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CTRI Number  CTRI/2024/03/063662 [Registered on: 06/03/2024] Trial Registered Prospectively
Last Modified On: 22/04/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Case Control Study 
Study Design  Other 
Public Title of Study   To study the impact of obesity on maternal and fetal outcomes. 
Scientific Title of Study   “Prospective Observational Comparative Single Centre Study To Evaluate The Impact Of Maternal Obesity On Maternal And Fetal Outcomes” 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  DR Madiha Memon 
Designation  Dnb Obgy Resident 
Affiliation  Bhakti Vedanta hospital and Research Institute 
Address  Floor no 4, Maternity Ward , Bhakti Vedanta hospital and Research Institute, Bhakti Vedanta Swami Marg, Mira Road east, Thane.

Mumbai
MAHARASHTRA
401107
India 
Phone  7021448497  
Fax    
Email  madihamemon96@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yogini Patil 
Designation  HOD - OBGY Dept 
Affiliation  BhaktiVedanta Hospital and Research Institute 
Address  OPD No 3, Ground Floor , BhaktiVedanta Hospital and Research Institute, Srishti complex, Bhakti Vedanta swami Marg, Mira Road East , Thane,401107

Mumbai
MAHARASHTRA
401107
India 
Phone  9322498480  
Fax    
Email  dryoginippatil@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr Madiha Memon 
Designation  Dnb Obgy Resident 
Affiliation  BhaktiVedanta Hospital and Research Institute 
Address  Floor no 4, Maternity ward, B wing , BhaktiVedanta Hospital and Research Institute, Bhaktivedanta Swami Marg, Mira Road (East), Thane- 401107

Mumbai
MAHARASHTRA
401107
India 
Phone  7021448497  
Fax    
Email  madihamemon96@gmail.com  
 
Source of Monetary or Material Support  
Bhakti Vedanta hospital and research institute, Srishti complex, Bhakti Vedanta swami Marg, Mira road, thane- 401107 
 
Primary Sponsor  
Name  BhaktiVedanta Hospital and Research Institute  
Address  Maternity ward , 4th floor , B wing Srishti Complex, Bhakti Vedanta Swami Marg, Mira Road East , Thane-401107 
Type of Sponsor  Research institution and hospital 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Madiha Memon  Bhakti Vedanta Hospital & Research Institute  B Wing, Maternity Ward, 4th Floor, Srishti Complex, Bhakti Vedanta Swami Marg, Mira Road East, Thane-401107.
Mumbai
MAHARASHTRA 		 7021448497

madihamemon96@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
BhaktiVedanta Hospital Ethics Committee for Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: O94||Sequelae of complication of pregnancy, childbirth, and the puerperium,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  nil  nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Pregnant females age 18 years to 45 years who are registered and delivered at bhakti Vedanta hospital. 
 
ExclusionCriteria 
Details  Patients with diagnosed diabetes mellitus before conception, preexisting heart disease, renal disease, liver disease, respiratory disease, bronchial asthma, uncontrolled hypothyroidism ,on steroid pharmacotherapy 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Obese females are more prone for high-risk pregnancies compared to non-obese patients.

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

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

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

Obese patients are more prone for postpartum complications such as postpartum hemorrhage, vaginal wall tears, episiotomy extension, difficult deliveries.  		 at the time of first antenatal visit , at 24 to 28 weeks, at the time of delivery 
 
Secondary Outcome  
Outcome  TimePoints 
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.  		 at the time of delivery and postpartum upto discharge 
 
Target Sample Size   Total Sample Size="108"
Sample Size from India="108" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   10/03/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Yet Recruiting 
Recruitment Status of Trial (India)  Open to Recruitment 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

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

  1. 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. 

  1. Study Duration: 1 Year 

  1. 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. 

  1. 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. 

     

    1. Fetal parameters- birth weight and APGAR 

     

     

    1. 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. 

     

    1. 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   

     

    1. OUTCOME- 

    1. Primary outcome measures- 

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

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

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

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

    1. 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. 

     

    1. Eligibility Criteria: 

    1. Inclusion criteria- 

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

    1. Exclusion criteria- 

    1. Patients were diagnosed with diabetes mellitus before conception. 

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

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

    1. Patients on steroid pharmacotherapy. 

 

 
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