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

• Conditions: Pregnancy

• Registration Number: NCT00909376
• Lead Sponsor: Shaare Zedek Medical Center

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 available

Study Timeline

• Study First Submitted: 2009-04-02
• Status Verified: 2009-05
• Study First Submitted QC: 2009-05-27
• Last Update Submitted: 2009-05-27
• Study First Posted: 2009-05-28
• Last Update Posted: 2009-05-28
• Study Start: 2009-07
• Primary Completion: 2010-12
• Study Completion: 2010-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 450

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
nuchal cord entanglement	at birth

Secondary Outcome Measures

Name	Time	Method
SGA	at birth
Admission to intensive care unit	at birth
meconium	at birth
fetal distress	at birth
low APGAR score	1 minute, 5 minutes after birth
need for c section	at birth

Trial Locations

Locations (1)

Shaare Zedek Medical Center; 🇮🇱 Jerusalem, Israel