Cervical Pessary vs. Vaginal Progesterone in Preventing Preterm Birth Among Women Presenting With Short Cervix: An Open-label Randomized Controlled Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 430
- 主要终点
- preterm birth before 34 weeks of gestation rate in singleton pregnancies
研究概览
简要总结
The purpose of this randomized control trial is to determine whether cervical pessary plus vaginal progesterone is superior to vaginal progesterone alone in decreasing preterm delivery rate, and improving perinatal outcome, among women presenting with an asymptomatic mid-pregnancy short cervix, in singleton and twin gestations.
All women with singleton or twin pregnancies undergoing routine ultrasonography up to 24 completed weeks of gestation (for examination of fetal anatomy and growth) and diagnosed with cervical length of ≤25 mm in singleton, or ≤38 mm in twins, will be invited to participate in the clinical trial.
Women who meet eligible criteria will be invited to participate in the clinical trial.
Women will be randomly assigned into one of the following groups: group A (vaginal progesterone) or group B (vaginal progesterone + pessary).
Follow-up visits for ultrasound assessment of fetal growth and cervical length will be carried out every two weeks until 37 weeks of gestation.
详细描述
Preterm birth represents a major challenge to obstetricians as well as healthcare policy makers. It is a leading cause of perinatal morbidity and mortality among singleton and multiple pregnancies. In the USA, the frequency of of preterm births (<37 completed weeks of gestation) is 10-13% in singleton pregnancies, and 57% in twins and these rate have not substantially changed in the last decade.
A short cervix (<25 mm) measured by vaginal ultrasonography during mid pregnancy (18-24 weeks of gestation) is a powerful predictor of spontaneous preterm birth (PTB). The relative risk for PTB increases as the cervical length decreases.
The two most studied treatment options in cases of short cervix at mid pregnancy are vaginal progesterone preparations, and cervical cerclage. Vaginal progesterone, given either as 90 mg gel or 200 mg suppository, was repeatedly shown to significantly reduce PTB rates and perinatal morbidity and mortality in women found to have a short cervix (20 mm or less) at 24 weeks gestation.
Progesterone were proven ineffective for the prevention of preterm birth in cases of multiple gestations, present preterm labor, or preterm premature rupture of membranes.
Cerclage may be considered an alternative for vaginal progesterone only in women with history of PTB that are found to have a short cervix in the present pregnancy (cervical length <25 mm before 24 weeks of gestation). According to a recently published indirect meta-analysis, vaginal progesterone and cerclage are equally efficacious in the prevention of PTB in women with a singleton gestation, mid trimester sonographic short cervix, and a history of previous preterm birth.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Diagnosed to be pregnant at up to 24+0 weeks of gestation, with a cervical length measurement of ≤25 mm with a singleton pregnancy, or ≤38 mm in twins pregnancy.
- •Does not meet with maternal/fetal/membrane/placental factors detailed in the exclusion criteria.
- •Willingness to comply with the protocol for the duration of the study.
- •Have signed an informed consent.
排除标准
- •Fetal factors: major fetal abnormalities, death of one or both of the fetuses, twins- twin-to-twin transfusion syndrome, and severe growth retardation.
- •Maternal factors: prophylactic cervical cerclage in situ, painful regular uterine contractions, active labor, active vaginal bleeding, maternal age under 18, uterine abnormalities (i.e. two cervices), and severe uterine prolapse.
- •Membranes and placental factors: placenta previa, ruptured membranes.
研究组 & 干预措施
Progesterone
200 mg daily of vaginal progesterone suppositories (Utrogestan)
干预措施: Progesterone (Drug)
Progesterone plus Experimental device
Experimental device + 200 mg daily progesterone vaginal suppositories (Utrogestan)
干预措施: Pessary (Device)
结局指标
主要结局
preterm birth before 34 weeks of gestation rate in singleton pregnancies
时间窗: up to 20 weeks from recruitment
preterm birth before 32 weeks of gestation rate in twin pregnancies
时间窗: up to 20 weeks from recruitment
次要结局
- Other preterm birth age before 34, 28 weeks in twin pregnancies(up to 20 weeks from recruitment)
- Neonatal/perinatal complications rate(up to 20 weeks from recruitment)
- Maternal Adverse events(up to 20 weeks from recruitment)