Status:
COMPLETED
Development of Standards for the New Ballard Maturation Score
Lead Sponsor:
NICHD Neonatal Research Network
Collaborating Sponsors:
National Center for Research Resources (NCRR)
Conditions:
Infant, Newborn
Infant, Low Birth Weight
Eligibility:
All Genders
Up to 48 years
Brief Summary
The primary purpose of this study was to evaluate the accuracy of gestational age (GA) estimates by using the New Ballard Score (NBS) in newborns 24 to 27 weeks GA with accurate obstetric estimates of...
Detailed Description
The Ballard maturational assessment is commonly used to estimate gestational age (GA) when the menstrual history and other obstetrical estimates of GA are uncertain. The original Ballard Score and the...
Eligibility Criteria
Inclusion
- \<28 weeks gestational age by best obstetrical estimate
- Availability of mother's prenatal records for review
- First prenatal visit occurred before 17 weeks' gestation
- Mother's menstrual history allowed calculation of GA at birth
- Mother reported the duration of her usual menstrual cycles as 21 to 35 days
- Mother had 3 consecutive normal menstrual cycles before the missed menstrual period identifying the index pregnancy
- Mother reported that she was certain within 4 days of the first day of the last menstrual period (as recorded at the time of the first prenatal visit)
- Mother denied use of birth control medication during the 3 months preceding the last menstrual period.
Exclusion
- Inaccurate or unavailable menstrual histories
Key Trial Info
Start Date :
June 1 1994
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
March 1 1996
Estimated Enrollment :
1090 Patients enrolled
Trial Details
Trial ID
NCT01203449
Start Date
June 1 1994
End Date
March 1 1996
Last Update
June 8 2015
Active Locations (11)
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1
Stanford University
Palo Alto, California, United States, 94304
2
Yale University
New Haven, Connecticut, United States, 06504
3
George Washington University
Washington D.C., District of Columbia, United States, 20052
4
Emory University
Atlanta, Georgia, United States, 30303