Preterm Labor
Conditions
Keywords
Premature Obstetric Labor, Premature Birth
Brief summary
The primary objective of this study is to assess the efficacy of a single dose of OBE001, an oral oxytocin antagonist, given for up to 7 days to delay preterm birth by 7 days compared to placebo.
Detailed description
The study will be a multi-centre, randomised, parallel group, double-blind, placebo-controlled study in pregnant women with threatened preterm labour between 34\^0/7 and 35\^6/7 weeks of gestation. The study will be in 2 parts as follows: * from screening until the day of delivery (including a treatment period up to seven days) * a maternal and neonatal follow-up period from the day of delivery until 28 days post expected term date (or until 28 days post-delivery should this be later). In addition, there will be an observational, safety follow-up of the infants for 2 years to evaluate developmental outcome.
Interventions
DRUGOBE001
OBE001 dispersible tablets for a single oral dose a day for up to 7 days.
DRUGPlacebo
Placebo dispersible tablets for a single oral dose a day for up to 7 days.
Sponsors
ObsEva SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Gestational age (GA) between 34\^0/7 and 35\^6/7 weeks. * Subjects with symptoms of preterm labour. * Subjects with a singleton pregnancy.
Exclusion criteria
* Foetal death in utero in current pregnancy or in previous pregnancy after gestational week 24 or expected high risk of foetal death in the current pregnancy. * Any contraindications for the mother or the foetus to stop labour or prolong pregnancy or any maternal or foetal conditions likely to indicate iatrogenic delivery. * Use of cervical cerclage or a pessary in situ in the current pregnancy. * The Subject has any condition which in the opinion of the PI constitutes a risk or a contraindication for the participation of the subject in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| EFFICACY ENDPOINTS: Incidence of women delivering within 7 days post first dose | within 7 days of first dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| EFFICACY ENDPOINTS: Incidence of women delivering within 48 hours post first dose | within 48 hours of first dose | — |
| EFFICACY ENDPOINTS: Incidence of women delivering before gestational age 37^0/7 weeks | up to 3 weeks post first dose | — |
| EFFICACY ENDPOINTS: Progression of uterine contractions from pre-dose to 6 hours and 24 hours post first dose | up to 24 hours post first dose | Contractions measured by tocodynamometry. |
| EFFICACY ENDPOINTS: Assessment of maternal and foetal exposure to OBE001 (Maternal plasma concentrations of OBE001) | up to 7 weeks post first dose | Maternal plasma concentrations of OBE001 on Day 1 (2 hours post first dose), on Day 2 (pre-dose and 2 hours post-dose) on Day 3 (pre-dose), Day 7 (post-dose) and at the time of delivery. Umbilical cord plasma concentration of OBE001 at the time of delivery. |
Other
| Measure | Time frame | Description |
|---|---|---|
| SAFETY ENDPOINTS: Evaluation of the foetal safety of OBE001 (clinically significant changes in growth retardation and/or foetal heart rate monitoring and/or Amniotic Fluid Indices (AFI) | up to 14 days post first dose or birth whichever is earlier | Incidence of foetal distress as determined by clinically significant changes in growth retardation and/or foetal heart rate monitoring and/or Amniotic Fluid Indices (AFI) from Day 1 to Day 14 or birth, whichever is earlier |
| SAFETY ENDPOINTS: Evaluation of the newborn neonatal morbidity | up to 28 days post expected term date | Incidence of infants experiencing adverse events assessed by vital signs, temperature, APGAR score, weight and head circumference at birth as well as measures of neonatal morbidity from birth until 28 days after birth or term whichever is later |
| SAFETY ENDPOINTS: Evaluation of infant neurodevelopmental outocme. | up to 2 years after birth | Incidence of infants with one or more Ages and Stages Questionnaire-3 domain score(s) below the cutoff at 6, 12, and 24 months, adjusted for gestational age. |
| SAFETY ENDPOINTS: Evaluation of the maternal safety of OBE001 (Maternal incidence of adverse events (AEs), treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory safety tests, 12-lead ECGs morphology or vital signs) | up to 28 days post expected term date | Maternal incidence of adverse events (AEs), treatment-emergent adverse events (TEAEs), clinically significant changes in laboratory safety tests, 12-lead ECGs morphology or vital signs from Day 1 until 28 days after birth or term whichever is later. |
Countries
Belgium, Germany, Poland, Spain, Switzerland, United Kingdom
Outcome results
None listed