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CTRI Number  CTRI/2018/05/013645 [Registered on: 03/05/2018] Trial Registered Prospectively
Last Modified On: 02/05/2018
Post Graduate Thesis  Yes 
Type of Trial  Observational 
Type of Study   Cross Sectional Study 
Study Design  Other 
Public Title of Study   Physical activity in pregnancy. 
Scientific Title of Study   Physical activity and pregnancy outcome: A hospital-based cross- sectional observational study. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Aravind Minache 
Designation  MBBS DGO, Secondary DNB Post Graduate 
Affiliation  Dr TMA Pai hospital Udupi, Karnataka. 
Address  Dept of OBGY Dr TMA Pai hospital Opposite old taluka office Udupi. Pin Code-576101 Karnataka
Dept of OBGY Dr TMA Pai hospital Opposite old taluka office Udupi. Pin Code-576101 Karnataka
Udupi
KARNATAKA
576101
India 
Phone  9604625150  
Fax    
Email  aravindminache60@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Shashikal Bhat 
Designation  MBBS MS 
Affiliation  Dr TMA Pai hospital Udupi, Karnataka. 
Address  Dept of OBGY Dr TMA Pai hospital Opposite old taluka office Udupi. Pin Code-576101 Karnataka
Dr TMA Pai hospital Opposite old taluka office Udupi. Pin Code-576101 Karnataka
Udupi
KARNATAKA
576101
India 
Phone  9611362119  
Fax    
Email  shashidixith@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Aravind Minache 
Designation  MBBS DGO, Secondary DNB Post Graduate 
Affiliation  Dr TMA Pai hospital Udupi, Karnataka. 
Address  Dept of OBGY Dr TMA Pai hospital Opposite old taluka office Udupi. Pin Code-576101 Karnataka
Dept of OBGY Dr TMA Pai hospital Opposite old taluka office Udupi. Pin Code-576101 Karnataka
Udupi
KARNATAKA
576101
India 
Phone  9604625150  
Fax    
Email  aravindminache60@gmail.com  
 
Source of Monetary or Material Support  
Dr TMA Pai hospital udupi. And Kasturba medical collage and hospital 
 
Primary Sponsor  
Name  Dr Aravind Minache 
Address  Dr TMA Pai hospital, opposite old taluka office Udupi, 576101 karnataka 
Type of Sponsor  Other [Principle investigator is only sponsorer, no other funding source is there] 
 
Details of Secondary Sponsor  
Name  Address 
Dr Shashikal Bhat  Dr TMA Pai hospital, opposite old taluka office Udupi, 576101 karnataka 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Aravind Minache  2nd floor general and special wards,Dept of OBGY,  Dr TMA Pai hospital Opposite old taluka office Udupi PIN- 576101 Karnataka
Udupi
KARNATAKA 
9604625150

aravindminache60@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Kasturba medical collage and Kasturba hospital , Institutional ethics committe Manipal,Karnataka   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Post-natal women.,  
 
Intervention / Comparator Agent  
Type  Name  Details 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  35.00 Year(s)
Gender  Female 
Details  All post-natal women who had
1) Singleton pregnancy
2) Longitudinal lie
3) Excellent dates
 
 
ExclusionCriteria 
Details  Post-natal women who had
1) Incompetent cervix
2) Multiple Gestation
3) Heart disease with pregnancy
4) Placenta previa after 26 weeks of gestation
5) Severe anemia
6) Known hypertensive or diabetic before pregnancy
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Normal vaginal delivary
2)cessarian delivary
3)Gestational diabetis mellitus
4)Gestational hypertension 
At the end of december 2018 
 
Secondary Outcome  
Outcome  TimePoints 
1)Pre-term delivary
2)Intra uterine growth retardation 
At the end of december 2018 
 
Target Sample Size   Total Sample Size="393"
Sample Size from India="393" 
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)   07/05/2018 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Not Applicable 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  

  PURPOSE OF THE STUDY-

           Pregnancy is a physiological condition involving specific regulation of body weight. Maternal obesity and gestational weight gain that has become more common nowadays lead to the poor obstetric outcome. Evidence from scientific studies shows the important role of physical activity in health promotion by improving quality of life and prevention and control of various diseases.                                                                                               Regular moderate physical activity may improve risk profiles in pregnant women. A few decades ago, pregnant women were advised to reduce their physical activities and even interrupt their occupational work especially in last trimester of pregnancy. However, since 1990, experts have admitted the positive effect of regular physical activity during pregnancy and encourage it, unless it is contraindicated.                                               Maintaining light to moderate physical activity during an uncomplicated pregnancy provides various benefits for women‘s health like a decrease in gestational diabetes mellitus, decrease in weight gain, less fluid retention, decrease in the incidence of gestational hypertension and cardio-vascular stress and thrombosis. It also increases the chance of onset of spontaneous labor and normal vaginal delivery and reduces the rate of Cesarean delivery. Also, physical activity helps to make women self-confident and reduce the risk of post-partum depression.                                 

However, some studies show that strenuous physical activity during pregnancy is associated with increased risk of abortions and premature delivery.                                                                                                                                                                                                                                      Considering the persistent controversies on the above topic, the current study aims to find the association between physical activity during pregnancy and occurrence of adverse maternal and child health outcome.                                                                                       

AIM: To study the effect of physical activity on adverse pregnancy outcomes.

OBJECTIVES- To study the profile of physical activity in pregnancy.

To compare the risk of adverse pregnancy outcomes in the sedentary group and physically active group.

SAMPLE SIZE-

1.     We estimated the sample size anticipating 92% confidence interval 3% error margin accounting for 20% attrition and dropouts. 

 

Sample size (n)=Z(1-alpha/2)2 pq/d2

 

P= anticipated proportion=8%( Vigorously active pregnant women.)

q=1-p

d=3% , precision

Z(1-alpha/2)= 1.96

Alpha=5%, level of significance

 

So the sample size is  393.

METHODS:

   All women who deliver in Dr. T.M.A Pai hospital Udupi and fulfill the inclusion criteria will be included in the study.                                                   

   Physical activity questionnaire prepared according to activities of Indian women in this region by an expert group. A questionnaire including household activities, workplace activities and exercise during pregnancy in a 1 st, 2nd and 3rd trimester.                                                                    The intensity of physical activity will be calculated by WHO MET scores scale. Based on the MET scores, women will be divided into the sedentary, moderately active and h highly active group.                                                                             

 The profile of physical activity in pregnancy and its effect on pregnancy(GDM, Hypertension, Preterm birth, IUGR)in different groups and mode of delivery (LSCS/NVD/INDUCED NVD/ SPONTANEOUS NVD/INSTRUMENTAL ) will be studied.



 
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