Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicentre, randomised, double-blind, placebo-controlled trial (ASPRE-T)

Phase 1

Recruiting

• Conditions: Preeclampsia; Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]; MedDRA version: 20.0Level: PTClassification code: 10036485Term: Pre-eclampsia Class: 100000004868

• Registration Number: CTIS2023-503698-40-00
• Lead Sponsor: Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-02-28
• Last Update Posted: 22 July 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 1066

Inclusion Criteria

Age > 18 years., DCDA or MCDA twin pregnancies., Both live fetuses at 11+2-13+6 weeks of gestation., Informed and written consent.

Exclusion Criteria

Monoamniotic twins., Patients who are suffering from known gout, severe hepatic impairment or severe renal impairment., Hypersensitivity to salicylic acid compounds or prostaglandin synthetase inhibitors (e.g. certain asthma patients who may suffer an attack or faint and certain patients who may suffer from bronchospasm, rhinitis and urticaria) or to any excipients (see section 6.1 of the SmPC for details)., Patients on long term non-steroidal anti-inflammatory medication., Not fluent in local language and absence of interpreter., Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol., Triplet pregnancies that had undergone embryo reduction to twins or with one vanishing twin., Pregnancies complicated by major fetal abnormality or nuchal translucency thickness >3.5 mm identified at the 11+2-13+6 weeks scan., MCDA twin pregnancies in which there are early signs of TTTS or sFGR defined by a 20% discordance in CRL at the 11+2-13+6 weeks’ scan., Those who lack capacity and who are unable to provide informed consent to take part., Women taking low-dose aspirin regularly (administration must have ceased >7 days prior to randomization)., Participation in another drug trial within the previous 7 days., Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia or concurrent anticoagulant therapy., Active or history of recurrent peptic ulceration and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified