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

September 27, 2016 updated by: Eva Wiberg-Itzel, Karolinska Institutet
The study will compare orally administrated solution of Misoprostol (Cytotec®) with vaginal slow release (7ug/h) Misoprostol (Misodel®) regarding efficacy and safety during labour.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

320

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Sweden
      • Stockholm, Sweden, 18239
        • Recruiting
        • Eva Wiberg-Itzel

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

Primipara BS ≤ 4p Gestational week >37

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cytotec
orally administrated solution of misoprostol (Cytotec®)
Drug: Misoprostol
Women needed to be induced will get orally administrated solution of misoprostol (Cytotec®) or vaginal slow release misoprostol (Misodel®)
Other Names:
  • Cytotec
Experimental: Misodel
vaginal slow release misoprostol (Misodel®)
Drug: Misoprostol
Women needed to be induced will get orally administrated solution of misoprostol (Cytotec®) or vaginal slow release misoprostol (Misodel®)
Other Names:
  • Cytotec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cesarean section rate
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Collaborators

Karlstad Central Hospital

Investigators

  • Study Director: Per Tornvall, Prof, Karolinska Institutet

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2016

Primary Completion (Anticipated)

September 1, 2017

Study Completion (Anticipated)

September 1, 2017

Study Registration Dates

First Submitted

September 27, 2016

First Submitted That Met QC Criteria

September 27, 2016

First Posted (Estimate)

September 28, 2016

Study Record Updates

Last Update Posted (Estimate)

September 28, 2016

Last Update Submitted That Met QC Criteria

September 27, 2016

Last Verified

September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1cyt

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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