Preterm Labor Prediction by Cervical Contour in Ultrasound

This study is not yet open for participant recruitment.
Verified July 2013 by Meir Medical Center
Sponsor:
Information provided by (Responsible Party):
Meir Medical Center
ClinicalTrials.gov Identifier:
NCT01912508
First received: July 29, 2013
Last updated: July 30, 2013
Last verified: July 2013
  Purpose

Cervical length is a already known predictor for preterm labor. In this study the investigators want to examining the hypothesis that cervical curvature is also a predictor for preterm labor and that moderate transducer pressure influence cervical length.

study population: 200 consecutive pregnant women between 14-34w, visiting in the ultrasound unit ether for routine screening or because of preterm labor.

During their examination cervical length and curvature measurements will be taken. Another measurement will be taken after applying moderate cervical pressure.

The investigators will compere cervical contour and pressure influence between groups and according to cervical length Demographic data will be taken at the time of recruitment and pregnancy outcome measures in a later telephone interview.


Condition
Preterm Labor

Study Type: Observational
Study Design: Observational Model: Case Control

Further study details as provided by Meir Medical Center:

Primary Outcome Measures:
  • cervical curvature [ Time Frame: 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 200
Study Start Date: August 2013
Estimated Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
preterm labor
pregnant women with signs of preterm labor: uterine contractions or cervical shortening
control
pregnant women with no signs or symptoms of preterm labor

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

pregnant women 14-34w

Criteria

Inclusion Criteria:

  • pregnancy

Exclusion Criteria:

  • cervical cerclage
  • pre term rupture on membrane in current pregnancy
  • unknown dating of pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01912508

Contacts
Contact: Efrat Hadi, Dr 09-7472871/2
Contact: Ronnie Teper, Professor 09-74728671/2

Locations
Israel
Meir hospital Enrolling by invitation
Kfar Saba, Israel
Sponsors and Collaborators
Meir Medical Center
  More Information

No publications provided

Responsible Party: Meir Medical Center
ClinicalTrials.gov Identifier: NCT01912508     History of Changes
Other Study ID Numbers: MMC-12-0152CTIL
Study First Received: July 29, 2013
Last Updated: July 30, 2013
Health Authority: Israel: Ministry of Health

Keywords provided by Meir Medical Center:
cervical length
cervical curvature

Additional relevant MeSH terms:
Obstetric Labor, Premature
Obstetric Labor Complications
Pregnancy Complications

ClinicalTrials.gov processed this record on April 16, 2014