REgistry of MisOprostol 200 µg Vaginal dElivery System

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

106 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-09-30

Study Completion Date

2015-08-31

Brief Summary

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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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Detailed Description

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Conditions

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Induction of Labour

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Misoprostol 200 µg VDS

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

Misoprostol

Intervention Type DRUG

Interventions

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Misoprostol

Intervention Type DRUG

Other Intervention Names

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Misodel®

Eligibility Criteria

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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