REgistry of MisOprostol 200 µg Vaginal dElivery System (REMOVE)

Ferring

Status: Completed

Conditions: Induction of Labour

Treatments: Drug: Misoprostol

Study type: Observational

Funder types: Industry

Identifiers

NCT02242214

000188

Details and patient eligibility

About

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.

Enrollment: 106 patients

Sex: Female

Volunteers: No 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

Trial design

106 participants in 1 patient group

Misoprostol 200 µg VDS

Description:

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

Treatment:

Drug: Misoprostol