Effect of Maternal BMI on Measurement of Cervical Length | NCT01882738

Studies
Effect of Maternal BMI on Measurement of Cervical Length

NCT01882738

Sponsor

Hillel Yaffe Medical Center

Status

Unknown status

Last Update Posted

Jun 20, 2013Estimated

Enrollment

300Estimated

Phase

Not provided

Conditions

PREGNANCY

Interventions

Not provided

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2013

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2013

Primary Completion Date

Jul 2014Estimated

Completion Date

Jul 2015Estimated

First Submitted Date

Jun 11, 2013

First Submission Date that Met QC Criteria

Jun 18, 2013

First Posted Date

Jun 20, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2013

Last Update Posted Date

Jun 20, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Detailed Description

This study will include pregnant women in either 2nd or 3rd trimester of pregnancy. All consecutive pregnant patients in 2nd or 3rd trimester who will attend our unit for routine ultrasound exam 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. Accuracy would be defind as the delta of cervical length between abdominal and vaginal routs.

BMI would be calculated prior to the ultrasound exam (by weighing and measuring all patients).

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Gestational age at delivery according to cervical length	Gestational age at delivery according to cervical length	1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Known shore cervix
PPROM

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Alon Shrim, MD	Contact	+972-50-6246988		alon.shrim@gmail.com
Ron Belosseski, MD	Contact	+972-50-9205759		Tomor2304@yahoo.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hillel Yaffe Medical Center		Hadera			Israel