acetylsalicylic acid
DrugCapsule containing Acetylsalicylic Acid 80mg pill with lactose
Other names: Aspirin, ASA, Asaphen
NCT Number: NCT02280031
Low-dose aspirin started in the first-trimester has been associated with a decrease of preeclampsia, fetal growth restriction and preterm birth in high-risk pregnancies. Multiple pregnancies are considered a risk factor for all those adverse outcomes. The main objective of the current trial is to evaluate whether a dose of 80 mg of aspirin is associated with an improvement of birthweight compared to placebo in twin pregnancies.
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Notify Me18 year and older
Female
Interventional
Phase 2
Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL, Québec, Canada
Twin pregnancies represent approximately 3% of births and are associated with increased risks of complications such as preeclampsia, fetal growth restriction and preterm birth. All of these complications are commonly associated impaired placental function and low birth weight.
Most prophylactic measures tested over the years have failed to prevent these adverse outcomes in twin pregnancies. Since administration of low-dose of aspirin can improve placental function and all these adverse outcomes in high-risk pregnancies, mainly in women with prior adverse outcomes, we suggest that similar benefits could be seen in twins. We are expecting that the administration of low-dose of aspirin starting in the first-trimester in twin pregnancies could lead to an improvement of placental function, a reduction or these adverse perinatal outcomes and therefore to an improvement of birthweight.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Capsule containing Acetylsalicylic Acid 80mg pill with lactose
Other names: Aspirin, ASA, Asaphen
Capsule containing placebo pill with lactose
Other names: Control
Time frame: At delivery
Time frame: At delivery
(birthweight below 2,500 grams)
Time frame: At birth
(birthweight below 1,500 grams)
Time frame: 16-18 and 22-24 weeks
(birthweight below the 10th or 3rd percentile for gestational age)
Time frame: At delivery
(delivery before 37 weeks)
Time frame: At delivery
(delivery before 34 weeks)
Time frame: At delivery
(according to American College of Obstetricians and Gynecologists 2014 guidelines definition)
Time frame: At delivery
(onset of preeclampsia before 34 weeks)
Time frame: 22-24 weeks
Mean uterine artery pulsatility index
Time frame: 16-18 and 22-24 weeks
(PFA-100 below 150)
Time frame: 22-24 weeks
CHU de Quebec-Universite Laval
Other
Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial
Acronym: GAP
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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