NCT02280031

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Nov 2014

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 29, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 31, 2014

Completed
1 day until next milestone

Study Start

First participant enrolled

November 1, 2014

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2016

Completed
Last Updated

November 9, 2018

Status Verified

April 1, 2016

Enrollment Period

1.9 years

First QC Date

October 29, 2014

Last Update Submit

November 7, 2018

Conditions

Small for Gestational AgeInfant, Very Low Birth WeightFetal Growth RetardationPreeclampsiaPremature Birth

Keywords

Twin PregnancyPregnancy Complications

Outcome Measures

Primary Outcomes (1)

  • Birth weight

    At delivery

Secondary Outcomes (10)

  • Low birth weight

    At delivery

  • Very low birth weight

    At birth

  • Fetal growth restriction

    16-18 and 22-24 weeks

  • Preterm birth

    At delivery

  • Very preterm birth

    At delivery

  • +5 more secondary outcomes

Study Arms (2)

Experimental

ACTIVE COMPARATOR

Acetylsalicylic Acid 80mg administered daily at bedtime

Drug: Acetylsalicylic Acid

Control

PLACEBO COMPARATOR

Identical placebo administered daily at bedtime

Drug: Placebo

Interventions

Acetylsalicylic AcidDRUG

Capsule containing Acetylsalicylic Acid 80mg pill with lactose

Also known as: Aspirin, ASA, Asaphen
Experimental
PlaceboDRUG

Capsule containing placebo pill with lactose

Also known as: Control
Control

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Gestational age between 8 0/7 and 13 6/7 weeks
  • Twin pregnancy confirmed by ultrasound

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital St-François d'Assise-CHUQ

Québec, G1L 3L5, Canada

Location

Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL

Québec, G1V 4G2, Canada

Location

MeSH Terms

Conditions

Fetal Growth RetardationPre-EclampsiaPremature BirthPregnancy Complications

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Fetal DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesGrowth DisordersPathologic ProcessesPathological Conditions, Signs and SymptomsHypertension, Pregnancy-InducedObstetric Labor, PrematureObstetric Labor Complications

Intervention Hierarchy (Ancestors)

SalicylatesHydroxybenzoatesPhenolsBenzene DerivativesHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic Chemicals

Study Officials

  • Emmanuel Bujold, MD,MSc,FRCSC

    CHU de Québec

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 29, 2014

First Posted

October 31, 2014

Study Start

November 1, 2014

Primary Completion

October 1, 2016

Study Completion

November 1, 2016

Last Updated

November 9, 2018

Record last verified: 2016-04

Locations

CA(2)