Hysterectomy Vs Partial Myometrial Resection for Placenta Accreta Spectrum (PAS). A Feasibility Study of a Randomized Controlled Clinical Experiment (RCT-PAS)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study.
研究概览
简要总结
Currently, Placenta Accreta Spectrum (PAS) has two treatment options: hysterectomy (completely removing the uterus) and partial myometrial resection (resecting the part of the uterus affected by this pathology).
The present study is a feasibility study of a multicenter, randomized controlled clinical trial to be carried out in 3 health institutions. Patients who meet the inclusion criteria, after signing the informed consent, will be taken to the surgical procedure and before the start of the procedure they will be randomized to one of the two interventions, hysterectomy or partial myometrial resection, intra-surgical clinical outcomes will be explored and a follow-up will be carried out during the immediate post-surgical period (72 hours), in 7 to 12 days and at 42 days postpartum.
A sample size of 60 patients is estimated among the 3 health institutions, with an approximate duration of the study of 24 months.
详细描述
Placenta accreta spectrum is a serious condition associated with significant maternal morbidity and even mortality. The recommended treatment is hysterectomy. An alternative is 1-step conservative surgery, which involves the en bloc resection of the myometrium affected by placenta accreta spectrum along with the placenta, followed by uterine reconstruction. Currently, there are no studies comparing the 2 techniques in the setting of a randomized controlled trial.
We performed a prospectively registered multicenter randomized controlled trial comparing hysterectomy with 1-step conservative surgery. The aim was to collect feasibility and clinical outcomes of the 2 techniques in women assigned to hysterectomy or 1step conservative surgery. In addition to assessing participants' willingness to be randomized, we also collected data on intraoperative blood loss, transfusion requirement, serious adverse event, and other clinical outcomes.
Sixty women with strong antenatal suspicion of placenta accreta spectrum were assigned randomly to either hysterectomy (n=31) or 1-step conservative surgery (n=29).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
盲法说明
This is an open-label study as it is not possible to conceal the surgical procedure for each arm from the operator (Treating Physician) or from the participant
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Pregnant women over 18 years of age.
- •History of previous cesarean section and anterior placenta previa
- •Patients with prenatal diagnosis by ultrasound or MRI of PAS, regardless of the suspected degree of severity of the disease.
- •Requirement for surgical management of placental accreta on a scheduled basis.
- •Patients without active vaginal bleeding in the period immediately before surgery (Patients entering the operating room without active bleeding).
排除标准
- •Women without previous living children.
结局指标
主要结局
Feasibility: Proportion of Eligible Patients Who Agree to Participate in the Study.
时间窗: 6 weeks
Number of patients who agree to participate, out of the total number of eligible patients
Screening Failure Percentage
时间窗: During surgery
Percentage of patients who entered the study but did not present macroscopic findings of placenta accreta spectrum during laparotomy.
Percentage of Patients With Crossover Between Assigned Study Arms.
时间窗: During surgery
All patients had been randomized before surgery to a certain procedure; however, after performing intraoperative staging, it was identified that some women did not have signs of PAS (7 patients with false positive prenatal diagnosis, randomized to hysterectomy), so they were managed with OSCS, and that some women did not meet the criteria to perform OSCS (9 patients randomized to OSCS), so they were managed with hysterectomy;
Number of Participants Who Completed the Follow-up Evaluation.
时间窗: 42 days postpartum
Number of participants who completed follow-up at 42 days postpartum
次要结局
- Maternal Death(6 weeks)
- Intra-surgical Bleeding Volume(During surgery)
- Blood Component Transfusion Requirement(Up to 42 days postpartum)
- Median Transfusion of Red Blood Cell Units (RBCU)(Up to 42 days postpartum)
- Number of Patients Who Met at Least 1 Near Miss Criterion(Up to 42 days postpartum)
- Number of Patients Who Had Bladder Injuries(Up to 42 days postpartum)
- Number of Patients Who Need Surgical Reoperation.(Up to 42 days postpartum)
- Number of Patients Who Were Admitted to the Intensive Care Unit.(Up to 42 days postpartum)
- Number of Days of Postoperative Hospital Stay.(Up to 42 days postpartum)
研究者
Albaro Nieto
Gynecologist and Obstetrician
Fundacion Clinica Valle del Lili