Labor Onset, Obstetric Labor, Obstetric Labor, Premature
Conditions
Keywords
Elastography of the cervix, Cervical elastography, Predicting delivery
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.
Interventions
PROCEDURECervical ultrasound +elastography 1
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
BIOLOGICALVaginal fibronectin measurement
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
DRUGTocolytic treatment for 2 hours
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
PROCEDURECervical ultrasound +elastography 2
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.
Sponsors
Centre Hospitalier Universitaire de Nīmes
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ultrasound measure of the cervix (mm) | Day 0 | — |
| Elastography score | Day 0 or within 12 hours | The score ranges from 0 to 10. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Elastography score | after 2 hours of tocolytic treatment on day 0 | Score ranges from 0 to 10 |
| Vaginal fetal fibronectin | 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 | — |
Other
| Measure | Time frame |
|---|---|
| Patient age | baseline (day 0) |
| Body mass index | baseline (day 0) |
| Number of previous vaginal deliveries | baseline (day 0) |
| Pregnancy term | baseline (day 0) |
| Prescribed treatment (rest, hospitalization, medications) | baseline (day 0) |
| Delay between first cervical ultrasound upon patient arrival and first ultrasound with elastography | Day 0 or 1 |
Countries
France
Outcome results
None listed