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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Shaare Zedek Medical Center.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Shaare Zedek Medical Center
ClinicalTrials.gov Identifier:
NCT00909376
First received: April 2, 2009
Last updated: May 27, 2009
Last verified: May 2009
  Purpose

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.


Condition
Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?

Resource links provided by NLM:


Further study details as provided by Shaare Zedek Medical Center:

Primary Outcome Measures:
  • nuchal cord entanglement [ Time Frame: at birth ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SGA [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • Admission to intensive care unit [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • meconium [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • fetal distress [ Time Frame: at birth ] [ Designated as safety issue: No ]
  • low APGAR score [ Time Frame: 1 minute, 5 minutes after birth ] [ Designated as safety issue: No ]
  • need for c section [ Time Frame: at birth ] [ Designated as safety issue: No ]

Estimated Enrollment: 450
Study Start Date: July 2009
Estimated Study Completion Date: December 2010
Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

pregnant women with one fetus who has no malformations.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00909376

Contacts
Contact: Ori Shen, MD 972-2-6666666

Locations
Israel
Shaare Zedek Medical Center Not yet recruiting
Jerusalem, Israel
Contact    972-2-6666666      
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
Principal Investigator: Ori Shen, MD Shaare Zedek Medical Center
  More Information

No publications provided

Responsible Party: Dr. Ori Shen, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00909376     History of Changes
Other Study ID Numbers: 1-Ledmore
Study First Received: April 2, 2009
Last Updated: May 27, 2009
Health Authority: Israel: Ethics Commission

Keywords provided by Shaare Zedek Medical Center:
Pregnancy
Ultrasonography
outcome
adverse

ClinicalTrials.gov processed this record on September 22, 2014