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Completed

NCT Number: NCT00529295

Titrated Oral Compared With Vaginal Misoprostol for Labor Induction at Term

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.

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Key information

Conditions

Labor Induction

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

China Medical University Beigang Hospital

Douliu, 651, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

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

Primary outcomes

  1. 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.

    Time frame: within the first week after delivery

Secondary outcomes

  1. Total dosage of misoprostol and the rate of women given oxytocin, cesarean section and induction failure.

    Time frame: The days during induction

Sponsors and collaborators

Lead sponsor

China Medical University Hospital

Other

Registry information

Important dates

Study start
2005
Study completion
2007
First posted
Sep 14, 2007
Registry last updated
Sep 14, 2007

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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