Comparison of Bladder Filling vs. Non-Filling in Cesarean Hysterectomy for Placenta Percreta

Study Overview
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Brief Summary
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The placenta accreta spectrum (PAS) which includes accreta, increta, and percreta represents a significant obstetric challenge. PAS complicates as many as 1 per 500 pregnancies and this risk is increased with prior cesarean deliveries. Antenatal diagnosis of PAS allows for multidisciplinary planning and delivery before the onset of labor and/or vaginal bleeding. This approach has reduced maternal morbidity rates. including less blood loss, fewer transfusion requirements and, intraoperative urinary tract injury as well as improve fetal outcome. Ultrasound evaluation is the recommended first-line modality for diagnosing PAS. Ultrasound features suggestive of PAS include loss of the normal retroplacental clear zone, attenuation of the uterine-bladder interface, reduced retroplacental myometrial thickness, presence of intraplacental lacunar spaces, and bridging vessels between the placenta and bladder. A systematic review reported that the antenatal diagnosis of PAS significantly lowered the rate of urinary tract injury (from 63% to 39%) during cesarean hysterectomies in these cases. Unlike other elective cesarean hysterectomies, cesarean hysterectomy with a placenta previa increta/percreta, is more difficult. There is a greater need to both keep a margin from the vascular cervical-placental mass and simultaneously protect the urinary bladder. Case series reported that bladder filling helps the surgeon to more clearly identify the planes of dissection and secure the engorged aberrant vessels, thereby reduces bladder injury. Accordingly, a prospective randomized study in pregnant patients with placenta previa increta/percreta undergoing elective cesarean hysterectomy will be conducted to address this important issue.

Official Title
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Bladder Filling in Cesarean Hysterectomy for Placenta Percreta: A Randomized Trial

Conditions
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Placenta Accreta

Intervention / Treatment
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* Procedure: Filled-bladder
* Procedure: non filled-bladder


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Pregnant women in their third trimester (35-37 W). Placenta previa accreta spectrum identified by the Ultrasound (low lying anterior or major degree anterior). With at least one prior cesarean section. Elective cesarean hysterectomy. Evidence of gross placental invasion at the time of surgery (FIGO grade 3a. Exclusion Criteria: Patients undergoing conservative treatment. Emergency cesarean hysterectomy. No evidence of gross placental invasion at the time of surgery. Posterior placenta.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 44 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Filled-bladder<br>Bladder filling with 300ml diluted methylene blue. | Procedure: Filled-bladder<br>* Urinary bladder filling with 300 ml diluted methylene blue<br>|
| Active Comparator: non filled-bladder<br> | Procedure: non filled-bladder<br>* Pull up the empty (non-filled) urinary bladder using Allis forceps<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of urinary bladder injury | Unintentional bladder injury during elective cesarean hysterectomy | Intra-operative (i.e. during surgery). |