REgistry of MisOprostol 200 µg Vaginal dElivery System
- Registration Number
- NCT02242214
- Lead Sponsor
- Ferring Pharmaceuticals
- 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 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 106
- 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
- Misoprostol 200 µg VDS is contraindicated according to the SmPC
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Misoprostol 200 µg VDS Misoprostol At the discretion of the investigator in accordance with their usual practice and consistent with the Dutch prescribing information.
- Primary Outcome Measures
Name Time Method Time to vaginal delivery of the neonate in hours From insertion until vaginal delivery
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Isala Klinieken (there may be other sites in this country)
🇳🇱Zwolle, Netherlands