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

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.

Study Overview

• Status: Completed
• Conditions: Placenta Accreta
• Intervention / Treatment: Procedure: Jakarta Surgical Uterine Conservation (JSICA) Technique; Procedure: Standard Hysterectomy

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 323
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta Pusat, DKI Jakarta, Indonesia, 10430
      • Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria for JSICA:

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:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Jakarta Surgical Uterine Conservation (JSICA) technique; Cipto Mangunkusumo General Hospital's novel uterine preservation technique based on standard procedure	Procedure: 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
Active Comparator: Standard Hysterectomy; Surgery to remove the uterus	Procedure: Standard Hysterectomy; The main types of hysterectomy are abdominal, vaginal, and laparoscopic hysterectomy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative bleeding	Intraoperative bleeding in this study was measured by the amount of blood loss (cc) and classified into < 1.000 cc, 1.000-1.500 cc, and > 1.500 cc. .	Perioperative
Operation duration	The operation duration was the time interval from skin incision to closure (hours) and classified into < 3 hours and > 3 hours.	Perioperative
Number of Patients Admitted to ICU	ICU admission was identified by the documentation of number of patients' admission to the ICU	24 hours
Rate of Intraoperative complications	Rate of intraoperative complications were identified by the documentation of injury to adjacent structures (bladder or ureter) or a need for transfusion.	Intraoperative

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Intraoperative Bleeding in JSICA compared to hysterectomy	Intraoperative bleeding in this study was measured by the amount of blood loss (cc) and classified into < 1.000 cc, 1.000-1.500 cc, and > 1.500 cc in comparison of JSICA to hysterectomy	Perioperative
Operation duration in JSICA compared to hysterectomy	The operation duration was the time interval from skin incision to closure (hours) and classified into < 3 hours and > 3 hours in comparison of JSICA to hysterectomy	Perioperative
Number of Patients Admitted to ICU in JSICA compared to hysterectomy	ICU admission was identified by the documentation of number of patients' admission to the ICU in comparison of JSICA to hysterectomy	24 hours
Rate of Intraoperative complications in JSICA compared to hysterectomy	Rate of intraoperative complications were identified by the documentation of injury to adjacent structures (bladder or ureter) or a need for transfusion in comparison of JSICA to hysterectomy	Perioperative

Collaborators and Investigators

• Sponsor: Dr Cipto Mangunkusumo General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2015
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): February 28, 2022

Study Registration Dates

• First Submitted: February 27, 2023
• First Submitted That Met QC Criteria: May 20, 2023
• First Posted (Actual): May 23, 2023

Study Record Updates

• Last Update Posted (Actual): June 7, 2023
• Last Update Submitted That Met QC Criteria: June 5, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Keywords: Placenta Accreta; JSICA technique; Uterine Preservation
• Additional Relevant MeSH Terms: Pregnancy Complications; Obstetric Labor Complications; Placenta Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Accreta
• Other Study ID Numbers: 22-05-0541

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No