Placenta Accreta Spectrum Outcome After Uterine Conservation

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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 clo
• Диагностический тест 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 t
• Диагностический тест 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 w

Первичные конечные точки

• date of resumed menses [Срок оценки: from 2 weeks to 6 months after surgery]
• menstrual abnormalities [Срок оценки: from 2 to 6 months after surgery]
• abnormal uterine bleeding [Срок оценки: from 2 to 6 months after surgery]
• pelvic pain [Срок оценки: from 2 to 6 months after surgery]
• isthmocele [Срок оценки: from 3 to 6 months after surgery]
• intrauterine adhesions [Срок оценки: from 3 to 6 months after surgery]
• puerperal blood loss [Срок оценки: 48 hours until 2 months after surgery]
• contraception use [Срок оценки: intraoperative until 5 months after surgery]
• fibrosis [Срок оценки: from 3 to 6 months after surgery]

Вторичные конечные точки (12)

• operation time [Срок оценки: intraoperative]
• repair time [Срок оценки: intraoperative]
• Estimated blood loss [Срок оценки: intraoperative]
• packed red blood cells transfusion [Срок оценки: intraoperative until 24 hours after surgery]
• fresh frozen plasma (FFP) transfusion [Срок оценки: intraoperative until 24 hours postoperative]
• bladder injury [Срок оценки: intraoperative until 2 weeks post operative]
• ureter injury [Срок оценки: intraoperative until 2 weeks post operative]
• bowel injury [Срок оценки: intraoperative until 2 weeks post operative]
• surgical site infection [Срок оценки: 24 hours until 1 month after surgery]
• urine output [Срок оценки: intraoperative]
• internal iliac artery ligation [Срок оценки: intraoperative]
• pre-operative hemoglobin [Срок оценки: preoperative]

Критерии участия

Критерии включения

• • Diagnosed sonographically to have placenta accreta spectrum.

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

Критерии исключения

• • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Faculty of Medicine — Alexandria

Публикации

• 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. PMID 39551821

Идентификаторы

NCT: NCT04866888 · H.R1987

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