Cervical ripening prior labor induction MedDRA version: 20.0 Level: SOC Classification code 10036585 Term: Pregnancy, puerperium and perinatal conditions System Organ Class: 10036585 - Pregnancy, puerperium and perinatal conditions
Conditions
Interventions
Trade Name: Misofar 25mcg vaginal tablet
Pharmaceutical Form: Vaginal tablet
INN or Proposed INN: MISOPROSTOL
Other descriptive name: MISOPROSTOL
Sponsors
SOLEDAD CARREGUI, NATIVIDAD BANEGAS, SARA CRUZ
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? At term pregnancy with indication of cervical ripening of low and medium risk according to the Basic Control of Pregnancy card of the Valencian Community (Annex II) ? At term pregnancy with indication of cervical ripening with well-controlled thyroid endocrinopathy during pregnancy. ? Single fetus in longitudinal situation and cephalic presentation ? Previous CTG without pathological findings ? Acceptance of the IC by the pregnant woman to participate in the study 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 30 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: ? Hypersensitivity to latex ? Pregnant women with low insertion placenta in 3rd trimester ultrasound ? Pregnant women classified as high and very high risk according to the Basic Control of Pregnancy card of the Valencian Community. ? Premature rupture of membranes. ? Contraindication of administration of prostaglandins (misoprostol) ? Language barrier
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the efficacy and safety of the intracervical Foley catheter and vaginal misoprostol for cervical ripening in pregnant women with a medical indication for labor induction with an unfavorable cervical state; Secondary Objective: Determine the time difference in hours from the start of cervical ripening to the active period of labor between both groups. ? Determine the time difference in hours from the start of cervical ripening to delivery between both groups. ? Determine the type of delivery: eutocic, instrumented or cesarean section. ? Compare the Apgar test at the first minute and at the fifth minutes of life between both groups. ? Determine the presence of alterations in uterine dynamics during ripening in both groups. ? Determine the presence of FHR alterations during ripening in both groups. ? Compare the requeriments of analgesia during cervical ripening between both groups. ? To compare the requirements of induction with exogenous oxytocin after cervical ripening in both groups ; Primary end point(s): ? Bishop test pre-maturation (0-5 points) ? Bishop test pre-induction (0-15 points) ? Uterine dynamics during ripening. ? Alterations of the FHR during ripening: YES / NO ; Timepoint(s) of evaluation of this end point: Bishop test: 24 hours. The uterine dynamics and the alterations of the FHR during ripening: every 4 hours. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): ? Time in hours from the start of cervical ripening to the active period of labor ? Time in hours from the start of cervical ripening to delivery ? Termination of delivery: eutocic, instrumented, cesarean. ? Cesarean reason: induction failure, risk of loss of fetal well-being, parity, disproportion, anomalous presentation and others. ? Maternal age ? Parity: nulliparous / multiparous ? Weeks of gestation ? Apgar at minute and five minutes of life. ? Need for analgesia during maturation: YES / NO ? Induction with exogenous oxytocin after maturation: SI / NO ? Membrane rupture: Spontaneous / Artificial ? Epidural analgesia: YES / NO ;Timepoint(s) of evaluation of this end point: At the end of labor | — |
Countries
Spain
Contacts
Public ContactSOLEDAD CARREGUI
HOSPITAL UNIVERSITARI DE LA PLANA
Outcome results
None listed