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

NCT02021539 | Terminated

• 1 other identifier: LOCAL/2013/VL-01
• Study Type: observational
• Target: 66
• Locations: 1 country
• Sites: 1

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).

Conditions

Obstetric Labor; Labor Onset; Obstetric Labor, Premature

Keywords

Elastography of the cervix; Cervical elastography; Predicting delivery

Outcome Measures

Primary Outcomes (3)

• Ultrasound measure of the cervix (mm)

  Day 0

• Ultrasound measure of the cervix (mm)

  Day 2

• Elastography score

  The score ranges from 0 to 10.

  Day 0 or within 12 hours

Secondary Outcomes (5)

• Elastography score

  after 2 hours of tocolytic treatment on day 0

• Vaginal fetal fibronectin

  Day 0

• Vaginal fetal fibronectin

  Day 2

• Avoidable hospital costs

  Hospital discharge (expected maximum of 20 days)

• Was the first ultrasound/elastography carried out while the patient was already on tocolytics? yes/no

  Day 0 or 1

Other Outcomes (6)

• Patient age

  baseline (day 0)

• Body mass index

  baseline (day 0)

• Number of previous vaginal deliveries

  baseline (day 0)

Study Arms (1)

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; Biological: Vaginal fibronectin measurement; Drug: Tocolytic treatment for 2 hours; Procedure: Cervical ultrasound +elastography 2

Interventions

Cervical ultrasound +elastography 1 PROCEDURE

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.

The study population

Vaginal fibronectin measurement BIOLOGICAL

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.

The study population

Tocolytic treatment for 2 hours DRUG

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.

The study population

Cervical ultrasound +elastography 2 PROCEDURE

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.

The study population

Eligibility Criteria

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

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 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

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
• The patient has lost her water (placental rupture)
• History of cervical surgery

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nīmes: lead

Study Sites (1)

CHRU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

MeSH Terms

Conditions

Obstetric Labor, Premature

Interventions

Tocolysis

Condition Hierarchy (Ancestors)

Obstetric Labor Complications; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Reproductive Techniques; Therapeutics

Study Officials

• Vincent Letouzey, MD

  Centre Hospitalier Universitaire de Nîmes

  STUDY DIRECTOR

Study Design

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

Study Record Dates

• First Submitted: December 20, 2013
• First Posted: December 27, 2013
• Study Start: February 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: June 19, 2017

Record last verified: 2017-06

Locations

FR (1)