Clinical trial NCT02408783: Simplified Gestational Age Score
Official title: Validation of a New Simplified Score for Assessing Gestational Age of Newborns in Community
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gestational Age and Weight Conditions
Lead sponsor: NICHD Global Network for Women's and Children's Health
Sponsor class: NETWORK
Collaborators: name: Massachusetts General Hospital
name: Lata Medical Research Foundation, Nagpur
First posted: 2015-04-03
Enrollment: 15920
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
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.

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: Validation of score tool
timeFrame: All gestational age assessments will be taken within 24 hours of birth
Secondary outcomes:
measure: Variability of observer use of score tool
timeFrame: All gestational age assessments will be taken within 24 hours of birth
Other outcomes:
Locations:
city: Nagpur
country: India
facility: Daga Memorial
city: Nagpur
country: India
facility: GH Bhandara
city: Nagpur
country: India
facility: GH Wardha
Study officials:
affiliation: Lata Medical Research Foundation
name: Archana Patel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: International Institute for Population Sciences (IIPS) and ORC Macro (2006). National Family Health Survey (NFHS-3), 2005-06: India. Mumbai: IIPS.
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.
citation: 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.
citation: 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.
citation: 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.
citation: Williams obstetrics. Ed. 22nd Ch. 8. Naegele rule Page 208.
citation: 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.
citation: 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.