| CTRI Number |
CTRI/2022/08/044863 [Registered on: 24/08/2022] Trial Registered Prospectively |
| Last Modified On: |
20/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Can pregnancy affect the way of living? |
|
Scientific Title of Study
|
Quality of life,stress ,anxiety and depression among high risk and low risk pregnant women-An 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 |
MANASA S |
| Designation |
DNB POSTGRADUATE |
| Affiliation |
DR TMA PAI HOSPITAL |
| Address |
DR TMA PAI HOSPITAL
UDUPI
COURT ROAD, OPP OLD TALUK OFFICE,BRAHMAGIRI,UDUPI,KARNATAKA
Udupi
KARNATAKA
576101
India |
| Phone |
9741823963 |
| Fax |
|
| Email |
manasapearl043@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
shashikala bhat |
| Designation |
professor & HOD,department of OBG |
| Affiliation |
DR TMA PAI HOSPITAL |
| Address |
DR TMA PAI HOSPITAL
UDUPI
COURT ROAD, OPP OLD TALUK OFFICE,BRAHMAGIRI,UDUPI,KARNATAKA
Udupi
KARNATAKA
576010
India |
| Phone |
9611362119 |
| Fax |
|
| Email |
shashikala.bhat@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
shashikala bhat |
| Designation |
professor & HOD,department of OBG |
| Affiliation |
DR TMA PAI HOSPITAL |
| Address |
DR TMA PAI HOSPITAL
UDUPI
COURT ROAD, OPP OLD TALUK OFFICE,BRAHMAGIRI,UDUPI,KARNATAKA
Udupi
KARNATAKA
576010
India |
| Phone |
9611362119 |
| Fax |
|
| Email |
shashikala.bhat@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Dr TMA Pai hospital,Udupi |
|
|
Primary Sponsor
|
| Name |
Dr TMA PAI HOSPITAL |
| Address |
Opposite taluk office,court road,udupi |
| Type of Sponsor |
Research institution and hospital |
|
|
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 |
| Dr MANASA S |
Dr TMA Pai hospital |
Department of OBG
Dr TMA Pai hospital
Opp Taluk office,court road,UDUPI
Udupi
KARNATAKA |
9741823963
manasapearl043@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O099||Supervision of high risk pregnancy, unspecified, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
Group 1
Inclusion criteria:
Pregnant women between 16-28 weeks of gestation with following risk factors in present or previous pregnancy-
Previous LSCS
Recurrent abortion>2
Hypertension
GDM
Medical disorder of pregnancy
multiple gestation
Obesity (BMI >28)
Psychiatric illness
IUFD
Preterm births
Oligohydraminos
Polyhdraminos
IUGR
Fibroid complicating pregnancy.
Ovarian cyst in pregnancy
Postpartum hemorrhage
Antepartum hemorrhage
Rh negative pregnancy
Instrumental deliveries
Neonatal complications-ICU stay/medical and surgical intervention to neonate
Group 2
Inclusion criteria
Pregnant women between 16-26 weeks of gestation without any risk factors.
|
|
| ExclusionCriteria |
| Details |
Exclusion criteria
Pregnant women <16 weeks and >26 weeks
Any other factor other than the mentioned inclusion criteria
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| TO ASSESS THE QUALITY OF LIFE OF PREGNANT WOMEN AND CLASIIFY THEM AS NORMAL/STRESSED/ANXIOUS/DEPRESSED,based on scoring from SF-36 questionnaire. |
Assesment is done only once. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To increase the awareness on mental health among pregnant women and seek psychologists/psychiatric help if necessary |
6 months |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="170"
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)
|
01/09/2022 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
01/09/2021 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
A prospective study conducted by Sofia Rallis in
2014 showed that higher please specify symptoms early in pregnancy predicted higher
symptoms throughout the pregnancy. A systematic review done by Hamideh in 2018 showed
that several risk factors (previous pregnancy loss, pregnancy complications) contribute to
worsening of mental health during pregnancy are detectable(previous pregnancy
loss,pregnancy complications), underlying emphasizing the significance of mental health
screening. Lack of recognition of early symptoms may result inhas serious implications., it is
now widely recognized that maternal depression, anxiety and stress during pregnancy have
powerful long-term effects on both mother and baby ..(Dunkel Schetter and Tanner,
2012, Glover, 2015 |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Pregnancy is associated with lot of changes in physical and psychological health. The prevalance of antenatal depression s estimated to be between 7 and 20 percent. These changes can impact the quality of life of pregnnant women and much aggravated in high risk pregnancy. Hence a study is being done to compare both. Pregnant women between 16-28 weeks will be recruited for the study with and without risk factors. Quality of life will be assessed using SF 36 QOL questionnaire. DASS -21 questionnaire will be used to classify them as normal/stressed/anxious. |