Pre-treatment during late pregnancy to reduce prolonged labour.
Conditions
Interventions
Product Name: DF01 150 mg/ml solution for injection
Pharmaceutical Form: Solution for injection
Current Sponsor code: DF01
Other descriptive name: Low molecular weight derivative of heparin with low a
Sponsors
Dilafor AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: a) Healthy nulliparous females, 18-40 years of age with the gestation age confirmed by ultrasound. b) Normal singleton pregnancy c) Intact membranes d) In the opinion of the investigator, the subject will be able to comply with the requirements of the protocol, including ability to present for all required visits. e) Subject is capable of understanding and signing an informed consent form. 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 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: a) Breech presentation including other abnormal presentations b) Vaginal bleeding in the last 10 weeks of the pregnancy c) Intercurrent illness (e.g. essential hypertension, diabetes, coagulation disorders) d) Pregnancy complications (e.g. hypertension in pregnancy, preeclampsia, hepatosis) e) Coagulation defects (prolonged APTT; Prothrombin complex (INR) > 1.2 ); Thrombocytes 30 kg/m2.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of pre-treatment with DF01 compared with placebo on labour delivery time, which is defined as time from cervical dilatation of at least 3 cm and 3 contractions of minimum one minute´s duration/10 minutes until partus in women with vaginal delivery.;Secondary Objective: To assess safety and tolerability of DF01, Complications of labour (e.g. caesarean section, instrumental delivery, vaginal tears, sphincter rupture, post-partum bleeding), Use of epidural anaesthesia, Foetal complications [e.g. cord artery pH 12 mmol/L , Apgar score < 7 at 5 minutes, neonatal intensive care unit (NICU) admission, neonatal diagnoses. ;Primary end point(s): Labour delivery time, defined as the time from cervical dilatation of at least 3cm and 3 contractions of minimum 1 minute´s duration/10 minutes until partus. | — |
Countries
Sweden
Outcome results
None listed