Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour

Labour Induction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539199
• Other study ID #: R15109M
• Secondary ID: 2015-001972-23
• Status: Completed
• Phase: Phase 4
• First received: August 31, 2015
• Last updated: April 16, 2018
• Start date: September 2015
• Est. completion date: March 2, 2018

Study information

• Verified date: April 2018
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 270
• Est. completion date: March 2, 2018
• Est. primary completion date: March 2, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Labour Induction

Intervention

Drug:
• Misoprostol, modified-release pessary
Misoprostol pessary (7 ug/h) placed in vaginal fornix until labour is induced or maximum 24 hours
• 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.

Locations

Country	Name	City	State
Finland	Helsinki University hospital	Helsinki
Finland	Kuopio University Hospital	Kuopio
Finland	Oulu University Hospital	Oulu
Finland	Tampere University Hospital	Tampere
Finland	Turku University Hospital	Turku

Sponsors (3)

Lead Sponsor	Collaborator
Tampere University Hospital	Helsinki University Central Hospital, Oulu University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cesarean section rate		at time of child birth
Secondary	The time from beginning of induction to child birth		up to child birth
Secondary	Neonatal Apgar score		1, 5, 10 minutes after child birth