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

Karolinska Institute

Status and phase: Unknown; Phase 4

Conditions: Induced Deliveries

Treatments: Drug: Misoprostol

Study type: Interventional

Funder types: Other

Identifiers

NCT02918110

1cyt

Details and patient eligibility

About

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

Full 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.

Enrollment: 320 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Primipara BS ≤ 4p Gestational week >37

Exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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320 participants in 2 patient groups

Cytotec

Experimental group

Description:

orally administrated solution of misoprostol (Cytotec®)

Treatment:

Drug: Misoprostol

Misodel

Experimental group

Description:

vaginal slow release misoprostol (Misodel®)

Treatment:

Drug: Misoprostol