Does aspirin reduce the risk of pre-eclampsia in women with twin pregnancies?

Phase 1

• Conditions: Preeclampsia; MedDRA version: 23.1Level: PTClassification code 10084825Term: Superimposed pre-eclampsiaSystem Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions; Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

• Registration Number: EUCTR2019-003341-15-IT
• Lead Sponsor: FUNDACIóN PARA LA FORMACIóN E INVESTIGACIóN SANITARIA DE LA REGIóN DE MURCIA

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-01-30
• Last Update Posted: 28 August 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Female
• Target Recruitment: 2400

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.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2400
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

• Monoamniotic twins
• 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;¿
• 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.

Study & Design

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