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

Labor, Induced Clinical Trial

— ElastoDéclench  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02373800
• Other study ID #: LOCAL/2013/VL-02
• Secondary ID: 2014-A00828-39
• Status: Terminated
• Start date: February 4, 2016
• Est. completion date: September 2018

Study information

• Verified date: January 2019
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 95
• Est. completion date: September 2018
• Est. primary completion date: September 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor, Induced

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Age in years		Day 0 (baseline)
Other	Body mass index		Day 0 (baseline)
Other	Number of previous vaginal deliveries		Day 0 (baseline)
Other	Duration of labor		Day 2
Other	Birthweight of the newborn		Day 2
Other	Maternal complications		Day 2
Other	Complications for the newborn		Day 2
Other	Indication for cesarian: fetal cause, cervical cause, non descent		Day 2
Primary	Cervical hardness score	A score varying from 0 to 10 determined during cervical ultrasound with elastography.	Day 0 (baseline)
Primary	Mode of delivery: vaginal delivery versus cesarean		Day 2
Secondary	Bishop score		Day 0 (baseline)
Secondary	Parity		Day 0 (baseline)
Secondary	Time lapsed between labor induction and delivery		Day 2
Secondary	Induction mode	oxytocin alone or with an intravaginal device releasing PGE2	Day 0 (baseline)
Secondary	Cervical hardness score for reproductibility 1	Second reading (by the same, original operator) of ultrasound+elastography recording	Day 0 (baseline)
Secondary	Cervical hardness score for reproductibility 2	Third reading (by a second operator) of ultrasound+elastography recording	Day 0 (baseline)
Secondary	Cost of hospital stay		Expected average of 4-5 days