Is Early Second Trimester Vaginal Ultrasound Scan Associa... | NCT00909376

Studies
Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?

NCT00909376

Sponsor

Shaare Zedek Medical Center

Status

Unknown status

Last Update Posted

May 28, 2009Estimated

Enrollment

450Estimated

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

May 2009

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 2009

Primary Completion Date

Dec 2010Estimated

Completion Date

Dec 2010Estimated

First Submitted Date

Apr 2, 2009

First Submission Date that Met QC Criteria

May 27, 2009

First Posted Date

May 28, 2009Estimated

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

May 27, 2009

Last Update Posted Date

May 28, 2009Estimated

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

Many pregnant women have an ultrasound done of their fetus in the beginning of the second trimester of pregnancy. Some have a transvaginal sonography while others have a transabdominal one, depending on clinical parameters such as weight, scars etc. In the transvaginal ultrasound there is some amount of version of the fetus done by the examiner to maintain a better aspect of the fetus, while this is not done in a transabdominal sonography.

The objective of this trail is to determine whether having a transvaginal ultrasound as opposed to a transabdominal one has an association to adverse perinatal outcomes.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

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

450Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1 - transabdominal sonography		Women who will have a transabdominal sonography done in the early second trimester.
2 - transvaginal sonography		Women who will have a transvaginal sonography done in the early second trimester.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
nuchal cord entanglement		at birth

Secondary Outcomes

Measure	Description	Time Frame
SGA		at birth
Admission to intensive care unit		at birth
meconium

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Pregnant women who choose to have a ultrasound done in the early second trimester.

Exclusion Criteria:

More than one fetus,
No agreement to participate in the study,
Malformative fetus.

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

pregnant women with one fetus who has no malformations.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Ori Shen, MD	Contact	972-2-6666666

Overall Officials

Name	Affiliation	Role
Ori Shen, MD	Shaare Zedek Medical Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Shaare Zedek Medical Center		Jerusalem			Israel