Simplified Gestational Age Score

Gestational Age and Weight Conditions Clinical Trial

— SGAS  

Official title:

Validation of a New Simplified Score for Assessing Gestational Age of Newborns in Community

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02408783
• Other study ID #: CP SGA
• Status: Completed
• Phase: N/A
• First received: March 31, 2015
• Last updated: November 28, 2016
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: November 2016
• Source: NICHD Global Network for Women's and Children's Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15920
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Gestational Age and Weight Conditions

Locations

Country	Name	City	State
India	Daga Memorial	Nagpur
India	GH Bhandara	Nagpur
India	GH Wardha	Nagpur

Sponsors (3)

Lead Sponsor	Collaborator
NICHD Global Network for Women's and Children's Health	Lata Medical Research Foundation, Nagpur, Massachusetts General Hospital

Country where clinical trial is conducted

India, 

References & Publications (6)

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. — View Citation

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.

Dubowitz LM, Dubowitz V, Goldberg C. Clinical assessment of gestational age in the newborn infant. J Pediatr. 1970 Jul;77(1):1-10. — View Citation

International Institute for Population Sciences (IIPS) and ORC Macro (2006). National Family Health Survey (NFHS-3), 2005-06: India. Mumbai: IIPS.

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. — View Citation

Williams obstetrics. Ed. 22nd Ch. 8. Naegele rule Page 208.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Validation of score tool	Validity of Simplified Gestational Age Score (SGAS) when used by the ANMs and verified using the GA assessed using LMP and Sonologic GA.	All gestational age assessments will be taken within 24 hours of birth	No
Secondary	Variability of observer use of score tool	The inter observer variability in the GA assessed by the ANM and the RO	All gestational age assessments will be taken within 24 hours of birth	No