infusion
Arm Title
oxytocin plus misoprostol
Arm Type
Active Comparator
Arm Description
The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mc sublingual misoprostol
Arm Title
Carbetocin
Arm Type
Active Comparator
Arm Description
The patient will be received Carbetocin 100 mic gm IV
Intervention Type
Drug
Intervention Name(s)
oxytocin
Other Intervention Name(s)
Active comparator
Intervention Description
The patient will be received oxytocin 20 IU by intravenous infusion
Intervention Type
Drug
Intervention Name(s)
oxytocin plus misoprostol
Other Intervention Name(s)
Active Comparator
Intervention Description
The patient will be received oxytocin 20 IU by intravenous infusion plus 400 mic gm sublingual misoprostol
Intervention Type
Drug
Intervention Name(s)
Carbetocin
Other Intervention Name(s)
Active Comparator
Intervention Description
The patient received Carbetocin 100 mic gm
Primary Outcome Measure Information:
Title
The amount of blood loss
Description
calculation of the amount of blood loss by weighing the swabs and using pictorial charts
Time Frame
6 hours post delivery
Secondary Outcome Measure Information:
Title
The number of patients develop blood loss more than 1000 ml
Description
Calculation of the number of patients develop blood loss more than 1000 ml
Time Frame
24 hours post delivery
Title
The number of patient need blood transfusion
Description
Calculation of number of patient need blood transfusion
Time Frame
24 hours post delivery

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
All participants had PPH defined as vaginal bleeding>500 ml after vaginal delivery and uterine atony confirmed by abdominal palpation
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hany f allam, md
Organizational Affiliation
Aswan University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Aswan University Hospital
City
Aswan
ZIP/Postal Code
81528
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33232518
Citation
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.
Results Reference
derived

Learn more about this trial

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

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