Cervical Pessary to Prevent Preterm Birth in Singleton Pregnancies With a Sonographically Measured Short Cervix: an Open-label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Preterm Birth Before 37 Weeks
研究概览
简要总结
The purpose of this study is to learn if the Arabin pessary can reduce preterm birth less than 37 weeks 0 days in singleton pregnancies that have a short cervix.
详细描述
This is an open label randomized controlled study. The pessary will be offered to those patients who have a transvaginal cervical length less than 25 mm before 23 weeks 0 days. The control group will receive the current standard of care which includes surveillance of cervical length, vaginal progesterone, and emergency cerclage. The primary outcome of the study is preterm delivery less than 37 weeks 0 days.
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
- 否
入选标准
- •singleton
- •cervical length < 25 mm measured by transvaginal ultrasound prior to 23 weeks 0 days
- •agrees to refrain from sexual intercourse
排除标准
- •major fetal anomalies
- •painful regular uterine contractions
- •active vaginal bleeding
- •ruptured membranes
- •evidence of chorioamnionitis or other maternal/fetal infectious morbidity
- •placenta previa
- •cervical cerclage in situ
- •visual cervical dilation of 2 cm or greater with visible amnion/chorion
- •significant maternal-fetal complications (chronic hypertension, insulin dependent diabetes mellitus, systemic lupus erythematosus with nephritis, chronic hypertension, red cell alloimmunization, drug abuse)
研究组 & 干预措施
Device: Arabin Pessary
Participants randomized to this group will receive the pessary.
干预措施: Arabin Pessary (Device)
Standard of Care
Patients randomized to the control group will receive standard of care for their condition. This includes surveillance of cervical length, vaginal progesterone, and emergency cerclage.
结局指标
主要结局
Preterm Birth Before 37 Weeks
时间窗: Up to 37 weeks 0 days
Preterm birth refers to pregnancies that deliver before 37 weeks. Count of participants that deliver before they reach 37 weeks.
次要结局
- Admission to Neonatal Intensive Care Unit(participants will be followed for the duration of hospital stay, up to 17 weeks after delivery)
- Total Days in the Neonatal Intensive Care Unit(participants will be followed for the duration of hospital stay, up to 17 weeks after delivery)
- Retinopathy of Prematurity Requiring Treatment(participants will be followed for the duration of hospital stay, up to 17 weeks after delivery)
- Use of Antenatal Steroids(participants will be followed for the duration of pregnancy, up to nine months)
- Vaginal Bleeding(participants will be followed for the duration of pregnancy, up to nine months)
- Preterm Birth Before 34 Weeks(up to 34 weeks 0 days)
- Neonatal Composite Morbidity(antepartum and up to 28 days after postnatal gestational age of 36 weeks)
- Preterm Premature Rupture of Membranes(participants will be followed for the duration of pregnancy, up to nine months)
- Neonatal Length of Stay(participants will be followed for the duration of hospital stay, up to 17 weeks after delivery)
- Duration of Ventilator Support(participants will be followed for the duration of hospital stay, up to 17 weeks after delivery)
- Birthweight < 1500 Grams(at time of birth, expected to be within 4 weeks of due date)
- Birthweight < 2500 Grams(at time of birth, expected to be within 4 weeks of due date)
- Gestational Age at Delivery(at time of birth, expected to be within 4 weeks of due date)
- Chorioamnionitis(participants will be followed for the duration of pregnancy, up to nine months)
- Cesarean Delivery(at time of delivery, expected to be within 4 weeks of due date)
- Use of Tocolysis(participants will be followed for the duration of pregnancy, up to nine months)
研究者
Gene Lee, MD
Assistant Professor
University of Kansas Medical Center