ISRCTN86684235进行中（未招募）3 期
Aspirin versus placebo in twin pregnancies for preeclampsia prevention: a multicenter, randomised, double-blind, placebo-controlled trial (ASPRE-T)
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia0 个研究点目标入组 2,400 人开始时间: 2022年8月22日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,400
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Female
入选标准
- •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
排除标准
- •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
研究者
相似试验
招募中
1 期
Does aspirin reduce the risk of pre-eclampsia in women with twin pregnanciesEUCTR2019-003341-15-ATFundación para la Formación e Investigación Sanitaria2,400
招募中
1 期
Does aspirin reduce the risk of pre-eclampsia in women with twin pregnancies?EUCTR2019-003341-15-ITFUNDACIóN PARA LA FORMACIóN E INVESTIGACIóN SANITARIA DE LA REGIóN DE MURCIA2,400
招募中
1 期
Aspirin versus placebo in twin pregnancies for preeclampsia prevention: A multicentre, randomised, double-blind, placebo-controlled trial (ASPRE-T)PreeclampsiaMedDRA version: 20.0Level: PTClassification code: 10036485Term: Pre-eclampsia Class: 100000004868CTIS2023-503698-40-00Fundacion Para La Formacion E Investigacion Sanitaria De La Region De Murcia1,066
已完成
3 期
Aspirin administration from early pregnancy versus initiation after 11 week’s gestations, for prevention of pre-eclampsia in high-risk pregnant women.High Risk Pregnancy for preeclampsia.Supervision of high-risk pregnancyIRCT20221126056611N1Tehran University of Medical Sciences200
Unknown
4 期
Low-dose Aspirin for Prevention of Adverse Pregnancy Outcomes in Twin PregnanciesTwin PregnancyPreeclampsiaPreterm BirthFetal Growth RestrictionNCT04051567Ministry of Science and Technology of the People´s Republic of China425