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CompletedNCT02242214REMOVEUpdated Sep 16, 2015

REgistry of MisOprostol 200 µg Vaginal dElivery System

An observational study in Induction of Labour, sponsored by Ferring Pharmaceuticals. Completed at 1 site in Netherlands. Open to female participants. Per ClinicalTrials.gov, last updated 2015-09-16.

Sponsored by Ferring Pharmaceuticals · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
106
Sex
Female
01

Study 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.

02

Conditions studied

  • Induction of Labour
03

In context

Lead sponsor

Ferring Pharmaceuticals is the lead sponsor of 244 studies on the registry; 4 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 13 (93%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Academic and peripheral hospitals in the Netherlands

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

Exclusion Criteria:

  • Misoprostol 200 µg VDS is contraindicated according to the SmPC
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
106 participants (actual)
Target follow-up
3 Days
Patient registry
Yes

Groups and cohorts

  • 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

  • DrugMisoprostol

    Also known as: Misodel®

06

What researchers measure

Primary outcomes

  1. Time to vaginal delivery of the neonate in hours

    Time frame: From insertion until vaginal delivery

07

Study locations

1 site
  • Isala Klinieken (there may be other sites in this country)
    Zwolle, Netherlands
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 16, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02242214
Lead sponsor
Ferring Pharmaceuticals
Responsible party
Sponsor
First posted
Sep 17, 2014
Start date
Sep 2014
Primary completion
Aug 2015
Completion
Aug 2015
Last update
Sep 16, 2015

Study contacts

Clinical Development Support
study director · Ferring Pharmaceuticals
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2015. You cannot join it, but the record below documents what was studied.

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