Status:
COMPLETED
REgistry of MisOprostol 200 µg Vaginal dElivery System
Lead Sponsor:
Ferring Pharmaceuticals
Conditions:
Induction of Labour
Eligibility:
FEMALE
Brief 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 p...
Eligibility Criteria
Inclusion
- Diagnosis of induction of labour in women with an unfavourable cervix, from 36 weeks gestation, in whom induction is clinically indicated
- Decision made to prescribe misoprostol 200 µg VDS according to Summary of Product Characteristics (SmPC)
- Willingness and ability to provide written informed consent
Exclusion
- Misoprostol 200 µg VDS is contraindicated according to the SmPC
Key Trial Info
Start Date :
September 1 2014
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2015
Estimated Enrollment :
106 Patients enrolled
Trial Details
Trial ID
NCT02242214
Start Date
September 1 2014
End Date
August 1 2015
Last Update
September 16 2015
Active Locations (1)
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1
Isala Klinieken (there may be other sites in this country)
Zwolle, Netherlands