MISOPROSTOL FOR THE TREATMENT OF SUSPECTED POSTPARTUM RETAINED PRODUCTS OF CONCEPTION - A RANDOMIZED TRIAL
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Cases of retained products of conception
研究概览
简要总结
The goal of this current study is to evaluate the efficacy of treatment of postpartum patients with suspected retained products of conception (RPOC) with Misoprostol in reducing the frequency of postpartum RPOC compared to a control group of patients that will be managed expectantly, in a prospective randomized trial.
详细描述
Misoprostol (Cytotec) is used widely in Obstetrics and Gynecology, whether for labor induction (1), prevention (2), and treatment (3) of early postpartum hemorrhage (ePPH), induced and missed abortions (4) and for cases suspected for having retained products of conception postabortion and postpartum (RPOC, residua).
While it has been shown in previous studies that misoprostol is efficacious for most of the above-mentioned indications, it is less well-established that the treatment for suspected postpartum RPOC alters the natural course of events and reduces the number of patients requiring surgical intervention and actually having RPOC.
RPOC is estimated to complicate about 1% of term pregnancies and is more prevalent than after miscarriages and termination of pregnancy (5).
The diagnosis and treatment of RPOC might be challenging, as there are no clearly determined diagnostic criteria, evidence-based guidelines or treatment protocols (6).
Different protocols for the follow-up and treatment of cases suspected of RPOC are in use worldwide, including expectant management, administrating uterotonics, performing suction curettage (6), and performing hysteroscopy (7, 8). Evidence in the literature supports the treatment of RPOC with operative hysteroscopy since curettage seems to increase the risk for intrauterine adhesions and Asherman syndrome (9, 10) with the possibility for menstrual abnormalities, infertility or subfertility, recurrent pregnancy losses, preterm labor, and preterm premature rupture of membranes (11).
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
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Women between the ages of 18 years - 45 years.
- •Spontaneous vaginal delivery or vacuum extraction, including VBAC cases
- •Revision of the uterine cavity or manual lysis of the placenta postpartum
- •Early postpartum hemorrhage
- •Cases with a history of treated postpartum residua (by curettage or hysteroscopy)
- •Placental pathology (succenturiate placenta, bilobed placenta)
- •Pregnancy that started as a multifetal gestation with only one fetus reached advanced pregnancy
- •Bumm curettage post-delivery
- •Patients are able to provide written consent
排除标准
- •Patients with no risk factors of RPOC
- •Cesarean section on index pregnancy
- •Cases requiring urgent curettage for late postpartum hemorrhage
- •Inability to consent due to cognitive or language barrier
研究组 & 干预措施
Intervention group
The intervention group will include patients with suspected postpartum RPOC that will receive treatment with Misoprostol, 600 microgram SL/PO/PV
干预措施: Misoprostol 200mcg Tab (Drug)
结局指标
主要结局
Cases of retained products of conception
时间窗: 8-16 weeks postpartum
The primary endpoint will be the number of patients with histopathology-proven retained products of conception at 8-16 weeks postpartum in each group.
次要结局
- Need for hysteroscopy due to suspected RPOC(8-16 weeks postpartum)
- endomyometritis / PID(6-18 weeks postpartum)
- side effects of treatment(8-16 weeks postpartum)
- Blood transfusions(6-18 weeks postpartum)
- Late postpartum hemorrhage(6 weeks postpartum)
- Re-admissions to the hospital(up to 18 weeks)
研究者
Oshri Barell
DR OSHRI BAREL
Assuta Ashdod Hospital