Overview

This trial is active, not recruiting.

Conditions pre-eclampsia, intra-uterine growth restriction
Treatments aspirin, placebo
Phase phase 4
Sponsor University Hospital, Tours
Start date June 2012
End date December 2016
Trial size 1106 participants
Trial identifier NCT01729468, 2011-003536-30, 2012-R8, 912140, A120316-72, PHRN08-FP/PERASTUN

Summary

The objective of this study is to test the efficacy of low-dose aspirin (160 mg/day), given bedtime and started early during pregnancy (≤ 15 +6 weeks of gestation) in nulliparous pregnant women selected as "high-risk" by the presence of a bilateral uterine artery notch and/or bilateral uterine artery PI ≥ 1.7 during the first trimester ultrasound scan (11-13+6 weeks), to prevent the occurrence of pre-eclampsia or small for gestational age at birth.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose prevention
Arm
(Experimental)
Aspirin 160 mg per day
aspirin
Aspirin, 160 mg per day until 34 weeks of gestation
(Placebo Comparator)
Placebo 160 mg per day
placebo
Placebo, 160 mg per day until 34 weeks of gestation

Primary Outcomes

Measure
Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (≤5th percentile on customized growth curves)
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks

Secondary Outcomes

Measure
Small for gestational age at birth (≤5th percentile on customized growth curves)
time frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Severe pre-eclampsia (ACOG criteria)
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Perinatal death (22 weeks of gestation to 7 days postnatal)
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Pre-eclampsia (ACOG criteria)
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Adverse effects of treatment
time frame: women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks

Eligibility Criteria

Female participants at least 18 months old.

Inclusion Criteria: - Age ≥ 18 years - Nulliparous (no previous pregnancy ≥ 22 SA) - Singleton pregnancy - Gestational age ≤ 15 +6 weeks - Bilateral uterine artery notch (grade ≥ 2) and/or bilateral uterine artery PI ≥ 1.7 during first trimester ultrasound (CRL between 45 and 84 mm) - Maternal informed consent obtained - Affiliated to social security system Exclusion Criteria: - Women considering voluntary pregnancy termination (≤ 14 weeks) - Pre-existing (maternal) indication for premature delivery before 37 weeks - Fetal condition detected during the first trimester scan (fetal malformation or nuchal translucency ≥ 95th percentile) - Women under anticoagulation - Allergy or hypersensitivity to Kardegic® or one of its constituents - Secondary hemostasis disorder responsible for bleeding or risk of bleeding - Peptic ulcer under evolution - Lupus or antiphospholipid syndrome

Additional Information

Official title Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
Principal investigator Franck PERROTIN, MD-PhD
Trial information was received from ClinicalTrials.gov and was last updated in June 2016.
Information provided to ClinicalTrials.gov by University Hospital, Tours.