Health TrialsbyHealthPanel

Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders

ConditionPlacenta Accreta Spectrum
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorUniversity of Pennsylvania

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Provision of signed and dated informed consent form.

Stated willingness to comply with all study procedures and availability for the duration of the study.

A person with a uterus, age 18 or older

Currently pregnant with an intrauterine gestation or postpartum

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

  • Conservative/Expectant Management

    Other intervention

    At time of caesarean section, participants will not have a hysterectomy, but will be treated clinically to preserve their uterus.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Uterine preservationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Hysterectomy rate

Percent of participants who undergo a hysterectomy

Time frame
Delivery through 1 year

Secondary outcomes

1

Endometritis rate

Percent of participants who have endometritis

Time frame
Delivery through 1 year
2

Coagulopathy rate

Percent of participants who have coagulopathy

Time frame
Delivery through 1 year
3

Frequency of vaginal bleeding

Percent of participants with vaginal bleeding at each time point

Time frame
Delivery through 1 year
4

Frequency of pelvic pain

Percent of participants with pelvic pain at each time point

Time frame
Delivery through 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Pennsylvania

Lead sponsor

Source ClinicalTrials.gov
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