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

Phase 2

Completed

• Conditions: Fetal Growth Retardation; Premature Birth; Infant, Very Low Birth Weight; Small for Gestational Age; Preeclampsia
• Interventions: Drug: Placebo; Drug: Acetylsalicylic Acid

• Registration Number: NCT02280031
• Lead Sponsor: CHU de Quebec-Universite Laval

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2014-10-29
• Study First Submitted QC: 2014-10-29
• Study First Posted: 2014-10-31
• Study Start: 2014-11
• Status Verified: 2016-04
• Primary Completion: 2016-10
• Study Completion: 2016-11
• Last Update Submitted: 2018-11-07
• Last Update Posted: 2018-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Placebo	Identical placebo administered daily at bedtime
Experimental	Acetylsalicylic Acid	Acetylsalicylic Acid 80mg administered daily at bedtime

Primary Outcome Measures

Name	Time	Method
Birth weight	At delivery

Secondary Outcome Measures

Name	Time	Method
Low birth weight	At delivery	(birthweight below 2,500 grams)
Very low birth weight	At birth	(birthweight below 1,500 grams)
Fetal growth restriction	16-18 and 22-24 weeks	(birthweight below the 10th or 3rd percentile for gestational age)
Preterm birth	At delivery	(delivery before 37 weeks)
Very preterm birth	At delivery	(delivery before 34 weeks)
Preeclampsia	At delivery	(according to American College of Obstetricians and Gynecologists 2014 guidelines definition)
Early-onset preeclampsia	At delivery	(onset of preeclampsia before 34 weeks)
UtA_PI	22-24 weeks	Mean uterine artery pulsatility index
Aspirin resistance	16-18 and 22-24 weeks	(PFA-100 below 150)
Cervical length	22-24 weeks

Trial Locations

Locations (2)

Hôpital St-François d'Assise-CHUQ; 🇨🇦 Quebec, Canada

Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL; 🇨🇦 Québec, Canada