Preeclampsia
Conditions
Interventions
Trade Name: Aspirin 75mg Gastro-resistant Tablets
Product Name: Aspirin 75mg Gastro-resistant Tablets
Pharmaceutical Form: Gastro-resistant tablet
INN or Proposed INN: ACETYLSALICYLIC ACID
CAS Number:
Sponsors
Fundación para la Formación e Investigación Sanitaria
Eligibility
Sex/Gender
All
Inclusion criteria
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
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To investigate whether aspirin therapy will reduce the incidence of preeclampsia in women who are carrying a twin pregnancy.;Secondary Objective: To determine the effect of low-dose aspirin on the incidence of preeclampsia with delivery at 97 µmol/L (1.1 mg / dL) b. liver involvement with elevated transaminases (ALT or AST >90 IU/L or twice the normal concentration) c. hematological complications (thrombocytopenia with platelet count <100,000/µL), disseminated intravascular coagulation or hemolysis. d. neurological complications such as eclampsia, altered mental status, blindness, stroke, clonus, severe headaches, persistent visual scotomata;Timepoint(s) of evaluation of this end point: The pregnancy outcomes will be collated prospectively and where there is documentation of hypertensive disease, the outcomes will be further investigated to confirm or refute pre-eclamptic criteria as defined within our protocol. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): To determine the effect of low-dose aspirin on the incidence of (stratified according to chorionicity) : o Delivery with PE at 160 mmHg on at least one occasion o diastolic blood pressure >110 mmHg on at least one occasion o respiratory failure requiring intubation or mechanical ventilation o myocardial ischemia or infarction o pulmonary edema o hepatic dysfuction (INR >1.2 in the absence of DIC) o hepatic hematoma or raprure o platelet count 67 iu/litre) o acute kidney injury o creatinine >150 µmol/L o cortical blindness o retinal detachment o tranfusion of any blood products o HELLP syndrome o placental abruption o postpartum hemorrhage (defined as blood loss =1 L within the first 24 hours after birth) o intensive therapy or high-dependency unit admission o confirmed sepsis (positive blood or urine cultures) up to post-natal discharge o total number of nights in hospital o Gestational hypertension (GH) o Birth at <32 weeks, <34 weeks and <37 weeks o Spontaneous o Iatrogenic for PE, GH or FGR o Iatrogenic for other reason o Death of one twin and / or both twins before discharge from hospital o Miscarriage of the whole pregnancy or death of one twin <24 weeks’ gestation. o Stillbirth or neonatal death of one or both twins at <32 weeks, <34 weeks, <37 weeks and at any gestation. o Birthweight <3rd, <5th and <10th percentile for gestational age. o Placental abruption (clinically or on placental examination) at <32 weeks, <34 weeks, <37 weeks and at any gestation. o Postpartum hemorrhage (defined as blood loss =1 L within the first 24 hours after birth). o Neonatal morbidity o Intraventricular hemorrhage (IVH) grade II or above – Defined as bleeding into the ventricles ? Grade II (moderate) – IVH occupies <50% of the lateral ventricle volume ? Grade III (severe) – IVH occupies =50% of the lateral ventricle volume ? Grade IV (severe) – Hemorrhagic infarction in periventricular white matter ipsilateral to a large IVH | — |
Countries
Argentina, Australia, Austria, Belgium, Brazil, Bulgaria, Czechia, Denmark, Germany, Greece, Hungary, Ireland, Israel, Italy, Poland, Portugal, Spain, United Kingdom
Contacts
Public ContactKypros Nicolaides
King's College Hospital
Outcome results
None listed