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

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

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.

Study Overview

• Status: Unknown
• Conditions: Placenta Accreta
• Intervention / Treatment: Procedure: Filled-bladder; Procedure: non filled-bladder

• Study Type: Interventional
• Enrollment (Anticipated): 64
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Hatem Abu Hashim, MD.FRCOG.PhD; Phone Number: +20502300002; Email: hatem_ah@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 44 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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).

Collaborators and Investigators

• Sponsor: Hatem AbuHashim
• Investigators: Principal Investigator: Mostafa Aboelenin, MBBCh, Samnoud General Hospital

Publications and helpful links

General Publications

• Matsubara S. Caesarean hysterectomy for placenta praevia accreta: filling the bladder technique to identify an appropriate bladder separation site. J Obstet Gynaecol. 2013 Feb;33(2):163-4. doi: 10.3109/01443615.2012.740525. No abstract available.

Study record dates

Study Major Dates

• Study Start (Anticipated): January 15, 2020
• Primary Completion (Anticipated): March 31, 2021
• Study Completion (Anticipated): June 30, 2021

Study Registration Dates

• First Submitted: December 21, 2019
• First Submitted That Met QC Criteria: December 23, 2019
• First Posted (Actual): December 24, 2019

Study Record Updates

• Last Update Posted (Actual): December 24, 2019
• Last Update Submitted That Met QC Criteria: December 23, 2019
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Placenta Accreta
• Other Study ID Numbers: MS.19.12.939

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No