Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour
2 other identifiers
interventional
270
1 country
5
Brief Summary
The purpose of this study is to investigate the effectiveness and safety of vaginally administered misoprostol (Misodel) versus per orally administered misoprostol (Cytotec) in induction of labour in nulliparous women.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Sep 2015
Typical duration for phase_4
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 31, 2015
CompletedStudy Start
First participant enrolled
September 1, 2015
CompletedFirst Posted
Study publicly available on registry
September 2, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 2, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
March 2, 2018
CompletedApril 18, 2018
April 1, 2018
2.5 years
August 31, 2015
April 16, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Cesarean section rate
at time of child birth
Secondary Outcomes (2)
The time from beginning of induction to child birth
up to child birth
Neonatal Apgar score
1, 5, 10 minutes after child birth
Study Arms (2)
Misoprostol modified-release pessary
ACTIVE COMPARATORMisoprostol, per-oral tablets
ACTIVE COMPARATORInterventions
Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours
First day: 50 ug PO in every 4 hours maximum 3 times per day. Second day: 100 ug PO in every 4 hours maximum 3 times per day. Third day: 50 ug vaginally in every 4 hours maximum 3 times per day or until labour is induced.
Eligibility Criteria
You may qualify if:
- Nulliparous
- Singleton at term pregnancy (\>36+6 weeks)
- Unfavourable cervix (Bishop score \< 6)
- Fetal cephalic position
You may not qualify if:
- Pre-term pregnancy (\<37 weeks)
- Multiple pregnancy
- Rupture of membranes
- Other than fetal cephalic position
- Intra-uterine growth retardation
- Severe pre-eclampsia
- Severe hypertension
- Previous cesarean section
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Tampere University Hospitallead
- Helsinki University Central Hospitalcollaborator
- Oulu University Hospitalcollaborator
Study Sites (5)
Helsinki University hospital
Helsinki, Finland
Kuopio University Hospital
Kuopio, Finland
Oulu University Hospital
Oulu, Finland
Tampere University Hospital
Tampere, Finland
Turku University Hospital
Turku, Finland
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kati Tihtonen, PhD, MD
Tampere University Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 31, 2015
First Posted
September 2, 2015
Study Start
September 1, 2015
Primary Completion
March 2, 2018
Study Completion
March 2, 2018
Last Updated
April 18, 2018
Record last verified: 2018-04