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
EgymedicalpediaProduct
AspirinIndication
pre-eclampsia