Acta obstetricia et gynecologica Scandinavica · 2026
Priming of labor with tafoxiparin in nulliparous term pregnant women with unripe cervix-Proof-of-concept and dose-finding results from a randomized controlled trial.
СтатьяРандомизированное исследованиеКлиническое исследование II фазыНазвание и аннотация: Перевод в очереди
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Ekman-Ordeberg Gunvor, Jonsson Maria, Blomberg Marie, Melin Malin, Stjernholm-Vladic Ylva, Gidlöf Sebastian B, Wide-Swensson Dag, Tihtonen Kati, Olsen Inge C, Degling-Wikingsson Lena, Blom Per, Rahkonen Leena
Аннотация
INTRODUCTION: New therapies are needed to improve the risk-benefit profile of intervention for labor induction. Tafoxiparin, a depolymerized form of heparin with no anticoagulant effects, has demonstrated potential to increase cervical ripening and influence the onset and outcome of labor. We assessed the effects of tafoxiparin in women with an unripe cervix scheduled for labor induction.
MATERIAL AND METHODS: Phase 2 randomized double-blind placebo-controlled study (PPL17; EudraCT 2019-000620-17), conducted in two parts. The first part compared tafoxiparin 300 mg vs. placebo, while the second part assessed tafoxiparin 150 and 75 mg. Study treatment was administered once daily up to 7 days or until onset of labor or ripened cervix. Study participants were nulliparous women at term with an unripe cervix and planned labor induction. The primary endpoint was the cervical ripening rate during treatment, as measured by Bishop score.
RESULTS: Of 348 randomized women, 347 received study treatment. The primary analysis of Bishop score showed statistically significant increases in cervical ripening with tafoxiparin. The difference from placebo was most pronounced in the 300 mg group (mean slope 0.86 vs. 0.62, p = 0.006). Spontaneous onset of labor occurred in 39.8%-42.4% of women treated with tafoxiparin versus 28.4% with placebo. The rate of instrumental vaginal deliveries (vacuum extractions) was lowest in the tafoxiparin 300 mg group (10.0% vs. 24.1% with placebo; p = 0.013). Few serious adverse events were reported, and there was no hypercontractility related to tafoxiparin.
CONCLUSIONS: Tafoxiparin was effective in cervical ripening, facilitating spontaneous onset of labor and reducing the need for instrumental delivery. Benefits were most pronounced with the 300 mg dose, and a favorable safety profile was observed. These results suggest that tafoxiparin may be suitable for obstetrical use in outpatient and home-based settings.
MATERIAL AND METHODS: Phase 2 randomized double-blind placebo-controlled study (PPL17; EudraCT 2019-000620-17), conducted in two parts. The first part compared tafoxiparin 300 mg vs. placebo, while the second part assessed tafoxiparin 150 and 75 mg. Study treatment was administered once daily up to 7 days or until onset of labor or ripened cervix. Study participants were nulliparous women at term with an unripe cervix and planned labor induction. The primary endpoint was the cervical ripening rate during treatment, as measured by Bishop score.
RESULTS: Of 348 randomized women, 347 received study treatment. The primary analysis of Bishop score showed statistically significant increases in cervical ripening with tafoxiparin. The difference from placebo was most pronounced in the 300 mg group (mean slope 0.86 vs. 0.62, p = 0.006). Spontaneous onset of labor occurred in 39.8%-42.4% of women treated with tafoxiparin versus 28.4% with placebo. The rate of instrumental vaginal deliveries (vacuum extractions) was lowest in the tafoxiparin 300 mg group (10.0% vs. 24.1% with placebo; p = 0.013). Few serious adverse events were reported, and there was no hypercontractility related to tafoxiparin.
CONCLUSIONS: Tafoxiparin was effective in cervical ripening, facilitating spontaneous onset of labor and reducing the need for instrumental delivery. Benefits were most pronounced with the 300 mg dose, and a favorable safety profile was observed. These results suggest that tafoxiparin may be suitable for obstetrical use in outpatient and home-based settings.