Clinical trial NCT05013749: Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum
Official title: Hysterectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum (PAS). A Feasibility Study of a Randomized Controlled Clinical Experiment (RCT-PAS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Placenta Accreta
Keywords: Placenta accreta
Resective reconstructive treatment
Hysterectomy
Lead sponsor: Fundacion Clinica Valle del Lili
Sponsor class: OTHER
First posted: 2021-08-19
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Eligible women will receive complete information about the study. If they agree to participate in it, they will sign the informed consent for both interventions: hysterectomy and partial myometrial resection. The final modality of intervention will be decided at randomization prior to the start of the surgical procedure.

If the diagnosis of PAS is confirmed by observing the clinical criteria endorsed by the International Federation of Gynecology and Obstetrics (FIGO), the patient's participation in the study is confirmed and the surgical procedure defined by randomization is continued, that is, one of the two arms of the study: Primary hysterectomy or Partial myometrial resection.
Primary purpose: TREATMENT

Brief summary: 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.

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study.
timeFrame: 6 weeks
measure: Screening Failure Percentage
timeFrame: During surgery
measure: Percentage of Patients With Crossover Between Assigned Study Arms.
timeFrame: During surgery
measure: Number of Participants Who Completed the Follow-up Evaluation.
timeFrame: 42 days postpartum
Secondary outcomes:
measure: Maternal Death
timeFrame: 6 weeks
measure: Intra-surgical Bleeding Volume
timeFrame: During surgery
measure: Blood Component Transfusion Requirement
timeFrame: Up to 42 days postpartum
measure: Median Transfusion of Red Blood Cell Units (RBCU)
timeFrame: Up to 42 days postpartum
measure: Number of Patients Who Met at Least 1 Near Miss Criterion
timeFrame: Up to 42 days postpartum
measure: Number of Patients Who Had Bladder Injuries
timeFrame: Up to 42 days postpartum
measure: Number of Patients Who Need Surgical Reoperation.
timeFrame: Up to 42 days postpartum
measure: Number of Patients Who Were Admitted to the Intensive Care Unit.
timeFrame: Up to 42 days postpartum
measure: Number of Days of Postoperative Hospital Stay.
timeFrame: Up to 42 days postpartum
Other outcomes:
Locations:
city: Cali
country: Colombia
facility: Fundación Valle del Lili
Study officials:
affiliation: Fundacion Clinica Valle del Lili
name: Albaro Nieto-Calvache, MD
role: PRINCIPAL_INVESTIGATOR
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