Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

China Medical University

Status and phase: Completed; Phase 3

Conditions: Labor Induction

Treatments: Drug: misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT00529295

DMR95-IRB-116

Details and patient eligibility

About

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.

Full 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.

Enrollment: 220 patients

Sex: Female

Ages: 18 to 45 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

220 participants in 2 patient groups

1

Experimental group

Description:

Titrated oral misoprostol

Treatment:

Drug: misoprostol

2

Active Comparator group

Description:

Vaginal misoprostol

Treatment:

Drug: misoprostol