Small for Gestational AgePhase 2GAPNCT02280031
Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial.
A Phase 2 study testing Acetylsalicylic Acid in people with Small for Gestational Age and Infant, Very Low Birth Weight, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Small for Gestational Age, Infant, Very Low Birth Weight, Fetal Growth Retardation
- What is being tested?
- Acetylsalicylic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 2 sitesCanada
- Study dates
- Nov 2014to Nov 2016
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Gestational age between 8 0/7 and 13 6/7 weeks
- Twin pregnancy confirmed by ultrasound
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hôpital St-François d'Assise-CHUQ
Québec, G1L 3L5
Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL
Québec, G1V 4G2
About this study
Official title: 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.
Read the 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.
- Conditions
- Small for Gestational Age, Infant, Very Low Birth Weight, Fetal Growth Retardation, Preeclampsia, Premature Birth
- Being tested
- Acetylsalicylic Acid, Placebo
- Keywords
- Twin Pregnancy, Pregnancy Complications
- Medical subject headings
- Fetal Growth Retardation, Pre-Eclampsia, Premature Birth, Pregnancy Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Acetylsalicylic AcidDrug
Also called Aspirin, ASA, Asaphen
Capsule containing Acetylsalicylic Acid 80mg pill with lactose
PlaceboDrug
Also called Control
Capsule containing placebo pill with lactose
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Active comparator | Acetylsalicylic Acid 80mg administered daily at bedtime Receives: Drug: Acetylsalicylic Acid |
| Control | Placebo comparator | Identical placebo administered daily at bedtime Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth weight
Measured: At delivery
Secondary outcomes (10)
Low birth weight
(birthweight below 2,500 grams)
Measured: At delivery
Very low birth weight
(birthweight below 1,500 grams)
Measured: At birth
Fetal growth restriction
(birthweight below the 10th or 3rd percentile for gestational age)
Measured: 16-18 and 22-24 weeks
Preterm birth
(delivery before 37 weeks)
Measured: At delivery
Very preterm birth
(delivery before 34 weeks)
Measured: At delivery
Preeclampsia
(according to American College of Obstetricians and Gynecologists 2014 guidelines definition)
Measured: At delivery
Early-onset preeclampsia
(onset of preeclampsia before 34 weeks)
Measured: At delivery
UtA_PI
Mean uterine artery pulsatility index
Measured: 22-24 weeks
Aspirin resistance
(PFA-100 below 150)
Measured: 16-18 and 22-24 weeks
Cervical length
Measured: 22-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2014 (estimated)
- Study startNov 2014
- Primary completionOct 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Small for Gestational AgeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuel Bujold, MD,MSc,FRCSC, Principal investigator, CHU de Québec
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02280031
- Sponsor's protocol ID
- 2014-1817
- Acronym
- GAP
- Status last verified
- Apr 2016
- First submitted
- 29 Oct 2014
- Last updated
- 9 Nov 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Low Dose Aspirin on Birthweight in Twins: The GAP Trial
- ClinicalTrials.gov ID
- NCT02280031
- Acronym / sponsor ID
- GAP / 2014-1817
- Conditions
- Small for Gestational Age, Infant, Very Low Birth Weight, Fetal Growth Retardation, Preeclampsia, Premature Birth
- Keywords
- Twin Pregnancy, Pregnancy Complications
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- Oct 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 31 Oct 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Active comparator | Drug: Acetylsalicylic AcidAcetylsalicylic Acid 80mg administered daily at bedtime |
| Control | Placebo comparator | Drug: PlaceboIdentical placebo administered daily at bedtime |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Gestational age between 8 0/7 and 13 6/7 weeks
- Twin pregnancy confirmed by ultrasound
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Acetylsalicylic AcidAlso: Aspirin, ASA, AsaphenCapsule containing Acetylsalicylic Acid 80mg pill with lactose | Drug | Experimental |
| PlaceboAlso: ControlCapsule containing placebo pill with lactose | Drug | Control |
Primary outcome
Birth weight
Time frame: At delivery
10 secondary outcomes
Low birth weight
Time frame: At delivery
Very low birth weight
Time frame: At birth
Fetal growth restriction
Time frame: 16-18 and 22-24 weeks
Preterm birth
Time frame: At delivery
Very preterm birth
Time frame: At delivery
Preeclampsia
Time frame: At delivery
Early-onset preeclampsia
Time frame: At delivery
UtA_PI
Time frame: 22-24 weeks
Aspirin resistance
Time frame: 16-18 and 22-24 weeks
Cervical length
Time frame: 22-24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuel Bujold, MD,MSc,FRCSC principal investigator
CHU de Québec
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Acetylsalicylic Acid in people with Small for Gestational Age and Infant, Very Low Birth Weight, run by CHU de Quebec-Universite Laval at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Birth weight (time frame: At delivery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Nov 2018.