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

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ClinicalTrials.gov Identifier: NCT00909376
Recruitment Status : Unknown
Verified May 2009 by Shaare Zedek Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : May 28, 2009
Last Update Posted : May 28, 2009
Sponsor:
Information provided by:
Shaare Zedek Medical Center

Study Description
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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.


Condition or disease
Pregnancy

Study Design
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Study Type : Observational
Estimated Enrollment : 450 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?
Study Start Date : July 2009
Estimated Primary Completion Date : December 2010
Estimated Study Completion Date : December 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pregnancy

Groups and Cohorts
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Group/Cohort
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.


Outcome Measures
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Primary Outcome Measures :
  1. nuchal cord entanglement [ Time Frame: at birth ]

Secondary Outcome Measures :
  1. SGA [ Time Frame: at birth ]
  2. Admission to intensive care unit [ Time Frame: at birth ]
  3. meconium [ Time Frame: at birth ]
  4. fetal distress [ Time Frame: at birth ]
  5. low APGAR score [ Time Frame: 1 minute, 5 minutes after birth ]
  6. need for c section [ Time Frame: at birth ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00909376


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

Locations
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Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Contact    972-2-6666666      
Sponsors and Collaborators
Shaare Zedek Medical Center
Investigators
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Principal Investigator: Ori Shen, MD Shaare Zedek Medical Center
More Information
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Responsible Party: Dr. Ori Shen, Shaare Zedek Medical Center
ClinicalTrials.gov Identifier: NCT00909376    
Other Study ID Numbers: 1-Ledmore
First Posted: May 28, 2009    Key Record Dates
Last Update Posted: May 28, 2009
Last Verified: May 2009
Keywords provided by Shaare Zedek Medical Center:
Pregnancy
Ultrasonography
outcome
adverse