Aspirin Role for Preventing Clinical Risks Related to High Risk Pregnancy

NCT07087067 | Completed DMC

• 1 other identifier: 0230201
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief Summary

Preeclampsia and its related consequences significantly contribute to maternal and neonatal morbidity and mortality, particularly in high-risk pregnancies. Low-dose aspirin has shown promise in reducing these risks, particularly when initiated early in gestation. This study evaluated the effectiveness of 75 mg aspirin, started before 12 weeks of gestation, in reducing adverse pregnancy outcomes among high-risk pregnant women. A randomized controlled trial was undertaken with high-risk pregnant women. Pregnant women were randomized in a 1:1 ratio to receive 75 mg of aspirin or a control daily from enrollment (\<12 weeks of gestation) until 36 weeks of delivery. High-risk status was defined by established clinical criteria. The incidence of preeclampsia was the primary outcome. The researchers considered preterm birth, fetal growth restriction (FGR), perinatal mortality, neonatal intensive care unit (NICU) admission, gestational hypertension, neonatal morbidity, and postpartum hemorrhage as secondary outcomes. The outcomes were compared using Fisher's exact test, chi-square, and two-sample z-tests. Initiation of 75 mg of low-dose aspirin early in high-risk pregnancies significantly reduced preeclampsia and several adverse neonatal outcomes without increasing maternal risk. These findings support the early start of low-dose aspirin as a safe and effective strategy for preeclampsia prevention in high-risk women.

Conditions

Preeclampsia; Pregnancy

Keywords

Preeclampsia; Pregnancy; Aspirin

Outcome Measures

Primary Outcomes (1)

• preeclampsia occurance

  preeclampsia occurance in high risk pregnancy in both groups

  till end of pregnancy from week 12 to delivery

Secondary Outcomes (7)

• Preterm birth

  through study completion, an average of 1 year

• Fetal growth restriction (FGR):

  through study completion, an average of 1 year

• Perinatal death:

  at ≥20 weeks of gestation or neonatal death within 7 days of birth.

• Neonatal intensive care unit admission (NICU).

  delivery day

• Composite neonatal morbidity

  through study completion, an average of 1 year

Study Arms (2)

Control

NO INTERVENTION

Control (pregnant patient but not receiving Aspirin)

Aspirin

EXPERIMENTAL

Receiving low dose Aspirin

Drug: Aspirin 75 mg

Interventions

Aspirin 75 mg DRUG

patients received aspirin 75 mg daily prior to 12 weeks gestation

Aspirin

Eligibility Criteria

• Gender Eligibility Details: pregnant females
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Pregnant women were considered according to the subsequent criteria:
• Age ≥18 years.
• These criteria applied to both singleton and multifetal pregnant women.
• The gestational age was less than 12 weeks at the time of randomization, confirmed by a first-trimester ultrasound.
• Each participant must possess at least one of the major risk factors mentioned above.

You may not qualify if:

• Current or prior use of aspirin or other antiplatelet/anticoagulant therapy during the current pregnancy.
• Known hypersensitivity to aspirin.
• Peptic ulcer history, gastrointestinal bleeding, or coagulopathy.
• A platelet count of less than 100,000/μL or the presence of known bleeding disorders is a concern.
• Severe hepatic or renal dysfunction (CKD stage IV or above).
• Known major fetal anomaly or chromosomal abnormality.
• Engaging in a different clinical trial could potentially impact the results.

Sponsors & Collaborators

• Galala University: lead

Study Sites (1)

Eman Hamed

Suez, Suiz, 55443, Egypt

Location

Related Publications (1)

• Alsulami FT, Hamed EM. Early initiation of low-dose aspirin for the prevention of pre-eclampsia in high-risk pregnancies. Sci Rep. 2026 Jan 13;16(1):1761. doi: 10.1038/s41598-025-28078-3.

  PMID: 41530193 DERIVED

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy

Model Details: 2 groups at same time

Study Record Dates

• First Submitted: June 9, 2025
• First Posted: July 25, 2025
• Study Start: February 5, 2023
• Primary Completion: February 12, 2025
• Study Completion: February 12, 2025
• Last Updated: July 25, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)