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.
Primary objective:
To assess the efficacy of tafoxiparin on cervical ripening.
Secondary objective:
To assess the maternal and neonatal safety, tolerability and dose response of tafoxiparin as a supplement therapy in term pregnant, nulliparous women with an unripe cervix undergoing labor induction
Term pregnant, nulliparous women with unripe cervix and planned for labor induction are potential study patients unless enrolled in another study. Subjects may be preinformed about the stuyd through the use of advertisement or information at the physician/midwife visits during pregnancy and at the hospital admission.
The whole study includes the following steps:
Screening and Baseline including informed consent and randomization Study treatment and Induction of Labor Labor Discharge
| Condition | Labor Onset and Length Abnormalities |
|---|---|
| Treatment | DF01, PL1 |
| Clinical Study Identifier | NCT04000438 |
| Sponsor | Dilafor AB |
| Last Modified on | 6 February 2023 |
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