Preterm preeclampsia in twin pregnancy Pregnancy and Childbirth
Conditions
Interventions
Women will be recruited from their routine first-trimester scan where the eligibility criteria will be assessed. Women who accept to take part in the trial and sign the consent form will agree to have
Sponsors
Fundación para la Formación e Investigación Sanitarias de la Región de Murcia
Eligibility
Sex/Gender
Female
Age
18 Years to 55 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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). | — |
Secondary
| Measure | Time frame |
|---|---|
| All measured by examination of hospital records and patient interviews 1. Incidence of PE requiring delivery before 32 weeks, 34 weeks, 37 weeks and at any gestation, 2. For all features of severe PE the timepoint is from diagnosis of PE until maternal discharge from hospital- Features of severe PE include: 2.1. Stroke 2.2. Eclampsia 2.3. Systolic blood pressure >160 mmHg on at least one occasion 2.4. Systolic blood pressure >160 mmHg on at least one occasion 2.5. Respiratory failure 2.6. Myocardial ischemia or infarction 2.7. Pulmonary edema 2.8. Hepatic dysfunction 2.9. Hepatic hematoma or rapture 2.10. Platelet count 67 iu/litre), 2.12. Acute kidney injury 2.13. Creatinine >150 µmol/L 2.14. Cortical blindness 2.15. Retinal detachment 2.16. Transfusion of any blood products, 2.17. HELLP syndrome, 2.18. Placental abruption 2.19. Postpartum hemorrhage 2.20. Intensive therapy or high-dependency unit admission; 2.21. Confirmed sepsis 2.22. Total number of nights in hospital 3. Gestational hypertension (GH) requiring delivery before 37 weeks’ gestation defined by ACOG 2013 4. Birth before 32, 34 and 37 weeks, either: 4.1. Spontaneous 4.2. Iatrogenic for PE, GH or Fetal Growth Restriction (FGR) 4.3. Iatrogenic for other reasons 5. Death of one twin and/or both twins at timepoint before discharge from hospital 5.1. Miscarriage of the whole pregnancy or death of one twin before 24 weeks’ gestation 5.2. Stillbirth or neonatal death of one or both twins at 32 weeks, 34 weeks, 37 weeks and at any gestation 6. Birthweight <3rd, <5th and <10th percentile for gestational age measured by Fetal Medicine Foundation birthweight chart (Nicolaides et al., 2018) 7. Placental abruption timepoint at 32 weeks, 34 weeks, 37 weeks and at any gestation 8. Postpartum hemorrhage timepoint first 24 hours after delivery 9. Neonatal morbidity including any of the following measured by examination of hospital records and patients’ interviews, timepoint until discharge from hospit | — |
Countries
Austria, Belgium, Bulgaria, Denmark, England, Germany, Greece, Hungary, Ireland, Israel, Italy, Poland, Portugal, Spain, United Kingdom
Outcome results
None listed