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
Overview
- Phase
- Phase 2
- Intervention
- DF01
- Conditions
- Labor Onset and Length Abnormalities
- Sponsor
- Dilafor AB
- Enrollment
- 365
- Locations
- 7
- Primary Endpoint
- Cervical Ripening Rate, Measured by Bishop Score - Slope
- Status
- Completed
- Last Updated
- 12 months ago
Overview
Brief 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.
Detailed Description
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
Investigators
Eligibility Criteria
Inclusion Criteria
- •Pregnant women of ≥18 and ≤ 64 years of age
- •Nulliparous
- •Unripe cervix with ≤ 4points according to Bishop/Westin score (0-10 points scale)
- •Planned for labor induction after 4-7 days of IMP treatment
- •Examples of diagnosis as a basis for induction:
- •Post term pregnancy (40-41 weeks of gestation)
- •Gestational diabetes
- •Diabetes type 1 - well controlled
- •Pre-eclampsia (BP diastolic \<100, systolic \<140)
- •Hypertension - well controlled
Exclusion Criteria
- •Subjects who are unable to understand the written and verbal instructions in local language
- •Breech presentation and other abnormal fetal presentations
- •Previous uterine scar
- •Spontaneous rupture of membranes at inclusion
- •Pathologic CTG at inclusion
- •Fetal estimated weight \> 2SD of normal fetal estimated weight earlier diagnosed by ultrasound and documented in patient record
- •Mother's BMI \> 35 at early pregnancy
- •Known IUGR defined as ≤ 2SD of normal
- •Presence of eclampsia
- •Severe Pre-eclampsia
Arms & Interventions
Experimental DF01 high dose
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
Intervention: DF01
Experimental: DF01 medium dose
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
Intervention: DF01
Experimental: DF01 low dose
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
Intervention: DF01
Placebo comparator: PL1
The subject receives sc injections once daily for up to 7 days until labor induction or spontaneous onset of labor.
Intervention: PL1
Outcomes
Primary Outcomes
Cervical Ripening Rate, Measured by Bishop Score - Slope
Time Frame: Daily measures of Bishop Score from start of study drug administration until delivery (up to 7 days).
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.