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

Sponsor
CHU de Quebec-Universite Laval (Other)
Overall Status
Completed
CT.gov ID
NCT02280031
Collaborator
(none)
50
Enrollment
2
Locations
2
Arms
24
Duration (Months)
25
Patients Per Site
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Acetylsalicylic Acid
  • Drug: Placebo
 Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Prevention
Official Title:
Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial
Study Start Date :
Nov 1, 2014
Actual Primary Completion Date :
Oct 1, 2016
Actual Study Completion Date :
Nov 1, 2016

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Experimental

Acetylsalicylic Acid 80mg administered daily at bedtime

Drug: Acetylsalicylic Acid
Capsule containing Acetylsalicylic Acid 80mg pill with lactose
Other Names:
  • Aspirin
  • ASA
  • Asaphen

    		•
    Placebo Comparator: Control

    Identical placebo administered daily at bedtime

    Drug: Placebo
    Capsule containing placebo pill with lactose
    Other Names:
  • Control

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Birth weight [At delivery]

    Secondary Outcome Measures

    1. Low birth weight [At delivery]

      (birthweight below 2,500 grams)

    2. Very low birth weight [At birth]

      (birthweight below 1,500 grams)

    3. Fetal growth restriction [16-18 and 22-24 weeks]

      (birthweight below the 10th or 3rd percentile for gestational age)

    4. Preterm birth [At delivery]

      (delivery before 37 weeks)

    5. Very preterm birth [At delivery]

      (delivery before 34 weeks)

    6. Preeclampsia [At delivery]

      (according to American College of Obstetricians and Gynecologists 2014 guidelines definition)

    7. Early-onset preeclampsia [At delivery]

      (onset of preeclampsia before 34 weeks)

    8. UtA_PI [22-24 weeks]

      Mean uterine artery pulsatility index

    9. Aspirin resistance [16-18 and 22-24 weeks]

      (PFA-100 below 150)

    10. Cervical length [22-24 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hôpital St-François d'Assise-CHUQ Quebec Canada G1L 3L5
    2 Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL Québec Canada G1V 4G2

    Sponsors and Collaborators

    • CHU de Quebec-Universite Laval

    Investigators

    • Principal Investigator: Emmanuel Bujold, MD,MSc,FRCSC, CHU de Québec

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    CHU de Quebec-Universite Laval
    ClinicalTrials.gov Identifier:
    NCT02280031
    Other Study ID Numbers:
    • 2014-1817
    First Posted:
    Oct 31, 2014
    Last Update Posted:
    Nov 9, 2018
    Last Verified:
    Apr 1, 2016
    Keywords provided by CHU de Quebec-Universite Laval
    Twin Pregnancy
    Pregnancy Complications
    Additional relevant MeSH terms:
    Pre-Eclampsia
    Premature Birth
    Fetal Growth Retardation
    Birth Weight
    Aspirin

    Study Results

    No Results Posted as of Nov 9, 2018