Clinical Research Directory

Inclusion Criteria: * Pregnant women aged ≥18 and ≤56 years * An unripe cervix, ≤6 points according to the Bishop score assessment (0-10-point scale) * Planned induction of labor by balloon catheter method * Gestational age at the time of the study ≥ 37 weeks (gestational age confirmed by ultrasound before the 21st week of pregnancy) * Singleton pregnancy * Cephalic presentation * The subject understands the study information and signs the informed consent Exclusion Criteria: * Preterm induction of labor (\<37 weeks of gestation) * Abnormal Cardiotocography (CTG) at inclusion * Spontaneous rupture of membranes at inclusion * Clinically significant vaginal bleeding with a need of hospitalization in the third trimester * Clinical active vaginal or uterine infection * Maternal Human Immunodeficiency Virus (HIV), hepatitis C, or hepatitis B * Uterine scar (including previous cesarean section) * Condition requiring immediate delivery of the fetus or mother * Presence of eclampsia * Severe Preeclampsia \[Blood pressure (BP)≥ 160/110 and any of the following: thrombocytopenia with platelet count \<100 × 10e9/L, HELLP- syndrome ( Hemolysis, Elevated Liver enzymes and Low Platelets), progressive renal insufficiency, pulmonary edema \] * Severe fetal growth restriction (Fetal Growth Restriction (FGR) fetal growth \<-2 SD/\<10th percentile) * Estimated fetal weight ≥ 2 Standard Deviation /≥ 95th percentile * Reduced amniotic fluid volume (deepest vertical pocket \<30 mill meter) * Breech or transverse fetal position * Multiple pregnancy * Vasa previa or placenta previa * Umbilical cord prolapses * Bishop score ≥6 on cervical assessment prior to labor induction * Receiving epidural anesthesia prior to catheter insertion * Refusal to participate in the study and/or insufficient language skills to understand the study information and/or consent form