Safety and Efficacy Study of Misoprostol Vaginal Insert for Induction of Labour

• Status: Completed
• Trial end date: 2004-03-01
• Target enrollment: 0
• Participant gender: Female

Summary

The primary objective of the study was assessment of the efficacy of four dose reservoirs (25 mcg, 50 mcg, 100 mcg, 200 mcg) of intravaginal controlled release misoprostol administered for up to 24 hours. Efficacy was measured in terms of time from insert placement to vaginal delivery.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ferring Pharmaceuticals
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• At term (37 to 42 weeks inclusive gestation).

• Aged 18 years or older.

• One previous full term delivery (at least 37 weeks gestation).

• Singleton pregnancy.

• Cephalic presentation (normal lie).

• Bishop score more than 6 as determined by MBS criteria.

• Uncomplicated pregnancy as judged by the physician.

• Written informed consent.

Exclusion Criteria:

• four previous full term deliveries.

• Previous uterine surgery, including C-section and surgery to the cervix of the uterus (cone biopsy of the cervix is permitted).

• In spontaneous labour.

• Administration of oxytocin or a tocolytic drug or any other cervical ripening or labour inducing agent prior to enrolment (within seven days of enrolment).

• Suspected cephalo-pelvic disproportion.

• Evidence or suggestion of fetal distress.

• Subject has received NSAID (including aspirin) within four hours of study treatment (topical is permitted).

• Pyrexia (oral or aural temperature > 37.5C).

• Unexplained genital bleeding during this pregnancy after 24 weeks.

• Current pelvic inflammatory disease, unless adequate prior treatment has been instituted.

• Placenta praevia.

• Known or suspected allergy to misoprostol or other prostaglandins.

• Prior serious adverse event related to prostaglandin administered by any route for any indication.

• Subject unable to comply with the requirements of the protocol.