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

NCT02373800 | Terminated

• 2 other identifiers: LOCAL/2013/VL-022014-A00828-39
• Study Type: observational
• Target: 95
• Locations: 1 country
• Sites: 1

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).

Conditions

Labor, Induced

Keywords

Induced; pre-term labor

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (7)

• Bishop score

  Day 0 (baseline)

• Parity

  Day 0 (baseline)

• Time lapsed between labor induction and delivery

  Day 2

• Induction mode

  Day 0 (baseline)

• Cervical hardness score for reproductibility 1

  Day 0 (baseline)

Other Outcomes (8)

• Age in years

  Day 0 (baseline)

• Body mass index

  Day 0 (baseline)

• Number of previous vaginal deliveries

  Day 0 (baseline)

Study Arms (1)

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

Interventions

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.

The study population

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Interventions

Elasticity Imaging Techniques

Intervention Hierarchy (Ancestors)

Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Vincent Letouzey, MD

  Centre Hospitalier Universitaire de Nîmes

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2015
• First Posted: February 27, 2015
• Study Start: February 4, 2016
• Primary Completion: September 1, 2018
• Study Completion: September 1, 2018
• Last Updated: January 11, 2019

Record last verified: 2019-01

Locations

FR (1)