Treatment Arms: Tromalyt® 150mg prolong release capsule for oral ingestion. The capsule contains 150mg of anti-platelet agent acetylsalicylic acid, maize starch and Sucrose 20:80. The capsule also contains Copovidone (Kollidon VA-64), Eudragit L, Ethylcellulose and Triacetin. The capsule is made with gelatin, erythrosine, quinoline yellow, titanium dioxide. Tromalyt® is trademark of Meda Pharma SL (Reg 59.210).
There is no requirement for the first dose to be administered in the clinic under observation.
The dosing frequency is once daily. Subjects will be instructed to take the study medication at the same time each day.
No specific precautions are required in relation to concomitant food intake.

Placebos to be used are hard gelatin capsules (Sanitatis®) for patients randomized to the placebo arm. These capsules are externally identical to Tromalyt capsule. The capsules contain 198mg microcrystalline cellulose and 2mg of magnesium stearate (Sanitatis®) Placebo: There is no requirement for the first dose to be administered in the clinic under observation.
The dosing frequency is once daily. Subjects will be instructed to take the study medication at the same time each day.
No specific precautions are required in relation to concomitant food intake.

Pre-Gestational Diabetes

Tromalyt® 150mg prolong release capsule for oral ingestion. The capsule contains 150mg of anti-platelet agent acetylsalicylic acid, maize starch and Sucrose 20:80. The capsule also contains Copovidone (Kollidon VA-64), Eudragit L, Ethylcellulose and Triacetin. The capsule is made with gelatin, erythrosine, quinoline yellow, titanium dioxide.

Aspirin

Size 0 hard gelatin capsules containing 99% of microcrystalline cellulose and 1% of magnesium stearate (Sanitatis®). The capsules contain 198mg microcrystalline cellulose and 2mg of magnesium stearate

Placebos

IRELAnD: Investigating the Role of Early Low-dose Aspirin in Diabetes

Investigating the Role of Early Low-dose Aspirin in Diabetes: A Phase III Multicentre Double-blinded Placebo-controlled Randomised Trial of Low-dose Aspirin Initiated in the First Trimester of Diabetes Pregnancy

(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

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.

Birth weight less than the 10th percentile for gestational age:

Respiratory morbidity: Duration of hospital stay

Respiratory morbidity: Use of nitric oxide

Respiratory morbidity: Number and type of inotropes

Respiratory morbidity: Duration of inotrope use

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.

Evidence of bleeding within the intraventricular or periventricular areas of the neonatal brain, identified with cranial ultrasound or alternate imaging.

A diagnosis of neonatal sepsis will be made when appropriate clinical features are confirmed by positive microbiological cultures.

Defined as presence of radiologic signs (Bell Stage II or greater).

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

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

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

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)

acetylsalicylic acid/hypoxia

IRELAnD: Investigating the Role of Early Low-dose Aspirin in Diabetes

An bunachar luibheanna míochaine is iomláine le tacaíocht ón eolaíocht