NCT04866888

Placenta Accreta Spectrum Outcome After Uterine Conservation

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Alexandria University · Academic / Other
• Sex: Female
• Age: 20 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Placenta Accreta Spectrum

Interventions

Type	Name	Description
PROCEDURE	closure of the uterine wall defect	Uterine exteriorization followed by pealing of amniotic membranes to reach an accessible pole of the placenta to detect a plan of cleavage behind it. The independent hand of the surgeon passed through the previous plan from points of least resistance to high resistance. The defect will be repaired from the inner aspect of the uterus via running sutures using Vicryl (1-0) on a round needle, 45mm. the suture will pass from one edge to hitch the bed and pass to the other edge till we completely close the defect subsequently, controlling the bleeding. Uterine scar closure by running sutures in two layers, where the first layer compresses the placental bed defect externally.
DIAGNOSTIC_TEST	ultrasound	Before the procedure transabdominal and transvaginal ultrasound will be done to diagnose PAS and to map the uterine wall defects. After 3 months,Transabdominal and transvaginal ultrasound with different modalities to assess the uterine wall, the cavity, endometrium, myometrium and the cervix. Isthmocele will be defined as a defect at uterine wall where residual myometrium thickness and ratio between residual myometrium and total myometrium thickness will be measured and recorded. The shape of the isthmocele will be also recorded.
DIAGNOSTIC_TEST	outpatient hysteroscopy	Office hysteroscope will be done after patient consent to evaluate the uterine cavity if the patient is symptomatic or with abnormal sonography. It will be performed in the proliferative phase of the menstrual cycle. Non-steroidal anti-inflammatory will be given one hour before the procedure, then the patient will be in lithotomy position. Following aseptic rules, the rigid 4 mm hysteroscope will be inserted into the uterus through the cervix without using speculum nor tenaculum. Any pathology will be identified, and data will be recorded.

Timeline

• Start date: 2021-04-28
• Primary completion: 2025-12-01
• Completion: 2026-03-15
• First posted: 2021-04-30
• Last updated: 2025-02-12

Locations

1 site across 1 country: Egypt