## Protocol Section
### Identification Module
**NCT ID:** NCT04210479

**Brief Title:** 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

#### Organization Study ID Info
**ID:** MS.19.12.939
#### Organization
**Class:** OTHER
**Full Name:** Mansoura University
### Status Module
#### Completion Date
**Date:** 2021-06-30

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** NOT_YET_RECRUITING
#### Last Update Post Date
**Date:** 2019-12-24

**Type:** ACTUAL

**Last Update Submit Date:** 2019-12-23

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2021-03-31

**Type:** ESTIMATED

#### Start Date
**Date:** 2020-01-15

**Type:** ESTIMATED

**Status Verified Date:** 2019-12

#### Study First Post Date
**Date:** 2019-12-24
**Type:** ACTUAL
**Study First Submit Date:** 2019-12-21
**Study First Submit QC Date:** 2019-12-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Hatem AbuHashim

#### Responsible Party

**Investigator Affiliation:** Mansoura University

**Investigator Full Name:** Hatem AbuHashim

**Investigator Title:** Professor

**Type:** SPONSOR_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

### Description Module

**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 Module

**Conditions:**

- Placenta Accreta

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** SINGLE

**Who Masked:**

- OUTCOMES_ASSESSOR

**Primary Purpose:** PREVENTION

#### Enrollment Info

**Count:** 64

**Type:** ESTIMATED

**Phases:**

- NA

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Bladder filling with 300ml diluted methylene blue.

**Intervention Names:**

- Procedure: Filled-bladder

**Label:** Filled-bladder

**Type:** EXPERIMENTAL

#### Arm Group 2

**Intervention Names:**

- Procedure: non filled-bladder

**Label:** non filled-bladder

**Type:** ACTIVE_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Filled-bladder

**Description:** Urinary bladder filling with 300 ml diluted methylene blue

**Name:** Filled-bladder

**Type:** PROCEDURE

#### Intervention 2

**Arm Group Labels:**

- non filled-bladder

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

**Name:** non filled-bladder

**Type:** PROCEDURE

### Outcomes Module

#### Primary Outcomes

**Description:** Unintentional bladder injury during elective cesarean hysterectomy

**Measure:** Rate of urinary bladder injury

**Time Frame:** Intra-operative (i.e. during surgery).

### Eligibility Module

**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.

**Maximum Age:** 44 Years

**Minimum Age:** 18 Years

**Sex:** FEMALE

**Standard Ages:**

- ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** hatem_ah@hotmail.com

**Name:** Hatem Abu Hashim, MD.FRCOG.PhD

**Phone:** +20502300002

**Role:** CONTACT

#### Overall Officials

**Official 1:**

**Affiliation:** Faculty of Medicine, Mansoura University

**Name:** Hatem Abu Hashim, MD. FRCOG. PhD

**Role:** STUDY_CHAIR

**Official 2:**

**Affiliation:** Samnoud General Hospital

**Name:** Mostafa Aboelenin, MBBCh

**Role:** PRINCIPAL_INVESTIGATOR

### References Module

#### 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.

**PMID:** 23445140

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000007744

- Term: Obstetric Labor Complications

- ID: D000011248

- Term: Pregnancy Complications

- ID: D000005261

- Term: Female Urogenital Diseases and Pregnancy Complications

- ID: D000091642

- Term: Urogenital Diseases

- ID: D000010922

- Term: Placenta Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

- Abbrev: All

- Name: All Conditions

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M13811

- Name: Placenta Accreta

- Relevance: HIGH

- As Found: Placenta Accreta

- ID: M10764

- Name: Obstetric Labor Complications

- Relevance: LOW

- As Found: Unknown

- ID: M14127

- Name: Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M2875

- Name: Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M27093

- Name: Female Urogenital Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M8399

- Name: Female Urogenital Diseases and Pregnancy Complications

- Relevance: LOW

- As Found: Unknown

- ID: M13812

- Name: Placenta Diseases

- Relevance: LOW

- As Found: Unknown

- ID: T4583

- Name: Placenta Disorder

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000010921

- Term: Placenta Accreta

### Intervention Browse Module - Browse Branches

- Abbrev: All

- Name: All Drugs and Chemicals

### Intervention Browse Module - Browse Leaves

- ID: M11726

- Name: Methylene Blue

- Relevance: LOW

- As Found: Unknown

### Misc Info Module

- Version Holder: 2024-05-24
