REgistry of MisOprostol 200 µg Vaginal dElivery System

Induction of Labour Clinical Trial

— REMOVE  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02242214
• Other study ID #: 000188
• Status: Completed
• Phase: N/A
• First received: September 12, 2014
• Last updated: September 15, 2015
• Start date: September 2014
• Est. completion date: August 2015

Study information

• Verified date: September 2015
• Source: Ferring Pharmaceuticals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 106
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• Misoprostol 200 µg VDS is contraindicated according to the SmPC

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Induction of Labour

Intervention

Drug:
• Misoprostol

Locations

Country	Name	City	State
Netherlands	Isala Klinieken (there may be other sites in this country)	Zwolle

Sponsors (1)

Lead Sponsor	Collaborator
Ferring Pharmaceuticals

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to vaginal delivery of the neonate in hours		From insertion until vaginal delivery	No