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Prostaglandin E2 vaginal gel or tablets for induction of labour at term

A comparison of the effectiveness of prostaglandin gel and tablet preparations in the induction of labour at term: a randomised controlled trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN78483537
Enrollment
220
Registered
2010-09-23
Start date
2005-04-01
Completion date
Unknown
Last updated
2015-01-13

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

Conditions

Induction of labour Pregnancy and Childbirth Induction of labour

Interventions

In patients randomised to receive dinoprostone gel, in nulliparous with an unfavourable cervix (modified bishop score less than 4), an initial dose of 2 mg was administered. In multiparaous and nullip

Sponsors

Queen Charlotte's and Chelsea Hospital (QCCH) (UK)
Lead Sponsor

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women undergoing induction of labour with a cephalic presentation (singleton) or first twin cephalic at term (greater than or equal to 36+6 to 42 weeks gestation)

Exclusion criteria

Exclusion criteria: 1. Favourable cervix (defined as a modified Bishop score of greater than or equal to 8) 2. Any contraindication to vaginal birth 3. Previous uterine surgery (including caesarean section) 4. Unwillingness to participate in the trial

Design outcomes

Primary

MeasureTime frame
Time interval between induction of labour to delivery in minutes, irrespective of the mode of delivery, and the rate of failed induction of labour leading to caesarean section. Assessed in every patient during the process of labour induction at gestation (greater than or equal to 36+6 to 42 weeks gestation).

Secondary

MeasureTime frame
1. Requirement for oxytocin augmentation 2. Incidence of uterine hyperstimulation, defined as uterine tachysystole (with five or more contractions in a 10 minute period for two consecutive 10 minute periods) or uterine hypertonus (a uterine contraction lasting for more than two minutes) resulting in pathological cardiotocography trace that necessitated intervention by administering of a tocolytic or delivery 3. Incidence of intrapartum foetal blood sampling 4. Epidural requirement 5. Mode of delivery 6. Blood loss at delivery 7. Incidence of maternal pyrexia 8. Perineal lacerations require suturing 9. 1 and 5-minute Apgar score 10. Need for admission to NICU

Countries

United Kingdom

Outcome results

None listed

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