Status:
UNKNOWN
PoC Study of OBE022 in Threatened Preterm Labour
Lead Sponsor:
ObsEva SA
Collaborating Sponsors:
Scope International AG
Iqvia Pty Ltd
Conditions:
Preterm Labor
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
This is a proof-of-concept study in 2 parts. In Part A, patients will receive OBE022 open-label in order to assess the safety and pharmacokinetics in pregnant women with spontaneous preterm labour wi...
Eligibility Criteria
Inclusion
- Key
- 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:
- positive IGFBP-1 or fœtal Fibronectin test
- cervical length ≤ 25mm
- progressive cervical change
- Key
Exclusion
- 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:
- Premature rupture of membranes
- Evidence or suspicion of abruptio placenta
- Signs and/or symptoms of chorio-amnionitis
- 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
Key Trial Info
Start Date :
January 10 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2022
Estimated Enrollment :
115 Patients enrolled
Trial Details
Trial ID
NCT03369262
Start Date
January 10 2018
End Date
August 1 2022
Last Update
June 7 2021
Active Locations (18)
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1
Gynekologicko-porodnická klinika Fakultní nemocnice Brno
Brno, Czechia
2
Gynekologicko-porodnická klinika 1. LF UK a VFN v Praze
Prague, Czechia
3
Ústav pro péči o matku a dítě
Prague, Czechia
4
Helsinki Universisty Hospital
Helsinki, Finland