CTRI

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CTRI Number

CTRI/2023/12/060983 [Registered on: 29/12/2023] Trial Registered Prospectively

Last Modified On:

18/02/2025

Post Graduate Thesis

Type of Trial

Interventional

Type of Study

Drug

Study Design

Randomized, Parallel Group Trial

Public Title of Study

Comparison of 75 mg and 150 mg Aspirin for prevention of high blood pressure in women who are at higher risk during pregnancy.

Scientific Title of Study

Comparison of 75 mg versus 150 mg Aspirin for prevention of preterm preeclampsia in high risk women at Tertiary level hospital-A Randomized double blind clinical 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	Prof Upma Saxena
Designation	Consultant & Head of Unit
Affiliation	Vardhman Mahavir Medical college & Safdarjung hospital
Address	Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi New Delhi 110029 South DELHI 110029 India
Phone	9971460540
Fax
Email	upma_saxena@hotmail.com

Details of Contact Person
Scientific Query

Name	Prof UPMA SAXENA
Designation	CONSULTANT AND HOU
Affiliation	VARDHMAN MAHAVIR MEDICAL COLLEGE & SAFDARJUNG HOSPITAL
Address	Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi New Delhi 110029 South DELHI 110029 India
Phone	9971460540
Fax
Email	upma_saxena@hotmail.com

Details of Contact Person
Public Query

Name	Prof UPMA SAXENA
Designation	CONSULTANT AND HOU
Affiliation	VARDHMAN MAHAVIR MEDICAL COLLEGE & SAFDARJUNG HOSPITAL
Address	Department of Obstetrics and Gynaecology, Vardhman Mahavir Medical College and Safdarjung Hospital, New Delhi New Delhi 110029 South DELHI 110029 India
Phone	9971460540
Fax
Email	upma_saxena@hotmail.com

Source of Monetary or Material Support

ICMR

Primary Sponsor

Name	Indian Council of Medical Research
Address	Ansari Nagar,New Delhi 110029
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 Upma Saxena	Safdarjung Hospital	Room no 203, Ward 4 Department of Obstetric & Gynecology South DELHI	9971460540 upma_saxena@hotmail.com

Details of Ethics Committee

No of Ethics Committees= 1
Name of Committee	Approval Status
Vardhman Mahavir Medical College & Safdarjung hospital ,Institutional Ethics Committee	Approved

Regulatory Clearance Status from DCGI

Status

Not Applicable

Health Condition / Problems Studied

Health Type	Condition
Patients	(1) ICD-10 Condition: O141\|\|Severe pre-eclampsia,

Intervention / Comparator Agent

Type	Name	Details
Comparator Agent	Acetylsalicylic acid (Aspirin)150 mg	Aspirin 150mg to prevent preterm pre eclampsia in women at high risk of developing pre eclampsia started at 12-14 weeks of pregnancy at night , till onset of preterm pre eclampsia or till 37 weeks of pregnancy if preterm preeclampsia doesnot develop.
Intervention	Acetylsalicylic acid (Aspirin)75 mg	Aspirin 75mg to prevent preterm pre eclampsia in women at high risk of developing pre eclampsia ,started at 12-14 weeks of pregnancy at night , till onset of preterm pre eclampsia or till 37 weeks of pregnancy if preterm preeclampsia doesnot develop.

Inclusion Criteria
Modification(s)

Age From	18.00 Year(s)
Age To	45.00 Year(s)
Gender	Female
Details	Women with singleton pregnancy 12 to 16 weeks of POG who will found high risk to develop preterm preeclampsia on first trimester Quadruple test

ExclusionCriteria

Details

Hypersensitivity to aspirin or other nsaids
Active peptic ulcer disease
Active bleeding in pregnancy
Severe liver disease
Mother on anticoagulant or anti platelet
Underlying bleeding disorder in mother
Fetus diagnosed with malformation or aneuploidy

Method of Generating Random Sequence

Computer generated randomization

Method of Concealment

Pre-numbered or coded identical Containers

Blinding/Masking

Participant and Investigator Blinded

Primary Outcome

Outcome	TimePoints
1.Number of screen positive high risk women taking 75mg Aspirin developing preterm PE 2. Number of screen positive high risk women taking 150 mg Aspirin developing preterm PE	At 20,24,28,30,32,34,36,37,38,39 &40 weeks of pregnancy

Secondary Outcome
Modification(s)

Outcome

TimePoints

1.Fetal
Abortion Preterm Birth Birth weight Stillbirth NICU admission Apgar score less than 7
Early neonatal death Intracranial bleeding
2.Maternal
Intrapartum Bleeding GI bleed Gestational HT Eclampsia HELLP Abruption Acute kidney injury
Mode of delivery
Number of screen positive high risk women taking 75mg Aspirin developing term PE
Number of screen positive high risk women taking 150 mg Aspirin developing term PE
Postpartum Post partum haemorrhage HDU ICU stay Hematoma formation Mortality

Fetai Time of delivery
Maternal At 20weeks 24 weeks 28 weeks 30 weeks 32 weeks 34 weeks 36 weeks 37 weeks 38 weeks 39 & 40 weeks of pregnancy

Target Sample Size

Total Sample Size="370"
Sample Size from India="370"
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)

01/03/2024

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="3"
Months="0"
Days="0"

Recruitment Status of Trial (Global)

Not Yet Recruiting

Recruitment Status of Trial (India)

Open to Recruitment

Publication Details
Modification(s)

Saxena U, Lachyan A, Goyal C, et al. Comparison of 75 mg versus 150 mg aspirin for the prevention of preterm preeclampsia in high-risk women at a tertiary level hospital: study protocol for a randomized double-blind clinical trial. Trials. 2024; 25:679. doi:10.1186/s13063-024-08520-z.

Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?

Response - NO

Brief Summary

1. Rationale/ gaps in existing knowledge-

Lack of evidence about: i). Optimum dose of aspirin ,75 versus 150 mg, for prevention of preterm PE. ii). When to start and stop aspirin during pregnancy for prevention of preterm PE.

Novelty- No international or Indian prospective randomized double blind interventional trial comparing 75mg vs 150mg Aspirin for prevention of preterm PE in high risk /screen positive women.

Objectives-To compare 75 mg versus 150 mg Aspirin, for prevention of preterm preeclampsia in high risk women .

Methods- All women attending ANC and Fetal medicine OPD of VMMC & Safdarjung hospital between 11- 13+6 weeks of gestational age will be screened for preterm PE using first trimester Quadruple test. Women with risk for preterm PE , â‰¥1:100 will be labelled as Screen positive. 1T Quad will be done using Perkin Elmer LifeCycle 7.0 software by DELFIA. Screen positive women fulfilling the criteria will be enrolled and randomized using randomization chart into two groups, Group A and B to receive 75 mg or 150 mg Aspirin respectively at night , from 12 -16 weeks of pregnancy. The blinding of the trial drugs will be done by sequential number order method. Both groups will be followed up and onset of preterm PE, fetomaternal outcome and side effects of Aspirin will be recorded. Data will be coded and recorded in MS Excel spreadsheet program. SPSS v23 (IBM Corp.) will be used for data analysis and p < 0.05 will be considered as statistically significant.

Expected outcome-Number of screen positive women developing preterm PE, various fetomaternal outcomes and aspirin side effects in 75 mg versus 150 mg Aspirin group.