Cervical Pessary to Prevent Preterm Singleton Birth in High Risk Population
试验速览
- 阶段
- 不适用
- 入组人数
- 214
- 试验地点
- 2
- 主要终点
- Spontaneous preterm birth before 37 weeks of gestation
研究概览
简要总结
DESIGN: Observational prospective study. INCLUSION CRITERIA: All women are 18 years old of age or older with high risk for preterm birth, based on clinical history, and between 18.0 weeks and 23.6 weeks of pregnancy. SAMPLE SIZE: 214 asymptomatic high risk pregnant women.
METHODOLOGY: Patient selection, obtaining of informed consent, randomization for cervical placement of pessary. Current follow-up until delivery. Pessary is removed at 37 week or before in some specific situations.
MAIN OUTCOME: sPTB <370 weeks of gestation. SECONDARY OUTCOMES: Pregnancy outcomes and a neonatal composite morbidity. EXPECTED RESULTS: Cervical pessary reduces sPB below 37 weeks in high risk of preterm birth population.
详细描述
Spontaneous preterm birth (sPB) is still a leading cause of neonatal and infant death and responsible of neonatal morbidity as cerebral palsy. In spite of improvements of neonatal care, rates of preterm birth have not changed in the recent 10 years.
Clinical risk factors for preterm birth include: 1) Demographic characteristics such a low socioeconomic status, poor antenatal care, malnutrition or extremes in maternal age; 2) Behavioral factors including smoking, illicit drug abuse, alcohol consumption or heavy physical work; 3) Obstetric history including uterine malformation, previous preterm labor or preterm rupture of membranes (PROM), previous cervical surgery, late miscarriage >16-17 weeks; 4) Aspects of the current pregnancy as multiple pregnancy, genital tract bleeding or infection, Preterm Rupture of Membranes (PROM), short cervix and others.
In nulliparous women with no previous pregnancies or fetal losses >16 weeks, screening based on clinical history (maternal racial origin, age, height, smoking status and method of conception) could detect about 20% of sPB. In women with previous pregnancies at or beyond 16 weeks the detection rate is doubled by incorporating obstetric history.
The risks for women with a previous spontaneous preterm birth with a normal cervix in pregnancy are not negligible. It has been suggested that there is a continuum risk dependent on absolute cervical length while other authors showed that absolute length of cervix above 25mm had little impact on the risk of preterm birth before 35 weeks. A posterior study has not identified any clinical or obstetric risk factors in high-risk women with cervical length greater than 25mm that could help to identify those who will subsequently have a spontaneous preterm birth.
The risk of preterm birth is inversely related to cervical length (CL) as measured by ultrasound. Current options for the management of short cervix in singleton pregnancies are: vaginal progesterone, with proved benefit; cervical cerclage in high risk and short cervix, and cervical pessary.
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
- 是
入选标准
- •Singleton pregnancy.
- •Age > 18 years old.
- •Gestational age between 18.0 -23.6 weeks of gestation.
- •Asymptomatic singleton pregnancies, with at least one of the following:
- •Previous spontaneous preterm delivery or PPROM (23 - 34.6 weeks).
- •Previous spontaneous second trimester miscarriage (16.0-22.6 weeks).
- •Previous surgery on uterine cervix.
- •Uterine malformation.
- •Able to sign informed consent form.
排除标准
- •Congenital, chromosomal abnormalities or stillbirth in current pregnancy before randomization.
- •Women with an obstetrical history of iatrogenic preterm birth indicated for maternal or fetal conditions.
- •Symptomatic high-risk women or preterm prelabor rupture of membranes (PROM) in the current pregnancy.
- •Pregnant women with an indication of prophylactic cervical cerclage due to her own obstetrical history.
- •Pregnant women with an indication to perform a cervical cerclage, prior to study inclusion.
- •Cerclage in situ.
- •Active vaginal bleeding.
结局指标
主要结局
Spontaneous preterm birth before 37 weeks of gestation
时间窗: 3 years
Delivery \< 37.0 weeks of gestation (Yes/No)
次要结局
- Pessary tolerance(5 months)
- Neonatal outcomes NEC(5 months)
- Neonatal outcomes. Death(5 months)
- Threatened preterm labor(5 months)
- Infection(5 months)
- Neonatal outcomes SDR(5 months)
- Neonatal outcomes IVH(5 months)
- Preterm birth 34 weeks(5 months)
- Preterm birth 28 weeks(5 months)
- PPROM before 34 weeks(5 months)
- Cervical trauma(5 months)
- Progesterone co-treatment(5 months)
- Maternal mortality or morbidity(5 months)
- Neonatal birthweight(5 months)
- Neonatal outcomes APGAR(5 months)
- Neonatal outcomes for respiratory support(5 months)
- Choriomanionitis(5 months)
- Neonatal outcomes umbilical artery pH(5 months)
- Neonatal outcomes NICU(5 months)
- Neonatal outcomes. Sepsis(5 months)