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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-11-30

Study Completion Date

2016-11-30

Brief Summary

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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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Detailed Description

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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.

Conditions

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Small for Gestational Age Infant, Very Low Birth Weight Fetal Growth Retardation Preeclampsia Premature Birth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Experimental

Acetylsalicylic Acid 80mg administered daily at bedtime

Group Type ACTIVE_COMPARATOR

Acetylsalicylic Acid

Intervention Type DRUG

Capsule containing Acetylsalicylic Acid 80mg pill with lactose

Control

Identical placebo administered daily at bedtime

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Capsule containing placebo pill with lactose

Interventions

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Acetylsalicylic Acid

Capsule containing Acetylsalicylic Acid 80mg pill with lactose

Intervention Type DRUG

Placebo

Capsule containing placebo pill with lactose

Intervention Type DRUG

Other Intervention Names

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Aspirin ASA Asaphen Control

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes