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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04210479
Enrollment
64
Registered
2019-12-24
Start date
2020-01-15
Completion date
2021-06-30
Last updated
2019-12-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Placenta Accreta

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.

Interventions

PROCEDUREFilled-bladder

Urinary bladder filling with 300 ml diluted methylene blue

PROCEDUREnon filled-bladder

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

Sponsors

Hatem AbuHashim
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 44 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Rate of urinary bladder injuryIntra-operative (i.e. during surgery).Unintentional bladder injury during elective cesarean hysterectomy

Contacts

Primary ContactHatem Abu Hashim, MD.FRCOG.PhD
hatem_ah@hotmail.com+20502300002

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026