NCT Number: NCT07779057
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.
Interested in participating?
Request Info18 year–45 year
Female
Interventional
Phase 4
Multan, Punjab Province, 60000, Pakistan
Location status: Recruiting
Fiza A Principal Investigator, MBBS
CONTACT
Fiza A Principal Investigator, MBBS
PRINCIPAL_INVESTIGATOR
Samee A Professor, FRCOG
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Aspirin 75 mg administered orally once daily at bedtime from 11-14 weeks of pregnancy until 36 weeks of pregnancy.
Time frame: 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),
Time frame: 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.
Time frame: From enrollment at 11-14 weeks of pregnancy until delivery, up to 36 weeks of gestation
Birth weight of the newborn measured in grams using a digital weighing scale within 3 hours of birth.
Contact information is provided by the study sponsor or research team.
Fiza A Principal Investigator, MBBS
CONTACT
Samee A Professor, FRCOG
CONTACT
Medicare Hospital (Pvt) Limited
Other
High Versus Low Dose Aspirin Effects on Fetomaternal Outcomes in Women With High Risk of Preeclampsia
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT06033131
Birth Weight, Body Weight
Helsinki, Finland
View Trial DetailsNCT06861309
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Death
Roanoke, Virginia, United States
View Trial DetailsNCT06918236
Congenital, Hereditary, and Neonatal Diseases and Abnormalities, Death
Pleven, Bulgaria
View Trial DetailsNCT05810545
Birth Weight, Body Weight
View Trial Details