Clinical trial NCT04866888: Placenta Accreta Spectrum Outcome After Uterine Conservation
Official title: Short and Intermediate Term Outcomes of Uterine Conservation After Cesarian Section in Cases of Placenta Accreta Spectrum
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Placenta Accreta Spectrum
Keywords: PAS
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2021-04-30
Enrollment: 120
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Uterus will be incised 5mm above the placenta bulge. 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. After 3 months ultrasound and out-patient hysteroscopy will be done to check for any uterine abnormalities
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: date of resumed menses
timeFrame: from 2 weeks to 6 months after surgery
measure: menstrual abnormalities
timeFrame: from 2 to 6 months after surgery
measure: abnormal uterine bleeding
timeFrame: from 2 to 6 months after surgery
measure: pelvic pain
timeFrame: from 2 to 6 months after surgery
measure: isthmocele
timeFrame: from 3 to 6 months after surgery
measure: intrauterine adhesions
timeFrame: from 3 to 6 months after surgery
measure: puerperal blood loss
timeFrame: 48 hours until 2 months after surgery
measure: contraception use
timeFrame: intraoperative until 5 months after surgery
measure: fibrosis
timeFrame: from 3 to 6 months after surgery
Secondary outcomes:
measure: operation time
timeFrame: intraoperative
measure: repair time
timeFrame: intraoperative
measure: Estimated blood loss
timeFrame: intraoperative
measure: packed red blood cells transfusion
timeFrame: intraoperative until 24 hours after surgery
measure: fresh frozen plasma (FFP) transfusion
timeFrame: intraoperative until 24 hours postoperative
measure: bladder injury
timeFrame: intraoperative until 2 weeks post operative
measure: ureter injury
timeFrame: intraoperative until 2 weeks post operative
measure: bowel injury
timeFrame: intraoperative until 2 weeks post operative
measure: surgical site infection
timeFrame: 24 hours until 1 month after surgery
measure: urine output
timeFrame: intraoperative
measure: internal iliac artery ligation
timeFrame: intraoperative
measure: pre-operative hemoglobin
timeFrame: preoperative
measure: post-operative hemoglobin
timeFrame: postoperative within 6 hours from surgery
measure: hospital stay
timeFrame: postoperative until 10 days after surgery
measure: ICU admission
timeFrame: immediate postoperative until 5 days after surgery
measure: intermediate care admission
timeFrame: recording the number of patients admitted to the ICU
measure: surgical diagnosis
timeFrame: intraoperative
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Faculty of Medicine
Study officials:
affiliation: faculty of medicine department of obstetrics and gyneacology
name: Mervat S Al-sedik, MD
role: STUDY_CHAIR
References: