A randomised, double-blind, placebo-controlled, multicentre trial to access the safety and efficacy of pre-treatment with DF01 during late pregnancy in reducing prolonged labour.
- Conditions
- Pre-treatment during late pregnancy to reduce prolonged labour.
- Registration Number
- EUCTR2006-005839-20-SE
- Lead Sponsor
- Dilafor AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
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
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 <130 x 109/L
f) Infections (HIV, hepatitis, STDs)
g) Suspected foetal malformation
h) Suspected intrauterine growth retardation
i) Hospitalized due to complication during the last 10 weeks of the pregnancy
j) Any known history of allergy to heparin and/or dalteparin (Fragmin)
k) Any known history of heparin-induced thrombocytopenia
l) Fear of injections
m) Body mass index (BMI) > 30 kg/m2.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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,<br>Complications of labour (e.g. caesarean section, instrumental delivery, vaginal tears, sphincter rupture, post-partum bleeding),<br>Use of epidural anaesthesia,<br>Foetal complications [e.g. cord artery pH < 7.10 and/or base deficit > 12 mmol/L , Apgar score < 7 at 5 minutes, neonatal intensive care unit (NICU) admission, neonatal diagnoses.<br>;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.
- Secondary Outcome Measures
Name Time Method