Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02373800
Recruitment Status : Terminated (insufficient inclusions)
First Posted : February 27, 2015
Last Update Posted : January 11, 2019
Sponsor:
Information provided by (Responsible Party):
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).

Condition or disease Intervention/treatment
Labor, Induced 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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 95 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Elastography for Evaluating Cervical Maturity in Preparation for Labor Induction at 37 to 42 Weeks of Gestation
Actual Study Start Date : February 4, 2016
Actual Primary Completion Date : September 2018
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

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.




Primary Outcome Measures :
  1. Cervical hardness score [ Time Frame: Day 0 (baseline) ]
    A score varying from 0 to 10 determined during cervical ultrasound with elastography.

  2. Mode of delivery: vaginal delivery versus cesarean [ Time Frame: Day 2 ]

Secondary Outcome Measures :
  1. Bishop score [ Time Frame: Day 0 (baseline) ]
  2. Parity [ Time Frame: Day 0 (baseline) ]
  3. Time lapsed between labor induction and delivery [ Time Frame: Day 2 ]
  4. Induction mode [ Time Frame: Day 0 (baseline) ]
    oxytocin alone or with an intravaginal device releasing PGE2

  5. Cervical hardness score for reproductibility 1 [ Time Frame: Day 0 (baseline) ]
    Second reading (by the same, original operator) of ultrasound+elastography recording

  6. Cervical hardness score for reproductibility 2 [ Time Frame: Day 0 (baseline) ]
    Third reading (by a second operator) of ultrasound+elastography recording

  7. Cost of hospital stay [ Time Frame: Expected average of 4-5 days ]

Other Outcome Measures:
  1. Age in years [ Time Frame: Day 0 (baseline) ]
  2. Body mass index [ Time Frame: Day 0 (baseline) ]
  3. Number of previous vaginal deliveries [ Time Frame: Day 0 (baseline) ]
  4. Duration of labor [ Time Frame: Day 2 ]
  5. Birthweight of the newborn [ Time Frame: Day 2 ]
  6. Maternal complications [ Time Frame: Day 2 ]
  7. Complications for the newborn [ Time Frame: Day 2 ]
  8. Indication for cesarian: fetal cause, cervical cause, non descent [ Time Frame: Day 2 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02373800


Locations
Layout table for location information
France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Layout table for investigator information
Principal Investigator: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
Layout table for additonal information
Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02373800    
Other Study ID Numbers: LOCAL/2013/VL-02
2014-A00828-39 ( Other Identifier: RCB number )
First Posted: February 27, 2015    Key Record Dates
Last Update Posted: January 11, 2019
Last Verified: January 2019
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Induced
pre-term labor