| CTRI Number |
CTRI/2025/08/092818 [Registered on: 11/08/2025] Trial Registered Prospectively |
| Last Modified On: |
05/05/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Placebo Controlled Trial |
|
Public Title of Study
|
Can aspirin prevent dangerous high blood pressure in high risk pregnancies? A study comparing Aspirin and an inactive placebo pill |
|
Scientific Title of Study
|
Aspirin Vs Placebo in pregnancies at high risk for pre-eclampsia:-A Randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shreya Mishra |
| Designation |
Junior resident |
| Affiliation |
Dr Rajendra Prasad government medical college Kangra at Tanda |
| Address |
Department of obstetrics and gynaecology , Dr Rajendra Prasad government medical college Kangra at Tanda , Kangra,Himachal Pradesh,
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9140500935 |
| Fax |
|
| Email |
Shreyasheenu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ajay Sood |
| Designation |
Professor |
| Affiliation |
Dr Rajendra Prasad government medical college Kangra at Tanda |
| Address |
Department of obstetrics and gynaecology Dr Rajendra Prasad government medical college Kangra at Tanda, Kangra
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9816021100 |
| Fax |
|
| Email |
ajayshalu95@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Shreya Mishra |
| Designation |
Junior resident |
| Affiliation |
Dr Rajendra Prasad government medical college Kangra at Tanda |
| Address |
Department of obstetrics and gynaecology Dr Rajendra Prasad government medical college Kangra atTanda, Kangra Himachal Pradesh,
Kangra
HIMACHAL PRADESH
176001
India |
| Phone |
9140500935 |
| Fax |
|
| Email |
Shreyasheenu@gmail.com |
|
|
Source of Monetary or Material Support
|
| Dr Rajendra Prasad government medical college Kangra at Tanda, Himachal Pradesh 176001 , India |
|
|
Primary Sponsor
|
| Name |
Dr Rajendra Prasad government medical college Kangra at Tanda |
| Address |
VPO Tanda at Kangra Himachal Pradesh 176001 |
| Type of Sponsor |
Government medical college |
|
|
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 Shreya Mishra |
Dr RPGMC Tanda at Kangra |
Department of obstetrics and gynaecology
Kangra
HIMACHAL PRADESH |
9140500935
Shreyasheenu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethics committee Dr Rajendra Prasad Government Medical college Tanda |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O140||Mild to moderate pre-eclampsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Drug aspirin 150 mg |
NSAIDS , one tablet of aspirin 150 mg will be given daily starting from 12-20 weeks of gestation till 36 of gestation |
| Comparator Agent |
Placebo |
One tab folic acid will be given daily starting from 12-20 weeks of gestation till 36 weeks of gestation |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
39.00 Year(s) |
| Gender |
Female |
| Details |
Live fetus at gestational age 12 to 20 weeks, history of pre eclampsia, chronic hypertension, diabetes mellitus, Multi fetal gestation,nulliparity,obesity BMI more than 30, family, history of pre eclampsia |
|
| ExclusionCriteria |
| Details |
Allergy to aspirin , asthma,known case of peptic ulcers , severe heart,liver or renal disease and bleeding disorders,autoimmune diseases,mental disorders, history of alcohol or drug abuse within 6 months, conception after IVF |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Delivery with pre eclampsia |
Before at or after 37 weeks of gestation |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Fetomaternal out omes |
As mentioned above |
|
|
Target Sample Size
|
Total Sample Size="200"
Sample Size from India="200"
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
|
Phase 3 |
|
Date of First Enrollment (India)
|
23/08/2025 |
| 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 Yet Recruiting |
| 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 - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- 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 whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Proposals should be directed to [Shreyasheenu@gmail.com].
- For how long will this data be available start date provided 09-04-2024 and end date provided 09-04-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Thesis for post graduation in ms obgy |