| CTRI Number |
CTRI/2017/06/008947 [Registered on: 30/06/2017] Trial Registered Prospectively |
| Last Modified On: |
29/06/2017 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
to assess the dangers of overweight/obesity during pregnancy |
|
Scientific Title of Study
|
“A retrospective cohort study to assess the effect of "first trimester BMI and weight gain" on pregnancy and fetal outcome among pregnant women in selected hospitals of Udupi District, 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 |
Pratibha Kamath |
| Designation |
Assistant Professor |
| Affiliation |
Manipal College of nursing |
| Address |
Department of OBG Nursing
Manipal College of nursing
Manipal University
Manipal
Udupi District
Karnataka state
Udupi
KARNATAKA
576104
India |
| Phone |
09964025177 |
| Fax |
08202922572 |
| Email |
pratibha.prakash@manipal.edu |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Judith A Noronha |
| Designation |
Associate Dean and Head of the OBG Nursing department |
| Affiliation |
Manipal College of nursing |
| Address |
Obstetrics and Gynaecology Nursing Department
1st Floor, MCON Building
Manipal College of nursing
Manipal University
Manipal
Udupi District
Karnataka state- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
08202923123 |
| Fax |
08202922572 |
| Email |
judith.n@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Judith A Noronha |
| Designation |
Associate Dean and Head of the OBG Nursing Department |
| Affiliation |
Manipal College of nursing |
| Address |
Obstetrics and Gynaecological Nursing Department
1st floor, MCON building
Manipal College of nursing
Manipal University
Manipal
Udupi District
Karnataka state- 576104
Udupi
KARNATAKA
576104
India |
| Phone |
08202923123 |
| Fax |
08202922572 |
| Email |
judith.n@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Manipal college of Nursing, Manipal University, Manipal, Udupi District, Karnataka state, 576104 |
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Mrs Pratibha |
Manipal groups of Hospitals |
Kasturba Hospital Manipal and Dr.T.M.A Pai Hospital Udupi Karnataka state
Udupi
KARNATAKA |
9964025177
08202922572
pratibha.prakash@manipal.edu |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Hospital Manipal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
A retrospective survey to assess the effect of first trimester BMI and weight gain on pregnancy and fetal outcome among pregnant women in selected hospitals of Udupi District, Karnataka., |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
All the pregnant women;
1. who have registered for the antenatal clinic between seven and twelve weeks of pregnancy and delivered and got admitted in the Manipal group of Hospitals and present during data collection
2. with complete antenatal, intranatal and fetal outcome record
|
|
| ExclusionCriteria |
| Details |
Women with missing gestational weight gain values |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Prevalence of obesity and its effect on pregnancy and fetal outcome and also influence of physical activities and lifestyle practices on body weight |
31/12/2017 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| outcome of obesity on pregnancy on during intrapartum, postpartum and fetal outcome |
31/12/2017 |
|
|
Target Sample Size
|
Total Sample Size="245"
Sample Size from India="245"
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)
|
15/08/2017 |
| 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="6"
Days="10" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The researcher will meet the mothers who were delivered and got admitted to postnatal wards of Kasturba Hospital Manipal and Dr.T.M.A Pai Hospital Udupi, after obtaining written consent from the participants, the researcher will collect the demographics and antenatal lifestyle practices during pregnancy by using a “semi-structured questionnaire by interview method, which will take 20 to 30 minutes (for each mother). Further researcher will collect some of the other information’s like mothers weight, height and information related to first trimester BMI and weight gain in pregnancy and its effect on pregnancy outcome (which includes antenatal, intranatal and fetal outcome) from mothers medical records. |