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

Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00909376
• Other study ID #: 1-Ledmore
• Status: Not yet recruiting
• Phase: N/A
• First received: April 2, 2009
• Last updated: May 27, 2009
• Start date: July 2009
• Est. completion date: December 2010

Study information

• Verified date: May 2009
• Source: Shaare Zedek Medical Center
• Contact: Ori Shen, MD
• Phone: 972-2-6666666
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 450
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Pregnancy

Locations

Country	Name	City	State
Israel	Shaare Zedek Medical Center	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Shaare Zedek Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	nuchal cord entanglement		at birth	No
Secondary	SGA		at birth	No
Secondary	Admission to intensive care unit		at birth	No
Secondary	meconium		at birth	No
Secondary	fetal distress		at birth	No
Secondary	low APGAR score		1 minute, 5 minutes after birth	No
Secondary	need for c section		at birth	No