NCT02280031

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 50 (actual)
• Sponsor: CHU de Quebec-Universite Laval · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Small for Gestational Age
• Infant, Very Low Birth Weight
• Fetal Growth Retardation
• Preeclampsia
• Premature Birth

Interventions

Type	Name	Description
DRUG	Acetylsalicylic Acid	Capsule containing Acetylsalicylic Acid 80mg pill with lactose
DRUG	Placebo	Capsule containing placebo pill with lactose

Timeline

• Start date: 2014-11-01
• Primary completion: 2016-10-01
• Completion: 2016-11-01
• First posted: 2014-10-31
• Last updated: 2018-11-09

Locations

2 sites across 1 country: Canada