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

NCT ID: NCT02918110

Last Updated: 2016-09-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

320 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-09-30

Study Completion Date

2017-09-30

Brief Summary

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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

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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.

Conditions

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Induced Deliveries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Cytotec

orally administrated solution of misoprostol (Cytotec®)

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

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

Misodel

vaginal slow release misoprostol (Misodel®)

Group Type EXPERIMENTAL

Misoprostol

Intervention Type DRUG

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

Interventions

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Misoprostol

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

Intervention Type DRUG

Other Intervention Names

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Cytotec

Eligibility Criteria

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Inclusion Criteria

Primipara BS ≤ 4p Gestational week \>37

Exclusion Criteria

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

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Karlstad Central Hospital

OTHER

Sponsor Role collaborator

Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Eva Wiberg-Itzel

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per Tornvall, Prof

Role: STUDY_DIRECTOR

Karolinska Institutet

Locations

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Eva Wiberg-Itzel

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Eva Wiberg-Itzel, Professor

Role: CONTACT

708775346

Tove Wallström, PhD student

Role: CONTACT

+4686161000

Facility Contacts

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Eva Wiberg-Itzel, Professor

Role: primary

+4686163768

Per Tornvall, Professor

Role: backup

+4686161000

References

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Strandberg M, Wallstrom T, Wiberg-Itzel E. Women's expectations and experiences of labor induction - a questionnaire-based analysis of a randomized controlled trial. BMC Pregnancy Childbirth. 2021 May 4;21(1):355. doi: 10.1186/s12884-021-03786-6.

Reference Type DERIVED
PMID: 33947349 (View on PubMed)

Other Identifiers

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1cyt

Identifier Type: -

Identifier Source: org_study_id

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