Comparing the Efficacy of 75mg Versus 150mg Aspirin for the Prevention of Preeclampsia in High-Risk Pregnant Women
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Aspirin 75 mg, Aspirin 150 mg.
- Who it may be relevant to
- Registry conditions: Preeclampsia (PE). Basic parameters: 18 years — 30 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Pakistan
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
This study aims to evaluate the effectiveness of 75 mg aspirin versus 150 mg aspirin in preventing preeclampsia among individuals with high risk for the condition. Existing literature suggests that the 150 mg aspirin dose may exhibit superior efficacy, yet inconclusive evidence exists in our local setting.
Detailed description
Pre-eclampsia is a major factor in both maternal and fetal morbidity and mortality. The most widely investigated preeclampsia prevention medication is low dose Aspirin. However, guidelines differ considerably regarding the prophylactic dose of Aspirin for preeclampsia. Pre-eclampsia (PE) affects 5-7% of all pregnancies and along with eclampsia is the major contributor to maternal morbidity and 10-15% of maternal mortality and also perinatal mortality. Low dose aspirin administration can reduce vasoconstriction and decreases thrombosis of the vessels related to placenta, thereby increases blood flow and protects against to pregnancy related complication like preeclampsia, IUGR or FGR. One of the major therapeutic interventions to prevent preeclampsia is the use of Aspirin (a COX-II inhibitor with anti-inflammatory and anti-thrombotic properties). Initiating low-dose aspirin (LDA) therapy in early pregnancy from 12 weeks can prevent the onset of pre-eclampsia or delay it. The antiplatelet and vasodilatory effect of aspirin induced by the inhibition of cyclooxygenase-1 (COX-1) and reduced production of thromboxane, a potent vasoconstrictor and platelet aggregator, enhances placental blood circulation. Moreover, potential anti-inflammatory properties can improve endothelial dysfunction and oxidative stress, which are the central pieces of preeclampsia mechanisms.
The dose of aspirin used in most hospital settings is low dose, which has its benefits outweigh the risks and side effects of the drug. Many studies evaluated low doses of Aspirin 60-80mg showing a 10%-50% reduction in the incidence of preeclampsia, while a few studies also evaluated the efficacy of a 150mg dose. To our knowledge, this is among very few studies to investigate the effectiveness of relatively higher doses of aspirin in the Pakistani population.
Interventions
- Drug Aspirin 75 mg
This study aims to evaluate the effectiveness of 75 mg aspirin versus 150 mg aspirin in preventing preeclampsia among individuals with high risk for the condition. Eligible women attending the antenatal clinic were screened by history, physical exam, and uterine artery Doppler. Risk assessment was entered into the Fetal Medicine Foundation software. Participants were randomized: Group A: 75 mg aspirin nightly. Group B: 150 mg aspirin nightly. - Drug Aspirin 150 mg
This study aims to evaluate the effectiveness of 75 mg aspirin versus 150 mg aspirin in preventing preeclampsia among individuals with high risk for the condition. Eligible women attending the antenatal clinic were screened by history, physical exam, and uterine artery Doppler. Risk assessment was entered into the Fetal Medicine Foundation software. Participants were randomized: Group A: 75 mg aspirin nightly. Group B: 150 mg aspirin nightly.
Primary outcome measures
- Pre - eclampsia [Time frame: 9 months]
Secondary outcome measures (1)
- Delivery [Time frame: 9 months]
Eligibility criteria
Inclusion criteria
- Screen positive women
- Age 18 - 30 y
- Gestational Age 11 - 13+6 weeks
- Singleton Pregnancy
- Estimated risk for preterm PE of > 1 in 100 (Reference - Fetal Medicine Foundation)
Exclusion criteria
- Screen negative women
- Age > 30 y
- Gestational Age > 14 weeks
- Multiple Gestation
- Estimated risk for preterm PE of < 1 in 100 (Reference - Fetal Medicine Foundation)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Pakistan · 1 center
- Shalamar Hospital — Lahore
Identifiers
NCT: NCT07041385 · IRB - 830