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

Primary Purpose

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

Status

Completed

Phase

Phase 2

Locations

Canada

Study Type

Interventional

Intervention

Acetylsalicylic Acid

Placebo

About this trial

This is an interventional prevention trial for Small for Gestational Age focused on measuring Twin Pregnancy, Pregnancy Complications

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Hôpital St-François d'Assise-CHUQ
Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Experimental

Control

Arm Description

Acetylsalicylic Acid 80mg administered daily at bedtime

Identical placebo administered daily at bedtime

Outcomes

Primary Outcome Measures

Birth weight

Secondary Outcome Measures

Low birth weight

(birthweight below 2,500 grams)

Very low birth weight

(birthweight below 1,500 grams)

Fetal growth restriction

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

Preterm birth

(delivery before 37 weeks)

Very preterm birth

(delivery before 34 weeks)

Preeclampsia

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

Early-onset preeclampsia

(onset of preeclampsia before 34 weeks)

UtA_PI

Mean uterine artery pulsatility index

Aspirin resistance

(PFA-100 below 150)

Cervical length

Full Information

NCT ID

NCT02280031

First Posted

October 29, 2014

Last Updated

November 7, 2018

Sponsor

CHU de Quebec-Universite Laval

1. Study Identification

Unique Protocol Identification Number

NCT02280031

Brief Title

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

Acronym

GAP

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

April 2016

Overall Recruitment Status

Completed

Study Start Date

November 2014 (undefined)

Primary Completion Date

October 2016 (Actual)

Study Completion Date

November 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

CHU de Quebec-Universite Laval

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

Keywords

Twin Pregnancy, Pregnancy Complications

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Experimental

Arm Type

Active Comparator

Arm Description

Acetylsalicylic Acid 80mg administered daily at bedtime

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Identical placebo administered daily at bedtime

Intervention Type

Drug

Intervention Name(s)

Acetylsalicylic Acid

Other Intervention Name(s)

Aspirin, ASA, Asaphen

Intervention Description

Capsule containing Acetylsalicylic Acid 80mg pill with lactose

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Control

Intervention Description

Capsule containing placebo pill with lactose

Primary Outcome Measure Information:

Title

Birth weight

Time Frame

At delivery

Secondary Outcome Measure Information:

Title

Low birth weight

Description

(birthweight below 2,500 grams)

Time Frame

At delivery

Title

Very low birth weight

Description

(birthweight below 1,500 grams)

Time Frame

At birth

Title

Fetal growth restriction

Description

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

Time Frame

16-18 and 22-24 weeks

Title

Preterm birth

Description

(delivery before 37 weeks)

Time Frame

At delivery

Title

Very preterm birth

Description

(delivery before 34 weeks)

Time Frame

At delivery

Title

Preeclampsia

Description

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

Time Frame

At delivery

Title

Early-onset preeclampsia

Description

(onset of preeclampsia before 34 weeks)

Time Frame

At delivery

Title

UtA_PI

Description

Mean uterine artery pulsatility index

Time Frame

22-24 weeks

Title

Aspirin resistance

Description

(PFA-100 below 150)

Time Frame

16-18 and 22-24 weeks

Title

Cervical length

Time Frame

22-24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Emmanuel Bujold, MD,MSc,FRCSC

Organizational Affiliation

CHU de Québec

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hôpital St-François d'Assise-CHUQ

City

Quebec

ZIP/Postal Code

G1L 3L5

Country

Canada

Facility Name

Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL

City

Québec

ZIP/Postal Code

G1V 4G2

Country

Canada

12. IPD Sharing Statement

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

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