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

Obstetric Labor, Premature Clinical Trial

— ElastoMAP  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02021539
• Other study ID #: LOCAL/2013/VL-01
• Status: Terminated
• Phase: N/A
• First received: December 20, 2013
• Last updated: June 16, 2017
• Start date: February 2014
• Est. completion date: December 2016

Study information

• Verified date: June 2017
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 66
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Labor Onset
• Obstetric Labor
• Obstetric Labor, Premature
• Premature Birth

Intervention

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.

Locations

Country	Name	City	State
France	CHRU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 9

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patient age		baseline (day 0)
Other	Body mass index		baseline (day 0)
Other	Number of previous vaginal deliveries		baseline (day 0)
Other	Pregnancy term		baseline (day 0)
Other	Prescribed treatment (rest, hospitalization, medications)		baseline (day 0)
Other	Delay between first cervical ultrasound upon patient arrival and first ultrasound with elastography		Day 0 or 1
Primary	Ultrasound measure of the cervix (mm)		Day 0
Primary	Ultrasound measure of the cervix (mm)		Day 2
Primary	Elastography score	The score ranges from 0 to 10.	Day 0 or within 12 hours
Secondary	Elastography score	Score ranges from 0 to 10	after 2 hours of tocolytic treatment on day 0
Secondary	Vaginal fetal fibronectin		Day 0
Secondary	Vaginal fetal fibronectin		Day 2
Secondary	Avoidable hospital costs		Hospital discharge (expected maximum of 20 days)
Secondary	Was the first ultrasound/elastography carried out while the patient was already on tocolytics? yes/no		Day 0 or 1