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

Pre-eclampsia Clinical Trial

— PERASTUN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01729468
• Other study ID #: PHRN08-FP/PERASTUN
• Secondary ID: 2011-003536-3020
• Status: Completed
• Phase: Phase 4
• First received: November 2, 2012
• Last updated: February 16, 2018
• Start date: June 27, 2012
• Est. completion date: October 25, 2016

Study information

• Verified date: February 2018
• Source: University Hospital, Tours
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1106
• Est. completion date: October 25, 2016
• Est. primary completion date: October 25, 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Months and older

Eligibility

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

Related Conditions & MeSH terms

• Eclampsia
• Fetal Growth Retardation
• Intra-uterine Growth Restriction
• Pre-eclampsia

Intervention

Drug:
• Aspirin
Aspirin, 160 mg per day until 34 weeks of gestation
• Placebo
Placebo, 160 mg per day until 34 weeks of gestation

Locations

Country	Name	City	State
France	Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux	Bordeaux
France	Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon	Bron
France	Service de gynécologie-obstétrique, Polyclinique du PARC	Caen
France	Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand	Clermont-Ferrand
France	Service de gynécologie-obstétrique, Hôpital Couple Enfant, CHRU de Grenoble	Grenoble
France	Cabinet Mosaïque Santé	La Chaussée St Victor
France	Service de gynécologie-obstétrique, CHR Le Mans	Le Mans
France	Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille	Lille
France	Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier	Montpellier
France	Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes	Nantes
France	Service de gynécologie-obstétrique, Polyclinique de l'Atlantique	Nantes
France	Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes	Nîmes
France	Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans	Orléans
France	Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP	Paris
France	Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse	Toulouse
France	Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours	Tours
Martinique	Service de gynécologie-obstétrique, Maison de la Femme de la Mère et de l'Enfant, CHU de Fort de France	Fort de France

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Tours

Countries where clinical trial is conducted

France,  Martinique, 

References & Publications (3)

Ayala DE, Ucieda R, Hermida RC. Chronotherapy with low-dose aspirin for prevention of complications in pregnancy. Chronobiol Int. 2013 Mar;30(1-2):260-79. doi: 10.3109/07420528.2012.717455. Epub 2012 Sep 24. — View Citation

Plasencia W, Maiz N, Poon L, Yu C, Nicolaides KH. Uterine artery Doppler at 11 + 0 to 13 + 6 weeks and 21 + 0 to 24 + 6 weeks in the prediction of pre-eclampsia. Ultrasound Obstet Gynecol. 2008 Aug;32(2):138-46. doi: 10.1002/uog.5402. — View Citation

Poon LC, Syngelaki A, Akolekar R, Lai J, Nicolaides KH. Combined screening for preeclampsia and small for gestational age at 11-13 weeks. Fetal Diagn Ther. 2013;33(1):16-27. doi: 10.1159/000341712. Epub 2012 Sep 13. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mode of delivery (vaginal or cesarean)		women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
Other	Mode of anesthesia for delivery		women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
Primary	Preeclampsia (diagnosed per ACOG criteria) and small for gestational age at birth (=5th percentile on customized growth curves)		women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Secondary	Small for gestational age at birth (=5th percentile on customized growth curves)		women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks
Secondary	Pre-eclampsia (ACOG criteria) requiring delivery before 34 weeks		women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Secondary	Severe pre-eclampsia (ACOG criteria)		women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Secondary	Perinatal death (22 weeks of gestation to 7 days postnatal)		women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Secondary	Pre-eclampsia (ACOG criteria)		women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks
Secondary	Adverse effects of treatment		women will be followed for the duration of pregnancy and postpartum, an expected average of 26 to 31 weeks