Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.

Laval University

Status and phase

Completed

Phase 2

Conditions

Fetal Growth Retardation

Preeclampsia

Small for Gestational Age

Infant, Very Low Birth Weight

Premature Birth

Treatments

Drug: Placebo

Drug: Acetylsalicylic Acid

Study type

Interventional

Funder types

Other

Identifiers

NCT02280031

2014-1817

Details and patient eligibility

About

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.

Full 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.

Enrollment

50 patients

Sex

Female

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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