Clinical trial NCT02280031: Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.
Official title: Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Small for Gestational Age
Infant, Very Low Birth Weight
Fetal Growth Retardation
Preeclampsia
Premature Birth
Keywords: Twin Pregnancy
Pregnancy Complications
Lead sponsor: CHU de Quebec-Universite Laval
Sponsor class: OTHER
First posted: 2014-10-31
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Birth weight
timeFrame: At delivery
Secondary outcomes:
measure: Low birth weight
timeFrame: At delivery
measure: Very low birth weight
timeFrame: At birth
measure: Fetal growth restriction
timeFrame: 16-18 and 22-24 weeks
measure: Preterm birth
timeFrame: At delivery
measure: Very preterm birth
timeFrame: At delivery
measure: Preeclampsia
timeFrame: At delivery
measure: Early-onset preeclampsia
timeFrame: At delivery
measure: UtA_PI
timeFrame: 22-24 weeks
measure: Aspirin resistance
timeFrame: 16-18 and 22-24 weeks
measure: Cervical length
timeFrame: 22-24 weeks
Other outcomes:
Locations:
city: Quebec
country: Canada
facility: Hôpital St-François d'Assise-CHUQ
city: Québec
country: Canada
facility: Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL
Study officials:
affiliation: CHU de Québec
name: Emmanuel Bujold, MD,MSc,FRCSC
role: PRINCIPAL_INVESTIGATOR
References: