Placenta AccretaNCT05871645

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

A study testing Jakarta Surgical Uterine Conservation (JSICA) Technique and Standard Hysterectomy in people with Placenta Accreta, run by Dr Cipto Mangunkusumo General Hospital at 1 site in Indonesia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older, women only
Conditions the study is for: Placenta Accreta
What is being tested?: Jakarta Surgical Uterine Conservation (JSICA) Technique and Standard Hysterectomy
Type of treatment: Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 323 participants
Where: 1 siteIndonesia
Study dates: 1 Jan 2015to 28 Feb 2022
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

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

Other trials in Indonesia

About this study

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.

Conditions: Placenta Accreta
Being tested: Jakarta Surgical Uterine Conservation (JSICA) Technique, Standard Hysterectomy
Keywords: JSICA technique, Placenta Accreta, Uterine Preservation
Medical subject headings: Placenta Accreta

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Jakarta Surgical Uterine Conservation (JSICA) TechniqueProcedure or surgery
1. 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 HysterectomyProcedure or surgery
The main types of hysterectomy are abdominal, vaginal, and laparoscopic hysterectomy

Study groups in NCT05871645
Study group	Role	What they receive
Jakarta Surgical Uterine Conservation (JSICA) technique	Experimental	Cipto Mangunkusumo General Hospital's novel uterine preservation technique based on standard procedure Receives: Procedure: Jakarta Surgical Uterine Conservation (JSICA) Technique
Standard Hysterectomy	Active comparator	Surgery to remove the uterus Receives: Procedure: Standard Hysterectomy

What is being measured

The primary outcome is the main question the study is designed to answer.

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. .
Measured: Perioperative
Operation duration
The operation duration was the time interval from skin incision to closure (hours) and classified into < 3 hours and > 3 hours.
Measured: Perioperative
Number of Patients Admitted to ICU
ICU admission was identified by the documentation of number of patients' admission to the ICU
Measured: 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.
Measured: Intraoperative

Secondary outcomes (4)

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
Measured: 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
Measured: 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
Measured: 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
Measured: Perioperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Jan 201528 Feb 2022

First posted23 May 2023
Study start1 Jan 2015
Primary completion31 Dec 2021
Study completion28 Feb 2022

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Placenta AccretaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Enrolment: 323 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05871645
Sponsor's protocol ID: 22-05-0541
Status last verified: Jun 2023
First submitted: 27 Feb 2023
Last updated: 7 Jun 2023
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
Placenta Accreta, Third Trimester
Not yet recruitingObservational study
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
Placenta Accreta Management
Recruiting
Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
Placenta Accreta Spectrum

All Placenta Accreta trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Placenta Accreta Spectrum Management: Uterine Preservation Using JSICA Technique - Retrospective Cross-Sectional Study
ClinicalTrials.gov ID: NCT05871645
Acronym / sponsor ID: 22-05-0541
Conditions: Placenta Accreta
Keywords: JSICA technique, Placenta Accreta, Uterine Preservation
Study type: Interventional
Recruitment status: Completed
Enrolment: 323 participants (actual)
Lead sponsor: Dr Cipto Mangunkusumo General HospitalUniversity, hospital or other
Study start: 1 Jan 2015 (actual)
Primary completion: 31 Dec 2021 (actual)
Study completion: 28 Feb 2022 (actual)
First posted: 23 May 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Sequential
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Jakarta Surgical Uterine Conservation (JSICA) technique	Experimental	Procedure: Jakarta Surgical Uterine Conservation (JSICA) TechniqueCipto Mangunkusumo General Hospital's novel uterine preservation technique based on standard procedure
Standard Hysterectomy	Active comparator	Procedure: Standard HysterectomySurgery to remove the uterus

Who may qualify

Ages: 18 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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)

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Jakarta Surgical Uterine Conservation (JSICA) Techniquea. 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	Procedure or surgery	Jakarta Surgical Uterine Conservation (JSICA) technique
Standard HysterectomyThe main types of hysterectomy are abdominal, vaginal, and laparoscopic hysterectomy	Procedure or surgery	Standard Hysterectomy

Primary outcome

Intraoperative bleeding
Time frame: Perioperative
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. .
Operation duration
Time frame: Perioperative
The operation duration was the time interval from skin incision to closure (hours) and classified into < 3 hours and > 3 hours.
Number of Patients Admitted to ICU
Time frame: 24 hours
ICU admission was identified by the documentation of number of patients' admission to the ICU
Rate of Intraoperative complications
Time frame: Intraoperative
Rate of intraoperative complications were identified by the documentation of injury to adjacent structures (bladder or ureter) or a need for transfusion.

4 secondary outcomes

Intraoperative Bleeding in JSICA compared to hysterectomy
Time frame: Perioperative
Operation duration in JSICA compared to hysterectomy
Time frame: Perioperative
Number of Patients Admitted to ICU in JSICA compared to hysterectomy
Time frame: 24 hours
Rate of Intraoperative complications in JSICA compared to hysterectomy
Time frame: Perioperative

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2023.
Individual participant dataSharing planned: No

Related trials for Placenta Accreta

Not yet recruitingObservational study
Placenta-Cervical Interface Angle for Predicting Placenta Accreta Spectrum Severity
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Hematological and Coagulation Markers in Predicting Placenta Accreta Spectrum in Placenta Previa
Placenta Accreta Spectrum, Placenta Previa
Not yet recruitingObservational study
Ultrasound Scoring System for Diagnosis and Prediction of Severity and Surgical Outcomes of Placenta Accreta Spectrum
Placenta Accreta, Third Trimester
Not yet recruitingObservational study
Total Lower Uterine Segmentectomy With Adjunctive Mechanical Towel Compression for the Surgical Management of Placenta Accreta Spectrum Disorders
Placenta Accreta Management
Recruiting
Comparison Between 3 Conservative Surgeries for Placenta Accreta Spectrum
Placenta Accreta Spectrum

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intraoperative bleeding (time frame: Perioperative). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05871645.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jun 2023.