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Clinical Trial Details

Trial ID: L6306
Source ID: NCT03574909
Associated Drug: Aspirin
Title: IRELAnD: Investigating the Role of Early Low-dose Aspirin in Diabetes
Acronym: IRELAnD
Status: UNKNOWN
Study Results: NO
Results:
Conditions: Pre-Gestational Diabetes
Interventions: DRUG: Aspirin|DRUG: Placebos
Outcome Measures: Primary: Preeclampsia - Change in blood pressure (Hypertension), (i) greater than or equal to 140mmHg systolic or greater than or equal to 90mmHg diastolic on two occasions at least 4 hours apart after 20 weeks' gestation in a woman with a previously normal blood pressure. Or (ii) greater than or equal to 160mmHg systolic or greater than or equal to 110mmHg diastolic (such hypertension can be confirmed within a short interval (minutes) to facilitate timely antihypertensive therapy.perinatal mortality, From 20 weeks gestation to delivery|Preeclampsia - Change in Proteinuria, Greater than or equal to 300mg per 24-hour urine collection, or a urinary protein: creatinine ratio greater than or equal to 0.3 or +3 proteinuria on dipstick urinalysis., From 20 weeks gestation to birth|Birth weight, Birth weight less than the 10th percentile for gestational age:, weight will be measured on the day of birth and plotted on standard WHO UK RCPCH growth charts (per gender).|Preterm birth, -Preterm birth less than 34+0 weeks:, Gestational age at birth will be verified with respect to the Estimated Date of Delivery calculated at the first study visit.|Perinatal mortality, Perinatal mortality, Stillbirth or neonatal death after 24 completed weeks of gestation and within 28 days of birth. | Secondary: Parameters of neonatal morbidity: Gestational age at delivery, Gestational age at delivery, recorded at the time of birth, in weeks and days post Last Menstrual Period, or in accordance with ultrasound-derived gestational age, as above|Parameters of neonatal morbidity: Birth weight, Birth weight, recorded (in grams) on the day of birth)|Parameters of neonatal morbidity: NICU admission, NICU admission, Up to 10 days post birth|Respiratory morbidity: Duration of invasive ventilation, Duration of invasive ventilation, Up to 6 weeks after birth|Duration of O2, Respiratory morbidity: Duration of O2, Up to 6 weeks after birth|Duration of hospital stay, Respiratory morbidity: Duration of hospital stay, Up to 6 weeks after birth|Use of nitric oxide, Respiratory morbidity: Use of nitric oxide, Up to 6 weeks after birth|Number and type of inotropes, Respiratory morbidity: Number and type of inotropes, Up to 6 weeks after birth|Duration of inotrope use, Respiratory morbidity: Duration of inotrope use, Up to 6 weeks after birth|Apgar score, Apgar score \<7 at 5 minutes, Apgar score will be recorded within 5 minutes of birth, as per standard clinical care.|Umbilical artery acidosis at birth, Umbilical arterial pH and acid-base status will be measured where clinically indicated at birth (namely in an infant born in the setting of suspected perinatal compromise). In addition to cord pH, the first infant pH will also be recorded, if obtained., measured where clinically indicated at birth|Intracranial haemorrhage:, Evidence of bleeding within the intraventricular or periventricular areas of the neonatal brain, identified with cranial ultrasound or alternate imaging., measured where clinically indicated at birth|Culture-proven sepsis:, A diagnosis of neonatal sepsis will be made when appropriate clinical features are confirmed by positive microbiological cultures., measured where clinically indicated at birth|Necrotising enterocolitis, Defined as presence of radiologic signs (Bell Stage II or greater)., measured where clinically indicated at birth|Hypoxic ischaemic encephalopathy, A diagnosis of hypoxic ischemic encephalopathy will be recorded where the following criteria are met: * Apgar score ≤5 at 10 minutes after birth * Continued need for endotracheal or mask ventilation at 10 minutes after birth * Acidosis within 60 minutes of birth (defined as any occurrence of umbilical cord arterial or capillary pH \<7.0 or a base deficit ≥16mmol/L) * And/ or clinical seizures or moderate to severe encephalopathy using the Sarnat grading system, measured where clinically indicated at birth|Shoulder dystocia, Shoulder dystocia is defined as a vaginal cephalic delivery that requires additional obstetric manoeuvres to deliver the fetus after the head has delivered and gentle traction has failed, birth|Composite measure of Maternal outcomes not directly related to primary outcome, Mode of delivery: Recorded on day of delivery, as follows: Spontaneous vaginal birth (with spontaneous onset of labour) Spontaneous vaginal birth (with induction of labour) Assisted vaginal birth (forceps) with spontaneous onset of labour Assisted vaginal birth (forceps) with induction of labour Assisted vaginal birth (ventouse) with spontaneous onset of labour Assisted vaginal birth (ventouse) with induction of labour Emergency intrapartum Caesarean section with induction of labour Emergency intrapartum Caesarean section with spontaneous onset of labour Emergency pre-labour Caesarean section (i.e. unscheduled) Elective Caesarean section (scheduled) Elective Caesarean section with spontaneous onset of labour, Delivery|Haemorrhage:, Loss of 500ml of blood or more from the genital tract within 24 hours of delivery. Peripartum blood loss will be recorded as average or excessive (500ml or more) for all deliveries. In addition, requirement for the following measures to reduce peripartum blood loss will be recorded: Oxytocin 10IU, oxytocin infusion, ergometrine, syntometrine, hemabate, misoprostol, intrauterine balloon tamponade, B-Lynch suture, interventional radiologic manoeuvres, hysterectomy, blood transfusion (including number and nature of blood products), During birth|Sepsis, Culture-proven infection in addition to systemic manifestations of infection, During birth
Sponsor/Collaborators: Sponsor: Royal College of Surgeons, Ireland | Collaborators: Health Research Board, Ireland
Gender: FEMALE
Age: ADULT, OLDER_ADULT
Phases: PHASE3
Enrollment: 300
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
Start Date: 2018-09
Completion Date: 2021-09
Results First Posted:
Last Update Posted: 2018-08-27
Locations:
URL: https://clinicaltrials.gov/show/NCT03574909