Full-term pregnancy women at week 40 + 5 of gestation with intact membranes, the first delivery, singleton physiological pregnancy MedDRA version: 21.1 Level: LLT Classification code 10036880 Term: Prolonged pregnancy, with delivery System Organ Class: 100000004868
Conditions
Interventions
Product Name: Mifepristone 150
Pharmaceutical Form: Tablet
INN or Proposed INN: MIFEPRISTONE
CAS Number: 84371-65-3
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number:
Sponsors
Disphar International B.V
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Age 18 – 40 years • Pregnancy = 40 Weeks + 5 days • Bishop Score = 5 • Intact membranes • BMI = 30 before pregnancy • Primiparous women • Singleton pregnancy • Physiological pregnancy (no risk factors, no abnormalities in clinical and laboratory examinations during pregnancy) • Agreeing to participate in the study • Signed written informed consent for study participation 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 150 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: • any contraindication to vaginal delivery • previous late abortion (= 12 week of pregnancy) • uterine scar • cephalopelvic disproportion • placenta praevia • fetal malpresentation • chorioamnionitis • fetal congenital abnormalities • participation in a clinical trial with investigational drugs within the last 3 months before the enrolment or during the present trial period. • significant maternal cardiac, renal or hepatic disease or any condition,which in the opinion of the Investigator place the patient at an unacceptable risk level for participating in a study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: • To explore the safety of Mifepristone tablet 150 mg • To explore the efficacy and safety of the dose of Mifepristone 75 mg in Part II of the study (if positive efficacy and safety outcomes are achieved in Part I) • To explore efficacy and safety of Mifepristone 300 mg in Part II of the study (if efficacy is not proven with a favourable safety profile in Part I) ;Primary end point(s): Gain in Bishop score 48 hours from baseline ;Timepoint(s) of evaluation of this end point: 48 hours after the drug administration;Main Objective: The primary objective of the study is to compare the efficacy of Mifepristone tablet 150 mg with placebo in cervix ripening in full-term pregnancy 48 hours after baseline | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Rate of subjects with Bishop score gain = 2 • Change in Bishop Score after 24 hours • Time to vaginal delivery • Rate of spontaneous vaginal delivery (without any assistance other than mifepristone or placebo in the control group) • Rate of Caesarean sections • Rate of subjects treated with Dilapan-S • Rate of subjects treated with Prostin E2 • Adverse events - subjects • Adverse events - infants • Consumption of analgesics ;Timepoint(s) of evaluation of this end point: • Rate of subjects with Bishop score gain = 2 ............48h after baseline • Change in Bishop Score after 24 hours................24h after baseline • Time to vaginal delivery ....until delivery • Rate of spontaneous vaginal delivery (without any assistance other than mifepristone or placebo in the control group)...until delivery • Rate of Caesarean sections......until delivery • Rate of subjects treated with Dilapan-S......until delivery • Rate of subjects treated with Prostin E2.....until delivery • Adverse events - subjects .............4-5 days from baseline • Adverse events - infants ................4-5 days from baseline • Consumption of analgesics...........4-5 days from baseline | — |
Countries
Czech Republic
Contacts
Public ContactClinical Trial Coordinator
Prague Clinical Services
Outcome results
None listed