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

NCT00909376 | Unknown

• 1 other identifier: 1-Ledmore
• Study Type: observational
• Target: 450
• Locations: 1 country
• Sites: 1

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.

Conditions

Pregnancy

Keywords

Pregnancy; Ultrasonography; outcome; adverse

Outcome Measures

Primary Outcomes (1)

• nuchal cord entanglement

  at birth

Secondary Outcomes (6)

• 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

Study Arms (2)

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.

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

pregnant women with one fetus who has no malformations.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Shaare Zedek Medical Center: lead

Study Sites (1)

Shaare Zedek Medical Center

Jerusalem, Israel

Location

Study Officials

• Ori Shen, MD

  Shaare Zedek Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ori Shen, MD

CONTACT

972-2-6666666

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: April 2, 2009
• First Posted: May 28, 2009
• Study Start: July 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: May 28, 2009

Record last verified: 2009-05

Locations

IL (1)