Vaginally Administered Versus Per Oral Misoprostol in Induction of Labour

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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02539199

Enrollment

270

Registered

2015-09-02

Start date

2015-09-30

Completion date

2018-03-02

Last updated

2018-04-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Labour Induction

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.

Interventions

DRUGMisoprostol, modified-release pessary

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

DRUGMisoprostol, 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

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

Design outcomes

Primary

Measure	Time frame
Cesarean section rate	at time of child birth

Secondary

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

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026