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

Placenta Accreta Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05871645
• Other study ID #: 22-05-0541
• Status: Completed
• Phase: N/A
• Start date: January 1, 2015
• Est. completion date: February 28, 2022

Study information

• Verified date: June 2023
• Source: Dr Cipto Mangunkusumo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. Researchers will compare both groups to see if there are any differences in the perioperative outcomes.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 323
• Est. completion date: February 28, 2022
• Est. primary completion date: December 31, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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:

-

Related Conditions & MeSH terms

• Placenta Accreta

Intervention

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
• Standard Hysterectomy
The main types of hysterectomy are abdominal, vaginal, and laparoscopic hysterectomy

Locations

Country	Name	City	State
Indonesia	Maternal Fetal Medicine Division, Obstetric Gynecology Department Cipto Mangunkusumo General Hospital	Jakarta Pusat	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Dr Cipto Mangunkusumo General Hospital

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Operation duration	The operation duration was the time interval from skin incision to closure (hours) and classified into < 3 hours and > 3 hours.	Perioperative
Primary	Number of Patients Admitted to ICU	ICU admission was identified by the documentation of number of patients' admission to the ICU	24 hours
Primary	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	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
Secondary	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
Secondary	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
Secondary	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