Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour

Phase 4

Completed

• Conditions: Labour Induction
• Interventions: Drug: Misoprostol, modified-release pessary; Drug: Misoprostol, per-oral tablets

• Registration Number: NCT02539199
• Lead Sponsor: Tampere University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2015-08-31
• Study Start: 2015-09
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-02
• Primary Completion: 2018-03-02
• Study Completion: 2018-03-02
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-16
• Last Update Posted: 2018-04-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 270

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Misoprostol modified-release pessary	Misoprostol, modified-release pessary	-
Misoprostol, per-oral tablets	Misoprostol, per-oral tablets	-

Primary Outcome Measures

Name	Time	Method
Cesarean section rate	at time of child birth

Secondary Outcome Measures

Name	Time	Method
The time from beginning of induction to child birth	up to child birth
Neonatal Apgar score	1, 5, 10 minutes after child birth

Trial Locations

Locations (5)

Helsinki University hospital; 🇫🇮 Helsinki, Finland

Turku University Hospital; 🇫🇮 Turku, Finland

Kuopio University Hospital; 🇫🇮 Kuopio, Finland

Oulu University Hospital; 🇫🇮 Oulu, Finland

Tampere University Hospital; 🇫🇮 Tampere, Finland