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

Overview

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.

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: December 2010

Arms, Groups and Cohorts

  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • nuchal cord entanglement
    • Time Frame: at birth

Secondary Measures

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

Participating in This Clinical Trial

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.

Gender Eligibility: Female

Minimum Age: N/A

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Shaare Zedek Medical Center
  • Provider of Information About this Clinical Study
    • Dr. Ori Shen, Shaare Zedek Medical Center
  • Overall Official(s)
    • Ori Shen, MD, Principal Investigator, Shaare Zedek Medical Center
  • Overall Contact(s)
    • Ori Shen, MD, 972-2-6666666

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