Randomized study to compare vaginal misoprostol to oral misoprostol in inducing labor

• Register: EUCTR
• Last refreshed on: 24 August 2015
• Main ID: EUCTR2015-001972-23-FI
• Date of registration: 29/06/2015
• Prospective Registration: Yes
• Primary sponsor: Tampere University Hospital
• Public title: Randomized study to compare vaginal misoprostol to oral misoprostol in inducing labor
• Scientific title: Randomized study to compare vaginal misoprostol to oral misoprostol in inducing labor
• Date of first enrolment: 29/06/2015
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2015-001972-23
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2

Countries of recruitment

Finland

Contacts

• Name: NaSy
• Affiliation: Tampere University Hospital

• Name: NaSy
• Affiliation: Tampere University Hospital

Key inclusion & exclusion criteria

Inclusion criteria:
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 200
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion criteria:


Age minimum:
Age maximum:
Gender:
Female: yes
Male: no

Health Condition(s) or Problem(s) studied

Pregnant women; induction of labor

Therapeutic area: Diseases [C] - Female diseases of the urinary and reproductive systems and pregancy complications [C13]

Intervention(s)

Trade Name: Misodel
Product Name: Misodel
Product Code: G02AD06
Pharmaceutical Form: Vaginal delivery system

Trade Name: Cytotec
Product Name: Cytotec
Product Code: A02BB01
Pharmaceutical Form: Tablet

Primary Outcome(s)

Main Objective: Efficacy of vaginal Misodel compared to standard oral use of Cytotec

Primary end point(s):

Secondary Objective: Safety issues of the therapy

Secondary ID(s)

2015-001972-23