At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Randomized, Placebo-Controlled, Proof of Concept Study to Evaluate the Efficacy on Cervical Ripening, Safety, Tolerability and Dose Response of SC Administered Tafoxiparin in Term Pregnant, Nulliparous Women With an Unripe Cervix Undergoing Labor Induction
In Brief
A Phase 2 clinical trial evaluating DF01 and PL1 for Labor Onset and Length Abnormalities. Completed, enrolled 365 participants across 7 sites in 2 countries.
Detailed Summary
The study is designed as a randomized, Double-Blind, Placebo-Controlled, Parallel-Group Proof of Concept Study (section A) with a conditional dose finding follow up (Section B) to Evaluate the Efficacy on Cervical ripening, Safety, Tolerability and dose response of Subcutaneously Administered Tafoxiparin in Term Pregnant, Nulliparous Women with an unripe cervix undergoing Labor Induction. If the efficacy and safety profiles of Section A are conclusive in favor of tafoxiparin, the study will continue by adding two additional tafoxiparin dose groups in Section B.
Study Details
Timeline
Interventions
DF01: The subject receives sc injections of tafoxiparin solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins
DF01: The subject receives sc injections of placebo solution once daily for up to 7 days until spontaneous onset of labor or ripe cervix (Amniotomy/oxytocin without restriction).If not enough ripening cervical ripening according to clinical practice with intracervical ballon/prostaglandins