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Completed

NCT Number: NCT05871645

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.

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Key information

Conditions

Placenta Accreta Female Urogenital Diseases and Pregnancy Complications Obstetric Labor Complications Placenta Diseases Pregnancy Complications Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Jakarta Pusat, DKI Jakarta, 10430, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for JSICA:

  • 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

Exclusion criteria

-

Treatment and study plan

Jakarta Surgical Uterine Conservation (JSICA) Technique

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

Procedure

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

Primary outcomes

  1. 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. .

  2. 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.

  3. 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

  4. 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.

Secondary outcomes

  1. Intraoperative Bleeding in JSICA compared to hysterectomy

    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 in comparison of JSICA to hysterectomy

  2. Operation duration in JSICA compared to hysterectomy

    Time frame: Perioperative

    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

  3. Number of Patients Admitted to ICU in JSICA compared to hysterectomy

    Time frame: 24 hours

    ICU admission was identified by the documentation of number of patients' admission to the ICU in comparison of JSICA to hysterectomy

  4. Rate of Intraoperative complications in JSICA compared to hysterectomy

    Time frame: Perioperative

    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

Sponsors and collaborators

Lead sponsor

Dr Cipto Mangunkusumo General Hospital

Other

Registry information

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
May 23, 2023
Registry last updated
Jun 7, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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