NCT02918110

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
320

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Sep 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2016

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

September 27, 2016

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 28, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2017

Completed
Last Updated

September 28, 2016

Status Verified

September 1, 2016

Enrollment Period

1 year

First QC Date

September 27, 2016

Last Update Submit

September 27, 2016

Conditions

Induced Deliveries

Outcome Measures

Primary Outcomes (1)

  • Cesarean section rate

    1 year

Study Arms (2)

Cytotec

EXPERIMENTAL

orally administrated solution of misoprostol (Cytotec®)

Drug: Misoprostol

Misodel

EXPERIMENTAL

vaginal slow release misoprostol (Misodel®)

Drug: Misoprostol

Interventions

MisoprostolDRUG

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

Also known as: Cytotec
CytotecMisodel

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Primipara BS ≤ 4p Gestational week \>37

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Eva Wiberg-Itzel

Stockholm, 18239, Sweden

RECRUITING

Related Publications (1)

  • 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.

    PMID: 33947349DERIVED

MeSH Terms

Interventions

Misoprostol

Intervention Hierarchy (Ancestors)

Prostaglandins E, SyntheticProstaglandins, SyntheticProstaglandinsEicosanoidsFatty Acids, UnsaturatedFatty AcidsLipidsAutacoidsInflammation MediatorsBiological Factors

Study Officials

  • Per Tornvall, Prof

    Karolinska Institutet

    STUDY DIRECTOR

Central Study Contacts

Eva Wiberg-Itzel, Professor

CONTACT

708775346eva.itzel@telia.com

Tove Wallström, PhD student

CONTACT

+4686161000tovemy@hotmail.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

September 27, 2016

First Posted

September 28, 2016

Study Start

September 1, 2016

Primary Completion

September 1, 2017

Study Completion

September 1, 2017

Last Updated

September 28, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)