NCT01882738

Brief Summary

All consecutive pregnant patients in 2nd or 3rd trimester will be asked to participate. Cervical length will be assessed in all patients, once abdominally and then vaginally (that would serve as golden standard). Correlation would be assessed between accuracy of measurement to BMI

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2013

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 11, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
11 days until next milestone

Study Start

First participant enrolled

July 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

June 20, 2013

Status Verified

June 1, 2013

Enrollment Period

1 year

First QC Date

June 11, 2013

Last Update Submit

June 18, 2013

Conditions

Keywords

Cervical lengthBMI

Outcome Measures

Primary Outcomes (1)

  • Accuracy of cervical length according to BMI

    the golden standard for cervical length measurement is vaginal scan. Our outcome measure will be the accuracy of cervical length measurement - measured abdominally, according to BMI. I other words - was there a difference between measurement by vaginal probe and abdominal probe and whether this difference correlates with BMI

    1 year

Secondary Outcomes (1)

  • Gestational age at delivery according to cervical length

    1 year

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

All pregnant women in 2nd or 3rd trimester who attend routine ultrasound exam

You may qualify if:

  • All pregnant women in 2nd or 3rd trimester who attend routine ultrasound exam

You may not qualify if:

  • Known shore cervix
  • PPROM

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hillel Yaffe Medical Center

Hadera, Israel

Location

Central Study Contacts

Ron Belosseski, MD

CONTACT

Study Design

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

Study Record Dates

First Submitted

June 11, 2013

First Posted

June 20, 2013

Study Start

July 1, 2013

Primary Completion

July 1, 2014

Study Completion

July 1, 2015

Last Updated

June 20, 2013

Record last verified: 2013-06

Locations