- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07520201
Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
April 3, 2026 updated by: Mohamed Gamal M.fekry, Assiut University
Modified One Step Surgery vs. Segment Resection vs. Placental Bed Suturing for Management of Placenta Accreta Spectrum
Comparison between modified one-step surgery vs. Segment Resection vs. placental bed suturing for management of placenta accreta spectrum
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
Detailed Description
Placenta accreta spectrum (PAS) represents a severe obstetric disorder, defined by abnormal migration of the placenta into the myometrium, which leads to incomplete or absent placental separation following delivery.
Peripartum caesarean hysterectomy remains the most widely used treatment and is regarded as the gold standard in the majority of clinical settings.
Recent international and national guidelines recognize uterus-preserving surgery, including focal resection, as a valid management option in centres of excellence for selected women.
However, long-term data on physical outcomes following these procedures remain limited.
This study aimed to evaluate intraoperative and postoperative outcomes of patients with placenta accreta spectrum treated with modified one-step conservative surgery, Myometrial segment Resection or placental bed suturing.
Study Type
Interventional
Enrollment (Estimated)
42
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
- Name: Mohammed Gamal, PhD
- Phone Number: +20882312388
- Email: mohamedbeethoven2040@gmail.com
Study Locations
-
-
-
Asyut, Egypt
- Women's health hospital
-
Contact:
- Women Hospital
- Phone Number: 0882414916
- Email: ethics_committee12@yahoo.com
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-
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
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- pregnant women with placenta accreta spectrum
Exclusion Criteria:
- Patients refuse to share in the study
- Pregnant < 28 weeks
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: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Modified one-step surgery
|
transverse uterine incision is made at the upper border of the placenta without cutting through the placenta, then fetal delivery.
A tourniquet is first put into the para-cervical area (using a Foley 12-F catheter) to stop active bleeding, and bilateral uterine artery ligation (using Chromic 1/0) is performed, followed by manual placental removal .
Myometrial resection is performed if the remaining lower uterine segment of the healthy myometrium measures more than 2 cm.
Suture of both edges of the uterine incision and hemostatic sutures of the placental bed surface (using chromic suture 1/0) are performed.
Finally, the tourniquet is released and a transverse B-Lynch compression suture is made
|
|
Experimental: Segment Resection
|
transverse uterine incision was applied just above the upper border of involved uterine wall .
And the fetus was extracted from this incision and the umbilical cord was clamped.
In order to decrease hemorrhage, anterior branches of hypogastric arteries were ligated bilaterally.
urinary bladder dissection from anterior uterine wall is done.
Then the involved segment is resected by leaving placental free tissue medially to the uterine arteries, below transverse uterine incision and above the cervix.
Resection was made by scissors or cautery and bleeding from the borders was controlled by ring forceps.
|
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Experimental: Placental bed suturing
|
After the separation of the placenta, all bleeding areas are clamped with several curved ovarian forceps.
After the mechanical hemostasis of the lower uterine segment has been achieved, the remaining small amounts of placental fragments are removed by instrument.
The clamps are removed sequentially, and the vesicouterine interface and all spaces are sutured with superficial stitches under the guidance of the surgeon's fingers.
These superficial continuous sutures are not very deep.
Cho sutures are used to achieve comlete hemostasis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Intraoperative Blood loss
Time Frame: 24 hours
|
Increased blood loss means bad outcome
|
24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
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 (Estimated)
June 1, 2026
Primary Completion (Estimated)
June 1, 2027
Study Completion (Estimated)
July 1, 2027
Study Registration Dates
First Submitted
April 3, 2026
First Submitted That Met QC Criteria
April 3, 2026
First Posted (Actual)
April 9, 2026
Study Record Updates
Last Update Posted (Actual)
April 9, 2026
Last Update Submitted That Met QC Criteria
April 3, 2026
Last Verified
April 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MOSCUS
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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