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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
Study 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 belowSelect...
I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day of delivery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day of delivery
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 moreTrial 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
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Who is running the clinical trial?
University of UtahLead Sponsor
1,099 Previous Clinical Trials
1,778,657 Total Patients Enrolled
1 Trials studying Placenta Accreta
40 Patients Enrolled for Placenta Accreta
Brett Einerson, MDPrincipal InvestigatorUniversity of Utah
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been advised to undergo a hysterectomy.You have experienced a stillbirth.Based on the images taken during pregnancy, there is a low suspicion that you have a condition called placenta accreta spectrum (PAS).You have had a previous C-section and currently have a condition called placenta previa or a low-lying placenta, which is suspected to be a condition called placenta accreta spectrum based on imaging tests like ultrasound or MRI.I am 18 years old or older.You are expecting more than one baby (twins, triplets).
Research Study Groups:
This trial has the following groups:- Group 1: Conservative Management for Placenta Accreta Spectrum (PAS)
- Group 2: Hysterectomy at time of delivery for Placenta Accreta Spectrum (PAS)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is participation in this clinical study still open to the public?
"The latest information available on clinicaltrials.gov affirms that this medical trial is actively enrolling participants, with the first posting taking place on May 26th 2022 and subsequent edits made two days later."
Answered by AI
How many test subjects are currently involved in this research?
"Affirmative. As per the information found on clinicaltrials.gov, this medical study is currently seeking patients for enrollment. This research initiative was first made public on May 26th 2022 and has been updated most recently on May 28th 2022 with a goal to acquire 32 participants from 2 different sites."
Answered by AI
Is the recruitment for this research study open to those who are 30 years of age or above?
"Per this trial's inclusion parameters, the minimum age for participants is 18 years old and the maximum age limitation is 99."
Answered by AI
May I be considered for enrollment in this research project?
"The criteria for entrance into this clinical trial requires having placenta accreta and being between 18-99 years old. 32 individuals are set to be accepted in total."
Answered by AI
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