Status:
COMPLETED
Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.
Lead Sponsor:
CHU de Quebec-Universite Laval
Conditions:
Small for Gestational Age
Infant, Very Low Birth Weight
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
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 consi...
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 complicati...
Eligibility Criteria
Inclusion
- Gestational age between 8 0/7 and 13 6/7 weeks
- Twin pregnancy confirmed by ultrasound
Exclusion
- 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
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2016
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT02280031
Start Date
November 1 2014
End Date
November 1 2016
Last Update
November 9 2018
Active Locations (2)
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1
Hôpital St-François d'Assise-CHUQ
Québec, Canada, G1L 3L5
2
Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL
Québec, Canada, G1V 4G2