1. What data in particular will be shared?
   Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Anyone
   


4. For what types of analyses will this data be available?
   Response - To achieve aims in the approved proposal.
   


5. By what mechanism will data be made available?
   Response - Proposals should be directed to [nandhinikjawahar@gmail.com].
   


6. For how long will this data be available start date provided 01-06-2027 and end date provided 01-01-2045?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - NIL

 Large for gestational age (LGA) is defined as birth weight more than 90^th percentile for the gestational age. It is a growing concern due to increased incidence of changing lifestyle, maternal diabetes and maternal obesity. Large for gestational age not only has an impact on the mother and the baby during the peripartum period, but it also has a long-term impact on the future health of the child. Studies show that factors like increased birth weight, maternal obesity and maternal GDM are risk factors for childhood obesity and metabolic syndrome.

 Large for gestational age newborns of diabetic women are more likely to have birth injuries, shoulder dystocia and fracture of long bones as compared to those born to non-diabetic women. Proportion of diabetic women who underwent LSCS are more likely to be higher than their non-diabetic counterparts. With maternal diabetes and obesity being the most important risk factors there are various other risk factors like gestational weight gain, gestational age, parity, sex of the baby, previous history of giving birth to large babies and type of conception.

Large for gestational age is likely to be associated with more operative interventions, maternal and neonatal complications. It is important to identify the associated risk factors. Since most of the risk factors are modifiable, preventive strategies can be enforced to reduce the maternal and neonatal complications.

There is a paucity of studies comparing the outcomes of Large for gestational age among non-diabetic and diabetic women in India and other parts of Asia. Through this study, we will be able to gauge the burden of Large for gestational age and its impact on maternal and neonatal health. 

This study will be conducted in the Women and Children Hospital, JIPMER. Data of all the Large for gestational age babies born during the study period will be obtained from the confinement register in the labor room of Obstetrics and Gynecology department in JIPMER. Birth weight of the babies will be plotted in Fenton’s growth chart and classified accordingly as AGA (appropriate for gestational age), SGA (small for gestational age) or LGA (large for gestational age). All the Large for gestational babies will be considered in the study. Informed consent will be obtained from the mothers once they are comfortable after getting shifted to the respective ward. 

Proforma will be filled, which will contain two sections. The first section will have details regarding the demographic details of the study participant, socioeconomic status, LMP, obstetric history, menstrual history, previous history of large babies, comorbidities, pre-pregnancy BMI, gestational weight gain, dating scan, scan done 1 week before delivery, mode of delivery. The second section will contain examination findings to assess the presence of maternal complications post-delivery. Details regarding the health status of the newborns will be obtained from the baby case sheet from Neonatology department. Once appropriate data are obtained in a predesigned structured proforma, statistical analysis will be done to find out the proportions of different outcomes in the two groups-non-diabetic and diabetic women.  The risk factors of Large for gestational age will be analyzed between the two groups to find out the presence of any significant association.

The categorical variables such as sex of the baby, parity, previous history of macrosomia, presence of GDM, mode of delivery, large for gestational age; Maternal complications -Postpartum hemorrhage, obstructed labor, perineal tear, chorioamnionitis, wound infection; Neonatal complications-shoulder dystocia, fractures of the clavicle, brachial plexus injury, hypoglycemia, hypoglycemia, respiratory problems, polycythemia, meconium aspiration, and increased rates of admission and prolonged admission (more than 3 days) to a neonatal intensive care unit, Maternal comorbidities, socioeconomic status, etc. will be expressed as frequency and percentage.

The continuous variables such age, amniotic fluid index, gestational age at delivery, APGAR score, etc. will be expressed as mean with SD or median with IQR according to the distribution of data.

The association of categorical variables mentioned above with the diabetic and non-diabetic mothers of Large for gestational age neonates will be assessed using Chi-square test/ Fishers’ Exact test.

The comparison of continuous variables mentioned above between the diabetic and non-diabetic mothers of Large for gestational age neonates will be analyzed by independent students’ t-test/ Mann Whitney U test.

All the statistical analysis will be carried out at 5% level of significance and p-value<0.05 will be considered statistically significant.