Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation

Study Overview
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Brief Summary
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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).

Detailed Description
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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.

Official Title
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Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation

Conditions
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Labor, Induced

Intervention / Treatment
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* Device: Cervical ultrasound with elastography


Participation Criteria
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Eligibility Criteria
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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 woman with a medical indication for pre-term labor induction: 37 to 42 weeks of gestation. 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 History of cervical surgery Malformation of the cervix

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| The study population<br>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 | Device: Cervical ultrasound with elastography<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bishop score |  | Day 0 (baseline) | 
| Parity |  | Day 0 (baseline) | 
| Time lapsed between labor induction and delivery |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Induced, pre-term labor