Uterine Preservation in the Management of Placenta Accreta Spectrum Disorders
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Hysterectomy rate
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
- •Suspected of having PAS based on history, clinical findings, and/or imaging
- •Patients for whom the usual management would be peripartum hysterectomy.
- •Patient desires uterine preservation or declines hysterectomy
- •Agreement to adhere to Lifestyle Considerations (see section 5.3) throughout study duration.
排除标准
- •Have a low antenatal suspicion for PAS based on imaging.
研究组 & 干预措施
Uterine preservation
Conservative management of PAS with the inclusion of antibiotics and uterine artery embolization, followed by close monitoring.
干预措施: Conservative/Expectant Management (Other)
结局指标
主要结局
Hysterectomy rate
时间窗: Delivery through 1 year
Percent of participants who undergo a hysterectomy
次要结局
- Endometritis rate(Delivery through 1 year)
- Frequency of vaginal bleeding(Delivery through 1 year)
- Frequency of pelvic pain(Delivery through 1 year)
- Coagulopathy rate(Delivery through 1 year)
研究者
Beth Pineles
Assistant Professor of Obstetrics and Gynecology,Assistant Professor of Obstetrics and Gynecology in Biostatistics and Epidemiology
University of Pennsylvania