“Prospective Observational Comparative Single Centre Study To Evaluate The Impact Of Maternal Obesity On Maternal And Fetal Outcomes”

1. Study design: Study is Single Center Prospective Observational Comparative Study.

2. Study site: The study will be conducted in the outpatient and inpatient departments of gynecology and obstetrics in Bhakti Vedanta hospital, Mira Road east, Thane.

3. Study Duration: 1 Year

4. Study population- The study will be conducted among pregnant females who visited the outpatient department (OPD) or admitted to the inpatient department (IPD) of obstetrics and gynecology department in Bhakti Vedanta hospital, Mira Road east, Thane. The study participants will be recruited based on the inclusion criteria for cases and otherwise non obese pregnant females for controls.

5. Methods: At the first antenatal visit, BMI will be calculated and after taking consent patient will be assigned into group 1 (if the BMI is less than 25) and group 2  (if the BMI is more than 25.)

• The following data will be collected during antenatal, intrapartum and postpartum period.

1-Antenatal- history taking and clinical examination, blood investigation, and ultrasonography.

  

2-Intrapartum-

1. Maternal data- such as fetal presentation, induction of labor, mode of delivery, any intrapartum complication, postpartum – immediate and delayed complication, length of hospital stay.

 

2. Fetal parameters- birth weight and APGAR

  

6. Statistical outcome- Data analysis will be done using the SPSS (Statistical package for the social science) version 23 for window. The demographic variables were calculated with no and percentage. The analysis will be done by using appropriate test of significance like chi square test. Z test, correlation, ANOVA test, etc. a probability value was accepted as the level of statistical significance.

 

7. Sample size calculation for prevalence study

GDM in obese = P1 = 35%

GDM in non-obese = P2 = 10%

Confidence level = 95%

Absolute precision = E = 15%

N= Z2V/ E2 where V= p1q1 + p2q2

= 35x65 + 10x90 = 3175

N= (1.96)2 x 3175/ (15)2

N= 54 cases in each group

Total sample size = 108

 

8. OUTCOME-

9. Primary outcome measures-

10. Obese females are more prone for high-risk pregnancies compared to non-obese patients.

11. Increased risk of antenatal complications such as Antepartum hemorrhage, preeclampsia, gestational diabetes mellitus

12. Obese patients are more prone for operative interference such as instrumental deliveries and caesarean sections.

13. Increased rates of Perinatal complications such as shoulder dystocia, birth asphyxia, admission of neonate in intensive care units.

14. Obese patients are more prone for postpartum complications such as postpartum hemorrhage, vaginal wall tears, episiotomy extension, difficult deliveries.

b) Secondary outcome measures-

1. To compare between increased risk of infections in obese and non-obese Postnatal mothers

2. To compare the increased length of hospital, stay between obese and non-obese postnatal mothers.

 

9. Eligibility Criteria:

10. Inclusion criteria-

11. Pregnant females who are registered and delivered at bhakti Vedanta hospital.

12. Exclusion criteria-

13. Patients were diagnosed with diabetes mellitus before conception.

14. Patients having any preexisting heart disease, renal disease, liver disease, respiratory disease, bronchial asthma.

15. Patients having uncontrolled hypothyroidism (serum TSH levels > 5 Miu/L)

16. Patients on steroid pharmacotherapy.