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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-A00828-39 | Other Identifier | RCB number |
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The primary objective of this study is to determine if a cervical hardness score (determined by cervical ultrasound with elastography) can predict delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering) regardless of the induction mode (ocytocin alone or with an intravaginal device releasing PGE2).
The secondary objectives of this study are:
A. To determine composite criteria (combining elastographic, parity and Bishop score information) that predict delivery mode.
B. To determine the prognostic value of elastography as concerns delivery within 24 hours among patients induced via oxytocin with an intravaginal device releasing PGE2 (Bishop score < 6).
C. To determine the prognostic value of elastography as concerns delivery mode (vaginal versus cesarian for slow dilatation (more than 2-3h without fetal suffering))among patients induced via oxytocin alone.
D. To evaluate the intra- and inter-operator reproducibility of the cervical hardness score determined via elastography.
E. To evaluate the economic impact of using the cervical hardness score from the point of view of the French social system (French health insurance) and the hospital.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| The study population | The study population is composed of pregnant women with a medical indication for the induction of pre-term (37-42 weeks of gestation) labor and who are consulting in the participating center. Intervention: Cervical ultrasound with elastography |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cervical ultrasound with elastography | Device | Following routine vaginal exam with determination of Bishop's score, cervical ultrasound with elastography will be used to determine a cervical hardness score varying from 1 to 10. Patients are then hospitalized and labor induced 12 to 48 hours after the elastography. |
| Measure | Description | Time Frame |
|---|---|---|
| Cervical hardness score | A score varying from 0 to 10 determined during cervical ultrasound with elastography. | Day 0 (baseline) |
| Mode of delivery: vaginal delivery versus cesarean | Day 2 |
| Measure | Description | Time Frame |
|---|---|---|
| Bishop score | Day 0 (baseline) | |
| Parity | Day 0 (baseline) | |
| Time lapsed between labor induction and delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Age in years | Day 0 (baseline) | |
| Body mass index | Day 0 (baseline) | |
| Number of previous vaginal deliveries |
Inclusion Criteria:
Exclusion Criteria:
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The study population is composed of pregnant women with a medical indication for the induction of pre-term (37-42 weeks of gestation) labor and who are consulting in the participating center.
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| Name | Affiliation | Role |
|---|---|---|
| Vincent Letouzey, MD | Centre Hospitalier Universitaire de Nīmes | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHRU de Nîmes - Hôpital Universitaire Carémeau | Nîmes | 30029 | France |
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| ID | Term |
|---|---|
| D054459 | Elasticity Imaging Techniques |
| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Day 2 |
| Induction mode | oxytocin alone or with an intravaginal device releasing PGE2 | Day 0 (baseline) |
| Cervical hardness score for reproductibility 1 | Second reading (by the same, original operator) of ultrasound+elastography recording | Day 0 (baseline) |
| Cervical hardness score for reproductibility 2 | Third reading (by a second operator) of ultrasound+elastography recording | Day 0 (baseline) |
| Cost of hospital stay | Expected average of 4-5 days |
| Day 0 (baseline) |
| Duration of labor | Day 2 |
| Birthweight of the newborn | Day 2 |
| Maternal complications | Day 2 |
| Complications for the newborn | Day 2 |
| Indication for cesarian: fetal cause, cervical cause, non descent | Day 2 |