Conservative Management for PAS Pilot

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

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. ;

Study Design

Related Conditions & MeSH terms

Placenta Accreta

Clinical Trial Details

NCT number	NCT05139498
Study type	Interventional
Source	University of Utah
Contact	Ashley Joseph
Phone	801-903-3278
Email	ashley.joseph@hsc.utah.edu
Status	Recruiting
Phase	N/A
Start date	May 26, 2022
Completion date	June 30, 2026

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04579172` - Conservative Management of Morbidly Adherent Anterior Situated Placenta	N/A
Completed	`NCT04593303` - Internal Iliac Artery Ligation During Management of Placenta Accreta Spectrum	N/A
Recruiting	`NCT03638024` - Cell-free Fetal DNA Concentration in Cases of Abnormal Placental Invasion .
Not yet recruiting	`NCT06100640` - Paracervical Pouch in Placenta Accreta Spectrum
Completed	`NCT05979181` - Peripartum Cesarean Hysterectomy for Placenta Percreta
Recruiting	`NCT04609527` - Management of Placenta Accreta Spectrum	Phase 2/Phase 3
Recruiting	`NCT06185894` - Single-step Placenta Accreta Resective Technique Tourniqueted vs Absence, Conservative Uterine Surgery	N/A
Completed	`NCT04573452` - Galectin-3 and Placenta Accreta
Not yet recruiting	`NCT03273569` - PDIUC Protocol for Placental Accreta	N/A
Completed	`NCT03707132` - Tourniquet Reduces Blood Loss in Postpartum Hemorrhage During Hysterectomy for Placenta Accreta
Not yet recruiting	`NCT05104177` - Effectivness of Conservative Techniques in Management of PAS
Completed	`NCT02806024` - Perioperative Administration of Tranexamic Acid for Placenta Previa and Accreta Study	Phase 4
Active, not recruiting	`NCT02784886` - Cell-free Fetal DNA Circulating in the Maternal Plasma as a Marker for Morbidly Adherent Placenta	N/A
Recruiting	`NCT05070689` - Placenta Accreta Spectrum Disorders: A. Chohan Continuous Squeezing Suture (ACCSS)	N/A
Completed	`NCT05813743` - Detection of Urinary Bladder Wall Involvement in Abnormally Invasive Placenta (AIP) by 3D Ultrasonography	N/A
Withdrawn	`NCT04003428` - Feasibility of HIFU for Management of Placenta Accreta (HIFU-ACCRETA)	N/A
Completed	`NCT04161521` - Conservative Surgical Novel Technique of Placenta Accreta in Menoufia University Hospital	N/A
Not yet recruiting	`NCT03530475` - Diagnostic Accuracy of Doppler Ultrasound and Role of Uterine Artery Doppler	N/A
Recruiting	`NCT05922397` - Placenta Accreta Spectrum Topographic Classification
Not yet recruiting	`NCT03129035` - Bilateral Internal Iliac Artery Ligation Before Cesarean Hysterectomy	N/A