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

Premature Birth Clinical Trial

— GAP  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280031
• Other study ID #: 2014-1817
• Status: Completed
• Phase: Phase 2
• Start date: November 2014
• Est. completion date: November 2016

Study information

• Verified date: April 2016
• Source: CHU de Quebec-Universite Laval
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2016
• Est. primary completion date: October 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Weight
• Fetal Growth Retardation
• Infant, Very Low Birth Weight
• Pre-Eclampsia
• Preeclampsia
• Premature Birth
• Small for Gestational Age

Intervention

Drug:
• Acetylsalicylic Acid
Capsule containing Acetylsalicylic Acid 80mg pill with lactose
• Placebo
Capsule containing placebo pill with lactose

Locations

Country	Name	City	State
Canada	Hôpital St-François d'Assise-CHUQ	Quebec
Canada	Centre Hospitalier Universitaire de Québec (CHU de Québec)/Pavillon CHUL	Québec

Sponsors (1)

Lead Sponsor	Collaborator
CHU de Quebec-Universite Laval

Country where clinical trial is conducted

Canada, 

Outcome

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