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Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage

Primary Purpose

Atonic Postpartum Hemorrhage, High Risk Pregnancy

Status

Not yet recruiting

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Oxytocin

Carbetocin

About this trial

This is an interventional prevention trial for Atonic Postpartum Hemorrhage focused on measuring Atonic Postpartum Hemorrhage, Carbetocin, Oxytocin, High Risk Pregnancy

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

• High risk patients for post-partum hemorrhage who will subjected to Caeserean section either elective or in labour at or after 36 weeks of gestation. This should include one or more of the following:
1. History of postpartum hemorrhage.
2. Delivery of a macrosomic baby (> 4000 g).
3. Multiple gestation.
4. Polyhydramnios.
5. Grand Multiparity.
6. Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata)
7. Chorioamnionitis.

Exclusion Criteria:

• Patients without high risk for post-partum hemorrhage.
- Patients at high risk for postpartum hemorrhage but will deliver vaginally.
- Patients with medical disorders complicating pregnancy.
- Patients with coagulation defects.
- Preterm pregnancies.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Oxytocin

Carbetocin

Arm Description

the control group will be given 10 iu intravenously.

the treatment group will be given 100 microgram intravenously.

Outcomes

Primary Outcome Measures

Amount of Postpartum Hemorrhage

Amount of Blood Loss in milliliters. Pre-operative patient's Hemoglobin (Hb) level and 24 hours post-operative will be assessed to quantify amount of blood loss. Additionally, all towels prepared for CS will weighed, and the weight will be marked on each pack before autoclaving. All towels (used and unused) will be weighed again after use, and a difference of 1 gm will be considered as equivalent to 1 mL of absorbed blood.

Secondary Outcome Measures

Full Information

NCT ID

NCT05479357

First Posted

July 27, 2022

Last Updated

July 31, 2022

Sponsor

Sohag University

1. Study Identification

Unique Protocol Identification Number

NCT05479357

Brief Title

Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage

Official Title

Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage in High-risk Patients in Sohag University Hospital: A Randomized Controlled Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2022

Overall Recruitment Status

Not yet recruiting

Study Start Date

July 28, 2022 (Anticipated)

Primary Completion Date

December 30, 2022 (Anticipated)

Study Completion Date

December 30, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sohag University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Comparison between Carbetocin and Oxytocin as prophylaxis against Primary Postpartum Hemorrhage.

Detailed Description

Patients will be allocated randomly by simple randomization into either 1- the control group which will be given 10 IU oxytocin intravenously, OR 2- the treatment group which will be given 100 micrograms of carbetocin intravenously. The trial will be conducted on patients with high risk of developing atonic primary postpartum hemorrhage. The trial will be single blinded. All patients fulfilling the inclusion criteria undergoing elective Caesarean section will be approached by the treating physician and will be asked to participate in the study. An informed written consent will be taken from each patient. The data collected will include base line characteristics such as age, parity, body mass index, the risk for Postpartum hemorrhage in each patient, amount of blood loss, blood units given, complete blood picture (pre and post operative) and coagulation profile.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Atonic Postpartum Hemorrhage, High Risk Pregnancy

Keywords

Atonic Postpartum Hemorrhage, Carbetocin, Oxytocin, High Risk Pregnancy

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

Randomized Clinical Trial (Simple randomization)

Masking

Participant

Masking Description

Patient will be blinded to the drug to be used

Allocation

Randomized

Enrollment

80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Oxytocin

Arm Type

Active Comparator

Arm Description

the control group will be given 10 iu intravenously.

Arm Title

Carbetocin

Arm Type

Active Comparator

Arm Description

the treatment group will be given 100 microgram intravenously.

Intervention Type

Drug

Intervention Name(s)

Oxytocin

Intervention Description

10 iu will be given intravenously.

Intervention Type

Drug

Intervention Name(s)

Carbetocin

Intervention Description

100 micrograms will be given intravenously.

Primary Outcome Measure Information:

Title

Amount of Postpartum Hemorrhage

Description

Time Frame

First 24 hours after Delivery

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: • High risk patients for post-partum hemorrhage who will subjected to Caeserean section either elective or in labour at or after 36 weeks of gestation. This should include one or more of the following: History of postpartum hemorrhage. Delivery of a macrosomic baby (> 4000 g). Multiple gestation. Polyhydramnios. Grand Multiparity. Interstitial or submucous fibroid. (Single larger than 4 cm or Multiple myomata) Chorioamnionitis. Exclusion Criteria: • Patients without high risk for post-partum hemorrhage. Patients at high risk for postpartum hemorrhage but will deliver vaginally. Patients with medical disorders complicating pregnancy. Patients with coagulation defects. Preterm pregnancies.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Eman M Sabry, MBBCh

Phone

+201012733125

emanmahmoud@med.sohag.edu.eg

First Name & Middle Initial & Last Name or Official Title & Degree

Amr O Abdelkareem, MD

Phone

+201001259562

AMR.OTH@med.sohag.edu.eg

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Magdy M Ameen, MD

Organizational Affiliation

Faculty of Medicine, Sohag University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Ahmed T Ahmed, MD

Organizational Affiliation

Faculty of Medicine, Sohag University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Amr O Abdelkareem, MD

Organizational Affiliation

Faculty of Medicine, Sohag University

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

11337436

Citation

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Results Reference

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Citation

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Citation

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Citation

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PubMed Identifier

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Citation

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Citation

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Citation

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Carbetocin Versus Oxytocin for Prophylaxis Against Atonic Primary Post-partum Hemorrhage

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