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

• ClinicalTrials.gov Identifier: NCT00909376
• Recruitment Status: Unknown
• First Posted: May 28, 2009
• Last Update Posted: May 28, 2009
• Sponsor: Shaare Zedek Medical Center
• Information provided by: Shaare Zedek Medical Center

Tracking Information

• First Submitted Date: April 2, 2009
• First Posted Date: May 28, 2009
• Last Update Posted Date: May 28, 2009
• Study Start Date: July 2009
• Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: May 27, 2009): nuchal cord entanglement [ Time Frame: at birth ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: May 27, 2009)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?
• Official Title: Is Early Second Trimester Vaginal Ultrasound Scan Associated With Adverse Perinatal Outcomes?

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 Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: pregnant women with one fetus who has no malformations.
• Condition: Pregnancy
• Intervention: Not Provided

Study 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.

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: May 27, 2009): 450
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: December 2010
• Estimated Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Israel

Administrative Information

• NCT Number: NCT00909376
• Other Study ID Numbers: 1-Ledmore
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Dr. Ori Shen, Shaare Zedek Medical Center
• Original Responsible Party: Same as current
• Current Study Sponsor: Shaare Zedek Medical Center
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Ori Shen, MD; Shaare Zedek Medical Center

• PRS Account: Shaare Zedek Medical Center
• Verification Date: May 2009