Assessment of Cervical SofTening and the Prediction of Preterm Birth'
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 390
- 试验地点
- 1
- 主要终点
- Spontaneous Preterm Birth < 34 weeks
研究概览
简要总结
Currently, transvaginal cervical length measurement is used to screen in asymptomatic pregnant women with a history of PTB. In symptomatic women, presenting with threatened PTB cervical length in combination with the fibronectin test is used to identify women at high risk to deliver preterm. However, the predictive capacity of transvaginal cervical length measurement is limited. In pregnant women with a history of PTB, it only identifies a proportion of women who will have recurrent PTB. For symptomatic women, 30-60% of these women admitted to the hospital, do not deliver within seven days, leading to overtreatment of these women.
Cervical softening is precursor of cervical shortening, effacement and dilatation and therefore cervical softening is a promising new marker that is based on tissue elasticity. However, the predictive value of cervical softening and the relation with spontaneous PTB still has to be determined. With the newly developed Pregnolia® System cervical softness could be measured on a standardized and safe manner. This study could help to improve care for women with a history of spontaneous PTB.
详细描述
Preterm birth (PTB) is amongst the leading causes of perinatal and childhood morbidity and mortality. Therefore, accurate identification of pregnant women at high risk of PTB is important. Identifying these women, enables obstetric healthcare professionals to apply interventions to postpone delivery and/or to prevent PTB to improve perinatal and childhood outcomes.
Currently, transvaginal cervical length measurement is used to screen asymptomatic pregnant women with a history of PTB to identify women requiring a cerclage. In symptomatic women, presenting with threatened (PTB), cervical length in combination with the fetal fibronectin(fFN) test is used to identify women at high risk to deliver within 7 days of presentation. However, the predictive capacity of transvaginal cervical length measurement is limited. In pregnant women with a history of PTB, it only identifies a proportion of women who will have recurrent PTB. For symptomatic women, 30-60% of these women admitted to the hospital, do not deliver within seven days, leading to overtreatment of these women.
Since cervical softening is a precursor of cervical shortening, effacement and dilatation, cervical softening is a promising new marker that is based on tissue elasticity. It can be measured with the CE-marked Pregnolia® System for accurate characterization of cervical softening status. It provides a value for tissue elasticity on a continuous scale.
A previous study has shown that softening of the cervix can be detected before shortening of the cervix. The Pregnolia® System may allow to detect women at risk for PTB earlier compared to traditional transvaginal ultrasound that measures shortening of the cervix, and therefore may prove useful for a more accurate risk assessment of PTB.
This current study is a single centre cohort study, where Two cohorts of women will be investigated. 1) Asymptomatic pregnant women with a history of spontaneous PTB before 34 weeks of gestation (Cohort A-STIPP). 2) Symptomatic women presenting with threatened PTB between 24 and 34 weeks (Cohort S-STIPP).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Age 18 years or above.
- •Ability to understand Dutch or English (both spoken and written).
- •Ultrasound-based gestational age determined by measurement of crown rump length (CRL) determined between 9 and 11 weeks of gestation.
- •Singleton and twin pregnancies.
- •Cohort A-STIPP specific:
- •Medical history of spontaneous preterm birth before 34 weeks of gestation
- •Cohort S-STIPP specific:
- •Threatened Preterm birth between 24 and 34 weeks of gestation.
- •Threatened preterm birth is defined as:
- •abdominal pain
- •(Braxton Hicks) contractions
- •vaginal blood loss.
排除标准
- •Under 18 years of age.
- •Signs of intrauterine infection.
- •Obstetric indication for immediate delivery (advanced labor, cord prolapse, abruption, signs of fetal distress).
- •Confirmed fetal abnormality.
- •Confirmed preterm rupture of membranes.
- •Confirmed vasa / placenta praevia.
- •Severe vaginal bleeding and light bleeding that cannot be stopped.
- •Signs of imminent labor such as blood loss, regular contractions.
结局指标
主要结局
Spontaneous Preterm Birth < 34 weeks
时间窗: Maximum time frame up to 28 weeks: from inclusion at 14 weeks of gestational age until delivery, with a maximum of 42 weeks of gestational age.
Spontaneous preterm birth before 34 weeks of gestation in the asymptomatic cohort
Delivery within seven days after inclusion
时间窗: From inclusion until 7 days later
Delivery within seven days after inclusion in the symptomatic cohort
次要结局
- Spontaneous preterm birth <34 weeks(From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age)
- Spontaneous preterm birth <37 weeks(From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age)
- Prediction of preterm birth using cervical softening.(From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age)
- Prediction of latency time using the combination of cervical softening and transvaginal cervical length measurement.(From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age.)
- Spontaneous preterm birth <28 weeks(From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age)
- Spontaneous preterm birth <32 weeks(From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age)
- Prediction of preterm birth using the combination of cervical softening and transvaginal cervical length measurement.(From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age)
- Prediction of preterm birth using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin.(From inclusion (symptomatic cohort 24-34 weeks) until delivery with a maximum of 42 weeks of gestational age)
- Prediction of latency time using cervical softening.(From inclusion (symptomatic cohort 24-34 weeks, asymptomatic cohort 14 weeks) until delivery with a maximum of 42 weeks of gestational age)
- Prediction of latency time using the combination of cervical softening, transvaginal cervical length measurement, and fetal fibronectin(From inclusion (symptomatic cohort 24-34 weeks) until delivery with a maximum of 42 weeks of gestational age.)
研究者
Martijn A. Oudijk, MD, PhD
Prof. Dr. M.A.Oudijk
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)