The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 66
- Locations
- 1
- Primary Endpoint
- Ultrasound measure of the cervix (mm)
Study Overview
Brief Summary
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).
Detailed Description
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
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
Intervention: 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
Intervention: 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
Intervention: 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
Intervention: Cervical ultrasound +elastography 2 (Procedure)
Outcomes
Primary Outcomes
Ultrasound measure of the cervix (mm)
Time Frame: Day 2
Elastography score
Time Frame: Day 0 or within 12 hours
The score ranges from 0 to 10.
Secondary Outcomes
- 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)