Using low-dose aspirin to prevent early pregnancy loss in women at risk of preeclampsia

Low Dose Aspirin for Prevention of Early Pregnancy Loss in Women at High Risk of Preeclampsia

This study is testing if low-dose aspirin can help prevent early pregnancy loss in women who are at high risk for developing preeclampsia.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 250 (estimated)
• Ages: 18 Years to 40 Years
• Sex: Female
• Sponsor: Egymedicalpedia (Industry-sponsored)
• Locations: 1 site (Asyūţ, Assuit)
• Trial ID: NCT06261203 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of low-dose aspirin in preventing early pregnancy loss among women who are at high risk for developing preeclampsia. The study focuses on women with specific risk factors, such as advanced maternal age, obesity, and previous adverse pregnancy outcomes. Participants will be administered low-dose aspirin before 8 weeks of gestation and monitored for outcomes related to early pregnancy loss. The trial aims to provide insights into whether this intervention can improve pregnancy outcomes in this vulnerable population.

Who should consider this trial

Good fit: Ideal candidates for this study are women with singleton pregnancies who are less than 8 weeks gestation and have multiple risk factors for preeclampsia.

Not a fit: Patients who have known allergies to aspirin or are on anticoagulant medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly reduce the incidence of early pregnancy loss in women at high risk for preeclampsia.

How similar studies have performed: Previous studies have shown that low-dose aspirin can be effective in reducing the risk of preeclampsia, suggesting potential success for this novel application in preventing early pregnancy loss.

Eligibility criteria

Inclusion Criteria:

* Singleton pregnancy
* Before 8 weeks gestation
* Women at high risk of preeclampsia according to Royal College of Obstetricians and Gynecologists (RCOG) (Robson et al., 2013):
* Maternal age ≥ 35 years.
* Nulliparity.
* BMI ≥ 30 kg/m2.
* Smoking of r ≥ 10 cigarettes per day.
* Previous history of small for gestational age (SGA) baby.
* Previous history of stillbirth.
* Pregnancy interval \< 6 months or ≥ 60months.
* Chronic hypertension.
* Diabetes with vascular disease.
* Willingness to participate in the study and provide informed written consent.

Exclusion Criteria:

* Known allergy or hypersensitivity to aspirin or other nonsteroidal anti-inflammatory drugs (NSAIDs)
* Use of any anticoagulant medication (e.g., heparin, warfarin, clopidogrel)
* Use of low-dose aspirin for any indication prior to the current pregnancy
* Chronic use of NSAIDs or corticosteroids
* History of bleeding disorder or active bleeding
* Any medical condition that may contraindicate the use of low-dose aspirin (e.g., peptic ulcer disease, asthma, liver, or kidney disease)
* Multiple gestation
* Inability to provide informed consent or comply with the study requirements.

Where this trial is running

Asyūţ, Assuit

• Assuit University hospitals — Asyūţ, Assuit, Egypt (Recruiting)

Study contacts

• Study coordinator: Hany Hosny, Resident

Conditions Pre-Eclampsia