Placenta Accreta Spectrum Outcome After Uterine Conservation

NCT ID: NCT04866888

Last Updated: 2025-02-12

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-04-28
• Study Completion Date: 2026-03-15

Brief 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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

pregnant women with placenta accreta spectrum

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.

Group Type: EXPERIMENTAL

closure of the uterine wall defect

Intervention Type: PROCEDURE

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.

ultrasound

Intervention Type: DIAGNOSTIC_TEST

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.

outpatient hysteroscopy

Intervention Type: DIAGNOSTIC_TEST

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.

Interventions

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.

Intervention Type: PROCEDURE

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.

Intervention Type: 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.

Intervention Type: DIAGNOSTIC_TEST

Other Intervention Names

double compression sutures; office hysteroscopy

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Alexandria University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mervat S Al-sedik, MD

Role: STUDY_CHAIR

faculty of medicine department of obstetrics and gyneacology

Locations

Faculty of Medicine

Alexandria, Alexandria Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Omar Y Elshorbagy, As.lec

Role: CONTACT

o_kamal13@alexmed.edu.eg

01111362322 ext. 002

Facility Contacts

omar Y Elshorbagy, AS.LEC

Role: primary

o_kamal13@alexmed.edu.eg

01111362322 ext. 002

References

Elshorbagy OY, Hamdy MA. Conservative surgical repair of placenta increta invading into uterine septum: case report. J Med Case Rep. 2024 Nov 18;18(1):549. doi: 10.1186/s13256-024-04814-7.

Reference Type: DERIVED

PMID: 39551821 (View on PubMed)

Other Identifiers

H.R1987

Identifier Type: -

Identifier Source: org_study_id