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The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery (ElastoMAP)

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ClinicalTrials.gov Identifier: NCT02021539
Recruitment Status : Terminated
First Posted : December 27, 2013
Last Update Posted : June 19, 2017
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes

Study Description
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Brief Summary:
The hypothesis tested is that the physical changes associated with cervical ripening result in a detectable decrease in rigidity. The main objective of this study is therefore to determine whether the measured elastographic rigidity of cervical tissues in addition to cervix size can be used to predict delivery within the next 48 hours (creation of a prognostic score).

Condition or disease Intervention/treatment
Obstetric Labor Labor Onset Obstetric Labor, Premature Procedure: Cervical ultrasound +elastography 1 Biological: Vaginal fibronectin measurement Drug: Tocolytic treatment for 2 hours Procedure: Cervical ultrasound +elastography 2

Detailed Description:

The secondary objectives of this study are:

A-To compare the prognostic qualities of elastography scores and fetal fibronectin measurements for predicting the risk of delivery in the next 48 hours.

B-To evaluate the economic impact of introducing elastographic and fibronectin measures during consultatios for obstetric emergencies from the point of vue of the French social security system and the hospital.

C-To evaluate the prognostic value of elastographic measurements in the subgroup twins.

D-To study elastography variation according to patient outcomes.

E-Evaluate the reproducibility of intra-and inter-rater elastographic measurements.

Study Design
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Study Type : Observational
Actual Enrollment : 66 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery
Actual Study Start Date : February 2014
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016
Groups and Cohorts
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Group/Cohort Intervention/treatment
The study population

The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included).

Intervention : Cervical ultrasound +elastography 1 Intervention : Vaginal fibronectin measurement Intervention : Tocolytic treatment for 2 hours Intervention : Cervical ultrasound +elastography 2

 Procedure: Cervical ultrasound +elastography 1
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.

Biological: Vaginal fibronectin measurement
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.

Drug: Tocolytic treatment for 2 hours
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.

Procedure: Cervical ultrasound +elastography 2
Included patients will have a cervical ultrasound upon arrival in the maternity ward. This latter exam will include elastographic measurements, and will be followed by a vaginal fibronectin measurement. Patients will then be treated via a tocolytic (anti-contraction treatment), and two hours later a second cervial ultrasound including elastographic measures will be performed.


Outcome Measures
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Primary Outcome Measures :
  1. Ultrasound measure of the cervix (mm) [ Time Frame: Day 0 ]
  2. Ultrasound measure of the cervix (mm) [ Time Frame: Day 2 ]
  3. Elastography score [ Time Frame: Day 0 or within 12 hours ]
    The score ranges from 0 to 10.


Secondary Outcome Measures :
  1. Elastography score [ Time Frame: after 2 hours of tocolytic treatment on day 0 ]
    Score ranges from 0 to 10

  2. Vaginal fetal fibronectin [ Time Frame: Day 0 ]
  3. Vaginal fetal fibronectin [ Time Frame: Day 2 ]
  4. Avoidable hospital costs [ Time Frame: Hospital discharge (expected maximum of 20 days) ]
  5. Was the first ultrasound/elastography carried out while the patient was already on tocolytics? yes/no [ Time Frame: Day 0 or 1 ]

Other Outcome Measures:
  1. Patient age [ Time Frame: baseline (day 0) ]
  2. Body mass index [ Time Frame: baseline (day 0) ]
  3. Number of previous vaginal deliveries [ Time Frame: baseline (day 0) ]
  4. Pregnancy term [ Time Frame: baseline (day 0) ]
  5. Prescribed treatment (rest, hospitalization, medications) [ Time Frame: baseline (day 0) ]
  6. Delay between first cervical ultrasound upon patient arrival and first ultrasound with elastography [ Time Frame: Day 0 or 1 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
The study population consists of pregnant women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm) who consult for obstetric emergencies (both single or multiple pregnancies can be included).
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 women presenting between the 24th and 34th week of pregnancy, with uterine contractions associated with cervical changes objectified by ultrasound examination of the cervix (5-25mm)
  • Single or multiple pregnancy

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
  • The patient has lost her water (placental rupture)
  • History of cervical surgery
Contacts and Locations
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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): NCT02021539


Locations
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France
CHRU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 9, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
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Study Director: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
More Information
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Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02021539    
Other Study ID Numbers: LOCAL/2013/VL-01
First Posted: December 27, 2013    Key Record Dates
Last Update Posted: June 19, 2017
Last Verified: June 2017
Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Elastography of the cervix
Cervical elastography
Predicting delivery
Additional relevant MeSH terms:
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Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
 Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs