Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum

Not Applicable

Completed

Interventions: Procedure: Hysterectomy
Procedure: Partial Myometrial Resection

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).

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Hysterectomy	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
Partial myometrial resection	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.

Primary Outcome Measures

Name	Time	Method
Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study.	6 weeks	Number of patients who agree to participate, out of the total number of eligible patients
Screening Failure Percentage	During surgery	Percentage of patients who entered the study but did not present macroscopic findings of placenta accreta spectrum during laparotomy.
Percentage of Patients With Crossover Between Assigned Study Arms.	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;
Number of Participants Who Completed the Follow-up Evaluation.	42 days postpartum	Number of participants who completed follow-up at 42 days postpartum

Secondary Outcome Measures

Name	Time	Method
Median Transfusion of Red Blood Cell Units (RBCU)	Up to 42 days postpartum	Median number of units of red blood cells transfused
Number of Patients Who Met at Least 1 Near Miss Criterion	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.
Number of Patients Who Had Bladder Injuries	Up to 42 days postpartum	Number of patients who had intraoperative bladder injuries.
Number of Patients Who Need Surgical Reoperation.	Up to 42 days postpartum	Number of patients who need surgical reoperation after index surgery
Maternal Death	6 weeks	Number of maternal deaths during the study period
Intra-surgical Bleeding Volume	During surgery	Surgical bleeding calculated in milliliters
Blood Component Transfusion Requirement	Up to 42 days postpartum	If during hospitalization the patient required transfusion of some type of blood component
Number of Patients Who Were Admitted to the Intensive Care Unit.	Up to 42 days postpartum	Number of patients that required management in the Intensive Care Unit
Number of Days of Postoperative Hospital Stay.	Up to 42 days postpartum	Number of days of hospital stay after index surgery