Study: NCT02702999

Adverse event: Neonatal death
Serious: yes
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: gestational hypertension (GHTN)/preeclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 15 affected / 102 at risk

Adverse event: Decreased fetal movement
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 102 at risk

Adverse event: Premature labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 102 at risk

Adverse event: Premature rupture of membranes (PROM)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 102 at risk

Adverse event: Cholestasis, pyelonephritis, fall, or fetal ventricular tachycardia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 9 affected / 102 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 4 affected / 102 at risk

Adverse event: Cesarean delivery in labor
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 6 affected / 102 at risk

Adverse event: Postpartum haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 102 at risk

Adverse event: Transfusion (maternal)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 102 at risk

Adverse event: Apgar score < 5 at 5 min
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Umbilical arterial pH < 7.00
Serious: no
Organ System: General disorders
Frequency: 2 affected / 102 at risk

Adverse event: Intubation over 24 hours (infant)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 102 at risk

Adverse event: Intraventricular hemorrhage (IVH) grade III or IV (infant)
Serious: no
Organ System: Vascular disorders
Frequency: 1 affected / 102 at risk

Adverse event: gestational hypertension (GHTN)/preeclampsia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 21 affected / 104 at risk

Adverse event: Decreased fetal movement
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 104 at risk

Adverse event: Premature labour
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 104 at risk

Adverse event: Premature rupture of membranes (PROM)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 3 affected / 104 at risk

Adverse event: Cholestasis, pyelonephritis, fall, or fetal ventricular tachycardia
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 104 at risk

Adverse event: Amniotic cavity infection
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 104 at risk

Adverse event: Cesarean delivery in labor
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 5 affected / 104 at risk

Adverse event: Postpartum haemorrhage
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 2 affected / 104 at risk

Adverse event: Transfusion (maternal)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 104 at risk

Adverse event: Wound infection (maternal)
Serious: no
Organ System: Pregnancy, puerperium and perinatal conditions
Frequency: 1 affected / 104 at risk

Adverse event: Intubation over 24 hours (infant)
Serious: no
Organ System: General disorders
Frequency: 1 affected / 104 at risk