Clinical trial NCT02021539: The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery
Official title: The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Obstetric Labor
Labor Onset
Obstetric Labor, Premature
Keywords: Elastography of the cervix
Cervical elastography
Predicting delivery
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2013-12-27
Enrollment: 66
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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).

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.

E-Evaluate the reproducibility of intra-and inter-rater elastographic measurements.

Eligibility criteria: 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

Primary outcomes:
measure: Ultrasound measure of the cervix (mm)
timeFrame: Day 0
measure: Ultrasound measure of the cervix (mm)
timeFrame: Day 2
measure: Elastography score
timeFrame: Day 0 or within 12 hours
Secondary outcomes:
measure: Elastography score
timeFrame: after 2 hours of tocolytic treatment on day 0
measure: Vaginal fetal fibronectin
timeFrame: Day 0
measure: Vaginal fetal fibronectin
timeFrame: Day 2
measure: Avoidable hospital costs
timeFrame: Hospital discharge (expected maximum of 20 days)
measure: Was the first ultrasound/elastography carried out while the patient was already on tocolytics? yes/no
timeFrame: Day 0 or 1
Other outcomes:
measure: Patient age
timeFrame: baseline (day 0)
measure: Body mass index
timeFrame: baseline (day 0)
measure: Number of previous vaginal deliveries
timeFrame: baseline (day 0)
measure: Pregnancy term
timeFrame: baseline (day 0)
measure: Prescribed treatment (rest, hospitalization, medications)
timeFrame: baseline (day 0)
measure: Delay between first cervical ultrasound upon patient arrival and first ultrasound with elastography
timeFrame: Day 0 or 1
Locations:
city: Nîmes Cedex 9
country: France
facility: CHRU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Vincent Letouzey, MD
role: STUDY_DIRECTOR
References: