Labor Induction
Conditions
Keywords
misoprostol, labor induction
Brief summary
The purpose of this study was to estimate the safety and efficacy of titrated oral misoprostol compared with vaginal route for labor induction at term.
Detailed description
Oral misoprostol absorption is more rapid and possible more predictable, with a peak serum concentration following oral administration of 34 minutes and a half-life of 20-40 minutes. Peak serum concentration for vaginal administration is 60-80 minutes, this level being sustained for up to four hours. Although the direct local effect of vaginal administration on cervical ripening may be advantageous, the shorter half-life of oral delivery may be beneficial in the event of uterine hyperstimulation.In order to avoid uterine hyperstimulation, it appears reasonable to suggest that oral misoprostol should be administered in small, frequent doses, titrated against the uterine response.
Interventions
DRUGmisoprostol
Titrated oral misoprostol: one tablet of 200 microgram was dissolved in water 200 ml, and 20 ml P.O. per one hour for 4 doses, then titrated against uterine response; Vaginal misoprostol: 25 microgram per vagina
Sponsors
China Medical University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 45 Years
Healthy volunteers
No
Inclusion criteria
* 34 to 42 weeks of gestation * live singleton * Bishop score \< or = 6 * reassuring fetal heart beat pattern
Exclusion criteria
* nonreassuring fetal heart beat pattern * parity ovr five * any contraindication to labor and/or vaginal delivery * uterine scar * suspected placental abruption with abnormal FHR pattern * vaginal bleeding other than bloody show * cervical dilatation of \> or = 4 cm * uterine contractions \> or = 3 in 10 minutes * significant maternal cardiac, renal or hepatic disease * hypersensitivity to misoprostol or prostaglandin analogs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The interval from the first misoprostol dose to vaginal delivery and the percentage of women who delivered infants vaginally within 12 and 24 hours of induction. The incidence of tachysystole, hypertonus, uterine hyperstimulation and neonatal outcomes. | within the first week after delivery |
Secondary
| Measure | Time frame |
|---|---|
| Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure. | The days during induction |
Countries
Taiwan
Outcome results
None listed