REgistry of MisOprostol 200 µg Vaginal dElivery System

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02242214

Acronym

REMOVE

Enrollment

106

Registered

2014-09-17

Start date

2014-09-30

Completion date

2015-08-31

Last updated

2015-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induction of Labour

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.

Interventions

DRUGMisoprostol

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Time to vaginal delivery of the neonate in hours	From insertion until vaginal delivery

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026