Trial Outcomes & Findings for Orchestra Pregnancy Observational Study in Poland (NCT NCT01779141)

NCT ID: NCT01779141

Last Updated: 2020-02-05

Results Overview

Changes in HbA1C from baseline to after delivery.

Recruitment status

COMPLETED

Target enrollment

481 participants

Primary outcome timeframe

from preconception phase to 6 weeks after delivery

Results posted on

2020-02-05

Participant Flow

Participant milestones

Participant milestones
Measure
CSII
Patients using CSII, with or without CGM
Overall Study
STARTED
481
Overall Study
COMPLETED
300
Overall Study
NOT COMPLETED
181

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
CSII
n=481 Participants
Patients using CSII, with or without CGM
Age, Categorical
<=18 years
0 Participants
n=481 Participants
Age, Categorical
Between 18 and 65 years
481 Participants
n=481 Participants
Age, Categorical
>=65 years
0 Participants
n=481 Participants
Age, Continuous
30.42 years
STANDARD_DEVIATION 4.04 • n=481 Participants
Sex: Female, Male
Female
481 Participants
n=481 Participants
Sex: Female, Male
Male
0 Participants
n=481 Participants
Region of Enrollment
Poland
481 participants
n=481 Participants

PRIMARY outcome

Timeframe: from preconception phase to 6 weeks after delivery

Population: Participants who have both baseline HbA1C and after delivery HbA1C available.

Changes in HbA1C from baseline to after delivery.

Outcome measures

Outcome measures
Measure
CSII
n=219 Participants
Patients using CSII, with or without CGM
HbA1c
-0.8 HbA1C percentage
Standard Deviation 1.0

PRIMARY outcome

Timeframe: During pregnancy

Population: Subjects with sensor information during pregnancy

Percent of sensor glucose values between and including 70 mg/dL to 140 mg/dL

Outcome measures

Outcome measures
Measure
CSII
n=190 Participants
Patients using CSII, with or without CGM
Percent of Sensor Glucose Values in 70-140 mg/dL
67.62 percentage of available sensor values
Standard Deviation 10.59

SECONDARY outcome

Timeframe: after birth

Population: Participants who delivered live babies

Percentage of mothers who delivered LGA babies. The Babies whose weight were greater than 90th percentiles at the gestational age when they were born, were defined as LGA Babies. (reference: Fetal biometry between 20-42 weeks of gestation for Polish population).

Outcome measures

Outcome measures
Measure
CSII
n=320 Participants
Patients using CSII, with or without CGM
Large for Gestational Age (LGA)
74 Participants

SECONDARY outcome

Timeframe: from birth to 6 weeks after delivery

Population: Participants who delivered alive babies

The number of participants who delivered babies classified as large for gestational age, with congenital malfunction, or who required mechanical ventilation.

Outcome measures

Outcome measures
Measure
CSII
n=320 Participants
Patients using CSII, with or without CGM
Unhealthy Babies
99 Participants

