Treatment Preventive for Pre-eclampsia by Acetylsalicylic Acid in Women Who Underwent Frozen Embryo Transfer

NCT05460416 | Recruiting Phase 3

• 2 other identifiers: 2021/3922024-516816-72-00
• Study Type: interventional
• Target: 276
• Locations: 1 country
• Sites: 1

Brief Summary

Title: A prospective multicentric 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

Conditions

Embryo Transfer; Hypertension, Pregnancy Induced

Keywords

embryo transfer; Hypertension, Pregnancy induced

Outcome Measures

Primary Outcomes (1)

• Mean number of women suffering from pre-eclampsia in the treated and not treated groups.

  4 years

Study Arms (2)

Treatment by acetylsalicylic acid

EXPERIMENTAL

Drug: Acetylsalicylic acid

No treatment

NO INTERVENTION

Interventions

Acetylsalicylic acid DRUG

160mg once a day

Treatment by acetylsalicylic acid

Eligibility Criteria

• Age: 18 Years - 43 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Liege: lead

Study Sites (1)

Centre Hospitalier Universitaire de Liège site Citadelle

Liège, Belgium

RECRUITING

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Aspirin

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

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

Study Officials

• Laurie Henry

  Centre Hospitalier Régional de la Citadelle

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Julie Collée

CONTACT

+32498973386; julie.collee@uliege.be

Marie Timmermans

CONTACT

marie.timmermans@chuliege.be;

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor, specialist in Obstetrics and Reproductive Medicine

Study Record Dates

• First Submitted: July 11, 2022
• First Posted: July 15, 2022
• Study Start: October 25, 2022
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: February 18, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)