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NCT Number: NCT02280031

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

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

acetylsalicylic acid

Drug

Capsule containing Acetylsalicylic Acid 80mg pill with lactose

Other names: Aspirin, ASA, Asaphen

Placebo

Drug

Capsule containing placebo pill with lactose

Other names: Control

Primary outcomes

  1. Birth weight

    Time frame: At delivery

Secondary outcomes

  1. Low birth weight

    Time frame: At delivery

    (birthweight below 2,500 grams)

  2. Very low birth weight

    Time frame: At birth

    (birthweight below 1,500 grams)

  3. Fetal growth restriction

    Time frame: 16-18 and 22-24 weeks

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

  4. Preterm birth

    Time frame: At delivery

    (delivery before 37 weeks)

  5. Very preterm birth

    Time frame: At delivery

    (delivery before 34 weeks)

  6. Preeclampsia

    Time frame: At delivery

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

  7. Early-onset preeclampsia

    Time frame: At delivery

    (onset of preeclampsia before 34 weeks)

  8. UtA_PI

    Time frame: 22-24 weeks

    Mean uterine artery pulsatility index

  9. Aspirin resistance

    Time frame: 16-18 and 22-24 weeks

    (PFA-100 below 150)

  10. Cervical length

    Time frame: 22-24 weeks

Sponsors and collaborators

Lead sponsor

CHU de Quebec-Universite Laval

Other

Registry information

Official study title

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

Acronym: GAP

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Oct 31, 2014
Registry last updated
Nov 9, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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