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Effectivness of Conservative Techniques in Management of PAS

Sponsor
Assiut University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05104177
Collaborator
(none)
80
Enrollment
13
Anticipated Duration (Months)

Study Details

Study Description

Brief Summary

To evaluate the effectiveness of conservative techniques for placenta accreta spectrum to reduce maternal mortality and morbidity

Condition or Disease Intervention/Treatment Phase
  • Procedure: conservative tecchniques in management of PAS

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 Design

Study Type:
Observational [Patient Registry]
Anticipated Enrollment :
80 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Effectivness of Conservative Techniques in Management of PAS
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Nov 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Outcome Measures

Primary Outcome Measures

  1. number of patients who undergo hysterectomy after failure of conservative techniques [baseline]

    Counting patients who undergo hystrectomy after conservative techniques to evalute it's effectivness

Secondary Outcome Measures

  1. recurrence of PAS [baseine]

    Nomber of cases recurrence who will have of PAS In subsequent pregnancies after conservative techniques

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years to 50 Years
Sexes Eligible for Study:
Female
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • Assiut University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Mohammed Heshmat Atrees Mohammed, Principal investigator, Assiut University
ClinicalTrials.gov Identifier:
NCT05104177
Other Study ID Numbers:
  • conservative techniques in PAS
First Posted:
Nov 2, 2021
Last Update Posted:
Nov 9, 2021
Last Verified:
Nov 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Placenta Accreta

Study Results

No Results Posted as of Nov 9, 2021