The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Ultrasound measure of the cervix (mm)
研究概览
简要总结
The hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).
详细描述
The secondary objectives of this study are:
A-To compare the prognostic qualities of elastography scores and fetal fibronectin measurements for predicting the risk of delivery in the next 48 hours.
B-To evaluate the economic impact of introducing elastographic and fibronectin measures during consultatios for obstetric emergencies from the point of vue of the French social security system and the hospital.
C-To evaluate the prognostic value of elastographic measurements in the subgroup twins.
D-To study elastography variation according to patient outcomes.
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
- •The patient must have given her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm)
- •Single or multiple pregnancy
排除标准
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient has lost her water (placental rupture)
- •History of cervical surgery
研究组 & 干预措施
The study population
The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included).
Intervention : Cervical ultrasound +elastography 1 Intervention : Vaginal fibronectin measurement Intervention : Tocolytic treatment for 2 hours Intervention : Cervical ultrasound +elastography 2
干预措施: Cervical ultrasound +elastography 1 (Procedure)
The study population
The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included).
Intervention : Cervical ultrasound +elastography 1 Intervention : Vaginal fibronectin measurement Intervention : Tocolytic treatment for 2 hours Intervention : Cervical ultrasound +elastography 2
干预措施: Vaginal fibronectin measurement (Biological)
The study population
The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included).
Intervention : Cervical ultrasound +elastography 1 Intervention : Vaginal fibronectin measurement Intervention : Tocolytic treatment for 2 hours Intervention : Cervical ultrasound +elastography 2
干预措施: Tocolytic treatment for 2 hours (Drug)
The study population
The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included).
Intervention : Cervical ultrasound +elastography 1 Intervention : Vaginal fibronectin measurement Intervention : Tocolytic treatment for 2 hours Intervention : Cervical ultrasound +elastography 2
干预措施: Cervical ultrasound +elastography 2 (Procedure)
结局指标
主要结局
Ultrasound measure of the cervix (mm)
时间窗: Day 2
Elastography score
时间窗: Day 0 or within 12 hours
The score ranges from 0 to 10.
次要结局
- Elastography score(after 2 hours of tocolytic treatment on day 0)
- Avoidable hospital costs(Hospital discharge (expected maximum of 20 days))
- Was the first ultrasound/elastography carried out while the patient was already on tocolytics? yes/no(Day 0 or 1)
- Vaginal fetal fibronectin(Day 2)