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To compare the fetomaternal outcome of 150 mg versus 75 mg aspirin in patient with high risk of preeclampsia (PE)

To compare the Fetomaternal outcome of 150 mg aspirin versus 75 mg aspirin in patients with high risk of preeclampsia ; a Randomized control trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2021/09/036927
Enrollment
98
Registered
2021-09-28
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: I10- Essential (primary) hypertension

Interventions

Intervention1: 150 MG ASPIRIN: PREGNANT WOMEN WHO WILL COME UNDER HIGH RISK FOR PREECLAMPSIA WITH FMF -ECLAMPSIA CALCULATOR WILL BE STARTED AND AFTER RANDOMIZATION WILL BE STARTED WITH 150 MG ASPIRIN

Sponsors

AIIMS RAIPUR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Maternal age >= 18y 2.Singleton pregnancy 3.Women at high risk of preeclampsia by means of first trimester screening at 11-14 weeks gestational age (crown-rump length of 45â??84 mm) : diagnosed by FETAL MEDICINE FOUNDATION(FMF) ECLAMPSIA CALCULATOR

Exclusion criteria

Exclusion criteria: 1. Contraindication to use of Aspirin Active peptic ulcer disease Bleeding disorder Chronic Kidney Disease Thrombocytopenia( Known allergy or hypersensitivity to aspirin . 2. Active treatment with heparin or aspirin before recruitment 3. Known Foetal malformation, Anomaly, Aneuploidy

Design outcomes

Primary

MeasureTime frame
1. Incidence of PE before 37 weeks in the two interventional groups . 2. The severity of PE, FGR and the neonatal outcome between the two groups Timepoint: OUTCOME WILL BE ASSESSED AT DAY 2 OF DELIVERY

Secondary

MeasureTime frame
SIDE EFFECTS ASPIRIN ALLERGY e.g. Uticaria Anaphylaxis GI BLEEDING GENITOURINARY BLEEDING/ BLEEDING PV Any other (specify)Timepoint: AT EACH ANTENATAL VISIT THAT IS MONTHLY AFTER STARTING OF MEDICATION ,UPTO 28 WEEKS.TWICE A MONTH FROM 28 WEEKS POG TILL 36 MONTH AND PATIENT WILL ALSO BE ASKED TO REPORT IMMEDIATELY ANYTIME ANY SIDE EFFECTS OCCUR. THEY WILL BE ASKED TO REPOERT ANY SIDE EFFECT AT ANYTIME SINCE THE START OF MEDICATION,IF ANY OCCURS

Countries

India

Contacts

Public ContactDrChandrashekhar Shrivastava

AIIMS RAIPUR

farhatkhan92786@gmail.com7651823044

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026