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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical ultrasound +elastography 1 | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Ultrasound measure of the cervix (mm) | Day 0 | |
| Ultrasound measure of the cervix (mm) | Day 2 | |
| Elastography score | The score ranges from 0 to 10. | Day 0 or within 12 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Elastography score | Score ranges from 0 to 10 | after 2 hours of tocolytic treatment on day 0 |
| Vaginal fetal fibronectin | Day 0 | |
| Measure | Description | Time Frame |
|---|---|---|
| Patient age | baseline (day 0) | |
| Body mass index | baseline (day 0) | |
| Number of previous vaginal deliveries |
Inclusion Criteria:
Exclusion Criteria:
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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).
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Letouzey, MD | Centre Hospitalier Universitaire de NÄ«mes | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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|
| Vaginal fibronectin measurement | Biological | 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. |
|
| Tocolytic treatment for 2 hours | Drug | 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. |
|
| Cervical ultrasound +elastography 2 | Procedure | 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. |
|
| Vaginal fetal fibronectin |
| Day 2 |
| 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 |
| 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 |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| ID | Term |
|---|---|
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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| ID | Term |
|---|---|
| D015145 | Tocolysis |
| ID | Term |
|---|---|
| D012099 | Reproductive Techniques |
| D013812 | Therapeutics |
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