drugset / Trial / NCT04000438

Effect of Tafoxiparin on Cervical Ripening and Induction of Labor in Term Pregnant Women With an Unripe Cervix

NCT04000438

Phase 2 Completed 365 enrolled Dilafor AB
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2019-06-21
Primary completion
2023-02-14
Completion
2023-03-30

Drugs

EvaluationDrugModalityDoseRoute
Subject DF01 Other / unclassified Subcutaneous

Indications

No indication recorded.