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OpenTrials
Completed

NCT Number: NCT02242214

REgistry of MisOprostol 200 µg Vaginal dElivery System

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.

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Key information

Conditions

Induction of Labour

Sex eligibility

Female

Study type

Observational

Primary location

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

Zwolle, Netherlands

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Misoprostol

Drug

Other names: Misodel®

Primary outcomes

  1. Time to vaginal delivery of the neonate in hours

    Time frame: From insertion until vaginal delivery

Sponsors and collaborators

Lead sponsor

Ferring Pharmaceuticals

Industry

Registry information

Acronym: REMOVE

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Sep 17, 2014
Registry last updated
Sep 16, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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