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

Phase 4

• Conditions: Induced Deliveries
• Interventions: Drug: Misoprostol

• Registration Number: NCT02918110
• Lead Sponsor: Karolinska Institutet

Brief 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.

Detailed 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.

Study Timeline

• Status Verified: 2016-09
• Study Start: 2016-09
• Study First Submitted: 2016-09-27
• Study First Submitted QC: 2016-09-27
• Last Update Submitted: 2016-09-27
• Study First Posted: 2016-09-28
• Last Update Posted: 2016-09-28
• Primary Completion: 2017-09
• Study Completion: 2017-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 320

Inclusion Criteria

Primipara BS ≤ 4p Gestational week >37

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cytotec	Misoprostol	orally administrated solution of misoprostol (Cytotec®)
Misodel	Misoprostol	vaginal slow release misoprostol (Misodel®)

Primary Outcome Measures

Name	Time	Method
Cesarean section rate	1 year

Trial Locations

Locations (1)

Eva Wiberg-Itzel; 🇸🇪 Stockholm, Sweden