Preeclampsia
Conditions
Keywords
Aspirin, Birth weight, Pregnancy, Preeclampsia, Stillbirth
Brief summary
The goal of this randomized clinical trial is to compare the effects of two doses of aspirin, 75 mg and 150 mg, in pregnant women who are at high risk of developing preeclampsia. The main question the study aims to answer is: 1. Does taking 150 mg of aspirin reduce the occurrence of preeclampsia more effectively than taking 75 mg of aspirin in pregnant women at high risk of preeclampsia? 2. Are there differences in stillbirth and newborn birth weight between the two aspirin doses? The study will include 224 pregnant women aged 18-45 years who are between 11 and 14 weeks of pregnancy and are identified as being at high risk for preeclampsia. Participants will be randomly assigned to one of two groups. * Participants in the low-dose group will take 75 mg of aspirin once daily at bedtime. * Participants in the high-dose group will take 150 mg of aspirin once daily at bedtime. Participants will continue their assigned aspirin dose until 36 weeks of pregnancy and will be followed every 2 weeks until delivery. The study will record whether participants develop preeclampsia and whether stillbirth occurs. The birth weight of each newborn will also be measured within 3 hours of birth. The study hypothesis is that 150 mg of aspirin will result in a lower incidence of preeclampsia than 75 mg of aspirin in pregnant women at high risk of preeclampsia.
Interventions
DRUGAspirin
Aspirin 75 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy.
Sponsors
Medicare Hospital (Pvt) Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* Gestational age 11-14 weeks * High risk of preeclampsia
Exclusion criteria
* Active gastritis * Abnormal coagulation profile (INR \> 1.5) * Renal disease * Platelet count \< 150,000/mm\^3 * Fetal malformations * Vaginal bleeding
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Preeclampsia | From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation | Proportion of participants who develop preeclampsia after 20 weeks of pregnancy and before delivery. Preeclampsia will be diagnosed if the patient has proteins excreted in urine (24-hour urine protein \>300 mg or urinary protein to creatinine ratio ≥ 0.3 or dipstick 2+) and persistent high blood pressure ≥ 140/90 mmHg for minimum of 4 hours or ≥160/110 mmHg), |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Stillbirth | From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation | Proportion of pregnancies resulting in stillbirth. Stillbirth will be defined as delivery of baby with no signs of life. |
Countries
Pakistan
Contacts
CONTACTFiza A Principal Investigator, MBBS
CONTACTSamee A Professor, FRCOG
STUDY_CHAIRSamee A Professor, FRCOG
Medicare Hospital (Pvt) Ltd.
Outcome results
None listed