Adverse Events

CSII

Serious events: 181 serious events
Other events: 11 other events
Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure
CSII
n=481 participants at risk
Patients using CSII, with or without CGM
Cardiac disorders
Fetal heart rate disorder
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Truncus arteriosus persistent
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
5.8%
28/481 • Number of events 28 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Abortion threatened
1.0%
5/481 • Number of events 5 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Amniotic cavity infection
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Blood and lymphatic system disorders
Anaemia
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Blood and lymphatic system disorders
Anaemia neonatal
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Investigations
Apgar score low
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Cardiac disorders
Arrhythmia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Respiratory, thoracic and mediastinal disorders
Asphyxia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Atrial septal defect
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Musculoskeletal and connective tissue disorders
Back pain
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Blighted ovum
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Vascular disorders
Blood pressure fluctuation
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Cardiac disorders
Bradycardia foetal
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Breech presentation
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Respiratory, thoracic and mediastinal disorders
Bronchopulmonary dysplasia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Surgical and medical procedures
Caesarean section
2.3%
11/481 • Number of events 11 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Cervical incompetence
1.0%
5/481 • Number of events 5 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Reproductive system and breast disorders
Cervical polyp
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Hepatobiliary disorders
Cholestasis of pregnancy
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Cholestasis of pregnancy
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Renal and urinary disorders
Chronic kidney disease
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Cleft Palate
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Nervous system disorders
Colloid brain cyst
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Congenital cystic kidney disease
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Congenital infection
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Congenital pneumonia
1.2%
6/481 • Number of events 6 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Gastrointestinal disorders
Crohn's disease
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Psychiatric disorders
Depression
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Metabolism and nutrition disorders
Diabetes mellitus inadequate control
1.7%
8/481 • Number of events 8 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Eye disorders
Diabetic eye disease
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Gastrointestinal disorders
Diabetic gastropathy
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Metabolism and nutrition disorders
Diabetic ketoacidosis
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Renal and urinary disorders
Diabetic nephropathy
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Eye disorders
Diabetic retinopathy
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Gastrointestinal disorders
Duodenogastric reflux
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Eclampsia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Fallot's tetralogy
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Cardiac disorders
Foetal cardiac disorder
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Foetal disorder
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Foetal distress syndrome
3.5%
17/481 • Number of events 18 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Foetal growth restriction
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Investigations
Foetal heart rate abnormal
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Investigations
Foetal heart rate decreased
0.83%
4/481 • Number of events 6 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Foetal hypokinesia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Foetal macrosomia
1.2%
6/481 • Number of events 7 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Foetal malformation
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Investigations
Foetal monitoring abnormal
0.83%
4/481 • Number of events 4 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Gastrointestinal disorders
Gastritis
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Gastroenteritis
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Gastroenteritis viral
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Gestational hypertension
0.62%
3/481 • Number of events 4 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Vascular disorders
Haemorrhage
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Nervous system disorders
Headache
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Gastrointestinal disorders
Hiatus hernia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Renal and urinary disorders
Hydronephrosis
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Hepatobiliary disorders
Hyperbilirubinaemia neonatal
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Hyperemesis gravidarum
0.83%
4/481 • Number of events 4 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Metabolism and nutrition disorders
Hyperglycaemia
0.83%
4/481 • Number of events 4 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Vascular disorders
Hypertension
0.83%
4/481 • Number of events 4 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Metabolism and nutrition disorders
Hypocalcaemia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Metabolism and nutrition disorders
Hypoglycaemia
1.0%
5/481 • Number of events 8 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Metabolism and nutrition disorders
Hypoglycaemia neonatal
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Imminent abortion
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Intrauterine infection
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
5.6%
27/481 • Number of events 27 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Metabolism and nutrition disorders
Ketoacidosis
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Kidney malformation
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Large for dates baby
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Low birht weight baby
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Maternal condition affecting foetus
0.83%
4/481 • Number of events 4 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Microtia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Respiratory, thoracic and mediastinal disorders
Neinatal respiratory failure
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Neonatal infection
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Neonatal pneumonia
1.0%
5/481 • Number of events 5 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory distress syndrome
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Respiratory, thoracic and mediastinal disorders
Neonatal respiratory failure
0.62%
3/481 • Number of events 4 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
General disorders
Oedema
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Oligohydramnios
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Ophthalmia neonatorum
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Reproductive system and breast disorders
Ovarian cyst
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Cardiac disorders
Pericardial effusion
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Placental insufficiency
0.62%
3/481 • Number of events 4 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Pneumonia
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Pre-eclampsia
1.7%
8/481 • Number of events 8 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Premature baby
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Premature delivery
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Premature labour
5.4%
26/481 • Number of events 26 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Preterm premature rupture of membranes
1.2%
6/481 • Number of events 6 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Prolonged labour
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Renal aplasia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Renal and urinary disorders
Renal colic
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Injury, poisoning and procedural complications
Reproductive tract and breast procedural complications
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Respiratory, thoracic and mediastinal disorders
Respiratory disorder
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Respiratory, thoracic and mediastinal disorders
Respiratory disorder neonatal
0.83%
4/481 • Number of events 4 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Respiratory, thoracic and mediastinal disorders
Respiratory failure
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Respiratory tract infection
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Stillbirth
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Cardiac disorders
Tachycardia foetal
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Threatened labour
3.5%
17/481 • Number of events 19 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Blood and lymphatic system disorders
Thrombocytopenia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Twin pregnancy
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Investigations
Ultrasound Doppler abnormal
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Upper respiratory tract infection
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Urinary tract infection
0.83%
4/481 • Number of events 4 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Urinary tract infection bacterial
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Urinary tract infection enterococcal
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Urinary tract infection neonatal
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Uterine contractions during pregnancy
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Injury, poisoning and procedural complications
Uterine rupture
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Vaginal infection
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Ventricular septal defect
0.42%
2/481 • Number of events 2 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Viral diarrhoea
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Vomiting in pregnancy
0.62%
3/481 • Number of events 3 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject

Other adverse events

Other adverse events
Measure
CSII
n=481 participants at risk
Patients using CSII, with or without CGM
Congenital, familial and genetic disorders
Atrial septal defect
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Surgical and medical procedures
Caesarean section
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Hepatobiliary disorders
Cholestasis of pregnancy
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Injury, poisoning and procedural complications
Clavicle fracture
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Congenital pulmonary artery anomaly
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Congenital, familial and genetic disorders
Ectopic kidney
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Vascular disorders
Haematoma
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Metabolism and nutrition disorders
Hyperglycaemia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Imminent abortion
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Jaundice neonatal
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Infections and infestations
Neonatal pneumonia
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Eye disorders
Retinopathy haemorrhagic
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject
Pregnancy, puerperium and perinatal conditions
Umbilical cord vascular disorder
0.21%
1/481 • Number of events 1 • from preconception phase, throughout pregnancy, during delivery and after delivery during lactation phase (up to 6 weeks), up to 22 months in total per subject

Additional Information

Suiying Huang, Statistician

Medtronic Minimed

Phone: 818-576-3319

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place

Restriction type: GT60