Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour

Tampere University Hospital

Status and phase: Completed; Phase 4

Conditions: Labour Induction

Treatments: Drug: Misoprostol, per-oral tablets; Drug: Misoprostol, modified-release pessary

Study type: Interventional

Funder types: Other

Identifiers

NCT02539199

R15109M

2015-001972-23 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 270 patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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270 participants in 2 patient groups

Misoprostol modified-release pessary

Active Comparator group

Treatment:

Drug: Misoprostol, modified-release pessary

Misoprostol, per-oral tablets

Active Comparator group

Treatment:

Drug: Misoprostol, per-oral tablets