Placenta Accreta Spectrum Outcome After Uterine Conservation (PAS)

Alexandria University

Status: Enrolling

Conditions: Placenta Accreta Spectrum

Treatments: Diagnostic Test: outpatient hysteroscopy; Procedure: closure of the uterine wall defect; Diagnostic Test: ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT04866888

H.R1987

Details and patient eligibility

About

study will be carried out on patients with placenta accreta spectrum having done uterine conservation and recording immediate outcome of conservation regarding success of the procedure, amount of blood loss and amount of blood transfused and followed up to check the return of menses, any uterine abnormalities by ultrasound or hysteroscopy especially isthmocele and intrauterine synechia.

Full description

After institutional review board approval and written informed consent, recruited cases will be subjected to the following:

1. Data registration including:

   • Age.
   • Obstetric history including gravidity, parity, number of previous cesarean deliveries, and number and gender of living children.
   • Details of the current pregnancy including duration in menstrual weeks, any problems encountered during its course.
   • Desire for future fertility.
   • Medical, surgical, and medication history.

2. Anthropometry including weight, height, and body mass index (BMI) before pregnancy and at the time of operation.

3. General examination including vital signs, and signs of any associated problems.

4. Routine laboratory investigations with particular emphasis on complete blood count, Coagulation profile and including blood glucose level, renal and liver function tests.

5. Detailed sonographic examination to evaluate fetal biometry, and wellbeing rule out exclusion factors, and confirm diagnosis of PAS and assess the degree of invasion, and its severity using both trans-abdominal transducer with frequency of 2-5 megahertz (MHZ) and trans-vaginal transducer with frequency of 4-10 MHZ.

Intraoperative details will be documented. Follow up of patients will be recorded. Sample size was calculated by estimating a single proportion distribution at a significance level of 0.05.

Enrollment: 120 estimated patients

Sex: Female

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• • Diagnosed sonographically to have placenta accreta spectrum.

  • Pregnancy is singleton and fetus is alive.
  • Elective caesarean section done from 35 gestational weeks.

Exclusion criteria

• • Patients requesting hysterectomy.

  • Coexisting uterine pathology such as fibroids or gynaecological malignancies.
  • Patients with bleeding diathesis.
  • Morbid obesity of BMI >40.
  • Patients having labour pains or vaginal bleeding before scheduled intervention.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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120 participants in 1 patient group

pregnant women with placenta accreta spectrum

Experimental group

Description:

Bladder will be dissected and mobilized down to the vagina after skeletonization and securing of bridging vessels either by electro-coagulation or ligation. Uterus will be incised 5mm above the placenta bulge, delivering the fetus followed by Carbetocin 100 microgram /1 ml intravascular. Repair of the uterine wall defect will be done. If extrauterine bleeding is excessive we may revert to internal iliac artery ligation followed by insertion of intra-peritoneal drain and regular abdominal wall closure. After 3 months from delivery, ultrasound with different modalities will be done to all patients and outpatient hysteroscopy if symptomatic patients or with abnormal sonography.

Treatment:

Diagnostic Test: ultrasound

Procedure: closure of the uterine wall defect

Diagnostic Test: outpatient hysteroscopy