Induction of labor in pregnant women with unripe cervix MedDRA version: 20.0 Level: LLT Classification code 10055563 Term: Labor induction System Organ Class: 100000004865
Conditions
Interventions
Product Name: Tafoxiparin
Product Code: DF01
Pharmaceutical Form: Solution for injection
INN or Proposed INN: TAFOXIPARIN SODIUM
CAS Number: 1638190-4
Current Sponsor code: DF01
Concentration unit: mg
Sponsors
Dilafor AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: i) Pregnant women of =18 and = 64 years of age ii) Nulliparous iii) Unripe cervix with = 4points according to Bishop/Westin score (0-10 points scale) iv) 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 37 weeks confirmed by ultrasound before 21 weeks of gestation vi) Singleton pregnancy vii) Subject is, as per the discretion of the Investigator, able to comply with the requirements of the protocol including an ability to be present at all required controls viii) Subject can understand and sign an informed form ix) Provision of written informed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 334 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: i) Subjects who are unable to understand the written and verbal instructions in local language ii) Breech presentation and other abnormal fetal presentations iii) Previous uterine scar iv) Spontaneous rupture of membranes at inclusion v) Pathologic CTG at inclusion vi) Fetal estimated weight > 2SD of normal fetal estimated weight earlier diagnosed by ultrasound and documented in patient record vii) Mother’s BMI > 35 at early pregnancy viii) Known IUGR defined as = 2SD of normal ix) Presence of eclampsia x) Severe Pre-eclampsia xi) HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets) xii) Clinically significant vaginal bleeding in need of hospitalization in the third trimester xiii) Placenta previa xiv) Previously known coagulation disorders (Leiden, heterozygote - OK) xv) Treatment with a heparin/LMWH product during the previous six months xvi) Current use of any drugs that interfere with hemostasis such as oral anti-coagulant medication, non-steroidal anti-inflammatory drugs (NSAID) compounds and vitamin K antagonists. xvii) Current use of acetylsalicylic acid (ASA) compounds or use within the week preceding inclusion xviii) Diagnosed with HIV or Acute hepatitis xix) Known history of allergy to standard heparin and/or LMWH heparin xx) History of heparin-induced thrombocytopenia xxi) Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study. xxii) Current participation in other interventional medicinal treatment studies xxiii) Subject has a fear of needles which is believed by the Investigator to affect study medication compliance xxiv) Any relevant condition, laboratory value or concomitant medication which, in the opinion of the investigator, makes the subject unsuitable for entry into the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main 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 an adjuvant therapy in term pregnant, nulliparous women with an unripe cervix;Primary end point(s): Cervical ripening rate during up to the first seven days of treatment, measured by Bishop score;Timepoint(s) of evaluation of this end point: During up to the first seven days of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Secondary Efficacy endpoints include: i) Time from start of treatment to increase in Bishop score of = 2 points or spontaneous onset of labor, whichever comes first ii) Time from start of treatment to increase in Bishop score of = 3 points or spontaneous onset of labor, whichever comes first iii) Time from start of treatment to increase in Bishop score of = 4 points or spontaneous onset of labor, whichever comes first iv) Cervical ripening as measured by change from baseline to end of treatment in Bishop score v) Time from onset of labor to partus. Onset of labor is defined as last record of 4 cm cervical dilatation visualized in the partogram and progress of labor or last record of 4 cm of cervical dilatation in combination with amniotomy and intravenous administration oxytocin vi) Proportion of women with established labor = 6 hours vii) Proportion of women with labor time = 8 hours viii) Proportion of women with established labor = 12 hours ix) Total dosages of study drug (IMP) x) Proportion of women with spontaneous labor (response group I) xi) Proportion of women with a ripe cervix (response group I+II) vii)xii) Proportion of women in response groups (I-IV) Secondary Safety and tolerability endpoints include: i) Proportion of patients undergoing caesarean sections (CS) ii) Indications for CS iii) Proportion of patients undergoing instrumental deliveries (vacuum extraction (VE)/forceps delivery) iv) Indications for VE and forceps deliveries v) Fetal outcome measured as Birth weight, Apgar score, Acidosis (pH 48 hours. viii) Uterine hyper stimulation in demand of tocolytic treatment ix) Proportion of patients with Postpartum Hemorrhage (PPH) > 2000 ml;Timepoint(s) of evaluation of this end point: From start of treatment until discharge | — |
Countries
Finland, Sweden
Contacts
Public ContactCEO
Dilafor AB
Outcome results
None listed