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NCT Number: NCT05013749

Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum

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.

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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–55 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fundación Valle del Lili

Cali, Colombia

About this study

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).

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Hysterectomy

Procedure

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

Partial Myometrial Resection

Procedure

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.

Primary outcomes

  1. 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

  2. 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.

  3. 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;

  4. 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

Secondary outcomes

  1. Maternal Death

    Time frame: 6 weeks

    Number of maternal deaths during the study period

  2. Intra-surgical Bleeding Volume

    Time frame: During surgery

    Surgical bleeding calculated in milliliters

  3. Blood Component Transfusion Requirement

    Time frame: Up to 42 days postpartum

    If during hospitalization the patient required transfusion of some type of blood component

  4. Median Transfusion of Red Blood Cell Units (RBCU)

    Time frame: Up to 42 days postpartum

    Median number of units of red blood cells transfused

  5. 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.

  6. Number of Patients Who Had Bladder Injuries

    Time frame: Up to 42 days postpartum

    Number of patients who had intraoperative bladder injuries.

  7. Number of Patients Who Need Surgical Reoperation.

    Time frame: Up to 42 days postpartum

    Number of patients who need surgical reoperation after index surgery

  8. 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

  9. Number of Days of Postoperative Hospital Stay.

    Time frame: Up to 42 days postpartum

    Number of days of hospital stay after index surgery

Sponsors and collaborators

Lead sponsor

Fundacion Clinica Valle del Lili

Other

Registry information

Official study title

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

Acronym: RCT-PAS

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Aug 19, 2021
Registry last updated
Nov 25, 2024

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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