Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour

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

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.

Study Overview

• Status: Completed
• Conditions: Labour Induction
• Intervention / Treatment: Drug: Misoprostol, modified-release pessary; Drug: Misoprostol, per-oral tablets

• Study Type: Interventional
• Enrollment (Actual): 270
• Phase: Phase 4

Contacts and Locations

Study Locations

• Finland
  • Helsinki, Finland
    • Helsinki University Hospital
  • Kuopio, Finland
    • Kuopio University Hospital
  • Oulu, Finland
    • Oulu University Hospital
  • Tampere, Finland
    • Tampere University Hospital
  • Turku, Finland
    • Turku University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Misoprostol modified-release pessary	Drug: Misoprostol, modified-release pessary; Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours; Other Names: Misodel
Active Comparator: Misoprostol, per-oral tablets	Drug: Misoprostol, per-oral tablets; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cesarean section rate	at time of child birth

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Tampere University Hospital
• Collaborators: Helsinki University Central Hospital; Oulu University Hospital
• Investigators: Principal Investigator: Kati Tihtonen, PhD, MD, Tampere University Hospital

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): March 2, 2018
• Study Completion (Actual): March 2, 2018

Study Registration Dates

• First Submitted: August 31, 2015
• First Submitted That Met QC Criteria: September 1, 2015
• First Posted (Estimate): September 2, 2015

Study Record Updates

• Last Update Posted (Actual): April 18, 2018
• Last Update Submitted That Met QC Criteria: April 16, 2018
• Last Verified: April 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Gastrointestinal Agents; Reproductive Control Agents; Anti-Ulcer Agents; Abortifacient Agents, Nonsteroidal; Abortifacient Agents; Oxytocics; Misoprostol
• Other Study ID Numbers: R15109M; 2015-001972-23 (EudraCT Number)