Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum (RCT-PAS)

November 15, 2024 updated by: Albaro Nieto, Fundacion Clinica Valle del Lili

Hysterectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum (PAS). A Feasibility Study of a Randomized Controlled Clinical Experiment (RCT-PAS)

Currently, Placenta Accreta Spectrum (PAS) has two treatment options: hysterectomy (completely removing the uterus) and partial myometrial resection (resecting the part of the uterus affected by this pathology).

The present study is a feasibility study of a multicenter, randomized controlled clinical trial to be carried out in 3 health institutions. Patients who meet the inclusion criteria, after signing the informed consent, will be taken to the surgical procedure and before the start of the procedure they will be randomized to one of the two interventions, hysterectomy or partial myometrial resection, intra-surgical clinical outcomes will be explored and a follow-up will be carried out during the immediate post-surgical period (72 hours), in 7 to 12 days and at 42 days postpartum.

A sample size of 60 patients is estimated among the 3 health institutions, with an approximate duration of the study of 24 months.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Placenta accreta spectrum is a serious condition associated with significant maternal morbidity and even mortality. The recommended treatment is hysterectomy. An alternative is 1-step conservative surgery, which involves the en bloc resection of the myometrium affected by placenta accreta spectrum along with the placenta, followed by uterine reconstruction. Currently, there are no studies comparing the 2 techniques in the setting of a randomized controlled trial.

We performed a prospectively registered multicenter randomized controlled trial comparing hysterectomy with 1-step conservative surgery. The aim was to collect feasibility and clinical outcomes of the 2 techniques in women assigned to hysterectomy or 1step conservative surgery. In addition to assessing participants' willingness to be randomized, we also collected data on intraoperative blood loss, transfusion requirement, serious adverse event, and other clinical outcomes.

Sixty women with strong antenatal suspicion of placenta accreta spectrum were assigned randomly to either hysterectomy (n=31) or 1-step conservative surgery (n=29).

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Colombia
      • Cali, Colombia
        • Fundación Valle del Lili

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 55 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Pregnant women over 18 years of age.
  • History of previous cesarean section and anterior placenta previa
  • Patients with prenatal diagnosis by ultrasound or MRI of PAS, regardless of the suspected degree of severity of the disease.
  • Requirement for surgical management of placental accreta on a scheduled basis.
  • Patients without active vaginal bleeding in the period immediately before surgery (Patients entering the operating room without active bleeding).

Exclusion Criteria:

  • Women without previous living children.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Hysterectomy
Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
Procedure: Hysterectomy
Hysterectomy: An incision will be made above the level of the placenta, delivering the newborn. Uterotonics will be administered, and spontaneous delivery of the placenta will be awaited using gentle traction. The absence of spontaneous separation of the placenta will confirm the diagnosis of PAS, the patient will undergo to hysterectomy. The complete removal of the uterus will be attempted, including the cervix, the duration of the intervention and intraoperative blood loss will be recorded, as well as the damage to organs neighboring the uterus. In this arm of the study, to hysterectomy will be performed in 100% of patients
Active Comparator: Partial myometrial resection
Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesicouterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.
Procedure: Partial Myometrial Resection
Partial myometrial resection: The technique described by Palacios-Jaraquemada et al5. will be followed. Briefly, the uterus will be dissected to free it from the posterior wall of the bladder to the cervix. The vesico-uterine vessels will be ligated and the parametrial space will be visualized. The hysterotomy will be performed in the upper segment, immediately above the area of invasion of the myometrium. The entire invaded myometrium and the entire placenta will be removed. The uterus will repair itself in one or two layers. Intrauterine balloon tamponade will be used if indicated.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study.
Time Frame: 6 weeks
Number of patients who agree to participate, out of the total number of eligible patients
6 weeks
Screening Failure Percentage
Time Frame: During surgery
Percentage of patients who entered the study but did not present macroscopic findings of placenta accreta spectrum during laparotomy.
During surgery
Percentage of Patients With Crossover Between Assigned Study Arms.
Time Frame: During surgery
All patients had been randomized before surgery to a certain procedure; however, after performing intraoperative staging, it was identified that some women did not have signs of PAS (7 patients with false positive prenatal diagnosis, randomized to hysterectomy), so they were managed with OSCS, and that some women did not meet the criteria to perform OSCS (9 patients randomized to OSCS), so they were managed with hysterectomy;
During surgery
Number of Participants Who Completed the Follow-up Evaluation.
Time Frame: 42 days postpartum
Number of participants who completed follow-up at 42 days postpartum
42 days postpartum

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal Death
Time Frame: 6 weeks
Number of maternal deaths during the study period
6 weeks
Intra-surgical Bleeding Volume
Time Frame: During surgery
Surgical bleeding calculated in milliliters
During surgery
Blood Component Transfusion Requirement
Time Frame: Up to 42 days postpartum
If during hospitalization the patient required transfusion of some type of blood component
Up to 42 days postpartum
Median Transfusion of Red Blood Cell Units (RBCU)
Time Frame: Up to 42 days postpartum
Median number of units of red blood cells transfused
Up to 42 days postpartum
Number of Patients Who Met at Least 1 Near Miss Criterion
Time Frame: Up to 42 days postpartum
Situation or indicator that almost led to a serious adverse event but did not actually result in harm. For this study, the event was cardiac arrest with successful resuscitation.
Up to 42 days postpartum
Number of Patients Who Had Bladder Injuries
Time Frame: Up to 42 days postpartum
Number of patients who had intraoperative bladder injuries.
Up to 42 days postpartum
Number of Patients Who Need Surgical Reoperation.
Time Frame: Up to 42 days postpartum
Number of patients who need surgical reoperation after index surgery
Up to 42 days postpartum
Number of Patients Who Were Admitted to the Intensive Care Unit.
Time Frame: Up to 42 days postpartum
Number of patients that required management in the Intensive Care Unit
Up to 42 days postpartum
Number of Days of Postoperative Hospital Stay.
Time Frame: Up to 42 days postpartum
Number of days of hospital stay after index surgery
Up to 42 days postpartum

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fundacion Clinica Valle del Lili

Investigators

  • Principal Investigator: Albaro Nieto-Calvache, MD, Fundacion Clinica Valle del Lili

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 20, 2021

Primary Completion (Actual)

April 17, 2023

Study Completion (Actual)

April 17, 2023

Study Registration Dates

First Submitted

July 22, 2021

First Submitted That Met QC Criteria

August 17, 2021

First Posted (Actual)

August 19, 2021

Study Record Updates

Last Update Posted (Estimated)

November 25, 2024

Last Update Submitted That Met QC Criteria

November 15, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1751

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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