Contact information
Type
Scientific
Primary contact
Prof Philip Bennett
ORCID ID
Contact details
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
+44 (0)20 7594 2141
pbennett@imperial.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
CTA/MHRA No: 13690/0212/001-0001
Study information
Scientific title
A comparison of the effectiveness of prostaglandin gel and tablet preparations in the induction of labour at term: a randomised controlled trial
Acronym
Study hypothesis
One dinoprostone formula is associated with less induction to delivery interval than the other one.
Ethics approval
Riverside Ethics Committee approved in 2004 (ref: 04/Q0401/139)
Study design
Randomised double blinded clinical controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Hospitals
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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 names
Prostaglandin E2
Primary outcome measure
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 outcome measures
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
Overall trial start date
01/04/2005
Overall trial end date
31/12/2006
Reason abandoned (if study stopped)
Eligibility
Participant 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)
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
220
Participant 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
Recruitment start date
01/04/2005
Recruitment end date
31/12/2006
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Professor of Obstetrics and Gynaecology
London
W12 0NN
United Kingdom
Sponsor information
Organisation
Queen Charlotte's and Chelsea Hospital (QCCH) (UK)
Sponsor details
DuCane Road
London
W12 0NN
United Kingdom
+44 (0)20 8383 1111
s.taher@imperial.ac.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
Hammersmith Hospitals NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21429067
Publication citations
-
Results
Taher SE, Inder JW, Soltan SA, Eliahoo J, Edmonds DK, Bennett PR, Prostaglandin E2 vaginal gel or tablets for the induction of labour at term: a randomised controlled trial., BJOG, 2011, 118, 6, 719-725, doi: 10.1111/j.1471-0528.2011.02901.x.