An interventional study of Aspirin in Pre-Eclampsia, sponsored by Egymedicalpedia. Recruiting at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2024-02-15.
Sponsored by Egymedicalpedia · Not applicable, Interventional, and Prevention
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
The pathogenesis of preeclampsia (PE) is not fully understood, but it is believed to be associated with impaired early placental development, primarily attributed to defective trophoblast invasion and remodeling of the spiral arterioles .
Various mechanisms have been proposed to contribute to the development of preeclampsia, including angiogenesis, endothelial injury, oxidative stress, and inflammation, which lead to clinical manifestations such as hypertension, proteinuria, and end organ damage .
Preeclampsia is associated with severe short- and long-term maternal and neonatal morbidities, and its occurrence is influenced by risk factors such as diabetes, hypertension, multifetal gestation, as well as the severity and timing of previous preeclampsia episodes .
While low-dose aspirin (LDA) has shown some benefit in preventing preeclampsia and fetal growth restriction when initiated before 16 weeks' gestation, there is no widely effective prophylactic therapy, and delivery remains the primary approach to prevent maternal morbidity and mortality.
Recent research has indicated that LDA intervention, following firsttrimester screening of women at risk of developing preeclampsia, can significantly reduce the occurrence of preterm PE .
As such, LDA's use is increasingly considered standard practice for women at high risk of developing preeclampsia .
Nevertheless, the potential role of low-dose aspirin in preventing early pregnancy loss in this specific high-risk population remains underexplored. Given that abnormal placentation and inflammation are associated with both early and late pregnancy losses, low-dose aspirin therapy has the potential to mitigate these complications.
However, current evidence on aspirin's efficacy in preventing early pregnancy loss is limited. Considering this, we propose a randomized, double-blind, placebocontrolled trial to investigate whether low-dose aspirin (81 mg daily) administered before 16 weeks of gestation can effectively reduce the rate of early pregnancy loss in women at high risk of developing preeclampsia.
916 studies on the registry are indexed under Pre-Eclampsia; 243 are open to participants now.
This study's planned enrollment of 250 is above the median of 110 across 480 interventional studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Egymedicalpedia is the lead sponsor of 58 studies on the registry; 13 are open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
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Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
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You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
About 125 Participants in the treatment group will receive 81 mg low-dose aspirin once daily starting from the time of enrollment and continuing until the end of pregnancy
Drug: Aspirin
About 125 Participants will receive only the routine care of pregnancy until the end of pregnancy
Drug: Aspirin
To investigate the efficacy of low dose aspirin for prevention of early pregnancy loss in women at high risk of preeclampsia.
Also known as: Low Dose Asprin
Prevention of pregnancy loss
To investigate the efficacy of low dose aspirin (81 mg) for prevention of early pregnancy loss in women at high risk of preeclampsia.
Time frame: From base line to the end of pregnancy
Plan to share: Undecided
No publications or documents are linked to this record.
Started Jul 2023 (actual). Primary completion is estimated for Jul 2025, 24 months after the start.
Of 176 interventional studies with no phase under Pre-Eclampsia, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 43. This study's planned 24 months is close to that.
How these figures are worked out, and which studies are left out of them.
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Studies of the drug tested here: Aspirin