Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With PASD Undergoing Cesarean Hysterectomy

July 2, 2024 updated by: Abdalla Mousa, Cairo University

Role of Uterotonics in Reducing Intraoperative Blood Loss in Patients With Placenta Accrete Spectrum Disorders Undergoing Cesarean Hysterectomy

Objectives: To evaluate the effect of oxytocin in reducing intraoperative blood loss in patients with PAS disorders planned for cesarean hysterectomy.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Pregnancy of singleton living fetus
  • Previous one or more cesarean sections
  • Gestational age: > 32 weeks
  • The following ultrasound markers such as "loss of clear retroplacental translucency", "myometrial thinning", "abnormal lacunae", "irregular bladder wall", "utero-vesicalhypervascularity".
  • Preoperative hemoglobin more than 10 gm/dl
  • Cases with PAS that will undergoing CS Hysterectomy

Exclusion Criteria:

  • Maternal medical disorders e.g.: coagulation defects, cardiac diseases etc.….
  • Any known or reported hypersensitivity to the used medication.
  • All cases with spontaneous placental separation at laparotomy.
  • All patients undergoing conservative management of PAS.
  • All cases which necessitate emergency termination.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group (A)
Patients will be given uterotonics
Drug: oxytocin
Uterotonics will be given in the form of an IV bolus of 10 units of oxytocin immediately with the uterine incision
Placebo Comparator: Group (B)
Patients will not be given uterotonics
Other: placebo
IV bolus of normal saline immediately with the uterine incision

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraoperative blood loss
Time Frame: during operation
amount of intraoperative blood loss in patients with PAS disorders undergoing cesarean hysterectomy
during operation

Secondary Outcome Measures

Outcome Measure
Time Frame
operative time
Time Frame: during operation
during operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 1, 2024

Primary Completion (Estimated)

December 31, 2024

Study Completion (Estimated)

December 31, 2024

Study Registration Dates

First Submitted

July 2, 2024

First Submitted That Met QC Criteria

July 2, 2024

First Posted (Actual)

July 10, 2024

Study Record Updates

Last Update Posted (Actual)

July 10, 2024

Last Update Submitted That Met QC Criteria

July 2, 2024

Last Verified

July 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Uterotonics in PASD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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