CompletedNot Applicable

Histerectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum

Colombia60 participantsStarted 2021-08-20

Plain-language 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.

Who can participate

Age range

18 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study.

Timeframe: 6 weeks

Screening Failure Percentage

Timeframe: During surgery

Percentage of Patients With Crossover Between Assigned Study Arms.

Timeframe: During surgery

Number of Participants Who Completed the Follow-up Evaluation.

Timeframe: 42 days postpartum

Trial details

NCT IDNCT05013749

SponsorFundacion Clinica Valle del Lili

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-04-17

Results submitted2024-04-01

View on ClinicalTrials.gov More Placenta Accreta trials

Plain-language summary

Who can participate

Age range

18 Years – 55 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study.

Timeframe: 6 weeks

Screening Failure Percentage

Timeframe: During surgery

Percentage of Patients With Crossover Between Assigned Study Arms.

Timeframe: During surgery

Number of Participants Who Completed the Follow-up Evaluation.

Timeframe: 42 days postpartum