Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum

Study Overview
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Brief Summary
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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.

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

Conditions
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Placenta Accreta

Intervention / Treatment
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* Procedure: Hysterectomy
* Procedure: Partial Myometrial Resection


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Hysterectomy<br>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<br>* 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<br>|
| Active Comparator: Partial myometrial resection<br>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<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of eligible patients who agree to participate in the study. | Number of patients who agree to participate, out of the total number of eligible patients | 24 months | 
| Screening failure percentage | Percentage of patients who entered the study but did not present macroscopic findings of placenta accreta spectrum during laparotomy. | 24 months | 
| Percentage of patients with crossover between assigned study arms. | Percentage of patients who were assigned to the partial myometrial resection arm, however, due to the severity of the injury or another factor, had to perform a hysterectomy. | 24 months | 
| Number of participants who completed the follow-up evaluation. | Number of participants who completed the follow-up evaluation. | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal death | Number of maternal deaths during the study period | 24 months | 
| Intra-surgical bleeding volume measured in mililiters | Surgical bleeding calculated in milliliters | During surgery | 
| Blood component transfusion requirement | 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) | 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 | Number of patients who met at least 1 Near Miss criterion | Up to 42 days postpartum | 
| Number of patients who had ureteral injuries | Number of patients who had ureteral injuries | Up to 42 days postpartum | 
| Number of patients who had Bladder injuries | Number of patients who had Bladder injuries | Up to 42 days postpartum | 
| Number of patients who need surgical reoperation. | 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. | Number of patients that required management in the Intensive Care Unit | Up to 42 days postpartum | 
| Number of days of postoperative hospital stay. | Number of days of hospital stay after index surgery | Up to 42 days postpartum | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Placenta accreta, Resective reconstructive treatment, Hysterectomy