Conservative Management as an Alternative to Hysterectomy for Placenta Accreta Spectrum: a Pilot Randomized Controlled Trial.
Status: Recruiting
Location: See location...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY
Conservative in situ management is a promising alternative treatment to hysterectomy for patients with placenta accreta spectrum and may be safer and preferable for some patients. This study will assess feasibility of a future randomized clinical trial comparing these treatments and provide novel data to inform shared decision-making and cost-effective care for patients with this deadly pregnancy disorder.
Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 99
Healthy Volunteers: f
View:
• Age 18 and older
• History of cesarean delivery AND placenta previa OR anterior low-lying placenta AND suspected of having PAS on prenatal imaging (ultrasound/MRI)
• Patients who would typically be recommended for hysterectomy
• Planned delivery between 34w0d and 36w0d gestation.
Locations
United States
Utah
University of Utah
RECRUITING
Salt Lake City
Contact Information
Primary
Ashley Joseph
ashley.joseph@hsc.utah.edu
801-903-3278
Backup
Elizabeth Turner
elizabeth.e.turner@hsc.utah.edu
801-213-2845
Time Frame
Start Date: 2022-05-26
Estimated Completion Date: 2026-06-30
Participants
Target number of participants: 32
Treatments
Experimental: Conservative Management for Placenta Accreta Spectrum (PAS)
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
Active_comparator: Hysterectomy at time of delivery for Placenta Accreta Spectrum (PAS)
Subjects who are randomized to cesarean hysterectomy will undergo a cesarean delivery followed immediately by hysterectomy to remove the placenta and uterus together
Related Therapeutic Areas
Sponsors
Leads: University of Utah