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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Active Comparator | Acetylsalicylic Acid 80mg administered daily at bedtime |
|
| Control | Placebo Comparator | Identical placebo administered daily at bedtime |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acetylsalicylic Acid | Drug | Capsule containing Acetylsalicylic Acid 80mg pill with lactose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Birth weight | At delivery |
| Measure | Description | Time Frame |
|---|---|---|
| Low birth weight | (birthweight below 2,500 grams) | At delivery |
| Very low birth weight | (birthweight below 1,500 grams) | At birth |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Emmanuel Bujold, MD,MSc,FRCSC | CHU de Québec | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital St-François d'Assise-CHUQ | Québec | G1L 3L5 | Canada | |||
| Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL |
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| ID | Term |
|---|---|
| D005317 | Fetal Growth Retardation |
| D011225 | Pre-Eclampsia |
| D047928 | Premature Birth |
| D011248 | Pregnancy Complications |
| ID | Term |
|---|---|
| D005315 | Fetal Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D001241 | Aspirin |
| ID | Term |
|---|---|
| D012459 | Salicylates |
| D062385 | Hydroxybenzoates |
| D010636 | Phenols |
| D001555 | Benzene Derivatives |
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| Placebo | Drug | Capsule containing placebo pill with lactose |
|
|
| Fetal growth restriction | (birthweight below the 10th or 3rd percentile for gestational age) | 16-18 and 22-24 weeks |
| Preterm birth | (delivery before 37 weeks) | At delivery |
| Very preterm birth | (delivery before 34 weeks) | At delivery |
| Preeclampsia | (according to American College of Obstetricians and Gynecologists 2014 guidelines definition) | At delivery |
| Early-onset preeclampsia | (onset of preeclampsia before 34 weeks) | At delivery |
| UtA_PI | Mean uterine artery pulsatility index | 22-24 weeks |
| Aspirin resistance | (PFA-100 below 150) | 16-18 and 22-24 weeks |
| Cervical length | 22-24 weeks |
| Québec |
| G1V 4G2 |
| Canada |
| D006130 | Growth Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D046110 | Hypertension, Pregnancy-Induced |
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D006841 |
| Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |