Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
Modified One Step Surgery vs. Segment Resection vs. Placental Bed Suturing for Management of Placenta Accreta Spectrum
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
Detailed Description
Study Type
Study Type
Enrollment (Estimated)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Contact
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
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- pregnant women with placenta accreta spectrum
Exclusion Criteria:
- Patients refuse to share in the study
- Pregnant < 28 weeks
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Single Group Assignment
- Masking: Double
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / 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
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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
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
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Estimated)
Study Start
Primary Completion (Estimated)
Primary Completion
Study Completion (Estimated)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- MOSCUS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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