Safety/Efficacy Study Comparing the Misoprostol Vaginal Insert to Cervidil for Cervical Ripening and Induction of Labor

Ferring

Status and phase: Completed; Phase 3

Conditions: Labor, Induced; Cervical Ripening

Treatments: Drug: Dinoprostone vaginal insert (Cervidil); Drug: Misoprostol vaginal insert 50 mcg; Drug: Misoprostol vaginal insert 100 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00308711

Miso-Obs-004

Details and patient eligibility

About

The purpose of this study is to determine whether the misoprostol vaginal insert (50 mcg and 100 mcg) can safely and effectively speed time to vaginal delivery compared to Cervidil (R) in women who need to have cervical ripneing and induction of labor.

Full description

Induction of labor is required in approximately 20% of pregnant women. Although contractions can be brought on by oxytocin ("pitocin"), some women need help in softening the cervix, or mouth of the womb (uterus), before oxytocin can be started. Prostaglandins have been shown to ripen, or soften, the cervix; at present, the only prostaglandin approved for marketing by FDA for this purpose is dinoprostone. Dinoprostone can be delivered in several ways; one method is to use a polymer vaginal insert that slowly releases the dinoprostone directly to the cervical tissues. This product is called Cervidil (R) and has been marketed for more than 10 years in the United States. Misoprostol is another form of prostaglandin that is approved for protecting the stomach and intestinal lining for patients taking NSAIDs. Misoprostol has also been used by many obstetricians for cervical ripening and inducing contractions, but, it is not approved by FDA for this purpose.

The same company that makes the Cervidil polymer insert has made an insert that will slowly release misoprostol. This study will determine whether this investigational insert containing misoprostol will decrease time to vaginal delivery compared to Cervidil. Two different doses of misoprostol will be tested (50 micrograms and 100 micrograms); each vaginal insert will gradually release a small, controlled amount of misoprostol over up to 24 hours.

Comparator: The Cervidil (R) vaginal insert containing dinoprostone will be the comparator in this study.

Enrollment: 1,308 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pregnant women at least 36 weeks gestation requiring cervical ripening and induction of labor

Exclusion criteria

• No uterine scar (no previous delivery by cesarean section)
• No multiple gestation
• No condition that disallows use of prostaglandins for induction of labor
• No more than 3 previous vaginal births beyond 24 weeks gestation

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,308 participants in 3 patient groups

MVI 100

Experimental group

Description:

Misoprostol vaginal insert 100 mcg over 24h

Treatment:

Drug: Misoprostol vaginal insert 100 mcg

MVI 50

Experimental group

Description:

Misoprostol vaginal insert 50 mcg over 24h

Treatment:

Drug: Misoprostol vaginal insert 50 mcg

Cervidil 10 mg vaginal insert

Active Comparator group

Description:

Cervidil 10 mg over 24h

Treatment:

Drug: Dinoprostone vaginal insert (Cervidil)