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)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 1 (2 locations)

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