Clinical Research Directory

Inclusion Criteria: * Pregnant women aged ≥18 and ≤56 years * An unripe cervix, ≤6 points according to the Bishop assessment (0-10 point scale) * Planned induction of labor by mechanical balloon catheter method * Examples of diagnoses as the basis for labor induction: * Post-term pregnancy (≥41 weeks of gestation) * Maternal request for labor induction * Gestational diabetes * Preeclampsia (with blood pressure \<150/100) * Well-controlled hypertension * Cholestasis of pregnancy * Humanitarian or psychosocial reasons * 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 consent form Exclusion Criteria: * Preterm induction of labor (\<37 weeks of gestation) * Pathological CTG at inclusion * Spontaneous rupture of membranes at inclusion * Clinically significant vaginal bleeding with need of hospitalization in the third trimester * Clinically active vaginal or uterine infection * Maternal HIV, hepatitis C, or hepatitis B * Uterine scar (including previous cesarean section) * Condition of the fetus or mother requiring immediate delivery * Presence of eclampsia * Severe Pre-eclampsia (Blood pressure ≥160/110 and any of the following: low platelet count (\<100 × 10 9/L), HELLP, progressive renal insufficiency, pulmonary edema) * Severe fetal growth restriction (FGR, fetal growth \< -2 SD) * Estimated fetal weight ≥ 2SD or ≥ 95th percentile * Breech or transverse fetal position * Multiple pregnancy * Vasa previa or placenta previa * Umbilical cord prolapse * Maternal refusal to participate in the study and/or insufficient language skills to understand the study information and/or consent form