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 Methodology: 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 study 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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
365
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
Naistenklinikka (HUS)
Helsinki, Finland
Tampere University Hospital
Tampere, Finland
Kvinnokliniken Universitetssjukhuset Linköping
Linköping, Sweden
Lund University Hospital
Lund, Sweden
Kvinnokliniken Skaraborgs Sjukhus
Skövde, Sweden
Kvinnokliniken Södersjukhuset
Stockholm, Sweden
Förlossningsavdelningen Akademiska Universitetssjukhuset
Uppsala, Sweden
Cervical Ripening Rate, Measured by Bishop Score - Slope
Cervical ripening rate during up to the first seven days of treatment, measured by Bishop Score - Slope. Bishop score is an Assessment of the cervical stage by its: dilatation, position, effacement and consistency. The score was calculated as the sum of the following 5 categories where each category is scored between 0-2: * Fetal station (0-2) * Cervical diameter at inner meatus (0-2) * Cervical effacement (0-2) * Consistency at inner meatus (0-2) * Cervical position (0-2) Graded from 0-10, Bishop score of ≤ 4 is unripe and ≥ 6 is ripe. Bishop score was measured daily from start of treatment up until 7 days. The cervical ripening rate was calculated from the slope of the curve (score/day) when plotting Bishop score against days of treatment.
Time frame: Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).
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