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

NCT ID: NCT06493968

Last Updated: 2024-07-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-01

Study Completion Date

2024-12-31

Brief Summary

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

Detailed Description

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Conditions

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Placenta Accreta Spectrum

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Group (A)

Patients will be given uterotonics

Group Type EXPERIMENTAL

oxytocin

Intervention Type DRUG

Uterotonics will be given in the form of an IV bolus of 10 units of oxytocin immediately with the uterine incision

Group (B)

Patients will not be given uterotonics

Group Type PLACEBO_COMPARATOR

placebo

Intervention Type OTHER

IV bolus of normal saline immediately with the uterine incision

Interventions

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oxytocin

Uterotonics will be given in the form of an IV bolus of 10 units of oxytocin immediately with the uterine incision

Intervention Type DRUG

placebo

IV bolus of normal saline immediately with the uterine incision

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

40 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Abdalla Mousa

Lecturer of obgyn Cairo university

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Cairo University

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Abdalla Mousa

Role: CONTACT

+201277664430

Facility Contacts

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Abdalla Mousa

Role: primary

+201277664430

Other Identifiers

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Uterotonics in PASD

Identifier Type: -

Identifier Source: org_study_id

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