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

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04210479
• Other study ID #: MS.19.12.939
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 15, 2020
• Est. completion date: June 30, 2021

Study information

• Verified date: December 2019
• Source: Mansoura University
• Contact: Hatem Abu Hashim, MD.FRCOG.PhD
• Phone: +20502300002
• Email: hatem_ah[@]hotmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 64
• Est. completion date: June 30, 2021
• Est. primary completion date: March 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 44 Years

Eligibility

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.

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

Procedure:
• Filled-bladder
Urinary bladder filling with 300 ml diluted methylene blue
• non filled-bladder
Pull up the empty (non-filled) urinary bladder using Allis forceps

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hatem AbuHashim

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of urinary bladder injury	Unintentional bladder injury during elective cesarean hysterectomy	Intra-operative (i.e. during surgery).