Conservative Management of Placenta Accreta Spectrum

NCT06253832 | Completed

• 1 other identifier: CMNT PAS
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

The resective-constructive surgery, detailed in prior research by Palacios-Jaraquemada JM, involves excising the placenta and its attachment on the myometrium, with modifications including the systematic use of a double JJ probe, omitting arterial ligation, and prioritizing careful dissection and reconstruction. A prospective single-center study conducted from January 4, 2020 to February 2, 2024, at the Tunisian maternity ward including cases of placenta accreta, increta and percreta. Data on the estimation of blood loss, complications, transfusions and intensive care admissions were recorded. Diagnosis of placenta accreta was based on imaging and histopathology. The blood loss calculation incorporates total blood volume and changes in hematocrit.

Conditions

Placenta Accreta; Post Partum Hemorrhage; Blood Loss Massive

Keywords

Placenta accreta; Conservative management; Uncontrolled hemorrhage

Outcome Measures

Primary Outcomes (5)

• Estimated blood loss

  Blood spoliation during procedure

  peroperatively

• Hemoglobin variation

  The difference between the Baseline concentration of Hemoglobin and the lowest hemoglobin concentration noted during the procedure

  First 24 hours]

• Transfusion requirements

  Number of red blood cells units transfused

  First 24 hours

• Procedure duration

  Time needed to perform surgery from incision to skin closure

  peroperatively

• Intensive care transfer rate

  Intensive care transfer following surgery for placenta accreta

  first 24 hours

Secondary Outcomes (4)

• Length of stay in ICU

  time from surgery up to 30 days postoperative

• Clotting disorders

  time from surgery up to 30 days postoperative

• Bladder wound

  Time from surgery up to 30 days postoperative

• Digestive wound

  Time from surgery up to 30 days postoperative

Study Arms (3)

conservative surgery

EXPERIMENTAL

resective-constructive surgery: the excision of the placenta and its attachment site on the myometrium. Subsequently, uterine reconstruction is undertaken.

Procedure: conservative surgery for placenta accreta spectrum

hysterectomy 1

ACTIVE COMPARATOR

Standard hysterectomy is performed

Procedure: hysterectomy

hysterectomy 2

ACTIVE COMPARATOR

Standard hysterectomy is performed

Procedure: hysterectomy

Interventions

conservative surgery for placenta accreta spectrum PROCEDURE

The surgical procedure involved a midline incision for the laparotomy approach. Dissection of the uterus from the posterior bladder wall extended down to the cervix, with coagulation of the vesicouterine vessels. Hysterotomy was executed in the upper segment, just above the area of myometrial invasion. Hemostasis of the lower uterus was achieved through either square compression sutures or ligation of the colpouterine vessels. A conservative approach to uterine surgery was considered viable only under conditions of stable hemodynamics and when at least 2 cm of healthy myometrium was visibly intact above the cervix. For cases involving conservative resection, all myometrium affected by invasion and the entire placenta were excised. Subsequently, the uterus was reconstructed using a continuous stitching technique.

conservative surgery

hysterectomy PROCEDURE

hysterectomy for placenta accreta spectrum

hysterectomy 1

Eligibility Criteria

• Age: 18 Years+
• Gender Eligibility Details: female pregnant subject
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients undergoing scheduled or emergency cesarean section for placenta accreta

You may not qualify if:

• No signs of Placenta Accreta Spectrum upon artificial delivery

Sponsors & Collaborators

• Tunis University: lead
• University Tunis El Manar: collaborator

Study Sites (1)

Haithem Aloui

Manouba, Tunis Governorate, 2010, Tunisia

Location

MeSH Terms

Conditions

Placenta Accreta; Postpartum Hemorrhage

Interventions

Hysterectomy

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Placenta Diseases; Puerperal Disorders; Uterine Hemorrhage; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Gynecologic Surgical Procedures; Urogenital Surgical Procedures; Surgical Procedures, Operative

Study Officials

• Ben Marzouk Maghrebi, Professor

  Tunis University Manar

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: university hospital assistant

Model Details: comparer le traitement conservateur chirurgical à l'hystérectomie dans le traitement du placenta accreta

Study Record Dates

• First Submitted: February 2, 2024
• First Posted: February 12, 2024
• Study Start: January 4, 2020
• Primary Completion: August 17, 2022
• Study Completion: January 30, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

TU (1)