| CTRI Number |
CTRI/2024/04/065412 [Registered on: 08/04/2024] Trial Registered Prospectively |
| Last Modified On: |
05/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
To assess quality of life of pregnant women with nausea and vomiting using Pregnancy Unique Quantification of emesis 24 questionnaire |
|
Scientific Title of Study
|
Role of Pregnancy Unique Quantification of emesis 24 questionnaire in
assessing the quality of life of pregnant women with nausea and vomiting |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Kaveri Shitoley |
| Designation |
Junior Resident Department of Obstetrics and Gynaecology |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology,
Women and Child Block, ground floor
Kasturba Medical college and Kasturba hospital, Manipal
Madhav Nagar, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9870116614 |
| Fax |
|
| Email |
kavdshitoley@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Shyamala Guruvare |
| Designation |
Professor and Head of Unit, Department of Obstetrics and Gynaecology |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology,
Women and Child Block, ground floor
Kasturba Medical college and Kasturba hospital, Manipal
Madhav Nagar, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9844551037 |
| Fax |
|
| Email |
shyamala.g@manipal.edu |
|
Details of Contact Person
Public Query
|
| Name |
Dr Nithesh Prabhu |
| Designation |
Assistant Professor, Department of Obstetrics and Gynaecology |
| Affiliation |
Kasturba Medical College, Manipal |
| Address |
Department of Obstetrics and Gynaecology,
Women and Child Block, ground floor
Kasturba Medical college and Kasturba hospital, Manipal
Madhav Nagar, Udupi
Udupi
KARNATAKA
576104
India |
| Phone |
9008897483 |
| Fax |
|
| Email |
nithesh.prabhu@manipal.edu |
|
|
Source of Monetary or Material Support
|
| Department of Obstetrics and Gynaecology,
Women and Child Block, ground floor
Kasturba Medical college and Kasturba hospital, Manipal
Madhav Nagar, Udupi
Pin- 576104 |
|
|
Primary Sponsor
|
| Name |
Dr Kaveri Shitoley |
| Address |
Department of Obstetrics and gynaecology, Kasturba Medical College, Manipal, 576104 |
| 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 |
| Dr Kaveri Shitoley |
Kasturba Hospital, Manipal |
Department of Obstetrics and Gynaecology,
Women and Child Block, ground floor
Kasturba Medical college and Kasturba hospital, Manipal
Madhav Nagar, Udupi
Udupi
KARNATAKA |
9870116614
kavdshitoley@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Kasturba Medical College and Kasturba Hospital, Institutional Ethics Committee 2 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, (2) ICD-10 Condition: O998||Other specified diseases and conditions complicating pregnancy, childbirth and the puerperium, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
Not Applicable |
| Comparator Agent |
NIL |
Not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Female |
| Details |
1. Pregnant patients between ages 18 to 45 years
2. Singleton, live gestation
3. Primigravida and Multigravida
4. Gestational age less than 12 weeks |
|
| ExclusionCriteria |
| Details |
1.Significant cardiac, renal, or hepatic maternal comorbidities, severe gestational
hypertension or preeclampsia with severe features
2. Molar pregnancy
3. Multiple gestation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the impact of severity of emesis in pregnancy on quality of life based on PUQE-24 score. |
Between 6 weeks of gestation till 12 weeks of gestation for 4 weeks minimum |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Correlation of emesis in pregnancy & Feto-maternal complications (FGR,
Preeclampsia, placental abruption, maternal anemia, pregnancy loss.) |
Between 6 weeks of gestation till 12 weeks of gestation for 4 weeks minimum |
|
|
Target Sample Size
|
Total Sample Size="385"
Sample Size from India="385"
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)
|
19/04/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [kavdshitoley@gmail.com].
- For how long will this data be available start date provided 01-04-2024 and end date provided 31-12-2025?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
As per the sample size calculations, 385 antenatal women will be included in the study A detailed history will be taken including patient’s occupation, socio-economic status, obstetric history, past medical and past surgical history and personal history. Clinical examination findings, ultrasound findings and blood/ urine test reports will be noted. PUQE-24-QOL questionnaire will be given when patient seeks medical advice for nausea and vomiting of pregnancy, at the time of NT scan and at the time of hospital admission if any. Women will also be asked mark on the scale for quality-of-life assessment. Severity of NVP will be compared with its impact on QOL and pregnancy outcome and secondary outcome measures mentioned above. For analysis, the highest score among the assessment time-points, mean score, number of episodes requiring medical advice will be considered as test objectives. Benefits: It will be beneficial in assessment of ability of pregnant women with NVP to take their iron containing prenatal vitamins , to estimate the health cost of NVP, use of emergency room or hospitalisation for NVP due to uncontrolled symptoms and dehydration and overall well being of pregnant women and quality of life. |