Actively Recruiting

Phase Not Applicable
Age: 20Years - 40Years
FEMALE
ID04866888

Short and Intermediate Term Outcomes of Uterine Conservation After Cesarean Section in Cases of Placenta Accreta Spectrum

Led by Alexandria University · Updated on 2025-02-12

120

Participants Needed

1

Research Sites

14 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying women with placenta accreta spectrum (PAS) who have undergone uterine conservation during cesarean delivery. The study aims to evaluate the immediate success of preserving the uterus, including measuring blood loss and transfusion needs, and to follow patients over time to assess menstrual return, uterine abnormalities, and related symptoms. This research focuses on short- and intermediate-term outcomes after cesarean section for PAS to better understand the procedure's effects. The treatment involves surgically delivering the fetus by incising the uterus above the placenta bulge, followed by administration of Carbetocin to aid uterine contraction. The uterine wall defect is repaired with running sutures, and if excessive bleeding occurs, additional procedures like internal iliac artery ligation may be used. Three months after delivery, all patients receive ultrasound assessments, and symptomatic patients or those with abnormal ultrasound findings undergo outpatient hysteroscopy to evaluate uterine health. Participants provide detailed medical and obstetric history, undergo physical exams and laboratory tests, and receive sonographic evaluations before surgery. During and after surgery, researchers record operative details, blood loss, transfusions, and complications. Follow-up includes monitoring return of menses, menstrual abnormalities, pelvic pain, uterine defects like isthmocele, and intrauterine adhesions between 2 weeks and 6 months post-surgery. Outcomes such as blood loss, surgical time, and hospital stay are also measured, with data collection extending up to 10 days post-operation and follow-up continuing for several months.

CONDITIONS

Brief Title

Placenta Accreta Spectrum Outcome After Uterine Conservation

Who Can Participate

Age: 20Years - 40Years
FEMALE

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed sonographically with placenta accreta spectrum
  • Singleton pregnancy with a live fetus
  • Elective cesarean section scheduled from 35 gestational weeks
  • Female aged between 20 and 40 years
Not Eligible

You will not qualify if you...

  • Patients requesting hysterectomy
  • Coexisting uterine pathology such as fibroids or gynecological malignancies
  • Bleeding disorders (bleeding diathesis)
  • Morbid obesity with BMI over 40
  • Presence of labor pains or vaginal bleeding before scheduled surgery

AI-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)

Treatment

Duration - Intraoperative and immediate postoperative period up to 10 days

Participants undergo cesarean section with uterine conservation involving closure of the uterine wall defect and associated surgical procedures.

Hospital stay with daily monitoring until discharge

Follow-up

Duration - From 3 to 6 months after surgery

Participants receive ultrasound evaluations at delivery and at 3 months post-surgery to assess uterine wall and placental site, with outpatient hysteroscopy if symptomatic or abnormal ultrasound findings occur.

1 ultrasound visit at 3 months and outpatient hysteroscopy if needed

Trial Site Locations

Total: 1 location

1

Faculty of Medicine

Alexandria, Alexandria Governorate, Egypt, 21131

Actively Recruiting

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Research Team

O

Omar Y Elshorbagy, As.lec

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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