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

ISRCTN	ISRCTN78483537
DOI	https://doi.org/10.1186/ISRCTN78483537
Protocol serial number	CTA/MHRA No: 13690/0212/001-0001
Sponsor	Queen Charlotte's and Chelsea Hospital (QCCH) (UK)
Funders	Hammersmith Hospitals NHS Trust (UK), National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre

Submission date: 25/07/2010
Registration date: 23/09/2010
Last edited: 27/09/2011

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Philip Bennett
Scientific

Professor of Obstetrics and Gynaecology
Imperial College Faculty of Medicine
Institute for Reproductive and Developmental Biology
Hammersmith Hospital Campus
Du Cane Road
London
W12 0NN
United Kingdom

Phone	+44 (0)20 7594 2141
Email	pbennett@imperial.ac.uk

Study information

Primary study design	Interventional
Study design	Randomised double blinded clinical controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title	A comparison of the effectiveness of prostaglandin gel and tablet preparations in the induction of labour at term: a randomised controlled trial
Study objectives	One dinoprostone formula is associated with less induction to delivery interval than the other one.
Ethics approval(s)	Riverside Ethics Committee approved in 2004 (ref: 04/Q0401/139)
Health condition(s) or problem(s) studied	Induction of labour
Intervention	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 nulliparous women with an favourable cervix (modified bishop score 5 to 7), an initial dose of 1 mg was administered. In the patients randomised to receive dinoprostone tablets, 3 mg was administered into the posterior vaginal fornix. The duration of dinopristone treatment is variable for each patient. It starts at patients admission to the hospital for induction of labour and can last between 1 - 4 days.
Intervention type	Drug
Phase	Not Applicable
Drug / device / biological / vaccine name(s)	Prostaglandin E2
Primary outcome measure(s)	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).
Key secondary outcome measure(s)	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
Completion date	31/12/2006

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	220
Key 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)
Key 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
Date of first enrolment	01/04/2005
Date of final enrolment	31/12/2006

Locations

Countries of recruitment

United Kingdom
England

Study participating centre

Professor of Obstetrics and Gynaecology

London
W12 0NN
United Kingdom

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/05/2011		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes