Fetal Growth Retardation, Infant, Very Low Birth Weight, Preeclampsia, Premature Birth, Small for Gestational Age
Conditions
Keywords
Twin Pregnancy, Pregnancy Complications
Brief summary
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.
Detailed description
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.
Interventions
DRUGAcetylsalicylic Acid
Capsule containing Acetylsalicylic Acid 80mg pill with lactose
DRUGPlacebo
Capsule containing placebo pill with lactose
Sponsors
CHU de Quebec-Universite Laval
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Gestational age between 8 0/7 and 13 6/7 weeks * Twin pregnancy confirmed by ultrasound
Exclusion criteria
* One or two negative heart beat * Previous hypertensive disorder of pregnancy * Pre-existing hypertension or diastolic blood pressure \>90 mmHg at randomization * Pre-existing nephropathy * Pre-existing diabetes (type 1 or 2) * Anaphylactic allergy to lactose * Known coagulopathy (antithrombin III deficiency, factor V Leiden, antiphospholipid syndrome, the prothrombin mutation, deficiency of protein S or protein C) * Use of heparin or other anticoagulants. * Contre-indications to aspirin * Discordance of crown-rump length greater than 20%. * Fetal anomalies (cystic hygroma, nuchal translucency \> 95th percentile, anencephaly, omphalocele, etc.) * Previous or current gastric ulcer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Birth weight | At delivery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Very low birth weight | At birth | (birthweight below 1,500 grams) |
| Fetal growth restriction | 16-18 and 22-24 weeks | (birthweight below the 10th or 3rd percentile for gestational age) |
| Preterm birth | At delivery | (delivery before 37 weeks) |
| Very preterm birth | At delivery | (delivery before 34 weeks) |
| Low birth weight | At delivery | (birthweight below 2,500 grams) |
| Early-onset preeclampsia | At delivery | (onset of preeclampsia before 34 weeks) |
| UtA_PI | 22-24 weeks | Mean uterine artery pulsatility index |
| Aspirin resistance | 16-18 and 22-24 weeks | (PFA-100 below 150) |
| Cervical length | 22-24 weeks | — |
| Preeclampsia | At delivery | (according to American College of Obstetricians and Gynecologists 2014 guidelines definition) |
Countries
Canada
Outcome results
None listed