- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02408783
Simplified Gestational Age Score (SGAS)
November 28, 2016 updated by: NICHD Global Network for Women's and Children's Health
Validation of a New Simplified Score for Assessing Gestational Age of Newborns in Community
A large number of mothers are uncertain of the date of their last menstrual period and where there is a high incidence of small-for-dates babies, there is a real need for a method of estimating gestational age that is both rapid and accurate for early referral and management of preterm newborns to reduce their mortality and morbidity.
The National Family Health Survey 2005-06 reports that the proportion of low birth weight babies (LBW) in India is 22%.
Of these LBW babies, the proportion of prematurity is not known in the survey as it is difficult to measure gestational age of the newborn due to lack of reliable and valid scores with ease of use at the primary health centers.
Different scores to assess maturity have been developed namely New Ballard score, Dubowitz score and Meharban Singh score.
It is not known whether these scores have regional, geographical, racial or ethnic robustness.
It has also been found that these scores tend to overestimate newborns > 37 weeks and underestimate those >32 and < 37 weeks.
The investigators conducted a cross sectional study to validate three neonatal gestational age (GA) assessment scores namely New Ballard, Dubowitz and Meharban Singh with the reference standard i.e.
GA assessed by LMP using Naegeles rule and validated by gestational ages also assessed by at least one ultrasound (GA-LMP), in Indian newborns delivered at a tertiary hospital.
The investigators derived a new "Simplified Gestational Age Score" (SGAS) using the best applicable items from the three validated scores and assessed its accuracy with the reference standard (GA-LMP).
This score has only 4 items (posture, skin texture, breast and genital assessment) and community health workers can be trained in implementing SGAS due to its simplicity.
The investigators propose a study in the GN sites to validate this simplified method of assessment of the GA using our SGAS protocol.
Study Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
15920
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Nagpur, India
- Daga Memorial
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Nagpur, India
- GH Bhandara
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Nagpur, India
- GH Wardha
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Sampling Method
Non-Probability Sample
Study Population
The Global Network Nagpur, India site will select 5 distinct Health Facilities with an average of more than 300 deliveries per year.
All women who deliver in the study Health Facilities will be eligible for study enrolment after fulfilling the inclusion criteria.
Description
Inclusion Criteria:
- Hospital Delivery
- Live Birth
- Correct LMP Known
- At least one USG of Ante-natal Period Reporting GA Available
- GA by LMP and USG within one week of each other
- Available for Examination up to 24 Hours of Birth
- Informed Consent Given
Exclusion Criteria:
- Menstrual Cycle Irregular
- Twin Babies
- Birth Asphyxia/ baby required Bag and Mask ventilation
- Major Congenital Anomaly
- Signs of neurological depression
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Validation of score tool
Time Frame: All gestational age assessments will be taken within 24 hours of birth
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Validity of Simplified Gestational Age Score (SGAS) when used by the ANMs and verified using the GA assessed using LMP and Sonologic GA.
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All gestational age assessments will be taken within 24 hours of birth
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Variability of observer use of score tool
Time Frame: All gestational age assessments will be taken within 24 hours of birth
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The inter observer variability in the GA assessed by the ANM and the RO
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All gestational age assessments will be taken within 24 hours of birth
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Archana Patel, MD, Lata Medical Research Foundation
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- International Institute for Population Sciences (IIPS) and ORC Macro (2006). National Family Health Survey (NFHS-3), 2005-06: India. Mumbai: IIPS.
- Barbara JS, Ira AC. The high risk infant. Cha. 97.2 Premature and intrauterine growth retardation. Nelson's Textbook of Pediatrics 18th ed. 1:701-2.
- Ballard JL, Khoury JC, Wedig K, Wang L, Eilers-Walsman BL, Lipp R. New Ballard Score, expanded to include extremely premature infants. J Pediatr. 1991 Sep;119(3):417-23. doi: 10.1016/s0022-3476(05)82056-6.
- Dubowitz LM, Dubowitz V, Goldberg C. Clinical assessment of gestational age in the newborn infant. J Pediatr. 1970 Jul;77(1):1-10. doi: 10.1016/s0022-3476(70)80038-5. No abstract available.
- Singh M, Razdan K, Ghai OP. Modified scoring system for clinical assessment of gestational age in the newborn. Indian Pediatr. 1975 Apr;12(4):311-6. No abstract available.
- Williams obstetrics. Ed. 22nd Ch. 8. Naegele rule Page 208.
- Patel AB, Kulkarni H, Kurhe K, Prakash A, Bhargav S, Parepalli S, Fogleman EV, Moore JL, Wallace DD, Hibberd PL. Early identification of preterm neonates at birth with a Tablet App for the Simplified Gestational Age Score (T-SGAS) when ultrasound gestational age dating is unavailable: A validation study. PLoS One. 2020 Aug 31;15(8):e0238315. doi: 10.1371/journal.pone.0238315. eCollection 2020.
- Patel AB, Kurhe K, Prakash A, Bhargav S, Parepalli S, Fogleman EV, Moore JL, Wallace DD, Kulkarni H, Hibberd PL. Early Identification of Preterm Neonates at Birth With a Tablet App for the Simplified Gestational Age Score (T-SGAS) When Ultrasound Gestational Age Dating Is Unavailable: Protocol for a Validation Study. JMIR Res Protoc. 2019 Mar 12;8(3):e11913. doi: 10.2196/11913.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2015
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
March 31, 2015
First Submitted That Met QC Criteria
April 2, 2015
First Posted (Estimate)
April 3, 2015
Study Record Updates
Last Update Posted (Estimate)
November 29, 2016
Last Update Submitted That Met QC Criteria
November 28, 2016
Last Verified
November 1, 2016
More Information
Terms related to this study
Other Study ID Numbers
- CP SGA
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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