A comparison of the effectiveness of prostaglandin gel and tablet preparations in induction of labour at term.

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2004-003797-28-GB

Enrollment

500

Registered

2005-06-13

Start date

2005-07-12

Completion date

Unknown

Last updated

2020-10-13

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

Conditions

Induction of Labour

Interventions

Trade Name: Prostin (Dinoprostone) Product Name: Dinoprostone Pharmaceutical Form: Tablet for vaginal solution INN or Proposed INN: Dinoprostone CAS Number: 363-24-6 Other descriptive name: Prostaglan

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Term, cephalic pregnancies (all parities) undergoing prostaglandin induction of labour (all indications). Are the trial subjects under 18? yes Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: Preterm induction of labour (ie before 37 weeks gestation)

Design outcomes

Primary

Measure	Time frame
Main Objective: To determine whether Prostaglandin Gel is more effective in term induction of labour than Prostaglandin Tablets. The main outcome measure will be time between the start of the induction process and delivery of the baby.;Secondary Objective: We also aim to determine if preparation used has any effect on several other measures during/after labour. These include mode of delivery and indication for delivery, time in labour, number of doses of prostaglandin needed, cervical dilation at transfer to labour Ward, frequency of artificial rupture of membranes, frequency of oxytocin use, frequency of meconium staining of liquor, frequency of uterine tachysystole/hyperstimulation, frequency of need for foetal blood sampling in labour, frequency of need for neonatal resuscitation or transfer to Neonatal Unit. ;Primary end point(s): Duration between start of the induction process and delivery of the baby.	—

Measure

Time frame

Main Objective: To determine whether Prostaglandin Gel is more effective in term induction of labour than Prostaglandin Tablets. The main outcome measure will be time between the start of the induction process and delivery of the baby.;Secondary Objective: We also aim to determine if preparation used has any effect on several other measures during/after labour. These include mode of delivery and indication for delivery, time in labour, number of doses of prostaglandin needed, cervical dilation at transfer to labour Ward, frequency of artificial rupture of membranes, frequency of oxytocin use, frequency of meconium staining of liquor, frequency of uterine tachysystole/hyperstimulation, frequency of need for foetal blood sampling in labour, frequency of need for neonatal resuscitation or transfer to Neonatal Unit. ;Primary end point(s): Duration between start of the induction process and delivery of the baby.

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Countries

United Kingdom

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026