Buccal Versus Vaginal Misoprostol for Third Trimester Induction of Labor

Stopped early · Phase 4 · Has a placebo group

Conditions studied: Pregnancy

In brief

Approximately 22% of term pregnancies are induced. Misoprostol, a prostaglandin E1 analogue, is a widely accepted induction agent, that has been proven safe and effective for induction of labor. It stimulates both cervical ripening and uterine contractions, thus making it an ideal induction agent for unfavorable cervices. Research has examined the pharmacokinetics of different administration routes and effects on uterine contractility, side effects, and safety. Vaginal misoprostol has been shown to be superior over oral administration however patients often prefer a more tolerable route. Buccal administration has already been shown to be as effective as vaginal misoprostol for cervical ripening and induction in both first trimester and second trimester abortions. There is minimal research comparing buccal versus vaginal for third trimester induction of labor. The investigators study is a prospective, double blinded, randomized control trial comparing vaginal misoprostol and buccal misoprostol in equal dosages of 25 mcg. The investigators seek to answer the question whether buccal misoprostol is as effective as vaginal misoprostol for third trimester induction of labor.

Key facts

Study ID

NCT01519765

Run by

University of California, Los Angeles

People needed

73

Starts

2011-07-01

Expected to finish

2014-12-01

Last updated by the study team

2016-09-27

Who can join

Age: 18 and older, up to 50. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Willingness to participate / consent in a placebo-controlled trial
• Age 18 and older
• Pregnancy between 34 and 42 years of gestation
• Admitted for labor induction because of either medical, obstetric, or psychosocial indications
• Live singleton fetus
• Bishop score less than or equal to six
• Cephalic presentation
• Reactive non-stress test or Negative contraction test

You may not qualify if…

• Premature rupture of membranes
• Multiparity > 5
• Contraindication to vaginal or labor delivery
• Suspected placental abruption
• Significant hepatic, renal or cardiac disease
• Known hypersensitivity to misoprostol or prostaglandin analogue
• Recent prostaglandin administration for induction of labor
• Multifetal pregnancy
• Macrosomia > 4500g estimated fetal weight by ultrasound or leopold

Where it is running

• Ronald Reagan UCLA Medical Center — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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