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NCT Number: NCT02408783

Simplified Gestational Age Score

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Daga Memorial, Nagpur, India

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Validation of score tool

    Time frame: All gestational age assessments will be taken within 24 hours of birth

    Validity of Simplified Gestational Age Score (SGAS) when used by the ANMs and verified using the GA assessed using LMP and Sonologic GA.

Secondary outcomes

  1. Variability of observer use of score tool

    Time frame: All gestational age assessments will be taken within 24 hours of birth

    The inter observer variability in the GA assessed by the ANM and the RO

Sponsors and collaborators

Lead sponsor

NICHD Global Network for Women's and Children's Health

Network

Collaborators

  • Lata Medical Research Foundation, Nagpur
  • Massachusetts General Hospital

Registry information

Official study title

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

Acronym: SGAS

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 3, 2015
Registry last updated
Nov 29, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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