Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour

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.

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Key information

Conditions

Labour Induction

Sex eligibility

Female

Study type

Interventional

Phase

Phase 4

Primary location

Helsinki University hospital, Helsinki, Finland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Nulliparous
Singleton at term pregnancy (>36+6 weeks)
Unfavourable cervix (Bishop score < 6)
Fetal cephalic position

Exclusion criteria

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

Treatment and study plan

Misoprostol, modified-release pessary

Drug

Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours

Other names: Misodel

Misoprostol, per-oral tablets

Drug

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.

Other names: Cytotec

Primary outcomes

Cesarean section rate

Time frame: at time of child birth

Secondary outcomes

The time from beginning of induction to child birth

Time frame: up to child birth
Neonatal Apgar score

Time frame: 1, 5, 10 minutes after child birth

Sponsors and collaborators

Lead sponsor

Tampere University Hospital

Other

Collaborators

Helsinki University Central Hospital
Oulu University Hospital

Registry information

Official study title

Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour: a Randomized Trial

Important dates

Study start: 2015
Primary completion: 2018
Study completion: 2018
First posted: Sep 2, 2015
Registry last updated: Apr 18, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed