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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  
Name  Address 
NIL  NIL 
 
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  
Status 
Not Applicable 
 
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.

 
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