| CTRI Number |
CTRI/2021/06/034093 [Registered on: 08/06/2021] Trial Registered Prospectively |
| Last Modified On: |
17/04/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Effect of mothers physical activity during pregnancy on fetal growth parameters |
|
Scientific Title of Study
|
Influence of maternal physical activity during pregnancy on fetal outcomes |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Suprita Waghray |
| Designation |
Postgraduate Student |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
8333031190 |
| Fax |
|
| Email |
suprita.waghray@learner.manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Preetha R |
| Designation |
Associate Professor |
| Affiliation |
Manipal College of Health Professions |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, Manipal Academy of Higher Education, Manipal
Udupi
KARNATAKA
576104
India |
| Phone |
9945670669 |
| Fax |
|
| Email |
preetha.r@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Suprita Waghray
Department of Physiotherapy,
Manipal College of Health Professions,
Manipal Academy of Higher Education,
Manipal,
India |
|
|
Primary Sponsor
|
| Name |
Suprita Waghray |
| Address |
Department of Physiotherapy, Manipal College of Health Professions, MAHE, Manipal, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Suprita Waghray |
Kasturba Hospital |
Ultrasound Scan Room, Department of Obstetrics and Gynecology
Udupi
KARNATAKA |
8333031190
suprita.waghray@learner.manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Kasturba Medical College and Kasturba Hospital |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O80||Encounter for full-term uncomplicated delivery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Pregnant women with singleton pregnancy
Able to understand English or Kannada |
|
| ExclusionCriteria |
| Details |
Pregnant women with unstable conditions
High risk pregnancies, in-vitro fertilization, incompetent cervix, bad obstetric history and those advised bed rest
Not planning to continue the antenatal check-ups in Kasturba Hospital, Manipal |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Maternal physical activity
Crown rump length
Fetal heart rate
Head circumference
Abdominal circumference
Biparietal diameter
Femoral length
Expected fetal weight
Amniotic fluid index
Fetal lie |
11 to 13 weeks of gestation
24 to 28 weeks of gestation
36 to 40 weeks of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Maternal height, weight and BMI |
11 to 13 weeks of gestation
24 to 28 weeks of gestation
36 to 40 weeks of gestation |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
01/07/2021 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Closed to Recruitment of Participants |
|
Publication Details
|
Nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Aim of this prospective cohort is to study the influence of maternal physical activity during pregnancy on fetal outcomes in women visiting a tertiary care hospital. Pregnant women coming to the outpatient department of Obstetrics and Gynecology, Kasturba Hospital will be screened for inclusion and exclusion criteria. Written informed consent will be obtained from eligible participants between 11 to 13 weeks after explaining the procedure in detail. Height and weight of the participant will be measured, GPAQ questionnaire will be administered and fetal outcomes will be documented from ultrasound records. The participants will be followed between 24 to 28 weeks and between 36 to 40 weeks during which weight will be measured, GPAQ questionnaire will be re-administered and trimester specific fetal outcomes will be recorded. The data will then be analyzed. Previous literature suggests that maternal physical activity during pregnancy may have a positive impact on maternal and fetal well-being. However, the influence of maternal physical activity on trimester specific fetal outcomes remains understudied. Knowledge on this influence may contribute for planning appropriate exercise regimen during pregnancy for better fetal outcomes. |