Aspirin for the Prevention of Preeclampsia and Pregnancy Outcomes After Assisted Reproductive Technology

NCT05625724 | Recruiting Phase 3 DMC

• 1 other identifier: RC31/21/0337
• Study Type: interventional
• Target: 1,164
• Locations: 1 country
• Sites: 21

Brief Summary

This study seeks to validate the hypothesis that nulliparous pregnant women after Assisted Reproductive Technology (ART) are at high risk of preeclampsia and perinatal complications and represent a subgroup for which aspirin prophylaxis during pregnancy may be effective in the prevention of preterm preeclampsia and other perinatal adverse outcomes.

Conditions

ART; Pre-Eclampsia

Outcome Measures

Primary Outcomes (1)

• Effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo in the prevention of preterm (<37 weeks of gestation) preeclampsia

  Occurrence of preterm (\<37 weeks of gestation) preeclampsia (binary variable yes/no)

  Up to 9 months

Secondary Outcomes (7)

• Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on spontaneous and total preterm birth <34 weeks of gestation

  Up to 8 months

• Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on spontaneous and total preterm birth <37 weeks of gestation

  Up to 9 months

• Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on occurrence of preeclampsia <34 weeks of gestation, term preeclampsia (≥ 37 weeks of gestation)

  Up to 8 months

• Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on occurrence of cesarean delivery

  Up to 9 months

• Compare the effect of aspirin 150mg daily initiated between 9 and 14 weeks of gestation versus placebo on occurrence of postpartum hemorrhage (>500ml)

  Up to 9 months

Study Arms (2)

Aspirin

EXPERIMENTAL

Low-dose Aspirin: 150mg, daily, oral route, at bedtime, initiated between 9 and 14 weeks of gestation, until 35 (+6) weeks of gestation, or in the event of earlier delivery, until the onset of labor.

Drug: Aspirin

Control

PLACEBO COMPARATOR

Matching placebo administrated daily, oral route, at bedtime, initiated between 9 and 14 weeks of gestation, until 35 (+6) weeks of gestation, or in the event of earlier delivery, until the onset of labor.

Drug: Placebo

Interventions

Aspirin DRUG

Experimental drug administrated orally

Aspirin

Placebo DRUG

Treatment for the control group

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Nulliparous women aged 18 years or more
• Pregnancy following ART, including in vitro fertilization (IVF), intracytoplasmic sperm injection (ICSI), oocyte donation or intrauterine insemination with sperm donor
• Singleton pregnancy
• Evolutive pregnancy between 9 and 14 weeks of gestation
• Women affiliated to a French Social Security Insurance or equivalent social protection
• Written informed consent

You may not qualify if:

• Major fetal abnormality
• Regular treatment with aspirin (including antiphospholipid syndrome)
• Aspirin contraindications (allergy, von Willebrand disease, peptic ulceration, hemophilia)
• Women protected by law.
• Women included in another interventional study.

Sponsors & Collaborators

• University Hospital, Toulouse: lead

Study Sites (21)

CHU Angers

Angers, France

RECRUITING

CHU Bordeaux

Bordeaux, France

RECRUITING

CHU Clermont-Ferrand

Clermont-Ferrand, France

RECRUITING

CHU Dijon-Bourgogne

Dijon, France

RECRUITING

CHU Lille

Lille, France

RECRUITING

HCL - Groupement Hospitalier Est, Hôpital Femme Mère Enfant

Lyon, France

RECRUITING

AP-HM Hôpital de la Conception

Marseille, France

RECRUITING

AP-HM Hôpital Nord

Marseille, France

RECRUITING

CHU Montpellier

Montpellier, France

RECRUITING

CHRU Nancy

Nancy, France

RECRUITING

CHU Nantes

Nantes, France

RECRUITING

CHU Nîmes

Nîmes, France

RECRUITING

Groupe hospitalier St Joseph

Paris, France

RECRUITING

Hôpital Armand - Trousseau

Paris, France

NOT YET RECRUITING

Hôpital Cochin

Paris, France

RECRUITING

CHI Poissy Saint Germain en Laye

Poissy, France

RECRUITING

CHU Poitiers

Poitiers, France

NOT YET RECRUITING

CHU Rennes

Rennes, France

RECRUITING

CHU Saint Etienne, Hôpital Nord

Saint-Etienne, France

RECRUITING

CHU Strasbourg

Strasbourg, France

RECRUITING

CHU Toulouse

Toulouse, France

RECRUITING

MeSH Terms

Conditions

Pre-Eclampsia

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Intervention Hierarchy (Ancestors)

Salicylates; Hydroxybenzoates; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals

Study Officials

• Christophe VAYSSIERE, MD

  University Hospital, Toulouse

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Paul GUERBY, MD

CONTACT

5 67 77 12 33; guerby.p@chu-toulouse.fr

Delphine DUCHANOIS, Midwife

CONTACT

5 67 77 12 33; duchanois.d@chu-toulouse.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2022
• First Posted: November 23, 2022
• Study Start: August 2, 2023
• Primary Completion (Estimated): August 1, 2028
• Study Completion (Estimated): May 1, 2029
• Last Updated: May 7, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

FR (21)