Comparative Bioavailability Study of Two Misoprostol Formulations

• Status: Completed
• Trial end date: 2016-02-01
• Target enrollment: 0
• Participant gender: Female

Summary

The purpose of this study is to compare pharmacokinetics of two formulations of misoprostol following single dose administration in adult women being given misoprostol for cervical ripening and induction of labour.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Region Skane
• Treatments: Misoprostol

Criteria

Inclusion Criteria:

• Adult females

• Women wanting to participate and having given informed consent

• Known to have reached week 37 + 0 days to week 42 + 2 days of gestation

• With a viable fetus in a vertex position

• Age above or equal to 18 years old

• Women opting for vaginal delivery

• BMI between 20 and 30 kg/m2

Exclusion Criteria:

• Women with known allergy to misoprostol or other prostaglandins

• Women with prior caesarean section

• Women with dead or anomalous fetus

• Women with twin pregnancy

• Women with known liver or renal dysfunction