Simplified Gestational Age Score

Completed

• Conditions: Gestational Age and Weight Conditions

• Registration Number: NCT02408783
• Lead Sponsor: NICHD Global Network for Women's and Children's Health

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-03-31
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-03
• Study Start: 2015-07
• Primary Completion: 2016-03
• Study Completion: 2016-03
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-28
• Last Update Posted: 2016-11-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15920

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Validation of score tool	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 Outcome Measures

Name	Time	Method
Variability of observer use of score tool	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

Trial Locations

Locations (3)

Daga Memorial; 🇮🇳 Nagpur, India

GH Bhandara; 🇮🇳 Nagpur, India

GH Wardha; 🇮🇳 Nagpur, India