The Efficacy and Safety of a CCT-102 Regimen or Expectant Management in the Treatment of First Trimester Pregnancy Loss
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 183
- 试验地点
- 30
- 主要终点
- Resolution of pregnancy loss
研究概览
简要总结
A Phase 3, multi-center clinical trial of a CCT-102 regimen or expectant management to promote uterine evacuation in first trimester non-progressing Delayed Pregnancy Loss (DPL).
详细描述
This is a Phase 3, open-label, multi-center study to assess the efficacy of a CCT-102 regimen for uterine evacuation in first trimester delayed pregnancy loss (DPL). Eligible study participants will have ultrasound documented DPL with estimated gestational age 10 weeks or less.
DPL is defined as arrest of embryonic or fetal development, in first trimester, where the cervix is closed and there is no or only slight bleeding. This includes: 1) anembryonic pregnancy, and 2) embryonic demise. Expectant management, which is an accepted treatment protocol recognized in 2018 ACOG Practice Bulletin on Early Pregnancy Loss (ACOG, 2018), consists of patient monitoring with no additional treatment.
Eligible participants will choose between the investigational product or expectant management on Day 1. They will be evaluated for the primary endpoint (resolution of DPL) on Study Day 7. All participants will be followed to Day 28.
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 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age 18 to 50
- •Ability to provide informed consent
- •Hemodynamically stable
- •Closed cervical os
- •If fetus exists, clinical observation indicates gestation is no more than 10 weeks
- •Diagnosis of delayed pregnancy loss, confirmed by ultrasound, based on:
- •Embryonic demise: no embryonic cardiac activity when embryo measures 7 mm or greater; OR,
- •Anembryonic pregnancy: mean gestational sac diameter of 25 mm or greater, with no detectable embryo.
排除标准
- •Unwillingness or inability to comply with the study protocol and visit schedule
- •Diagnosis of an incomplete or inevitable abortion including more than slight bleeding at enrollment and/or open os within the prior week.
- •Confirmed or suspected ectopic pregnancy or undiagnosed adnexal mass
- •Hemoglobin <10 g/dL
- •Coagulation disorder, inherited porphyrias, and/or current anticoagulants use
- •Chronic adrenal failure
- •Concurrent chronic corticosteroid therapy
- •History of trophoblastic disease
- •Current presence of an IUD
- •History of allergy or contraindications to the use to mifepristone, misoprostol, or other prostaglandins
- •Any condition that, in the opinion of the investigator, makes the patient unsuitable for study entry
- •Any other current medical condition that jeopardizes the patient's ability to safely participate in the trial
结局指标
主要结局
Resolution of pregnancy loss
时间窗: 7 Days
Evacuation of delayed pregnancy loss within 7 days (up to and including Day 7), confirmed by ultrasound.
次要结局
未报告次要终点