Could a daily aspirin protect diabetic Moms-to-Be?
NCT ID NCT03574909
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether taking low-dose aspirin (150 mg) daily, starting in the first trimester, could reduce pregnancy complications in women with type 1 or type 2 diabetes. The trial included 137 women and looked at outcomes like preeclampsia, early preterm birth, low birth weight, and infant death. The goal was to see if this simple, cheap medicine could improve safety for both mother and baby.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- low-dose aspirin (150 mg prolonged-release capsule)
- What this could lead to
- If it works, this could point toward a simple, low-cost way to lower the risk of serious pregnancy complications like preeclampsia and preterm birth in women with diabetes.
- What could go wrong
- This trial is relatively small (137 participants) and completed, but results may not apply to all women with diabetes. Aspirin also carries a small risk of bleeding or allergic reactions.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
-
137 people
The number who actually took part.
- Started
-
Sep 2018
- Finished
-
Aug 2023
- Lead sponsor
-
Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 years and older
- Sex
-
Female participants only
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Singleton pregnancy with a pre-pregnancy diagnosis of type I or type II diabetes of at least 6 months' duration Exclusion Criteria: * • Aspirin hypersensitivity (prior bronchospasm/ urticarial/ angioedema with aspirin) * Peptic ulcer disease * Known bleeding diathesis * Multifetal gestation * Severe early-onset preeclampsia in a previous pregnancy * Patient already on aspirin * Established chronic renal disease/ macroalbuminuria * Chronic hypertension (antihypertensive therapy in first trimester) * Current selective serotonin reuptake inhibitor (SSRI) use (or SSRI use within 7 days) * Inability to speak or read English * Age less than 18 years * Use of any other investigational medicinal product within previous 30 days * Presence of any illness or condition that might interfere with the patient's ability to comply with the study procedures
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
-
Rotunda Hospital
Dublin, Ireland
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Other studies related to the condition(s) this trial covers.