Prostaglandin E2 vaginal gel or tablets for induction of labour at term
| ISRCTN | ISRCTN78483537 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78483537 |
| Secondary identifying numbers | CTA/MHRA No: 13690/0212/001-0001 |
- 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
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 |
|---|---|
| pbennett@imperial.ac.uk |
Study information
| Study design | Randomised double blinded clinical controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2005 |
| Completion date | 31/12/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 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
- England
- United Kingdom
Study participating centre
Professor of Obstetrics and Gynaecology
London
W12 0NN
United Kingdom
W12 0NN
United Kingdom
Sponsor information
Queen Charlotte's and Chelsea Hospital (QCCH) (UK)
Hospital/treatment centre
Hospital/treatment centre
DuCane Road
London
W12 0NN
England
United Kingdom
| Phone | +44 (0)20 8383 1111 |
|---|---|
| s.taher@imperial.ac.uk | |
| Website | http://www.imperial.nhs.uk/qcch |
"ROR" |
https://ror.org/03af1tj71 |
Funders
Funder type
Government
Hammersmith Hospitals NHS Trust (UK)
No information available
National Institute for Health Research (NIHR) (UK) - Biomedical Research Centre
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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 |
