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A Randomized controlled trial to compare reduction in occurance of preeclampsia by giving Tab Aspirin before or after 12 weeks of pregnancy

Low dose aspirin therapy before or after 12 weeks gestation for preventing preeclampsia A randomized controlled trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2020/08/027416
Enrollment
120
Registered
2020-08-27
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

None listed

Interventions

Intervention1: Tab Aspirin 150 mg OD: Group A will receive tab aspirin 150 mg OD before 12 weeks of gestation of pregnancy Intervention2: Tab Aspirin 150 mg OD: Group B will receive tab aspirin 150 mg

Sponsors

AIIMS BHUBANESWAR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: women attending antenatal clinic in whom pregnancy has been diagnosed by ultrasonography that is only after appearance of cardiac activity, before 12 weeks of gestational age measured by crown rump length having either one major risk factor or more than one minor risk factor. major risk factors: 1) history of preeclampsia in previous pregnancy 2) chronic hypertension 3) type 1 or 2 diabetes 4) auto immune diseases like SLE antiphospholipid antibody syndrome etc 5) diagnosed renal disease 6) IVF conception 7) multifetal gestation minor risk factors 1) primiparity 2) obesity with BMI more than 30 meter square per kg body weight 3) age above 35 years 4)pregnancy interval of more than 5 years

Exclusion criteria

Exclusion criteria: if pregnant women coming to antenatal opd for the first time at or after 12 weeks of gestation, even with presence of risk factors patient will not be recruited in study. other risk factors: 1) aspirin hyper sensitivity 2) hypersensitivity to other salicylates 3) nasal polyps 4) bronchial asthma 5) gastrointestinal bleeding 6) peptic ulcer disease 7) genitourinary tract bleed 8) severe hepatic dysfunction 9) severe renal dysfunction where NSAIDS are contraindicated 10) if any anomaly detected in fetus in USG during recruitment 11) if pregnant women are already on aspirin therapy before recruitment

Design outcomes

Primary

MeasureTime frame
To compare the incidence of preeclampsia in women receiving low dose aspirin before or after 12 weeks of gestationTimepoint: after 20 weeks of gestation—

Secondary

MeasureTime frame
to compare occurence of foetal growth restrictionTimepoint: after 28 weeks of gestation;to compare the occurrence of gestational hypertensionTimepoint: after 20 weeks of gestation;to compare the occurrence of preterm deliveriesTimepoint: before 37 weeks of gestation;to evaluate the adverse feto maternal outcome in between two groups due to use of low dose aspirinTimepoint: through out the pregnancy duration and after delivery—

Countries

India

Contacts

Public ContactDr G Raja

AIIMS BHUBANESWAR

obgyn_saubhagya@aiimsbhubaneswar.edu.in9438884133

Outcome results

None listed

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