pregnancy patients between 37 - 42 weeks of gestation able for labor induction MedDRA version: 9.1 Level: LLT Classification code 10029759
Conditions
Interventions
Trade Name: CYTOTEC
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: Misoprostol
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 25-
Pharmaceutical form of t
Sponsors
A.U.S.L. RIMINI
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: pregnancy patients between 37 - 42 weeks of gestation age > = 18 years old 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
Exclusion criteria
Exclusion criteria: twins previous isterotomy PROM low fetal development Preclampsia Polidramnios controindication to misoprostol Placenta previa matern metrorragia podalic presentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: comparison of the number of physiological labor;Secondary Objective: time to labor time to labor pains number of vaginal and abdominal labors Ph, Lactate and BE Apgar index Number of recovery in neonatal rianimation or in neonatal pathology;Primary end point(s): number of physiological labor | — |
Countries
Italy
Outcome results
None listed