PoC Study of OBE022 in Threatened Preterm Labour

Key Inclusion Criteria: Part A * Pregnant females aged ≥ 18 years * Patients with a singleton or twin pregnancy * Gestational age between 28 0/7 and 33 6/7 * Administered or prescribed atosiban for the treatment of preterm labour Part B * Pregnant females aged ≥ 18 years * Patients with a singleton or twin pregnancy * Gestational age between 24 0/7 and 33 6/7 * Administered or prescribed atosiban for the treatment of preterm labour * ≥4 uterine contractions per 30 minutes * Cervical dilatation of 1 to 4 cm inclusive * At least one of the following signs of preterm labour: 1. positive IGFBP-1 or fœtal Fibronectin test 2. cervical length ≤ 25mm 3. progressive cervical change Key Exclusion Criteria: * Fœtal death in utero in current or previous pregnancy after gestational week 24 or expected high risk of fœtal death in the coming days * Oligohydramnios * Known pathological Doppler ultrasound of the umbilical artery * Any contraindications for the mother or the fœtus to stop labour or prolong pregnancy or any maternal or fœtal conditions likely to indicate iatrogenic delivery in the next 7 days, including but not limited to: 1. Premature rupture of membranes 2. Evidence or suspicion of abruptio placenta 3. Signs and/or symptoms of chorio-amnionitis 4. Pre-eclampsia, eclampsia or HELLP-syndrome * Use of cervical cerclage in the current pregnancy or a pessary in situ * Current use of anti-hypertensive medication * Treatment with other tocolytics within specified time before the baseline assessment of uterine contractions