Placenta Accreta Spectrum Management: Uterine Preservation Using JSICA Technique - Retrospective Cross-Sectional Study

NCT ID: NCT05871645

Last Updated: 2023-06-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

323 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-01-01

Study Completion Date

2022-02-28

Brief Summary

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The goal of this study is to present the Jakarta Surgical Uterine Conservation (JSICA) technique and its perioperative outcomes in Placenta Accreta Spectrum patients. Participants are all patients undergoing standard hysterectomy or the Jakarta Surgical Uterine Conservation (JSICA) technique. Researchers will compare both groups to see if there are any differences in the perioperative outcomes.

Detailed Description

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This study uses data from Cipto Mangunkusumo General Hospital's Placenta Accreta Case Register. This register includes all patients with a confirmed placenta accreta spectrum diagnosis. Data collected includes demographic characteristics, risk factors, surgery characteristics, and perioperative outcomes. In this study, researchers would like to evaluate the perioperative outcomes of the JSICA technique in comparison to a standard hysterectomy.

Conditions

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Placenta Accreta

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Jakarta Surgical Uterine Conservation (JSICA) technique

Cipto Mangunkusumo General Hospital's novel uterine preservation technique based on standard procedure

Group Type EXPERIMENTAL

Jakarta Surgical Uterine Conservation (JSICA) Technique

Intervention Type PROCEDURE

a. Identifying the placenta accrete site; b. Meticulous dissection to create a bladder flap; c. Incision 1 cm above the placenta accrete; d. Fetal delivery; e. Bottom incision to resect the placenta; f. Placental delivery; g. Uterus without placenta; h. The resection area is approximated using interrupted horizontal mattress suture; i. The continuous suture used to close all incision areas; j. Evaluation of uterine contraction

Standard Hysterectomy

Surgery to remove the uterus

Group Type ACTIVE_COMPARATOR

Standard Hysterectomy

Intervention Type PROCEDURE

The main types of hysterectomy are abdominal, vaginal, and laparoscopic hysterectomy

Interventions

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Jakarta Surgical Uterine Conservation (JSICA) Technique

a. Identifying the placenta accrete site; b. Meticulous dissection to create a bladder flap; c. Incision 1 cm above the placenta accrete; d. Fetal delivery; e. Bottom incision to resect the placenta; f. Placental delivery; g. Uterus without placenta; h. The resection area is approximated using interrupted horizontal mattress suture; i. The continuous suture used to close all incision areas; j. Evaluation of uterine contraction

Intervention Type PROCEDURE

Standard Hysterectomy

The main types of hysterectomy are abdominal, vaginal, and laparoscopic hysterectomy

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Focal accreta invasion ( \< 50% anterior wall)
2. Anterior invasion
3. No parametrial or bladder invasion
4. Residual tissue or healthy myometrium min 3 cm above the OUI or cervix
5. Good uterine contraction post-repair (with or without compression sutures)
6. Hemodynamically stable

Exclusion Criteria

\-
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Dr Cipto Mangunkusumo General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Amanda Rumondang

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital

Jakarta Pusat, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

Other Identifiers

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22-05-0541

Identifier Type: -

Identifier Source: org_study_id

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