Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis

January 30, 2024 updated by: Naglaa Mohamed, Assiut University

Placenta Accreta; Total Lower Uterine Segmentectomy With Cervico-corporeal Anastomosis, a Feasibility Study

To study feasibility and safety of Total lower uterine segmentectomy with cervico-corporeal anastomosis in conservative management of placenta accreta

Study Overview

Status

Completed

Conditions

Detailed Description

Placenta accreta represents a real challenge in modern obstetric care as its incidence is increasing in a parallelism with increased CSs rates. Its management represents another challenge and a multidisciplinary team with clear plans and alternative strategies that fulfill different situation and address different patient needs must be clearly settled in every referral center dealing with placenta accreta.

Hysterectomy without trials of placental separation seems to be the standard and logical procedure. However hysterectomy needs to be a total or at least including the entire invaded Lower uterine segment. Hysterectomy is associated with significant blood loss, and loss of future fertility. There are several fertility conservation approaches with variable success rates, complications, technical demands and costs.

Uterine plication sutures has been reported as successful uterine conservation strategy but subsequent intrauterine adhesions, weak uterine scar and uterine necrosis might culminate in a functionless uterus.

The present work describes total lower uterine segmentectomy with cervical-corporeal anastomosis as a relatively less invasive uterine conservation strategy with minimization of blood loss and transfusion needs. Furthermore, total lower uterine segmentectomy with cervico-corporeal anastomosis has the merits of leaving behind a strong scar and a well-functioning uterus.

Study Type

Observational

Enrollment (Actual)

57

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

Study Locations

  • Egypt
      • Assiut, Egypt, 71511
        • Assiut Medical School

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

Sampling Method

Probability Sample

Study Population

pregnant women diagnosed with placenta accreta by us and Doppler Accreta invading the entire or most of the lus Women who welling uterine conservation, planned and elective cs for women diagnosed with accreta, and accepting participation

Description

Inclusion Criteria:

pregnant women diagnosed with placenta accreta by us and Doppler Accreta invading the entire or most of the lus Women who welling uterine conservation, Planned and elective cs for women diagnosed with accreta, and accepting participation

Exclusion Criteria:

women who don't accept participation, women who desire hysterectomy. Women who diagnosed with accrete and placenta separated easily women with concomitant pathology and requiring hysterectomy .

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

  • Observational Models: Other
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Success of procedure
Time Frame: 1year

Success of procedure regarding ability to preserve the uterus and stoppage of bleeding.

The bleeding will be evaluated by haemoglobin level preoperative and postoperative.
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Chair: Ezzat H Sayed, professor, Assiut Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

June 1, 2022

Primary Completion (Actual)

July 1, 2023

Study Completion (Actual)

December 30, 2023

Study Registration Dates

First Submitted

May 30, 2022

First Submitted That Met QC Criteria

June 11, 2022

First Posted (Actual)

June 15, 2022

Study Record Updates

Last Update Posted (Estimated)

January 31, 2024

Last Update Submitted That Met QC Criteria

January 30, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TLUSCCA

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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