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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Centre Hospitalier Universitaire de Nīmes
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT02021539
First received: December 20, 2013
Last updated: March 4, 2014
Last verified: March 2014
  Purpose

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 Intervention
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

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Prognostic Value of Cervical Elastography for Identifying Patients at Risk for Preterm Delivery

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • Ultrasound measure of the cervix (mm) [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
  • Ultrasound measure of the cervix (mm) [ Time Frame: Day 2 ] [ Designated as safety issue: No ]
  • Elastography score [ Time Frame: Day 0 or within 12 hours ] [ Designated as safety issue: No ]
    The score ranges from 0 to 10.


Secondary Outcome Measures:
  • Elastography score [ Time Frame: after 2 hours of tocolytic treatment on day 0 ] [ Designated as safety issue: No ]
    Score ranges from 0 to 10

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

Other Outcome Measures:
  • Patient age [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Body mass index [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Number of previous vaginal deliveries [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Pregnancy term [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Prescribed treatment (rest, hospitalization, medications) [ Time Frame: baseline (day 0) ] [ Designated as safety issue: No ]
  • Delay between first cervical ultrasound upon patient arrival and first ultrasound with elastography [ Time Frame: Day 0 or 1 ] [ Designated as safety issue: No ]

Estimated Enrollment: 204
Study Start Date: February 2014
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02021539

Contacts
Contact: Vincent Letouzey, MD +33.(0)4.66.68.32.16 vincent.letouzey@chu-nimes.fr
Contact: Carey Suehs, PhD +33.(0)4.66.68.67.88 carey.suehs@chu-nimes.fr

Locations
France
CHRU de Nîmes - Hôpital Universitaire Carémeau Recruiting
Nîmes Cedex 9, France, 30029
Principal Investigator: Vincent Letouzey, MD         
Sub-Investigator: Eve Mousty, MD         
Sub-Investigator: Frédéric Grosjean, MD         
Sub-Investigator: Pierre Marès, MD, PhD         
Sub-Investigator: Renaud de Tayrac, MD, PhD         
Sub-Investigator: Florent Masia, MD         
Sub-Investigator: Arnaud Cornille, MD         
Sub-Investigator: Stéphanie Huberlant, MD         
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Study Director: Vincent Letouzey, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT02021539     History of Changes
Other Study ID Numbers: LOCAL/2013/VL-01
Study First Received: December 20, 2013
Last Updated: March 4, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Elastography of the cervix
Cervical elastography
Predicting delivery

Additional relevant MeSH terms:
Premature Birth
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications
Tocolytic Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014