NCT02242214

REgistry of MisOprostol 200 µg Vaginal dElivery System

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 106 (actual)
• Sponsor: Ferring Pharmaceuticals · Industry
• Sex: Female
• Age: —
• Healthy volunteers: Not accepted

Summary

The design of the study is post-marketing, observational, multi-centre and open-label. The study does not provide treatment; only patients to whom misoprostol 200 µg vaginal delivery system (VDS) is prescribed may be included. All directions for medication usage and patient monitoring are solely at the discretion of the investigator in accordance with their usual practice and must be consistent with the Dutch prescribing information of misoprostol 200 µg VDS. No other (invasive) study-related interventions or measurements are done, other than the procedures routinely performed during induction of labour. No effort is expected from the study subjects. 150 patients from 20 Dutch centres will be included.

Conditions

• Induction of Labour

Interventions

Type	Name	Description
DRUG	Misoprostol

Timeline

• Start date: 2014-09-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2014-09-17
• Last updated: 2015-09-16

Locations

1 site across 1 country: Netherlands