Informace o publikaci
A randomised, placebo-controlled, proof-of-concept trial of ebopiprant for spontaneous preterm labor (PROLONG)
| Autoři | |
|---|---|
| Rok publikování | 2021 |
| Druh | Konferenční abstrakty |
| Fakulta / Pracoviště MU | |
| Citace | |
| Popis | Objective Ebopiprant (OBE022) is a novel, oral and selective prostaglandin F2a (PGF2a) receptor antagonist being developed to delay preterm birth. We tested the efficacy, safety and pharmacokinetics of ebopiprant in women with spontaneous preterm labor. Design Double-blind, randomized, placebo controlled, parallel group clinical trial. Methods Women with threatened preterm labour at a gestational age (GA) of 24 to 34 weeks were eligible. Participants had to have ? 4 contractions/30 mins, cervical dilatation of 1 to 4 cm, and ? one other sign of preterm labor (cervical length ? 25 mm, progressive cervical change, or a positive test for preterm labor) and be receiving atosiban infusion for 48 h. After informed consent, participants were randomised to ebopiprant or placebo, starting with 1000 mg, administered ? 24 h after starting atosiban, then 500 mg twice a day for 7 days. Efficacy endpoints (including delivery ? 48 h or 7 d) were exploratory. Maternal, fetal and neonatal safety were assessed up to 28 d after delivery. Results Between Jan 2019 and Mar 2020, 113 pregnant women (83 singletons, 30 twins) were randomized and treated. Overall, 7/56 (12.5%) women delivered ? 48 h with ebopiprant versus 12/55 (21.8%) with placebo (OR 0.52 95% CI 0.22, 1.23)). This difference was observed for singletons (12.5% versus 26.8%) but not for twins (12.5% versus 7.1%). At 7 days after randomisation, no differences were observed, except for singletons, ? 30 weeks GA. The incidence of maternal, fetal and neonatal adverse events were comparable between the treatment groups. There were two neonatal deaths in the ebopiprant group versus three in the placebo group. Conclusions The PROLONG trial provides initial evidence that ebopiprant, when administered with atosiban infusion to women with preterm labour, reduces the probability of delivering within 48 h. Trial registration NCT03369262. |