| CTRI Number |
CTRI/2025/11/097380 [Registered on: 13/11/2025] Trial Registered Prospectively |
| Last Modified On: |
12/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of a smaller and a higher dose of aspirin to stop occurrence of a hypertension-related harmful condition seen in pregnant women having some risk factors |
|
Scientific Title of Study
|
Comparison of Efficacy and Safety of 150 mg versus 75mg of Aspirin in Preven-tion of Preeclampsia in Women at Risk: A Double-Blind
Randomized Controlled Trial |
| Trial Acronym |
Not Applicable |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Picklu Chaudhuri |
| Designation |
Professor |
| Affiliation |
Rampurhat Government Medical College |
| Address |
60 Batail, Hospital More,
Rampurhat Government Medical College and Hospital,
Rampurhat,
Birbhum.
Birbhum WEST BENGAL 731224 India |
| Phone |
9432277443 |
| Fax |
|
| Email |
picklu.chaudhuri@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Picklu Chaudhuri |
| Designation |
Professor |
| Affiliation |
Rampurhat Government Medical College |
| Address |
60 Batail, Hospital More,
Rampurhat Government Medical College and Hospital,
Rampurhat,
Birbhum.
Birbhum WEST BENGAL 731224 India |
| Phone |
9432277443 |
| Fax |
|
| Email |
picklu.chaudhuri@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Picklu Chaudhuri |
| Designation |
Professor |
| Affiliation |
Rampurhat Government Medical College |
| Address |
60 Batail, Hospital More,
Rampurhat Government Medical College and Hospital,
Rampurhat,
Birbhum.
Birbhum WEST BENGAL 731224 India |
| Phone |
9432277443 |
| Fax |
|
| Email |
picklu.chaudhuri@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rampurhat Government Medical College and Hospital, 60 Batail, Hospital More, Rampurhat, District Birbhum, West Bengal, India, PIN – 731224 |
|
|
Primary Sponsor
|
| Name |
Rampurhat Government Medical College |
| Address |
60 Batail, Hospital More,
Rampurhat,
Birbhum-731224 |
| 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 Picklu Chaudhuri |
Rampurhat Government Medical College and Hospital |
Outpatient Department (PP Unit), Room No. 6, Department of Gynaecology and Obstetrics, MCH Building Ground Floor, Rampurhat Government Medical College, 60 Batail, Hospital More, Rampurhat, Birbhum, PIN – 731224
Birbhum WEST BENGAL |
9432277443
picklu.chaudhuri@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Rampurhat Government Medical Colege and Hospital Rampurhat-731224 Institutional Ethics Committee for Human Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O098||Supervision of other high risk pregnancies, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
150 mg tablet of aspirin orally daily |
Oral administration tablet aspirin 150 mg at bedtime from 12 weeks of gestation till 36 completed weeks (total duration of therapy 24 weeks) |
| Comparator Agent |
75 mg aspirin tablet orally daily |
Oral administration daily at bed time from 12 weeks of gestation till 36 completed weeks (total duration of therapy 24 weeks) |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Female |
| Details |
1.Previous history of preeclampsia
2.chronic hypertension,
3.chronic renal disease,
4. known SLE,
5.known Antiphospholipid syndrome,
6.Type 1 or Type 2 Diabetes,
7.pregnancy by ART and the presence of at least two of the factors associated with a moderate risk of developing preeclampsia like primigravida, age 35 years or more, age less than 19 years,
pregnancy interval 10 years or more, multiple pregnancy, BMI 35 or more,
8.Known hypothyroid,
9.known PCOS,
10.anemia with Hb% less than 8 gm% |
|
| ExclusionCriteria |
| Details |
1.Active peptic ulcer disease
2.Coagulation disorder
3.Thrombocytopenia
4.History of vaginal bleeding and fetus diagnosed with malformations or aneuploidy in transvaginal ultrasound
5.Known allergy to Aspirin. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Estimating the efficacy of the two doses of aspirin in preventing or delaying the onset and reducing the severity of preeclampsia. |
After 20 weeks of gestational age |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To study and compare the serious adverse maternal and fetal outcomes in the two treatment groups.
|
After 20 weeks of gestational age |
| 2.To study the nature of and to compare the frequency of drug related adverse events in the two treatment groups. |
After 20 weeks of gestational age |
|
|
Target Sample Size
|
Total Sample Size="1518" Sample Size from India="1518"
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)
|
25/11/2025 |
| 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="6" 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 - NO
|
|
Brief Summary
|
We intend to conduct a randomized controlled interventional
study among individuals attending a peripherally located government-run
tertiary care hospital, to see whether the use of a higher 150 mg dose of
aspirin, compared with that of 75 mg aspirin, in women at risk of
pre-eclampsia, has greater benefit in terms of certain maternal and perinatal
outcomes. The present study primarily aims to compare differences in the efficacy
and safety of prophylactic use of 150 mg aspirin in comparison to
75 mg aspirin in women with known risk factors for development of
preeclampsia. A two-arm double-blind parallel group randomized control
trial will be conducted in the Department of Obstetrics and Gynaecology,
Rampurhat Govt Medical College, Birbhum. Pregnant women between 12 and
14 weeks of gestational age attending the antenatal clinic and meeting the
inclusion criteria will be enrolled in the study after obtaining a written
informed consent. The study will be carried out over a period of 1.5 years with a target sample size of 1518 . Exclusion criteria include active peptic ulcer disease, bleeding disorder,
thrombocytopenia , history of vaginal bleeding
and fetus diagnosed with malformations or aneuploidy during ultrasound screening, known allergy to aspirin. |