Clinical trial NCT04210479: Comparison of Bladder Filling vs. Non-Filling in Cesarean Hysterectomy for Placenta Percreta
Official title: Bladder Filling in Cesarean Hysterectomy for Placenta Percreta: A Randomized Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Placenta Accreta
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2019-12-24
Enrollment: 64
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 44
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Rate of urinary bladder injury
timeFrame: Intra-operative (i.e. during surgery).
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Faculty of Medicine, Mansoura University
name: Hatem Abu Hashim, MD. FRCOG. PhD
role: STUDY_CHAIR
affiliation: Samnoud General Hospital
name: Mostafa Aboelenin, MBBCh
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.