Gestational Age and Weight ConditionsSGASNCT02408783
Simplified Gestational Age Score
An observational study of Gestational Age and Weight Conditions, run by NICHD Global Network for Women's and Children's Health at 3 sites in India.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Gestational Age and Weight Conditions
- How many people
- 15,920 participants
- Where
- 3 sitesIndia
- Study dates
- Jul 2015to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Menstrual Cycle Irregular
- Twin Babies
- Birth Asphyxia/ baby required Bag and Mask ventilation
- Major Congenital Anomaly
- Signs of neurological depression
Trial locations and contacts
3 sites in 1 country.
About this study
Official title: 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.
- Conditions
- Gestational Age and Weight Conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: All gestational age assessments will be taken within 24 hours of birth
Secondary outcomes (1)
Variability of observer use of score tool
The inter observer variability in the GA assessed by the ANM and the RO
Measured: All gestational age assessments will be taken within 24 hours of birth
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2015 (estimated)
- Study startJul 2015
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Gestational Age and Weight ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 15,920 participants (actual)
Sponsor and investigators
- Lead sponsor
- NICHD Global Network for Women's and Children's Health
- Sponsor type
- Research network
- Collaborators
- Massachusetts General Hospital, Lata Medical Research Foundation, Nagpur
- Responsible party
- Sponsor
- Investigators
- Archana Patel, MD, Principal investigator, Lata Medical Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02408783
- Sponsor's protocol ID
- CP SGA
- Acronym
- SGAS
- Status last verified
- Nov 2016
- First submitted
- 31 Mar 2015
- Last updated
- 29 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 1880657Dubowitz 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.
PubMed 5430794Singh 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.
PubMed 1158500Williams 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.
PubMed 32866202Patel 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.
PubMed 30860484
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a New Simplified Score for Assessing Gestational Age of Newborns in Community
- ClinicalTrials.gov ID
- NCT02408783
- Acronym / sponsor ID
- SGAS / CP SGA
- Conditions
- Gestational Age and Weight Conditions
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15,920 participants (actual)
- Lead sponsor
- NICHD Global Network for Women's and Children's HealthResearch network
- Collaborators
- Massachusetts General Hospital, Lata Medical Research Foundation, Nagpur
- Study start
- Jul 2015
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 3 Apr 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (5 listed)
- Menstrual Cycle Irregular
- Twin Babies
- Birth Asphyxia/ baby required Bag and Mask ventilation
- Major Congenital Anomaly
- Signs of neurological depression
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Variability of observer use of score tool
Time frame: All gestational age assessments will be taken within 24 hours of birth
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2016.
- BackgroundInternational Institute for Population Sciences (IIPS) and ORC Macro (2006). National Family Health Survey (NFHS-3), 2005-06: India. Mumbai: IIPS.
- BackgroundBarbara 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.
- Background: PubMed 1880657Ballard 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.
- Background: PubMed 5430794Dubowitz 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.
- Background: PubMed 1158500Singh 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.
- BackgroundWilliams obstetrics. Ed. 22nd Ch. 8. Naegele rule Page 208.
- Derived from this study: PubMed 32866202Patel 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.
- Derived from this study: PubMed 30860484Patel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Archana Patel, MD principal investigator
Lata Medical Research Foundation
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Age and Weight Conditions, run by NICHD Global Network for Women's and Children's Health at 3 sites in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Validation of score tool (time frame: All gestational age assessments will be taken within 24 hours of birth). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02408783, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2016.