Study: NCT03774186

Adverse event: Abortion spontaneous
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Pre-viable pregnancy loss
Frequency: 2 affected / 12 at risk

Adverse event: Polyhydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 12 at risk

Adverse event: Preterm Birth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Delivery before 37 weeks gestation
Frequency: 2 affected / 12 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ketonuria
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 12 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 3 affected / 12 at risk

Adverse event: Preeclampsia without Severe Features
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Illness
Serious: no
Organ System: Infections and infestations
Notes: Cold, COVID-19 infection, Upper Respiratory Illness/Infection, Respiratory Virus, Sinus Infection
Frequency: 5 affected / 12 at risk

Adverse event: Sensor Site Irritation
Serious: no
Organ System: Product Issues
Notes: Bleeding, Bruising or Skin Irritation at Sensor Site
Frequency: 5 affected / 12 at risk

Adverse event: Anaemia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypothyroidism
Serious: no
Organ System: Metabolism and nutrition disorders
Frequency: 1 affected / 12 at risk

Adverse event: Musculoskeletal or Back Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ovarian cyst
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 12 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Large for Gestational Age Infant
Serious: no
Organ System: General disorders
Notes: The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization.
Frequency: 2 affected / 12 at risk

Adverse event: Tenosynovitis
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Mastitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 12 at risk

Adverse event: Seasonal Allergies
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infant Respiratory Distress
Serious: no
Organ System: General disorders
Notes: The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization.
Frequency: 2 affected / 12 at risk

Adverse event: Abdominal pain
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Mild Post-Partum Hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ankle/Feet Swelling
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Carpal Tunnel
Serious: no
Organ System: Nervous system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Pain in extremity
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Foetal arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Bradycardia foetal
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Blood Ketones
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 12 at risk

Adverse event: Increased Fetal Movement
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 12 at risk

Adverse event: Infant Gastroesophageal Reflux Disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infant Laryngomalacia/ Supraglottic Edema
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Short Cervix
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hip Soreness
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Leg Bruising
Serious: no
Organ System: General disorders
Notes: Not related to sensor site placement
Frequency: 1 affected / 12 at risk

Adverse event: Foetal death
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Fetal demise one day after randomization into the HCL group
Frequency: 1 affected / 12 at risk

Adverse event: DKA
Serious: yes
Organ System: Endocrine disorders
Notes: Diabetic Ketoacidosis
Frequency: 1 affected / 12 at risk

Adverse event: Hypoglycaemia
Serious: yes
Organ System: Endocrine disorders
Frequency: 1 affected / 12 at risk

Adverse event: Preeclampsia with Severe Features
Serious: yes
Organ System: Cardiac disorders
Frequency: 2 affected / 12 at risk

Adverse event: Chronic Hypertension with Superimpose Preeclampsia with Severe Features
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Polyhydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 12 at risk

Adverse event: Preterm Birth
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Delivery before 37 weeks gestation
Frequency: 2 affected / 12 at risk

Adverse event: Hyperglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 3 affected / 12 at risk

Adverse event: Ketonuria
Serious: no
Organ System: Endocrine disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypoglycaemia
Serious: no
Organ System: Endocrine disorders
Frequency: 2 affected / 12 at risk

Adverse event: Gestational hypertension
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Preeclampsia without Severe Features
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Illness
Serious: no
Organ System: Infections and infestations
Notes: Cold, COVID-19 infection, Upper Respiratory Illness/Infection, Respiratory Virus, Sinus Infection
Frequency: 2 affected / 12 at risk

Adverse event: Sensor Site Irritation
Serious: no
Organ System: Product Issues
Notes: Bleeding, Bruising or Skin Irritation at Sensor Site
Frequency: 1 affected / 12 at risk

Adverse event: Post-Partum Depression/Anxiety
Serious: no
Organ System: Psychiatric disorders
Notes: The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization.
Frequency: 1 affected / 11 at risk

Adverse event: Musculoskeletal or Back Pain
Serious: no
Organ System: Musculoskeletal and connective tissue disorders
Frequency: 2 affected / 12 at risk

Adverse event: Headache/Migraine
Serious: no
Organ System: General disorders
Frequency: 3 affected / 12 at risk

Adverse event: Nausea/Vomiting
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 12 at risk

Adverse event: Gastrooesophageal reflux disease
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Large for Gestational Age Infant
Serious: no
Organ System: General disorders
Notes: The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization.
Frequency: 1 affected / 11 at risk

Adverse event: Fungal infection
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 12 at risk

Adverse event: Mastitis
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 12 at risk

Adverse event: Hypoglycaemia neonatal
Serious: no
Organ System: General disorders
Notes: The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization.
Frequency: 1 affected / 11 at risk

Adverse event: Vaginal Aching
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infant Respiratory Distress
Serious: no
Organ System: General disorders
Notes: The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization.
Frequency: 2 affected / 11 at risk

Adverse event: Post-Partum Pain
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: The HCL group had 11 participants complete the study after randomization due to a fetal loss in one participant 1 day after randomization.
Frequency: 1 affected / 11 at risk

Adverse event: Pelvic pain
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Food poisoning
Serious: no
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 12 at risk

Adverse event: Cholestasis
Serious: no
Organ System: Hepatobiliary disorders
Frequency: 1 affected / 12 at risk

Adverse event: Ankle/Feet Swelling
Serious: no
Organ System: General disorders
Frequency: 2 affected / 12 at risk

Adverse event: Placental Hemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 12 at risk

Adverse event: Vaginal haemorrhage
Serious: no
Organ System: Reproductive system and breast disorders
Frequency: 1 affected / 12 at risk

Adverse event: Elevated Blood Pressure (Mild)
Serious: no
Organ System: Cardiac disorders
Frequency: 1 affected / 12 at risk

Adverse event: Thrombocytopenia
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Infant Shoulder Dystocia
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Urticaria
Serious: no
Organ System: Immune system disorders
Frequency: 1 affected / 12 at risk

Adverse event: Finger Wart
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Abnormal Ultrasound Findings
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk

Adverse event: Scratched Cornea
Serious: no
Organ System: Eye disorders
Frequency: 1 affected / 12 at risk

Adverse event: Eczema Flare-Up
Serious: no
Organ System: Skin and subcutaneous tissue disorders
Frequency: 1 affected / 12 at risk

Adverse event: Non-Reassuring Fetal Wellbeing
Serious: no
Organ System: General disorders
Frequency: 1 affected / 12 at risk