Evaluation of Planned Conservative Surgical Management of Placenta Accreta Spectrum in Women's Health Center, Assiut University Hospital

November 29, 2024 updated by: Ahmed Gamal Ahmed Saleh, Assiut University

In recent years, with the application of an abdominal artery balloon and the improvement of surgical techniques, efforts are made to preserve the uterus for patients PAS. the aim of the study To evaluate conservative surgical management of placenta accreta spectrum in Assiut University hospital regarding maternal and fetal outcomes.

Study Overview

Status

Not yet recruiting

Conditions

Placenta Accreta

Detailed Description

Placenta accreta spectrum disorder (PAS) is a serious obstetric disorder that is characterized by low lying and deep penetration of the villi which are abnormally attached to the myometrium of the uterus. This obstructs its complete separation during the third stage of labor which induces continued bleeding and have potentially life- threatening for the mother. Most commonly, it is a consequence of a partial or complete absence of the compact and spongy layer known as the decidua basalis, and mis-development of the fibrinoid Nitabuch's layer which lies between the boundary zone of the thick endometrium and the cytotrophoblastic shell in the placenta.

Traditionally, caesarean hysterectomy at the time of delivery has been the preferred management strategy for placenta previa accreta. Not only does this approach preclude future fertility, but it is also a procedure synonymous with significant perioperative risks. For women who wish to conserve their reproductive function, other treatment options have been described.

Different methods have been employed to manage the PA, ranging from uterine conservation, which involves leaving the placenta in situ, to conventional hysterectomy. Classical cesarean sections (C- sections) prevent the excessive bleeding by leaving the adherent placenta in situ and by adopting strategic planning with a comprehensive analysis that aids the reduction in maternal morbidity and mortality rates.

Study Type

Observational

Enrollment (Estimated)

150

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: Ahmed Gamal Ahmed Saleh, resident doctor
Phone Number: +2 01003787826
Email: Ahmed.16266067@med.aun.edu.eg

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

Adult
Older Adult

Accepts Healthy Volunteers

Sampling Method

Probability Sample

Study Population

patients with placenta accrete spectrum secondary to previous cesarean section and Gestational age above 28 weeks

Description

Inclusion Criteria:

Pregnant women with history of previous caesarean section.
Age above 18 years.
Gestational age above 28 weeks.
U/S signs suggestive of placenta previa accreta.
Confirmed diagnosis of Placenta previa accreta spectrum disorder by 3 D U/S, Doppler or MRI if needed.

Exclusion Criteria:

Gestational age less 28 weeks.
Age less than 18 years.
Patients with known bleeding disorders.
Multiple pregnancy.
Other pathology (fibroid, ………………..).
Patients with placental separation.

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

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
patients with placenta accrete spectrum patients with placenta accrete spectrum secondary to previous cesarean section will be recruited from the outpatient clinic and reception unit, Assiut, Egypt.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
amount of blood loss Time Frame: baseline	amount of blood loss during operation according to number of towels and amount of blood in suction pump	baseline

Collaborators and Investigators

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

Sponsor

Assiut University

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

Cali G, Forlani F, Giambanco L, Amico ML, Vallone M, Puccio G, Alio L. Prophylactic use of intravascular balloon catheters in women with placenta accreta, increta and percreta. Eur J Obstet Gynecol Reprod Biol. 2014 Aug;179:36-41. doi: 10.1016/j.ejogrb.2014.05.007. Epub 2014 May 21.

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)

January 1, 2025

Primary Completion (Estimated)

January 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

November 27, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Estimated)

December 2, 2024

Study Record Updates

Last Update Posted (Estimated)