What is the mechanism of action of this treatment?

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.

What side effects are associated with this type of intervention?

Conservative in situ management of Placenta Accreta, which involves preserving the placenta and avoiding immediate surgical removal, can lead to several side effects. These include an increased risk of infection, significant hemorrhage, and the potential need for subsequent surgical interventions if complications arise. Additionally, there may be prolonged hospital stays and the need for close monitoring to manage these risks effectively.

What prior FDA approvals exist?

There are no specific FDA-approved drugs for the treatment of Placenta Accreta that align directly with conservative in situ management approaches. The conservative in situ management strategy, which aims to preserve the placenta and avoid surgical intervention, is still under investigation and not yet established as a standard treatment. Current management of Placenta Accreta often involves surgical approaches, including hysterectomy, to control bleeding and ensure maternal safety.

What other types of research exist?

Promising novel alternatives to Conservative In Situ Management for Placenta Accreta patients include: 1) Uterine artery embolization, which reduces blood flow to the placenta and minimizes bleeding risks. 2) Radiofrequency ablation, a minimally invasive technique that targets and destroys placental tissue. 3) The use of methotrexate, a chemotherapeutic agent, to reduce placental tissue post-delivery. These methods offer potential benefits in terms of safety and efficacy, and may be considered in treatment plans for 2024.

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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

No Placebo-Only Group

Summary

This trial will compare a new treatment method where the placenta is left in the uterus to the standard practice of removing the uterus for patients with a severe pregnancy condition called placenta accreta spectrum. The goal is to see if this new method is safer and less costly.

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.

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.

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ day of delivery

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of patients completing the surgical treatment to which they are allocated

Secondary study objectives

Number of eligible people approached for enrollment.

Number of eligible people randomized.

Number of enrolled completing conservative management on day of delivery.

+4 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

0 / 1Eligibility criteria met

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.