- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05104177
Effectivness of Conservative Techniques in Management of PAS
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Placenta accreta spectrum (PAS) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium . Over the last 40 years, caesarean delivery rates around the world have risen from less than 10% to over 30%, and almost simultaneously a 10-fold increase in the incidence of PAS . PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality .
Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally. There is also wide variation globally on the management of PAS disorders, with some centres opting for a radical approach, whereas others have proposed a range of conservative approaches .
The conservative approaches include one-step conservative surgery, leaving the placenta in situ, the Triple-P procedure, and transverse B-Lynch suture . Recently, Women's health hospital has adopted a new approach for conservative management of most cases of PAS, including wedge resection of the myometrium over the adherent part of the placenta, or a staged-approach following delivery of the fetus starting with meticulous dissection of the urinary bladder form the lower uterine segment, then bilateral uterine artery ligation at a level below the apparent placenta-myometrial bulge, followed by removal of the placenta, after which a catheter is inserted in the cervix and the placental pouch is closed .
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: mohammed heshmat
- Phone Number: 01030752354
- Email: heshmatm905@gmail.com
Study Contact Backup
- Name: Alaa El-Din Ismail
- Phone Number: 01063224000
- Email: prof.alaaismail@gmail.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- - Gestational age starting from 28 weeks onwards.
- - Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy)
- - Elective or emergent Caesarean deliveries
Exclusion Criteria:
- A pre-existing decision of performing intrapartum hysterectomy
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
number of patients who undergo hysterectomy after failure of conservative techniques
Time Frame: baseline
|
Counting patients who undergo hystrectomy after conservative techniques to evalute it's effectivness
|
baseline
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
recurrence of PAS
Time Frame: baseine
|
Nomber of cases recurrence who will have of PAS In subsequent pregnancies after conservative techniques
|
baseine
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Anticipated)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- conservative techniques in PAS
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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