University of Utah
Salt Lake City, Utah, 84132, United States
NCT Number: NCT05139498
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.
This study is active but is not currently recruiting participants.
18 year–99 year
Female
Interventional
Not applicable
Salt Lake City, Utah, 84132, United States
Placenta accreta spectrum (PAS) is an extremely morbid and increasingly common pregnancy condition that often results in massive obstetric hemorrhage. The standard treatment in the United States is hysterectomy, but this treatment is complex, morbid, and costly. A promising alternative for PAS treatment is conservative in situ management (CM), a strategy in which the placenta is left in the uterus. Unfortunately, there are insufficient data available to compare outcomes of these two treatments because past studies are limited by non-randomized study designs, minimal inclusion of patient values in making treatment decisions, and nominal consideration of economic barriers to care. A large clinical trial comparing PAS treatments is needed. But there are key logistic barriers to an adequately powered trial, including questions of whether patients will enroll and adhere to randomization allocation. This pilot trial will evaluate the feasibility of randomizing patients to CM versus hysterectomy for PAS.
While pilot studies cannot make final assessments of safety and efficacy between interventions, safety and efficacy will be monitored, including those related to hemorrhage, transfusion, infection and re-operation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
Subjects who are randomized to cesarean hysterectomy will undergo a cesarean delivery followed immediately by hysterectomy to remove the placenta and uterus together
Time frame: Day of delivery
Number of patients completing the surgical treatment to which they are allocated (hysterectomy or conservative management) on the day of delivery.
Time frame: 20 weeks gestation through day of delivery
Number of eligible people approached for enrollment.
Time frame: From time of consent up to one week (1-7 days) before planned delivery
Number of eligible people randomized.
Time frame: Day of delivery
Number of enrolled completing hysterectomy on day of delivery.
Time frame: Day of delivery
Number of enrolled completing conservative management on day of delivery.
Time frame: Up to 6 weeks postpartum
Number of enrolled who don't complete their allocated treatment (drop-out).
Time frame: Up to 6 weeks postpartum
Number of enrolled who are lost to follow-up through study end (inverse of retention).
Time frame: Up to 6 weeks postpartum
Number of enrolled completing full postpartum follow-up visit schedule.
University of Utah
Other
Conservative Management as an Alternative to Hysterectomy for Placenta Accreta Spectrum: a Pilot Randomized Controlled Trial.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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