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Conservative Management vs Cesarean Hysterectomy for Placenta Accreta

N/A
Recruiting
Led By Brett Einerson, MD
Research Sponsored by University of Utah
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age 18 and older
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 weeks gestation through day of delivery
Awards & highlights

Summary

This trial will compare two treatments for placenta accreta spectrum and provide data to inform decisions about which treatment is best for patients.

Who is the study for?
This trial is for pregnant individuals over 18 with a history of cesarean delivery and placenta previa or an anterior low-lying placenta who are suspected of having Placenta Accreta Spectrum (PAS) based on prenatal scans. They should be planning to deliver between weeks 34 and 36. Those typically recommended for hysterectomy due to PAS can join, but not those with fetal demise, low suspicion for PAS, planned delivery before week 24, hospitalized due to bleeding, or carrying multiples.Check my eligibility
What is being tested?
The study compares conservative in situ management versus the standard Cesarean hysterectomy in treating Placenta Accreta Spectrum (PAS). It aims to determine if conservative treatment is a safer option that could replace hysterectomy while also gathering data to help patients make informed decisions about their care.See study design
What are the potential side effects?
Since this trial involves comparing surgical procedures rather than drugs, side effects may include typical risks associated with surgeries such as infection, bleeding complications, potential need for later surgery if conservative management fails and psychological impacts from different outcomes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am 18 years old or older.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of delivery
This trial's timeline: 3 weeks for screening, Varies for treatment, and day of delivery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of patients completing the surgical treatment to which they are allocated
Secondary outcome measures
Number of eligible people approached for enrollment.
Number of eligible people randomized.
Number of enrolled completing conservative management on day of delivery.
+4 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Conservative Management for Placenta Accreta Spectrum (PAS)Experimental Treatment1 Intervention
Subjects who are randomized to to conservative management will undergo a cesarean delivery followed by a period of close observation in the operating room for 30-45 minutes to be sure there is no excessive bleeding or risk to keep the placenta inside
Group II: Hysterectomy at time of delivery for Placenta Accreta Spectrum (PAS)Active Control1 Intervention
Subjects who are randomized to cesarean hysterectomy will undergo a cesarean delivery followed immediately by hysterectomy to remove the placenta and uterus together

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Conservative in situ management for Placenta Accreta involves leaving the placenta in place after delivery and using non-surgical methods to manage the condition. This approach aims to reduce the risks associated with surgical removal, such as severe hemorrhage and damage to surrounding organs. By preserving the placenta, the body can gradually reabsorb it, potentially leading to fewer complications and a safer recovery. This method is particularly important for patients who wish to avoid the morbidity associated with hysterectomy and retain their fertility.

Find a Location

Who is running the clinical trial?

University of UtahLead Sponsor
1,110 Previous Clinical Trials
1,788,524 Total Patients Enrolled
1 Trials studying Placenta Accreta
40 Patients Enrolled for Placenta Accreta
Brett Einerson, MDPrincipal InvestigatorUniversity of Utah

Media Library

Cesarean hysterectomy for placenta accreta spectrum (PAS) Clinical Trial Eligibility Overview. Trial Name: NCT05139498 — N/A
Placenta Accreta Research Study Groups: Conservative Management for Placenta Accreta Spectrum (PAS), Hysterectomy at time of delivery for Placenta Accreta Spectrum (PAS)
Placenta Accreta Clinical Trial 2023: Cesarean hysterectomy for placenta accreta spectrum (PAS) Highlights & Side Effects. Trial Name: NCT05139498 — N/A
Cesarean hysterectomy for placenta accreta spectrum (PAS) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05139498 — N/A
~14 spots leftby Mar 2026