Study: NCT02379728

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Death of the fetus at gestation ≥28 weeks or birthweight ≥1000 grams.
Frequency: 2 affected / 100 at risk

Adverse event: Placental abruption
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 100 at risk

Adverse event: Intrauterine growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Defined as fetal weight less than the 10th percentile for gestational age as determined through an ultrasound.
Frequency: 1 affected / 100 at risk

Adverse event: Pre-eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Severe preeclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Failure to progress
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 100 at risk

Adverse event: Persistent occiput posterior position
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Neonatal Intensive Care Unit admission
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Worsened sleep quality
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participants who reported worsened sleep quality on the PrenaBelt User Feedback Questionnaire.
Frequency: 2 affected / 100 at risk

Adverse event: Shorter sleep duration
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participants who reported shorter sleep duration on the PrenaBelt User Feedback Questionnaire.
Frequency: 22 affected / 100 at risk

Adverse event: Felt more drowsy during the day
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participants who reported feeling more drowsy during the day on the PrenaBelt User Feedback Questionnaire.
Frequency: 1 affected / 100 at risk

Adverse event: Felt too hot while wearing the device
Serious: no
Organ System: Product Issues
Notes: Participants who reported feeling too hot while wearing the device (PrenaBelt/sham) on the PrenaBelt User Feedback Questionnaire.
Frequency: 2 affected / 100 at risk

Adverse event: Felt too itchy while wearing the device
Serious: no
Organ System: Product Issues
Notes: Participants who reported feeling too itchy while wearing the device (PrenaBelt/sham) on the PrenaBelt User Feedback Questionnaire.
Frequency: 1 affected / 100 at risk

Adverse event: Macrosomia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Breech presentation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 100 at risk

Adverse event: Cephalopelvic disproportion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Cord presentation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Face presentation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Foetal distress syndrome
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 100 at risk

Adverse event: Meconium stained grade 2 liquor
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Moderate oligohydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Postterm pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Premature labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Reduced fetal movement
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Severe oligohydramnios
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Unexplained vaginal bleeding
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Uterine contractions during pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This participant discontinued participation in the trial because she felt uterine contractions while using the device.
Frequency: 1 affected / 100 at risk

Adverse event: Vomiting
Serious: no
Organ System: Gastrointestinal disorders
Notes: This participant discontinued participation in the trial because she started vomiting after she wore the device.
Frequency: 1 affected / 100 at risk

Adverse event: Stillbirth
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Death of the fetus at gestation ≥28 weeks or birthweight ≥1000 grams.
Frequency: 1 affected / 100 at risk

Adverse event: Placental abruption
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 100 at risk

Adverse event: Gastroenteritis
Serious: yes
Organ System: Gastrointestinal disorders
Frequency: 1 affected / 100 at risk

Adverse event: Intrauterine growth restriction
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Defined as fetal weight less than the 10th percentile for gestational age as determined through an ultrasound.
Frequency: 1 affected / 100 at risk

Adverse event: Severe preeclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Haemorrhage in pregnancy
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Amniotic cavity infection
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Failure to progress
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 100 at risk

Adverse event: Imminent eclampsia
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 100 at risk

Adverse event: Unfavourable cervix
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Neonatal Intensive Care Unit admission
Serious: yes
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 100 at risk

Adverse event: Worsened sleep quality
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participants who reported worsened sleep quality on the PrenaBelt User Feedback Questionnaire.
Frequency: 1 affected / 100 at risk

Adverse event: Shorter sleep duration
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: Participants who reported shorter sleep duration on the PrenaBelt User Feedback Questionnaire.
Frequency: 8 affected / 100 at risk

Adverse event: Felt too hot while wearing the device
Serious: no
Organ System: Product Issues
Notes: Participants who reported feeling too hot while wearing the device (PrenaBelt/sham) on the PrenaBelt User Feedback Questionnaire.
Frequency: 3 affected / 100 at risk

Adverse event: Felt too itchy while wearing the device
Serious: no
Organ System: Product Issues
Notes: Participants who reported feeling too itchy while wearing the device (PrenaBelt/sham) on the PrenaBelt User Feedback Questionnaire.
Frequency: 2 affected / 100 at risk

Adverse event: Macrosomia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 100 at risk

Adverse event: Breech presentation
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 100 at risk

Adverse event: Cephalopelvic disproportion
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 100 at risk

Adverse event: Cord prolapse
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Failed vacuum extraction
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Foetal distress syndrome
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 100 at risk

Adverse event: Multiple uterine fibroids
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Placental abnormality (nonspecific)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Postterm pregnancy
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Premature labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Prolonged premature ruptured of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Term premature rupture of membranes
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 100 at risk

Adverse event: Gastroesophageal reflux exacerbation
Serious: no
Organ System: Gastrointestinal disorders
Notes: This participant discontinued participation in the trial because she her gastroesophageal reflux was exacerbated while using the device.
Frequency: 1 affected / 100 at risk

Adverse event: Placenta praevia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Notes: This participant was disqualified from participation in the trial by the PI after placenta previa was discovered on ultrasound two weeks after she entered the study.
Frequency: 1 affected / 100 at risk

Adverse event: Felt too hot while wearing the device
Serious: no
Organ System: Product Issues
Notes: This participant discontinued participation in the trial because she felt too hot while wearing the device.
Frequency: 1 affected / 100 at risk