The Effectiveness of Cervical Pessary Versus Vaginal Progesterone for Preventing Premature Birth in IVF Twin Pregnancies: a Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Preterm birth before 34 weeks of gestation
研究概览
简要总结
To compare the effectiveness of cervical pessary (Arabin) and vaginal progesterone for preventing premature birth in twin pregnancies after IVF
详细描述
This will be a randomized controlled trial.
Women with twin pregnancies, at 16-22 weeks of gestation, will be invited to participate into the study.
Subjects meeting the study criteria will be randomized into two groups: (1) treated with cervical pessary (Arabin) or (2) treated with 400mg vaginal progesterone, once daily. Randomization will be done by third party via telephone, using a computer generated random list, with a variable block size of 2, 4 or 8. Apart from randomization, patients will be examined and treated according to local protocol.
Patients in pessary group will have an Arabin pessary placed within a week after randomization. A pessary certified by European Conformity (CE0482, MED/CERT ISO 9003/ EN 46003; Dr. Arabin, Witten, Germany) will be inserted through the vagina of the woman in the recumbent position and will be placed upward around the cervix. The research-team members who inserted the Arabin pessary have experience with Arabin pessary for singleton pregnancy before.
Patients in progesterone group will use vaginal progesterone (Cyclogest 400mg) once daily before bedtime, starting from the day of randomization onwards. They will be given a monitoring sheet and instructed to note everyday the date of using. If they forget one dose of any night, and remember it in the next morning or afternoon, they will use immediately the forgotten dose and continue with the dose of that day at night. If one dose is missed until the next evening, there will be no compensation use, they will only use the dose of the next day. Any change in using medication should be noted in the monitoring sheet.
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
- •To be eligible for enrolment into this trial, each female subject must fulfil all of the following criteria at the start of enrolment, unless specified otherwise:
- •Women with a twin pregnancy (mono- and di-chorionic)
- •16 0/7 to 22 0/7 weeks of gestation
- •Maternal age ≥ 18 yrs
- •Cervical length less than 38 mm
- •Informed consent
- •Not participating in another PTB study at the same time
排除标准
- •To be eligible for enrolment in this study each subject must not meet any of the following criteria:
- •History of cervical surgery
- •Cervical cerclage in place
- •Twin-to-twin transfusion syndrome
- •Stillbirth or major congenital abnormalities in any of the fetus
- •Severe vaginal discharge, acute vaginitis
- •Premature rupture of membranes
- •Premature labor
研究组 & 干预措施
Cervical pessary
Cervical pessary (Arabin) will be inserted to participants at 16-22 weeks and removed at 36 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 400 mg) once a day will be used, from 16-22 to 36 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
Preterm birth before 34 weeks of gestation
时间窗: At birth
Birth before 34 weeks
次要结局
- Delivery before 28 weeks of gestation(At birth)
- Delivery before 32 weeks of gestation(At birth)
- Mode of delivery(At birth)
- Delivery before 24 weeks of gestation(At birth)
- Maternal morbidity(From randomization to birth)
- 5-minute Apgar score(At birth)
- 5-minute Apgar score < 7(At birth)
- Length of NICU admission(Up to 28 days after birth)
- Severe respiratory distress syndrome(Within 24 hours after delivery)
- Labour induction(At birth)
- Use of tocolytics drug(From 24 weeks to 34 weeks)
- Admission days for preterm labor(From 24 weeks to 37 week)
- Choriamnionitis(From randomization to birth)
- Birthweight < 2500g(At birth)
- Congenital anomalies(At birth)
- Stillbirth(At birth)
- Use of corticosteroids(From 24 weeks to 34 weeks)
- Bronchopulmonary dysplasia(At time of discharge home or at 36 weeks of gestational age)
- Intrauterine death before 24 weeks of gestation(From randomisation to 24 weeks)
- Delivery before 37 weeks of gestation(At birth)
- Prelabour rupture of membrane(From randomization to less than 37 weeks)
- Livebirth at any gestational age(At birth)
- Birthweight(At birth)
- Birthweight < 1500g(At birth)
- Admission to NICU(Within 7 days after delivery)
- Intraventricular haemorrhage(Up to 28 days after birth)
- Death before discharge(Up to 28 days after birth)
- Maternal side effects(From randomisation to birth)
- Necrotising enterocolitis(Up to 28 days after birth)
- Proven sepsis(Up to 28 days after birth)
- Withdrawal from treatment(From randomization to 36 weeks of gestation)
研究者
Manh Tuong Ho
Doctor
Vietnam National University