Primary Slow Progress of Labor including prolonged latent phase and Primary Labor Arrest MedDRA version: 19.1 Level: LLT Classification code 10023539 Term: Labor abnormal System Organ Class: 100000004868
Conditions
Interventions
Product Name: Tafoxiparin
Product Code: DF01
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Tafoxiparin Sodium
CAS Numb
Sponsors
Dilafor AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Pregnant women of =18 to =45 years of age 2. Nulliparous 3. Gestational age > 36 weeks + 6 days confirmed by ultrasound 4. Experience slow progress of labor including prolonged latent phase and Primary labor arrest (according to the respective definitions) 5. Normal CTG at inclusion 6. Singleton pregnancy 7. Subject is as per the discretion of the Investigator, considered healthy and able to comply with the requirements of the protocol 8. 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 360 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: 1. Pregnant women of =18 to =45 years of age 2. Nulliparous 3. Gestational age > 36 weeks + 6 days confirmed by ultrasound 4. Experience slow progress of labor including prolonged latent phase and Primary labor arrest (according to the respective definitions) 5. Normal CTG at inclusion 6. Singleton pregnancy 7. Subject is as per the discretion of the Investigator, considered healthy and able to comply with the requirements of the protocol 8. Provision of written informed consent Exclusion criteria: 1. Subjects with secondary slow progress or secondary labor arrest 2. BMI=35 during first trimester of pregnancy 3. Breech presentation or other abnormal presentations 4. LGA (Large for Gestational Age) defined as = to normal weight earlier diagnosed by ultrasound and documented in patient record 5. Small for gestational age (SGA) defined as =-2SD to normal weight earlier diagnosed by ultrasound and documented in patient record 6. Presence of eclampsia 7. Severe preeclampsia, defined as severe by the [ACOG Committee Preeclampsia and Eclampsia (2002)] as preeclampsia with any or more of the following characteristics present: - Blood pressure of =160 mmHg systolic or =110 mmHg diastolic on two occasions at least 6 hours apart while the patient is on bed rest - Proteinuria of 5 g or higher in a 24-hour urine specimen or 3+ greater on two random urine samples collected at least 4 hours apart - Oliguria of less than 500 mL in 24 hours - Cerebral or visual disturbances - Pulmonary edema or cyanosis - Epigastric or right upper-quadrant pain - Impaired liver function - Thrombocytopenia 8. HELLP syndrome (hemolysis, elevated liver enzymes, and low platelets) 9. Clinically significant vaginal bleeding in the third trimester 10. Diagnosed renal insufficiency 11. Previously known coagulation disorders, including but not limited to: - Von Willebrand’s disease - Haemophilia A/B - Antithrombin deficiency - Vitamin K deficiency 12. Previously known coagulation defects, including but not limited to: - Prolonged activated partial thromboplastin time (APTT) - Thrombocytes <100 x 109/L 13. Current use of any drugs that interfere with hemostasis, including heparin / LMWH, non-steroidal anti-inflammatory drugs (NSAID) compounds, warfarin and vitamin K antagonists 14. Current use, or use within the week preceding screening, of acetylsalicylic acid (ASA) compounds 15. Previously known current infections (HIV or hepatitis) 16. Any known history of allergy to standard heparin and/or LMWH heparin 17. History of heparin-induced thrombocytopenia 18. Current drug or alcohol abuse which in the opinion of the Investigator should preclude participation in the study 19. Current participation in other clinical treatment studies 20. Previous uterine scar (e.g. myomectomy) 21. Labor
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the dose-response relationship of tafoxiparin on the labor time defined as the time from the start of continuous infusion of tafoxiparin/placebo as an Adjunct Treatment to Oxytocin, until partus in term-pregnant, nulliparous women requiring labor augmentation due to Primary Slow Progress of Labor including prolonged latent phase and Primary Labor Arrest;Secondary Objective: To assess the safety and efficacy of tafoxiparin based on the safety and secondary efficacy parameters evaluated in the protocol. PK response in pregnant women during labor;Primary end point(s): Time from start of infusion of tafoxiparin/placebo until vaginal partus;Timepoint(s) of evaluation of this end point: Up to 36 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Timepoint(s) of evaluation of this end point: Up to 36 hours ; Secondary end point(s): • Safety assessment • Time from cervical dilatation of 4 cm and progress of labor until vaginal partus • Proportion of women with dystocia/protracted labor defined as =8, 10, 12 and 14 hours of established labor (4 cm of cervical dilation to vaginal partus ) • Proportion of women with dystocia/protracted labor defined as =8, 10, 12 and 14 hours from start of IMP infusion to vaginal partus • Proportion of women with caesarean sections • Proportion of women undergoing instrumental deliveries • Number of instrumental deliveries • Use of analgesia (N2O, epidural, pudendal nerve block) • Proportion of women with postpartum hemorrhage > 1000 ml • Fetal outcome measured as Apgar score (5 min) = 7 points, Base Excess > -12 and referral to NICU for > 48 hours • Uterine hyperstimulation with fetal heart rate changes • Indication for referral to NICU • Use of Oxytocin (no.umber of mililitersls. according to instructions) • PK response measured between, at least 60 minutes after initiation of treatment with IMP and partus | — |
Countries
Denmark, Finland, Norway, Sweden
Contacts
Public ContactJenny Eriksson
IRW Consulting AB
Outcome results
None listed