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

NCT04210479 | Unknown

• 1 other identifier: MS.19.12.939
• Study Type: interventional
• Target: 64
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Placenta Accreta

Outcome Measures

Primary Outcomes (1)

• Rate of urinary bladder injury

  Unintentional bladder injury during elective cesarean hysterectomy

  Intra-operative (i.e. during surgery).

Study Arms (2)

Filled-bladder

EXPERIMENTAL

Bladder filling with 300ml diluted methylene blue.

Procedure: Filled-bladder

non filled-bladder

ACTIVE COMPARATOR

Procedure: non filled-bladder

Interventions

Filled-bladder PROCEDURE

Urinary bladder filling with 300 ml diluted methylene blue

Filled-bladder

non filled-bladder PROCEDURE

Pull up the empty (non-filled) urinary bladder using Allis forceps

non filled-bladder

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• Patients undergoing conservative treatment.
• Emergency cesarean hysterectomy.
• No evidence of gross placental invasion at the time of surgery.
• Posterior placenta.

Sponsors & Collaborators

• Hatem AbuHashim: lead

Related Publications (1)

• 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.

  PMID: 23445140 RESULT

MeSH Terms

Conditions

Placenta Accreta

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases

Study Officials

• Hatem Abu Hashim, MD. FRCOG. PhD

  Faculty of Medicine, Mansoura University

  STUDY CHAIR

• Mostafa Aboelenin, MBBCh

  Samnoud General Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Hatem Abu Hashim, MD.FRCOG.PhD

CONTACT

+20502300002; hatem_ah@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: December 21, 2019
• First Posted: December 24, 2019
• Study Start: January 15, 2020
• Primary Completion: March 31, 2021
• Study Completion: June 30, 2021
• Last Updated: December 24, 2019

Record last verified: 2019-12