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Trial record 19 of 252 for:    ASPIRIN AND low-dose aspirin

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

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ClinicalTrials.gov Identifier: NCT02280031
Recruitment Status : Completed
First Posted : October 31, 2014
Last Update Posted : November 9, 2018
Sponsor:
Information provided by (Responsible Party):
CHU de Quebec-Universite Laval

Tracking Information
First Submitted Date  ICMJE October 29, 2014
First Posted Date  ICMJE October 31, 2014
Last Update Posted Date November 9, 2018
Study Start Date  ICMJE November 2014
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 31, 2014)
Birth weight [ Time Frame: At delivery ]
Original Primary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
Birth weight [ Time Frame: At birth ]
Change History Complete list of historical versions of study NCT02280031 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2018)
  • Low birth weight [ Time Frame: At delivery ]
    (birthweight below 2,500 grams)
  • Very low birth weight [ Time Frame: At birth ]
    (birthweight below 1,500 grams)
  • Fetal growth restriction [ Time Frame: 16-18 and 22-24 weeks ]
    (birthweight below the 10th or 3rd percentile for gestational age)
  • Preterm birth [ Time Frame: At delivery ]
    (delivery before 37 weeks)
  • Very preterm birth [ Time Frame: At delivery ]
    (delivery before 34 weeks)
  • Preeclampsia [ Time Frame: At delivery ]
    (according to American College of Obstetricians and Gynecologists 2014 guidelines definition)
  • Early-onset preeclampsia [ Time Frame: At delivery ]
    (onset of preeclampsia before 34 weeks)
  • UtA_PI [ Time Frame: 22-24 weeks ]
    Mean uterine artery pulsatility index
  • Aspirin resistance [ Time Frame: 16-18 and 22-24 weeks ]
    (PFA-100 below 150)
  • Cervical length [ Time Frame: 22-24 weeks ]
Original Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
  • Low birth weight (birthweight below 2,500 grams) [ Time Frame: At birth ]
  • Very low birth weight (birthweight below 1,500 grams) [ Time Frame: At birth ]
  • Fetal growth restriction (birthweight below the 10th or 3rd percentile for gestational age) [ Time Frame: 16-18 and 22-24 weeks ]
  • Preterm birth (delivery before 37 weeks) [ Time Frame: At birth ]
  • Very preterm birth (delivery before 34 weeks) [ Time Frame: At birth ]
  • Preeclampsia (according to ACOG 2014 guidelines definition) [ Time Frame: At delivery ]
  • Early-onset preeclampsia (before 34 weeks) [ Time Frame: At delivery ]
  • Mean uterine artery pulsatility index [ Time Frame: 22-24 weeks ]
  • Aspirin resistance (PFA-100 below 150) [ Time Frame: 16-18 and 22-24 weeks ]
  • Cervical length [ Time Frame: 22-24 weeks ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.
Official Title  ICMJE Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Condition  ICMJE
  • Small for Gestational Age
  • Infant, Very Low Birth Weight
  • Fetal Growth Retardation
  • Preeclampsia
  • Premature Birth
Intervention  ICMJE
  • Drug: Acetylsalicylic Acid
    Capsule containing Acetylsalicylic Acid 80mg pill with lactose
    Other Names:
    • Aspirin
    • ASA
    • Asaphen
  • Drug: Placebo
    Capsule containing placebo pill with lactose
    Other Name: Control
Study Arms  ICMJE
  • Active Comparator: Experimental
    Acetylsalicylic Acid 80mg administered daily at bedtime
    Intervention: Drug: Acetylsalicylic Acid
  • Placebo Comparator: Control
    Identical placebo administered daily at bedtime
    Intervention: Drug: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 29, 2014)
50
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2016
Actual Primary Completion Date October 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02280031
Other Study ID Numbers  ICMJE 2014-1817
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party CHU de Quebec-Universite Laval
Study Sponsor  ICMJE CHU de Quebec-Universite Laval
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Emmanuel Bujold, MD,MSc,FRCSC CHU de Québec
PRS Account CHU de Quebec-Universite Laval
Verification Date April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP