To compare the safety and efficacy of 'low dose' vaginal misoprostol and dinoprostone vaginal gel for induction of labour at term
| ISRCTN | ISRCTN85744560 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN85744560 |
| Secondary identifying numbers | N0533091848 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 11/09/2013
- 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
Ms Sarah Gregson
Scientific
Scientific
Maternity Unit
Queen Mary's Sidcup NHS Trust
Frognal Avenue
Sidcup, Kent
DA14 6LT
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Number of patients projected for 2000/2001 - 200 |
| Scientific title | A single-blind randomised controlled trial comparing low dose vaginal misoprostol and dinoprostone vaginal gel for inducing labour at term |
| Study objectives | To determine if vaginal misoprostol is a better method of inducing labour at term than dinoprostone vaginal gel. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Pregnancy and Childbirth: Induction of labour |
| Intervention | 1. Misoprostol 2. Dinoprostone |
| Intervention type | Other |
| Primary outcome measure | 1. Uterine tachysystole 2. Hyperstimulation 3. Presence of meconium in the amniotic fluid 4. Apgar Scores at 5 min. Umbilical arterial pH and base deficit 5. Neonatal Unit admission 6. Induction - delivery interval 7. Method of delivery 8. Bishop score at onset of labour 9. Oxytocin requirements in labour 10. Mode of delivery 11. Analgesia requirements in labour |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/07/2000 |
| Completion date | 31/01/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| Key inclusion criteria | 1. Women at term (37-42 completed weeks of pregnancy) 2. Single fetus, cephalic presentation 3. Membranes may be intact or ruptured 4. Reactive fetal heart tracing |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 01/07/2000 |
| Date of final enrolment | 31/01/2004 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Maternity Unit
Sidcup, Kent
DA14 6LT
United Kingdom
DA14 6LT
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Hospital/treatment centre
Queen Mary's Sidcup NHS Trust (UK)
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 | 01/04/2005 | Yes | No |
