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CTRI Number  CTRI/2024/06/069670 [Registered on: 28/06/2024] Trial Registered Prospectively
Last Modified On: 28/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   A Study on pregnancy outcomes in Overweight and Obese Women and Their Newborn babies visiting Dr. Prabhakar Kore Hospital in Belagavi, Karnataka 
Scientific Title of Study   Maternal and Perinatal Outcomes in Overweight and Obese Pregnant Women- a cross sectional study in KAHERs Dr Prabhakar Kore Hospital, Belagavi, Karnataka 
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 Mulakala Sandhya Rani 
Designation  MS Post graduate 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Obstetrics and Gynecology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  8074560588  
Fax    
Email  sandhyamulakala1999@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr M C Metgud 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Obstetrics and Gynecology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9164693333  
Fax    
Email  metm@rediffmail.com  
 
Details of Contact Person
Public Query  
Name  Dr M C Metgud 
Designation  Professor 
Affiliation  Jawaharlal Nehru Medical College 
Address  Department of Obstetrics and Gynecology, Jawaharlal Nehru Medical College, Nehru Nagar, Belagavi

Belgaum
KARNATAKA
590010
India 
Phone  9164693333  
Fax    
Email  metm@rediffmail.com  
 
Source of Monetary or Material Support  
KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre, Nehru Nagar, Belagavi, Karnataka- 590010 Ph no 0831-2473777 
 
Primary Sponsor  
Name  Dr. Mulakala Sandhya Rani 
Address  Department of Obstetrics and Gynecology, KAHERs Jawaharlal Nehru Medical College, Nehru nagar, Belagavi 590010 
Type of Sponsor  Other [Self] 
 
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 Mulakala Sandhya Rani  KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre  Department of Obstetrics and Gynecology, KAHERs Dr. Prabhakar Kore Hospital and Medical Research Centre
Belgaum
KARNATAKA 		 8074560588

sandhyamulakala1999@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
JNMC Institutional Ethics Committee  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 
Intervention  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  45.00 Year(s)
Gender  Female 
Details  Singleton Pregnancies attending labour room of KAHERs Dr Prabhakar Kore Hospital, Belagavi, Karnataka having BMI of greater than 23.0
Greater than 28 weeks of gestation. 
 
ExclusionCriteria 
Details  Multifetal pregnancies
BMI lesser than or equal to 23
Pregnancies lesser than or equal to 28 weeks of gestation 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To assess the maternal outcomes in overweight and obese women based on
-First trimester BMI
-The difference in first trimester and third trimester BMI 		 During pregnancy, at delivery and postpartum. 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the perinatal outcomes in overweight & obese women based on
-First trimester BMI
-The difference in first trimester & third trimester BMI 		 During Intrauterine period, labour & soon after delivery up to 7 days 
 
Target Sample Size   Total Sample Size="267"
Sample Size from India="267" 
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)   11/07/2024 
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)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

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

Response - YES
  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 - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  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 [sandhyamulakala1999@gmail.com].

  6. For how long will this data be available start date provided 01-05-2025 and end date provided 01-05-2035?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   This study aims to interpret the maternal and perinatal outcomes in obese and overweight pregnant woman over a year-long cross sectional study. Through comprehensive analysis of maternal and perinatal outcomes, the study seeks to address the need for meticulous management of such pregnancies and also the need to prevent such complications. This observational cross sectional study conducted at KAHER’s Dr. Prabhakar Kore Hospital and MRC, Belagavi, will involve antenatal cases with BMI greater than 23 bearing single ton pregnancy and with period of gestation more than 28 weeks. This cross-sectional study at KAHERs Dr. Prabhakar Kore Hospital, Belagavi, Karnataka, will compare maternal and perinatal outcomes between two groups of pregnant women based on BMI categories: Group A (BMI 23-27.5 kg/m²) and Group B (BMI >27.5 kg/m²). Detailed records including maternal weight, BMI, gestational details, delivery outcomes, and neonatal health will be collected and analyzed over a one-year period with a minimum sample size of 267 participants. 
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