se of aspirin for the prevention of preeclampsia in twin pregnancies

Phase 3

• Conditions: Preterm preeclampsia in twin pregnancy; Pregnancy and Childbirth

• Registration Number: ISRCTN86684235
• Lead Sponsor: Fundación para la Formación e Investigación Sanitarias de la Región de Murcia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-22
• Last Update Posted: 4 December 2023
• Study Completion: 2025-09-01

Recruitment & Eligibility

• Status: Ongoing
• Sex: Female
• Target Recruitment: 2400

Inclusion Criteria

1. Aged 18 years old and over
2. DCDA or MCDA twin pregnancies
3. Both live fetuses at 11+2-13+6 weeks of gestation
4. Informed and written consent

Exclusion Criteria

1. Monoamniotic twins
2. Triplet pregnancies that had undergone embryo reduction to twins or with one vanishing twin
3. Pregnancies complicated by a major fetal abnormality or nuchal translucency thickness > 3.5 mm identified at the 11+2-13+6 weeks scan
4. 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
5. Those who lack capacity and who are unable to provide informed consent to take part
6. Women taking low-dose aspirin regularly (administration must have ceased > 7 days prior to randomization)
7. Participation in another drug trial within the previous 7 days
8. Haemorrhagic diathesis; coagulation disorders such as haemophilia and thrombocytopenia or concurrent anticoagulant therapy
9. Active or history of recurrent peptic ulceration and/or gastric/intestinal haemorrhage, or other kinds of bleeding such as cerebrovascular haemorrhages
10. Patients who are suffering from known gout, severe hepatic impairment or severe renal impairment
11. 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)
12. Patients on long-term non-steroidal anti-inflammatory medication
13. Not fluent in local language and absence of an interpreter
14. Any other reason the clinical investigators think will prevent the potential participant from complying with the trial protocol

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of preeclampsia (PE) requiring delivery before 37 weeks gestation in twin pregnancies, measured by examination of hospital records and patient interviews. PE will be defined by the American College of Obstetricians and Gynecologists (ACOG 2013).