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Aspirin and Omega-3 in intrauterine growth restriction

The Effect of Aspirin and Omega-3 Fatty Acids Combined in Preventing Intrauterine Growth Restriction in High-Risk Pregnancies: A Randomized Controlled Clinical Trial

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20250929067421N1
Enrollment
48
Registered
2026-05-14
Start date
2026-06-05
Completion date
Unknown
Last updated
2026-06-01

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

Conditions

• Intrauterine Growth Restriction (IUGR)• High-Risk Pregnancy. Maternal care for known or suspected poor fetal growth

Interventions

Intervention 1: Intervention group: Participants will receive a daily oral low-dose aspirin 81 mg, taken once nightly, plus one oral omega-3 capsule 1000 mg (containing EPA and DHA). The intervention

Sponsors

Sanandaj University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: PAPP A level less than 0.5 MoM in first trimester screening double marker test Gestational age between 12 and 16 weeks Presence of risk factors associated with intrauterine growth restriction such as history of preeclampsia or fetal weight below the tenth percentile in a previous pregnancy or chronic hypertension Singleton pregnancy Written informed consent from the mother to participate in the study

Exclusion criteria

Exclusion criteria: Presence of chronic underlying diseases such as diabetes, renal, or cardiac disorders Presence of structural or chromosomal abnormalities in the fetus Regular use of omega-3 supplements or anticoagulant medications prior to enrollment in the study Multiple pregnancy

Design outcomes

Primary

MeasureTime frame
Estimated fetal weight based on biometric parameters including head circumference, abdominal circumference, and femur length. Timepoint: At baseline, at twenty-eight weeks of gestation, and at thirty-six weeks of gestation. Method of measurement: Fetal ultrasound performed by a perinatology specialist using Doppler ultrasound equipment.;Doppler indices of the uterine artery and umbilical artery including vascular resistance and systolic to diastolic ratio. Timepoint: At baseline, at twenty-eight weeks of gestation, and at thirty-six weeks of gestation. Method of measurement: Color Doppler ultrasound performed by a perinatology specialist using standard ultrasound equipment.;Incidence of intrauterine growth restriction defined as fetal weight below the tenth percentile for gestational age. Timepoint: At twenty-eight weeks of gestation and at thirty-six weeks of gestation. Method of measurement: Fetal biometry ultrasound and assessment using standard fetal growth charts by a perinatology specialist.;Placental vascular resistance assessed by uterine artery resistance index. Timepoint: At baseline, at twenty-eight weeks, and at thirty-six weeks. Method of measurement: Uterine artery Doppler ultrasonography performed by a perinatology specialist.;Neonatal birth weight at delivery. Timepoint: At delivery. Method of measurement: Measurement using a digital neonatal scale.

Secondary

MeasureTime frame
Rate of neonatal admission to the neonatal intensive care unit. Timepoint: During the postnatal hospital stay until discharge. Method of measurement: NICU admission recorded from hospital records and reason for admission.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactAfsaneh Partoandazanpour

Sanandaj University of Medical Sciences

afsaneh.parto@yahoo.com+98 87 3328 5910

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Jun 11, 2026