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

Terminated

• Conditions: Labor, Induced

• Registration Number: NCT02373800
• Lead Sponsor: Centre Hospitalier Universitaire de Nīmes

Brief Summary

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

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 Timeline

• Study First Submitted: 2015-02-23
• Study First Submitted QC: 2015-02-26
• Study First Posted: 2015-02-27
• Study Start: 2016-02-04
• Primary Completion: 2018-09
• Study Completion: 2018-09
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-10
• Last Update Posted: 2019-01-11

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 95

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cervical hardness score	Day 0 (baseline)	A score varying from 0 to 10 determined during cervical ultrasound with elastography.
Mode of delivery: vaginal delivery versus cesarean	Day 2

Secondary Outcome Measures

Name	Time	Method
Bishop score	Day 0 (baseline)
Parity	Day 0 (baseline)
Time lapsed between labor induction and delivery	Day 2
Induction mode	Day 0 (baseline)	oxytocin alone or with an intravaginal device releasing PGE2
Cervical hardness score for reproductibility 1	Day 0 (baseline)	Second reading (by the same, original operator) of ultrasound+elastography recording
Cervical hardness score for reproductibility 2	Day 0 (baseline)	Third reading (by a second operator) of ultrasound+elastography recording
Cost of hospital stay	Expected average of 4-5 days

Trial Locations

Locations (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau; 🇫🇷 Nîmes Cedex 09, France