Comparison of the effect of two doses of aspirin on the prevention of pre-eclampsia in high risk pregnant women

Comparison of two various aspirin dosage (80mg and 120mg daily) on prevention of pre-eclampsia in high risk pregnant women

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20120918010876N6

Enrollment

729

Registered

2018-12-26

Start date

2018-11-22

Completion date

Unknown

Last updated

2023-10-16

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

Conditions

Preeclampsia. Pre-eclampsia

Interventions

Intervention 1: Intervention group: Daily oral aspirin (80mg). Intervention 2: Intervention group: Daily oral aspirin (120mg). Intervention 3: Control group: Placebo.

Eligibility

Sex/Gender

Female

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Pregnant women over 18 years of age Gestational age of 12-20 weeks High risk factors for pre-eclampsia (such as multiple pregnancy, chronic hypertension, diabetes mellitus type 1 or 2 , chronic kidney disease, autoimmune disease (antiphospholipid syndrome, lupus) History of pre-eclampsia or bad outcomes in previous pregnancies The presence of a viable fetus

Exclusion criteria

Exclusion criteria: Existence of Cardiovascular, liver, thyroid, hemorrhagic or peptic ulcer diseases History of asthma Sensitivity to aspirin Major fetal disorders Prolonged use of NSAIDs

Design outcomes

Primary

Measure	Time frame
The incidence of pre-eclampsia. Timepoint: Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time. Method of measurement: Blood pressure measurement and clinical examination.	—

Secondary

Measure	Time frame
Gastrointestinal complications of aspirin (heartburn, gastrointestinal bleeding). Timepoint: Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time. Method of measurement: Question from patient and clinical examination.;The incidence of intra-uterine growth retardation (IUGR). Timepoint: Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time. Method of measurement: Clinical examination.;The incidence of preterm delivery. Timepoint: Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time. Method of measurement: Gestational age at delivery.;Vaginal bleeding as side effect of aspirin. Timepoint: Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time. Method of measurement: Question from patient and clinical examination.	—

Measure

Time frame

Gastrointestinal complications of aspirin (heartburn, gastrointestinal bleeding). Timepoint: Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time. Method of measurement: Question from patient and clinical examination.;The incidence of intra-uterine growth retardation (IUGR). Timepoint: Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time. Method of measurement: Clinical examination.;The incidence of preterm delivery. Timepoint: Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time. Method of measurement: Gestational age at delivery.;Vaginal bleeding as side effect of aspirin. Timepoint: Monthly up to 28 weeks of pregnancy, then every two weeks up to 36 weeks of pregnancy and eventually every week until the delivery time. Method of measurement: Question from patient and clinical examination.

—

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMasoome Mirzamoradi

Shahid Beheshti University of Medical Sciences

drmoradi000@yahoo.com+98 21 5506 6263

Outcome results

None listed

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