REgistry of MisOprostol 200 µg Vaginal dElivery System

NCT02242214 | Completed

• 1 other identifier: 000188
• Study Type: observational
• Target: 106
• Locations: 1 country
• Sites: 1

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.

Conditions

Induction of Labour

Outcome Measures

Primary Outcomes (1)

• Time to vaginal delivery of the neonate in hours

  From insertion until vaginal delivery

Study Arms (1)

Misoprostol 200 µg VDS

At the discretion of the investigator in accordance with their usual practice and consistent with the Dutch prescribing information.

Drug: Misoprostol

Interventions

Misoprostol DRUG

Also known as: Misodel®

Misoprostol 200 µg VDS

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Academic and peripheral hospitals in the Netherlands

You may qualify if:

• 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

You may not qualify if:

• Misoprostol 200 µg VDS is contraindicated according to the SmPC

Sponsors & Collaborators

• Ferring Pharmaceuticals: lead

Study Sites (1)

Isala Klinieken (there may be other sites in this country)

Zwolle, Netherlands

Location

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, Synthetic; Prostaglandins, Synthetic; Prostaglandins; Eicosanoids; Fatty Acids, Unsaturated; Fatty Acids; Lipids; Autacoids; Inflammation Mediators; Biological Factors

Study Officials

• Clinical Development Support

  Ferring Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2014
• First Posted: September 17, 2014
• Study Start: September 1, 2014
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: September 16, 2015

Record last verified: 2015-09

Locations

NL (1)