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CompletedNCT05871645Updated Jun 7, 2023

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

An interventional study of Jakarta Surgical Uterine Conservation (JSICA) Technique and Standard Hysterectomy in Placenta Accreta, sponsored by Dr Cipto Mangunkusumo General Hospital. Completed at 1 site in Indonesia. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-06-07.

Sponsored by Dr Cipto Mangunkusumo General Hospital · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 8 years 1 month after the study started (first participant enrolled Jan 2015, registered Feb 2023).
Phase
Not applicable
Study type
Interventional
Enrollment
323
Allocation
Non-randomized
Ages
18 Years and older
Sex
Female
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Study 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.

Read the 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.

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Conditions studied

  • Placenta Accreta

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Keywords

  • JSICA technique
  • Placenta Accreta
  • Uterine Preservation
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In context

Placenta Accreta

147 studies on the registry are indexed under Placenta Accreta; 39 are open to participants now.

This study's enrollment of 323 is above the median of 62 across 63 interventional studies indexed under Placenta Accreta.

Browse Placenta Accreta studies →

Lead sponsor

Dr Cipto Mangunkusumo General Hospital is the lead sponsor of 37 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

-

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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
323 participants (actual)

Study arms

  • 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

  • Active comparator
    Standard Hysterectomy

    Surgery to remove the uterus

    Procedure: Standard Hysterectomy

Interventions

  • ProcedureJakarta 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

  • ProcedureStandard Hysterectomy

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

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What researchers measure

Primary outcomes

  1. 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. .

    Time frame: Perioperative

  2. Operation duration

    The operation duration was the time interval from skin incision to closure (hours) and classified into \< 3 hours and \> 3 hours.

    Time frame: Perioperative

  3. Number of Patients Admitted to ICU

    ICU admission was identified by the documentation of number of patients' admission to the ICU

    Time frame: 24 hours

  4. 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.

    Time frame: Intraoperative

Secondary outcomes

  1. 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

    Time frame: Perioperative

  2. 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

    Time frame: Perioperative

  3. 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

    Time frame: 24 hours

  4. 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

    Time frame: Perioperative

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Study locations

1 site
  • Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital
    Jakarta Pusat, DKI Jakarta 10430, Indonesia
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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 7, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05871645
Lead sponsor
Dr Cipto Mangunkusumo General Hospital
Responsible party
Amanda Rumondang (Principal Investigator, Dr Cipto Mangunkusumo General Hospital) — Principal investigator
First posted
May 23, 2023
Start date
Jan 1, 2015
Primary completion
Dec 31, 2021
Completion
Feb 28, 2022
Last update
Jun 7, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Jun 2023. You cannot join it, but the record below documents what was studied.

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