Vaginal Misodel® in Comparison With Orally Administrated Misoprostol (Cytotec®) at Induction of Labour

Induced Deliveries Clinical Trial

Official title:

Vaginal Misodel® in Comparison With Orally Administrated Misoprostol (Cytotec®) at Induction of Labour

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02918110
• Other study ID #: 1cyt
• Status: Recruiting
• Phase: Phase 4
• First received: September 27, 2016
• Last updated: September 27, 2016
• Start date: September 2016
• Est. completion date: September 2017

Study information

• Verified date: September 2016
• Source: Karolinska Institutet
• Contact: Eva Wiberg-Itzel, Professor
• Phone: 708775346
• Email: eva.itzel[@]telia.com
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

The study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour.

Description:

To compare orally administrated solution of misoprostol (Cytotec®) with vaginal slow release misoprostol (Misodel®) regarding efficacy and safety during labour Design: Randomised controlled trial (RCT)

Settings:

Obstetric departments of Sodersjukhuset, Stockholm Obstetric departments of Women's clinic, Karlstad.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 320
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

Primipara BS = 4p Gestational week >37

Exclusion Criteria:

Multipara Multiples Gestational week <37 BS >4 IUFD Previous uterine surgery

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Induced Deliveries

Intervention

Drug:
• Misoprostol
Women needed to be induced will get orally administrated solution of misoprostol (Cytotec®) or vaginal slow release misoprostol (Misodel®)

Locations

Country	Name	City	State
Sweden	Eva Wiberg-Itzel	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Karolinska Institutet	Karlstad Central Hospital

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean section rate		1 year	No