Clinical trial

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

Name
Hany Hosny
Description
Preeclampsia is a pregnancy-specific, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide. The World Health Organization estimates that approximately 76,000 maternal deaths annually are attributed to preeclampsia, accounting for 16% of global maternal mortality, with the majority occurring in low- and middle-income countries
Trial arms
Trial start
2023-07-01
Estimated PCD
2025-07-01
Trial end
2025-07-15
Status
Recruiting
Treatment
Aspirin
To investigate the efficacy of low dose aspirin for prevention of early pregnancy loss in women at high risk of preeclampsia.
Arms:
Group A (Experimental Group), Group B (Control Group)
Other names:
Low Dose Asprin
Size
250
Primary endpoint
Prevention of pregnancy loss
From base line to the end of pregnancy
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "The The study's findings have the potential to clarify aspirin's role in preventing adverse pregnancy outcomes related to placental dysfunction and improve the management of women at risk of placental-mediated complications.", 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 250, 'type': 'ESTIMATED'}}
Updated at
2024-02-15

1 organization

1 product

1 indication

Organization
Egymedicalpedia
Product
Aspirin
Indication
pre-eclampsia