NCT01912508

Brief Summary

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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 29, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 31, 2013

Completed
1 day until next milestone

Study Start

First participant enrolled

August 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
Last Updated

August 13, 2014

Status Verified

August 1, 2014

Enrollment Period

1 year

First QC Date

July 29, 2013

Last Update Submit

August 12, 2014

Conditions

Keywords

cervical lengthcervical curvature

Outcome Measures

Primary Outcomes (1)

  • cervical curvature

    12 months

Study Arms (2)

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 Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

pregnant women 14-34w

You may qualify if:

  • pregnancy

You may not qualify if:

  • cervical cerclage
  • pre term rupture on membrane in current pregnancy
  • unknown dating of pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Meir hospital

Kfar Saba, Israel

RECRUITING

MeSH Terms

Conditions

Obstetric Labor, Premature

Condition Hierarchy (Ancestors)

Obstetric Labor ComplicationsPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Central Study Contacts

Efrat Hadi, Dr

CONTACT

Ronnie Teper, Professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 29, 2013

First Posted

July 31, 2013

Study Start

August 1, 2013

Primary Completion

August 1, 2014

Last Updated

August 13, 2014

Record last verified: 2014-08

Locations