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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02918110

Enrollment

320

Registered

2016-09-28

Start date

2016-09-30

Completion date

2017-09-30

Last updated

2016-09-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Induced Deliveries

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.

Interventions

DRUGMisoprostol

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 60 Years

Healthy volunteers

Inclusion criteria

Primipara BS ≤ 4p Gestational week \>37

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Cesarean section rate	1 year

Countries

Sweden

Contacts

Primary ContactEva Wiberg-Itzel, Professor

eva.itzel@telia.com708775346

Backup ContactTove Wallström, PhD student

tovemy@hotmail.com+4686161000

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 15, 2026