Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum

  • STATUS
    Recruiting
  • End date
    Jul 15, 2024
  • participants needed
    60
  • sponsor
    Fundacion Clinica Valle del Lili
Updated on 16 October 2021

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.

Details
Condition Placenta Accreta
Treatment hysterectomy, Partial Myometrial Resection
Clinical Study IdentifierNCT05013749
SponsorFundacion Clinica Valle del Lili
Last Modified on16 October 2021

Eligibility

Yes No Not Sure

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
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