Actively Recruiting

Phase Not Applicable
Age: 25Years - 45Years
FEMALE
ID06465836

Beni-Suef University Hospital Simplified Conservative Approach for Managing Placenta Accreta Spectrum: Randomized Controlled Trial

Led by Nesreen Abdel Fattah Abdullah Shehata · Updated on 2024-06-20

172

Participants Needed

1

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are evaluating two surgical techniques to manage morbidly adherent placenta, a serious pregnancy condition where the placenta attaches too deeply to the uterus. The study aims to compare the effectiveness of modified uterine artery ligation and myometrial compression as conservative treatments to improve patient outcomes while preserving fertility. This approach follows guidelines recommending avoidance of hysterectomy, which can have negative effects on pelvic and physical functions. The study involves two groups of patients with placenta accreta. One group will receive bilateral uterine artery ligations using the O-lreay technique combined with standard conservative methods. The other group will undergo a modified O-lreay technique that includes uterine ligation with compression of the lower uterine segment after placental separation. Both procedures involve careful stitching and avoiding injury to surrounding organs. Participants will be monitored for blood loss six hours after surgery, along with maternal morbidity and mortality within 24 hours postoperatively. The study includes assessments of clinical stability, vaginal bleeding, and fetal condition before enrollment. The total participation period spans from surgery through early postoperative monitoring, with all data collected to evaluate the safety and effectiveness of these conservative surgical measures.

CONDITIONS

Brief Title

Simplified Conservative Measures in Managing Morbidly Adherent Placenta in Beni-Suef University

Who Can Participate

Age: 25Years - 45Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Gestational age more than 28 weeks as determined by last menstrual period and ultrasound
  • Diagnosis of placenta previa confirmed by ultrasound
  • Clinically stable with no or mild vaginal bleeding
  • No evidence of fetal compromise
  • Patient consent
Not Eligible

You will not qualify if you...

  • Vaginal bleeding
  • Medical disorders

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Surgery and Immediate Post-operative Care

Duration - Day of delivery and immediate recovery period

Participants undergo surgery involving either the O- lreay technique or the modified O- lreay technique as conservative approaches to manage placenta accreta spectrum, aiming to avoid hysterectomy and preserve fertility.

1 surgical procedure and immediate post-operative hospital stay

Post-operative Follow-up

Duration - 24 hours postoperatively

Participants are monitored for maternal morbidity and mortality, as well as amount of blood loss within 24 hours postoperatively.

1 to 2 post-operative visits

Trial Site Locations

Total: 1 location

1

Beni-Suef University

Cairo, Egypt

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Research Team

H

Hamada Ali, A. professor

N

nesreen shehata, professor

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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