NCT05871645

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
323

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jan 2015

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2022

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

February 27, 2023

Completed
3 months until next milestone

First Posted

Study publicly available on registry

May 23, 2023

Completed
Last Updated

June 7, 2023

Status Verified

June 1, 2023

Enrollment Period

7 years

First QC Date

February 27, 2023

Last Update Submit

June 5, 2023

Conditions

Placenta Accreta

Keywords

JSICA techniquePlacenta AccretaUterine Preservation

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • Intraoperative Bleeding in JSICA compared to hysterectomy

    Perioperative

  • Operation duration in JSICA compared to hysterectomy

    Perioperative

  • Number of Patients Admitted to ICU in JSICA compared to hysterectomy

    24 hours

  • Rate of Intraoperative complications in JSICA compared to hysterectomy

    Perioperative

Study Arms (2)

Jakarta Surgical Uterine Conservation (JSICA) technique

EXPERIMENTAL

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

Procedure: Jakarta Surgical Uterine Conservation (JSICA) Technique

Standard Hysterectomy

ACTIVE COMPARATOR

Surgery to remove the uterus

Procedure: Standard Hysterectomy

Interventions

Jakarta Surgical Uterine Conservation (JSICA) TechniquePROCEDURE

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

Jakarta Surgical Uterine Conservation (JSICA) technique
Standard HysterectomyPROCEDURE

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

Standard Hysterectomy

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThis study apply for women with placenta accreta spectrum
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Placenta Accreta

Interventions

Methods

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesPlacenta Diseases

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SEQUENTIAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 27, 2023

First Posted

May 23, 2023

Study Start

January 1, 2015

Primary Completion

December 31, 2021

Study Completion

February 28, 2022

Last Updated

June 7, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

ID(1)