N/A
N=60
Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum
Placenta Accreta
Bottom Line
View on ClinicalTrials.gov: NCT05013749 ↗Enrolled (actual)
60
Serious AEs
13.3%
Results posted
Nov 2024
Primary outcome: Primary: Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study. — 60 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Hysterectomy (Procedure); Partial Myometrial Resection (Procedure)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Fundacion Clinica Valle del Lili
- Primary completion
- Apr 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study. |
60 | — |
| PRIMARY Screening Failure Percentage |
7; 2 | — |
| PRIMARY Percentage of Patients With Crossover Between Assigned Study Arms. |
7; 9 | — |
| PRIMARY Number of Participants Who Completed the Follow-up Evaluation. |
31; 29 | — |
| SECONDARY Maternal Death |
0; 0 | — |
| SECONDARY Intra-surgical Bleeding Volume |
1500; 1740 | — |
| SECONDARY Blood Component Transfusion Requirement |
19; 17 | — |
| SECONDARY Median Transfusion of Red Blood Cell Units (RBCU) |
3; 2 | — |
| SECONDARY Number of Patients Who Met at Least 1 Near Miss Criterion |
1; 0 | — |
| SECONDARY Number of Patients Who Had Bladder Injuries |
2; 1 | — |
| SECONDARY Number of Patients Who Need Surgical Reoperation. |
1; 1 | — |
| SECONDARY Number of Patients Who Were Admitted to the Intensive Care Unit. |
4; 3 | — |
| SECONDARY Number of Days of Postoperative Hospital Stay. |
4; 5 | — |
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.
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.
Data sourced from ClinicalTrials.gov (NCT05013749). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.