Preventing pre-eclampsia with low-dose aspirin in women after frozen embryo transfer
A Prospective Interventional Randomized Controlled Trial to Assess the Effect of Low Dose Acetylsalicylic Acid As a Preventive Treatment of Pre-eclampsia in Pregnant Women Who Underwent Frozen Embryo Transfer
This study is testing if taking low-dose aspirin can help prevent pre-eclampsia in pregnant women who have had a frozen embryo transfer.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Enrollment | 276 (estimated) |
| Ages | 18 Years to 43 Years |
| Sex | Female |
| Sponsor | Centre Hospitalier Universitaire de Liege Academic / other |
| Locations | 1 site (Liège) |
| Trial ID | NCT05460416 on ClinicalTrials.gov |
What this trial studies
This clinical trial is a prospective, multicentric, interventional randomized controlled trial aimed at evaluating the effectiveness of low-dose acetylsalicylic acid as a preventive treatment for pre-eclampsia in pregnant women who have undergone frozen embryo transfer. Participants will be randomly assigned to receive either the treatment or no treatment after confirming an intrauterine pregnancy at six weeks. The primary goal is to assess the incidence of pre-eclampsia in both groups, with regular follow-ups to monitor health outcomes throughout the pregnancy. The study will include women aged 18 to 43 who meet specific eligibility criteria and have provided informed consent.
Who should consider this trial
Good fit: Ideal candidates are healthy women aged 18 to 43 who are planning a frozen embryo transfer and have a confirmed pregnancy at six weeks.
Not a fit: Patients with risk factors for pre-eclampsia or contraindications to acetylsalicylic acid will not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could significantly reduce the incidence of pre-eclampsia in women undergoing frozen embryo transfer.
How similar studies have performed: Other studies have shown promising results with low-dose aspirin in preventing pre-eclampsia, suggesting this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy women from \[18 - 43\] years-old, planned for a frozen embryo transfer, with natural and modified natural or HRT cycle * Who have given their informed consent * Who have a confirmed pregnancy at week 6 of amenorrhea. Exclusion Criteria: * Women presenting one risk factor for preeclampsia: multiple pregnancy, history of preeclampsia, BMI \> 30, lupus syndrome, preexistent proteinuria, non-treated chronic high blood pressure (\>140/90), antiphospholipid antibody syndrome, diabetes (fasting blood sugar \>126mg/dl) * Contraindication to acetylsalicylic acid (at risk of active hemorrhage (like hemophilia, …); at risk of or who have a gastro-duodenal ulcer; at risk or how have a terminal renal or hepatic in-sufficiency (only if acetylsalicylic acid is given at high dose) * Already treated with acetylsalicylic acid * Treatment with anticoagulants or non-steroid anti-inflammatory drugs
Where this trial is running
Liège
- Centre Hospitalier Universitaire de Liège site Citadelle — Liège, Belgium (Recruiting)
Study contacts
- Principal investigator: Laurie Henry — Centre Hospitalier Régional de la Citadelle
- Study coordinator: Julie Collée
- Email: julie.collee@uliege.be
- Phone: +32498973386
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.