The Effectiveness of Cervical Pessary Versus Vaginal Progesterone for the Prevention of Preterm Birth in Women With Singleton Pregnancies and Short Cervix: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 804
- 试验地点
- 3
- 主要终点
- Rate of preterm birth <37 weeks of gestation by any cause
研究概览
简要总结
This study compares the effectiveness of cervical pessary to vaginal progesterone for prevention of preterm birth in women with singleton pregnancies and a cervix ≤25 mm.
Participants will be randomly assigned in a 1:1 ratio to receive cervical pessary or vaginal progesterone.
详细描述
This open label, multi-center, randomized controlled trial aims to compare the effectiveness of cervical pessary to vaginal progesterone for prevention of PTB in women with singleton pregnancies and a cervix ≤25 mm.
All women at 16 0/7 to 22 0/7 weeks with singleton pregnancies will undergo cervical length (CL) measurement and digital examination at screening routinely. Women with a CL ≤25 mm will be eligible for the study.
Subjects meeting the study criteria will be randomized into two groups: (1) treated with cervical pessary (Arabin) or (2) treated with 200 mg vaginal progesterone, once daily.
After written informed consent, women will be randomly assigned in a 1:1 ratio to receive a cervical pessary or progesterone. Assignment to treatment allocation will be done via a web portal hosted by HOPE Research Center, Vietnam. The randomization schedule will be computer-generated at HOPE Research Center, with a permuted random block size of 2, 4 or 6. Blinding will not be possible due to the nature of interventions.
For those who randomised to pessary group, a pessary certified by European Conformity (Arabin®, Dr Arabin GmbH & Co KG, Germany) will be inserted through the vagina, upward around the cervix by 2-4 senior clinicians, who had experienced with pessary used at each site, within one week of randomization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •Singleton pregnancies
- •Cervical length ≤ 25 mm, measured by TVS at the second-trimester ultrasonography (16 0/7-22 0/7 weeks of gestation)
- •Not participating in any other study which has intervention on maternity or fetus at the same time
- •Provision of written informed consent to participate as shown by a signature on the patient consent form.
排除标准
- •Cervical dilation with visible amniotic membranes or amniotic membranes prolapsed into the vagina
- •Major congenital abnormalities of the fetus
- •Presence of severe vaginal discharge
- •Presence of vaginitis or cervicitis
- •Presence of vaginal bleeding
- •Preterm premature rupture of membranes
- •Premature labor without ruptured membrane at the time of screening
- •Suspected chorioamnionitis
- •Unable to have cervical pessary inserted
- •Cerclage or pessary in place
研究组 & 干预措施
Cervical pessary
Cervical pessary (Arabin) will be inserted to participants at 16-22 weeks and removed at 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.
干预措施: Cervical pessary (Device)
Vaginal Progesterone
Vaginal progesterone (Cyclogest 200 mg) once a day will be used, from 16-22 to 37 weeks of pregnancy or in case of premature rupture of membranes, signs of preterm labour or patient severe discomfort.
干预措施: Vaginal Progesterone (Drug)
结局指标
主要结局
Rate of preterm birth <37 weeks of gestation by any cause
时间窗: From date of randomisation until 36 6/7 weeks
Birth before 37 weeks
次要结局
- Gestational age at delivery(At birth)
- Time from randomization to delivery(From date of randomisation until the date of delivery.)
- Rate of preterm birth before 28 weeks of gestation(From date of randomisation until 27 6/7 weeks)
- Rate of preterm birth before 34 weeks of gestation(From date of randomisation until 33 6/7 weeks)
- Rate of spontaneous preterm birth <28 weeks(From date of randomisation until 27 6/7 weeks)
- Rate of spontaneous preterm birth <34 weeks(From date of randomisation until 33 6/7 weeks)
- Rate of spontaneous preterm birth <37 weeks(From date of randomisation until 36 6/7 weeks)
- Rate of iatrogenic preterm birth <28 weeks(From date of randomisation until 27 6/7 weeks)
- Rate of iatrogenic preterm birth <34 weeks(From date of randomisation until 33 6/7 weeks)
- Rate of iatrogenic preterm birth <37 weeks(From date of randomisation until 36 6/7 weeks)
- Rate of onset of labor(At birth)
- Rate of modes of delivery(At birth)
- Rate of all live births at any gestational age(At birth)
- Rate of use of tocolytic drugs(From 24 0/7 to 36 6/7 weeks' gestation)
- Rate of use of antenatal corticosteroids(From 24 0/7 to 36 6/7 weeks' gestation)
- Rate of use of MgSO4 for neuroprotection(From 28 0/7 to 31 6/7 weeks' gestation)
- Rate of preterm premature rupture of membranes(From randomization to less than 37 weeks, up to 21 weeks)
- Length of maternal admission for preterm labor (days)(From randomization to 37 week)
- Birthweight (mean)(At birth)
- Birthweight <1500 g(At birth)
- Birthweight <2500 g(At birth)
- Rate of congenital anomalies(At birth)
- 5-min Apgar score(At birth)
- 5-min Apgar score <7(At birth)
- Rate of admission to neonatal intensive care unit (NICU)(Up to 28 days of life after the due day)
- Length of NICU admission(Up to 28 days of life after the due day)
- Rate of death before discharge(Up to 28 days of life after the due day)
- Rate of neonatal death(Up to 28 days of life after the due day)
- Rate of perinatal death(After 20 weeks of gestation to 28 days of life after the due day)
- Rate of chorioamnionitis(From randomization to delivery, up to 28 weeks)
- Rate of maternal mortality(From randomization to delivery, up to 28 weeks)
- Rate of stillbirth(After 20 weeks of gestation until the date of delivery)
- Rate of composite of poor perinatal outcomes(Up to 28 days of life after the due day)
- Rate of respiratory distress syndrome(Up to 28 days of life after the due day)
- Rate of periventricular haemorrhage II B or worse(Up to 28 days of life after the due day)
- Rate of necrotizing enterocolitis(Up to 28 days of life after the due day)
- Rate of proven sepsis(Up to 28 days of life after the due day)
- Rate of maternal vaginal side effects(From date of randomisation until delivery, which is up to 24 weeks)
- Vaginal pain Score(From date of randomisation until delivery, which is up to 24 weeks)
- Rate of pessary repositioning(From date of randomisation until delivery, which is up to 24 weeks)
- Rate of maternal cervical side effects(From date of randomisation until delivery, which is up to 24 weeks)