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Trial record 100 of 126 for:    diabetes type 1 AND (woman OR women OR female) AND Metabolism

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

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ClinicalTrials.gov Identifier: NCT03574909
Recruitment Status : Not yet recruiting
First Posted : July 2, 2018
Last Update Posted : August 27, 2018
Sponsor:
Collaborator:
Health Research Board, Ireland
Information provided by (Responsible Party):
Royal College of Surgeons, Ireland

Brief Summary:
To investigate the effect of aspirin therapy initiated in the first trimester of pregnancy in women with pregestational type I or type II diabetes on a composite clinical measure of placental dysfunction (preeclampsia, preterm birth less than 34 weeks, birthweight below the 10th centile or perinatal mortality).

Condition or disease Intervention/treatment Phase
Pre-Gestational Diabetes Drug: Aspirin Drug: Placebos Phase 3

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: 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
Estimated Study Start Date : September 2018
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Aspirin

Arm Intervention/treatment
Experimental: Treatment Arm

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.

Drug: Aspirin
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.
Other Name: Tromalyt

Placebo Comparator: Control Arm

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.

Drug: Placebos
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
Other Name: Sanitatis




Primary Outcome Measures :
  1. Preeclampsia - Change in blood pressure (Hypertension) [ Time Frame: From 20 weeks gestation to delivery ]

    (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


  2. Preeclampsia - Change in Proteinuria [ Time Frame: From 20 weeks gestation to birth ]
    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.

  3. Birth weight [ Time Frame: weight will be measured on the day of birth and plotted on standard WHO UK RCPCH growth charts (per gender). ]
    Birth weight less than the 10th percentile for gestational age:

  4. Preterm birth [ Time Frame: Gestational age at birth will be verified with respect to the Estimated Date of Delivery calculated at the first study visit. ]
    -Preterm birth less than 34+0 weeks:

  5. Perinatal mortality [ Time Frame: Stillbirth or neonatal death after 24 completed weeks of gestation and within 28 days of birth. ]
    Perinatal mortality


Secondary Outcome Measures :
  1. Parameters of neonatal morbidity: Gestational age at delivery [ Time Frame: recorded at the time of birth, in weeks and days post Last Menstrual Period, or in accordance with ultrasound-derived gestational age, as above ]
    Gestational age at delivery

  2. Parameters of neonatal morbidity: Birth weight [ Time Frame: recorded (in grams) on the day of birth) ]
    Birth weight

  3. Parameters of neonatal morbidity: NICU admission [ Time Frame: Up to 10 days post birth ]
    NICU admission

  4. Respiratory morbidity: Duration of invasive ventilation [ Time Frame: Up to 6 weeks after birth ]
    Duration of invasive ventilation

  5. Duration of O2 [ Time Frame: Up to 6 weeks after birth ]
    Respiratory morbidity: Duration of O2

  6. Duration of hospital stay [ Time Frame: Up to 6 weeks after birth ]
    Respiratory morbidity: Duration of hospital stay

  7. Use of nitric oxide [ Time Frame: Up to 6 weeks after birth ]
    Respiratory morbidity: Use of nitric oxide

  8. Number and type of inotropes [ Time Frame: Up to 6 weeks after birth ]
    Respiratory morbidity: Number and type of inotropes

  9. Duration of inotrope use [ Time Frame: Up to 6 weeks after birth ]
    Respiratory morbidity: Duration of inotrope use

  10. Apgar score [ Time Frame: Apgar score will be recorded within 5 minutes of birth, as per standard clinical care. ]
    Apgar score <7 at 5 minutes

  11. Umbilical artery acidosis at birth [ Time Frame: measured where clinically indicated 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.

  12. Intracranial haemorrhage: [ Time Frame: measured where clinically indicated at birth ]
    Evidence of bleeding within the intraventricular or periventricular areas of the neonatal brain, identified with cranial ultrasound or alternate imaging.

  13. Culture-proven sepsis: [ Time Frame: measured where clinically indicated at birth ]
    A diagnosis of neonatal sepsis will be made when appropriate clinical features are confirmed by positive microbiological cultures.

  14. Necrotising enterocolitis [ Time Frame: measured where clinically indicated at birth ]
    Defined as presence of radiologic signs (Bell Stage II or greater).

  15. Hypoxic ischaemic encephalopathy [ Time Frame: measured where clinically indicated at birth ]

    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

  16. Shoulder dystocia [ Time Frame: birth ]
    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

  17. Composite measure of Maternal outcomes not directly related to primary outcome [ Time Frame: Delivery ]

    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


  18. Haemorrhage: [ Time Frame: During birth ]

    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)


  19. Sepsis [ Time Frame: During birth ]
    Culture-proven infection in addition to systemic manifestations of infection



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Singleton pregnancy with a pre-pregnancy diagnosis of type I or type II diabetes of at least 6 months' duration

Exclusion Criteria:

  • • Aspirin hypersensitivity (prior bronchospasm/ urticarial/ angioedema with aspirin)

    • Peptic ulcer disease
    • Known bleeding diathesis
    • Multifetal gestation
    • Severe early-onset preeclampsia in a previous pregnancy
    • Patient already on aspirin
    • Established chronic renal disease/ macroalbuminuria
    • Chronic hypertension (antihypertensive therapy in first trimester)
    • Current selective serotonin reuptake inhibitor (SSRI) use (or SSRI use within 7 days)
    • Inability to speak or read English
    • Age less than 18 years
    • Use of any other investigational medicinal product within previous 30 days
    • Presence of any illness or condition that might interfere with the patient's ability to comply with the study procedures

Responsible Party: Royal College of Surgeons, Ireland
ClinicalTrials.gov Identifier: NCT03574909     History of Changes
Other Study ID Numbers: Ireland-Rct-v1-0218
2018-000770-29 ( EudraCT Number )
First Posted: July 2, 2018    Key Record Dates
Last Update Posted: August 27, 2018
Last Verified: March 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications
Aspirin
Platelet Aggregation Inhibitors
Titanium dioxide
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Antipyretics
Sunscreening Agents
Radiation-Protective Agents
Protective Agents
Dermatologic Agents
Photosensitizing Agents