Conservative Management for Placenta Accreta

(U-PRESERVE Trial)

Overseen By Beth Pineles, MD Phd

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: University of Pennsylvania

Disqualifiers: Low antenatal suspicion for PAS

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: Standard postpartum inpatient stay

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This study for the conservative management of placenta accreta spectrum disorders (PAS), which are a major cause of maternal morbidity and mortality. The most common management strategy for PAS in the United States is a preterm cesarean-hysterectomy. However, accumulating data show that conservative management is safer and is preferred by some patients. In selected participants (n=15) who desire uterine preservation, the investigators provide the option of conservative management, which will be defined as leaving the placenta in the uterus after delivery of the infant. This is a single-arm single-site pilot study where all participants will be carefully monitored during a standard postpartum inpatient stay and with outpatient follow-up until the uterus is empty.

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 data supports the effectiveness of the treatment Conservative/Expectant Management for Placenta Accreta?

Research indicates that conservative management of placenta accreta can reduce major bleeding and the need for a hysterectomy (surgical removal of the uterus), suggesting it may be an effective approach for managing this condition. ^{1 2 3 4 5}

Is conservative management for placenta accreta generally safe for humans?

The research articles discuss adverse events and risk management in obstetrics, highlighting that adverse events can occur in medical care, including obstetrics. However, they do not provide specific safety data for conservative management of placenta accreta. ^{6 7 8 9 10}

How does the conservative management treatment for placenta accreta differ from other treatments?

Conservative management for placenta accreta involves leaving the placenta in place after childbirth and closely monitoring the mother, which is different from the standard treatment of surgical removal through a hysterectomy. This approach aims to preserve fertility and avoid surgery, but it requires careful monitoring for complications like bleeding and infection. ^{2 4 11 12 13}

Research Team

Beth Pineles, MD PhD

Principal Investigator

University of Pennsylvania

Eligibility Criteria

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

Provision of signed and dated informed consent form

Agreement to adhere to Lifestyle Considerations throughout study duration

I want to keep my uterus.

Exclusion Criteria

Have a low antenatal suspicion for PAS based on imaging

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Conservative management of PAS with antibiotics and uterine artery embolization, followed by close monitoring

Standard postpartum inpatient stay

Inpatient stay

Follow-up

Participants are monitored for safety and effectiveness after treatment until the uterus is empty

Up to 1 year

Outpatient follow-up

Treatment Details

Interventions

• Conservative/Expectant Management

Trial Overview The study tests conservative management of placenta accreta spectrum disorders by leaving the placenta in place after delivering the baby. This approach aims to preserve the uterus and avoid immediate surgery post-delivery. All participants will receive this intervention in a single-arm pilot study at one site.

Participant Groups

Group I: Uterine preservation Experimental Treatment 1 Intervention

Conservative management of PAS with the inclusion of antibiotics and uterine artery embolization, followed by close monitoring.

Who Is Running the Clinical Trial?

University of Pennsylvania

Lead Sponsor

Trials

2,118

Recruited

45,270,000+

References

1. United States pubmed.ncbi.nlm.nih.gov

Maternal outcome after conservative treatment of placenta accreta. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Hysterectomy after a failed conservative management of placenta increta: A case report. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Fertility and obstetric outcome after conservative management of placenta accreta. [2016]

4. France pubmed.ncbi.nlm.nih.gov

[Conservative treatment of placenta accreta]. [2013]

5. United States pubmed.ncbi.nlm.nih.gov

Conservative Management of Placenta Percreta: Three Cases and a Review of the Literature regarding Conservative Management of Placenta Accreta Spectrum (PAS) Disorders. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events detected by clinical surveillance on an obstetric service. [2009]

7. United States pubmed.ncbi.nlm.nih.gov

Cause and effect analysis of closed claims in obstetrics and gynecology. [2022]

8. United States pubmed.ncbi.nlm.nih.gov

Systematic approaches to adverse events in obstetrics, Part I: Event identification and classification. [2018]

9. Brazil pubmed.ncbi.nlm.nih.gov

Risk management of adverse events in a maternity hospital. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Clinical risk management in obstetrics. [2019]

11. Bulgaria pubmed.ncbi.nlm.nih.gov

[CONSERVATIVE MANAGEMENT OF PLACENTA ACCRETE DURING VAGINAL DELIVERY]. [2016]

12. Ireland pubmed.ncbi.nlm.nih.gov

Conservative management of placenta accreta. [2009]

13. United States pubmed.ncbi.nlm.nih.gov

Conservative management of morbidly adherent placenta: expert review. [2022]