Conservative Management for Placenta Accreta
(U-PRESERVE Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores a new method for managing placenta accreta spectrum disorders (PAS), which can cause serious health issues for pregnant individuals. Typically, doctors might remove the uterus to manage PAS, but this trial tests a method called Conservative/Expectant Management, which leaves the placenta in place after birth. This approach uses antibiotics and a procedure called uterine artery embolization to manage the condition while preserving the uterus. The trial targets pregnant individuals who have had a cesarean delivery and placenta previa or a low-lying placenta, and who wish to avoid a hysterectomy. Participants will receive close monitoring during and after delivery. As an unphased trial, this study offers participants the chance to contribute to innovative research that could transform PAS management and preserve reproductive health.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What prior data suggests that this conservative management technique is safe for placenta accreta spectrum disorders?
Research has shown that managing placenta accreta without surgery can be safer than the usual method of removing the uterus during a C-section. This approach often results in less blood loss and fewer injuries to nearby areas like the bladder, and it reduces the need for intensive care after birth.
One review found that women who chose this non-surgical method experienced better outcomes, with fewer complications and a good recovery after delivery. Another study found that babies were born healthy, often after 34 weeks of pregnancy, when this method was used.
While all medical treatments carry risks, evidence suggests that with careful monitoring and support, this approach can be well-tolerated. It is important for each person to discuss with their healthcare provider to determine if this option is suitable for them.12345Why are researchers excited about this trial?
Researchers are excited about the conservative management approach for placenta accreta because it offers a potential alternative to the standard treatment, which often involves a hysterectomy. This method focuses on preserving the uterus by using antibiotics and uterine artery embolization, combined with close monitoring. The key advantage here is the possibility of maintaining fertility, which is a significant concern for many patients. This approach is particularly appealing as it aims to manage the condition without resorting to more invasive surgical procedures.
What evidence suggests that conservative management is effective for placenta accreta?
Studies have shown that managing placenta accreta spectrum (PAS) without immediate surgery can lead to better outcomes than the usual method of removing the uterus during a C-section. In this trial, participants will undergo conservative management, which involves leaving the placenta in the uterus after the baby is born, using antibiotics and uterine artery embolization, and close monitoring. This approach can greatly reduce blood loss, damage to nearby organs, and the need for intensive care. Research indicates that this method works well in about 78% to 80% of cases. Women who choose this option often experience fewer complications compared to those who have the placenta surgically removed. This method also allows some women to keep their uterus, which is important for those who want to have more children.12345
Who Is on the Research Team?
Beth Pineles, MD PhD
Principal Investigator
University of Pennsylvania
Are You a Good Fit for This Trial?
This trial is for individuals with a uterus, aged 18 or older, who are currently 16-36 weeks pregnant and have been diagnosed with placenta accreta spectrum disorders. They must want to keep their uterus, have had a cesarean before, and usually would be offered a cesarean-hysterectomy. Participants need to consent to the study's requirements and lifestyle considerations.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Conservative management of PAS with antibiotics and uterine artery embolization, followed by close monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment until the uterus is empty
What Are the Treatments Tested in This Trial?
Interventions
- Conservative/Expectant Management
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of Pennsylvania
Lead Sponsor