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
|
|
Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
Post-natal women., |
|
Intervention / Comparator Agent
|
|
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 hospitalUdupi 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 1st, 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 hhighly 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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