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

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).

Study Overview

• Status: Terminated
• Conditions: Labor, Induced
• Intervention / Treatment: Device: Cervical ultrasound with elastography

Detailed Description

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.

• Study Type: Observational
• Enrollment (Actual): 95

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHRU de Nîmes - Hôpital Universitaire Carémeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Device: Cervical ultrasound with elastography; 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.

What is the study measuring?

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

Other Outcome Measures

Outcome Measure	Time Frame
Age in years	Day 0 (baseline)
Body mass index	Day 0 (baseline)
Number of previous vaginal deliveries	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

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes

Study record dates

Study Major Dates

• Study Start (ACTUAL): February 4, 2016
• Primary Completion (ACTUAL): September 1, 2018
• Study Completion (ACTUAL): September 1, 2018

Study Registration Dates

• First Submitted: February 23, 2015
• First Submitted That Met QC Criteria: February 26, 2015
• First Posted (ESTIMATE): February 27, 2015

Study Record Updates

• Last Update Posted (ACTUAL): January 11, 2019
• Last Update Submitted That Met QC Criteria: January 10, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: Induced; pre-term labor
• Other Study ID Numbers: LOCAL/2013/VL-02; 2014-A00828-39 (OTHER: RCB number)