Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01729468
• Date of registration: 02/11/2012
• Prospective Registration: No
• Primary sponsor: University Hospital, Tours
• Public title: Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers PERASTUN
• Scientific title: Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers
• Date of first enrolment: June 27, 2012
• Target sample size: 1106
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01729468
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Prevention. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 4

Countries of recruitment

France, Martinique

Contacts

• Name: Franck PERROTIN, MD-PhD
• Affiliation: University Hospital, Tours

Key inclusion & exclusion criteria

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



Age minimum: 18 Months
Age maximum: N/A
Gender: Female

Health Condition(s) or Problem(s) studied

Pre-eclampsia

Intra-uterine Growth Restriction

Intervention(s)

Drug: Aspirin

Drug: Placebo

Primary Outcome(s)

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 Outcome(s)

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]

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]

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]

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]

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]

Secondary ID(s)

2011-003536-30

A120316-72

PHRN08-FP/PERASTUN

2012-R8

912140

Source(s) of Monetary Support

Please refer to primary and secondary sponsors