UnknownPhase 2

PoC Study of OBE022 in Threatened Preterm Labour

Czechia, Finland, Israel115 participantsStarted 2018-01-10

Plain-language 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 with a gestational age between 28 0/7 and 33 6/7 weeks. Part B has a double-blind, randomised, placebo controlled, parallel group and multicentre design and will assess the efficacy, safety and pharmacokinetics in pregnant women with threatened spontaneous preterm labour with a gestational age between 24 0/7 and 33 6/7 weeks. All patients in part A and part B must receive atosiban infusion for 48 hours as standard of care treatment. Patients from Part A will receive OBE022 open label. Patients from Part B will be randomised to receive OBE022 or matching placebo. IMP treatment duration will be up to 7 days. IMP treatment will be stopped in case of delivery prior to Day 7.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. positive IGFBP-1 or fœtal Fibronectin test
. cervical length ≤ 25mm
. progressive cervical change

Exclusion criteria

. Premature rupture of membranes
. Evidence or suspicion of abruptio placenta
. Signs and/or symptoms of chorio-amnionitis
. Pre-eclampsia, eclampsia or HELLP-syndrome

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Incidence of delivery within 2 days (48 h) from start of IMP administration

Timeframe: 48 hours

Incidence of delivery within 7 days (168 h) from start of IMP administration

Timeframe: 168 hours

Incidence of delivery before 37 weeks of GA

Timeframe: Up to 13 weeks from start of IMP administration

Time to delivery measured from start of IMP administration

Timeframe: Up to 17 weeks from start of IMP administration

Trial details

NCT IDNCT03369262

SponsorObsEva SA

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-07-08

View on ClinicalTrials.gov More Preterm Labor trials