Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers (PERASTUN)
This study is currently recruiting participants.
Verified November 2012 by University Hospital, Tours
Sponsor:
University Hospital, Tours
Information provided by (Responsible Party):
University Hospital, Tours
ClinicalTrials.gov Identifier:
NCT01729468
First received: November 2, 2012
Last updated: November 14, 2012
Last verified: November 2012
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Pre-eclampsia Intra-uterine Growth Restriction |
Drug: Aspirin Drug: Placebo |
Phase 4 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Prevention |
| Official Title: | Prevention of Pre-eclampsia and SGA by Low-Dose Aspirin in Nulliparous Women With Abnormal First-trimester Uterine Artery Dopplers |
Resource links provided by NLM:
Further study details as provided by University Hospital, Tours:
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
Other Outcome Measures:
- Mode of delivery (vaginal or cesarean) [ Time Frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks ] [ Designated as safety issue: No ]
- Mode of anesthesia for delivery [ Time Frame: women will be followed for the duration of pregnancy, an expected average of 25 to 30 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 4972 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | June 2015 |
| Estimated Primary Completion Date: | June 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Aspirin
Aspirin 160 mg per day
|
Drug: Aspirin
Aspirin, 160 mg per day until 34 weeks of gestation
Other Name: Aspirin
|
|
Placebo Comparator: Placebo
Placebo 160 mg per day
|
Drug: Placebo
Placebo, 160 mg per day until 34 weeks of gestation
Other Name: Placebo
|
Eligibility| Ages Eligible for Study: | 18 Months and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01729468
Contacts
| Contact: Franck PERROTIN, MD-PhD | +33(0)2.47.47.47.39 | franck.perrotin@med.univ-tours.fr |
| Contact: Yoann DESVIGNES | +33(0)2.47.47.46.32 | yoann.desvignes@med.univ-tours.fr |
Locations
| France | |
| Service de Gynécologie-Obstétrique, Groupe Hospitalier Pellegrin, CHRU de Bordeaux | Not yet recruiting |
| Bordeaux, France, 33000 | |
| Contact: Dominique Dallay, MD-PhD | |
| Principal Investigator: Dominqiue Dallay, MD-PhD | |
| Service de Gynécologie-Obstétrique, HFME, Hospices Civils de Lyon | Not yet recruiting |
| Bron, France, 69677 | |
| Contact: Muriel Doret, MD | |
| Principal Investigator: Muriel Doret, MD | |
| Service de Gynécologie-Obstétrique, Hôpital Côte de Nacre, CHU de Caen | Not yet recruiting |
| Caen, France, 14033 | |
| Contact: Guillaume Benoist, MD | |
| Principal Investigator: Guillaume Benoist, MD | |
| Service de Gynécologie-Obstétrique, Hôpital d'Estaing, CHU de Clermont-Ferrand | Recruiting |
| Clermont-Ferrand, France, 63003 | |
| Contact: Didier Lemery, MD-PhD | |
| Principal Investigator: Didier Lemery, MD-PhD | |
| Cabinet Mosaïque Santé | Recruiting |
| La Chaussée St Victor, France, 41260 | |
| Contact: Georges Haddad, MD | |
| Principal Investigator: Georges Haddad, MD | |
| Centre Européen de Diagnostic et d'Exploration de la Femme | Not yet recruiting |
| Le Chesnay, France, 78150 | |
| Contact: Jean Pierre Bernard, MD | |
| Principal Investigator: Jean Pierre Bernard, MD | |
| Service de Gyénécologie-Obstétrique, Hôpital Jeanne de Flandre, CHRU de Lille | Not yet recruiting |
| Lille, France, 59037 | |
| Contact: Véronique Houfflin-Debarge, MD-PhD | |
| Principal Investigator: Véronique Houfflin-Debarge, MD-PhD | |
| Service de Gynécologie-Obstétrique, Hôpital Arnaud de Villeneuve, CHRU de Montpellier | Recruiting |
| Montpellier, France, 34295 | |
| Contact: Anaig Flandrin, MD | |
| Principal Investigator: Anaig Flandrin, MD | |
| Service de gynécologie-obstétrique, Hôpital Mère-Enfant, CHRU de Nantes | Recruiting |
| Nantes, France, 44093 | |
| Contact: Norbert Winer, MD | |
| Principal Investigator: Norbert Winer, MD | |
| Service de Gynécologie-Obstétrique, Hôpital Carémeau, CHRU de Nîmes | Not yet recruiting |
| Nîmes, France, 30029 | |
| Contact: Pierre Marès, MD-PhD | |
| Principal Investigator: Pierre Marès, MD-PhD | |
| Service de Gynécologie-Obstétrique, Hôpital Porte Madeleine, CHR d'Orléans | Recruiting |
| Orléans, France, 45032 | |
| Contact: Pascal Megier, MD | |
| Principal Investigator: Pascal Megier, MD | |
| Centre de dépistage PRIMA FACIE, Hôpital Necker, APHP | Recruiting |
| Paris, France, 75014 | |
| Contact: Yves Ville, Md-PhD | |
| Principal Investigator: Yves Ville, MD-PhD | |
| Service de Gynécologie-Obstétrique, Hôpital Paule de Viguier, CHU de Toulouse | Not yet recruiting |
| Toulouse, France, 31059 | |
| Contact: Christophe Vayssière, MD-PhD | |
| Principal Investigator: Christophe Vayssière, MD-PhD | |
| Service de Gynécologie-Obstetrique, Centre Olympe de Gouges, CHRU de Tours | Recruiting |
| Tours, France, 37044 | |
| Contact: Franck Perrotin, MD-PhD | |
| Principal Investigator: Franck Perrotin, MD-PhD | |
Sponsors and Collaborators
University Hospital, Tours
Investigators
| Principal Investigator: | Franck PERROTIN, MD-PhD | University Hospital, Tours |
More Information
Publications:
| Responsible Party: | University Hospital, Tours |
| ClinicalTrials.gov Identifier: | NCT01729468 History of Changes |
| Other Study ID Numbers: | PHRN08-FP/PERASTUN, 2011-003536-30, 2012-R8, A120316-72, 912140 |
| Study First Received: | November 2, 2012 |
| Last Updated: | November 14, 2012 |
| Health Authority: | France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) |
Keywords provided by University Hospital, Tours:
|
Low Dose Acetylsalicylic Acid Prevention Pre-eclampsia Intra-uterine Growth Restriction |
Primiparous Women Bilateral Uterine Artery Notches First Quarter |
Additional relevant MeSH terms:
|
Pre-Eclampsia Eclampsia Fetal Growth Retardation Hypertension, Pregnancy-Induced Pregnancy Complications Fetal Diseases Growth Disorders Pathologic Processes Aspirin Anti-Inflammatory Agents, Non-Steroidal Analgesics, Non-Narcotic Analgesics Sensory System Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Pharmacologic Actions Anti-Inflammatory Agents Therapeutic Uses Antirheumatic Agents Fibrinolytic Agents Fibrin Modulating Agents Molecular Mechanisms of Pharmacological Action Cardiovascular Agents Hematologic Agents Platelet Aggregation Inhibitors Cyclooxygenase Inhibitors Enzyme Inhibitors Antipyretics Central Nervous System Agents |
ClinicalTrials.gov processed this record on June 17, 2013