Randomised controlled trial of the clinical impact of an intelligent decision making support tool for labour management using the cardiotocogram
| ISRCTN | ISRCTN48614382 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN48614382 |
| Protocol serial number | G9721800 |
| Sponsor | Medical Research Council (MRC) (UK) |
| Funder | Medical Research Council (MRC) (UK) |
- Submission date
- 25/10/2000
- Registration date
- 25/10/2000
- Last edited
- 28/02/2018
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Pregnancy and Childbirth
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Prof Keith Greene
Scientific
Scientific
Perinatal Research Group
Postgraduate Medical School
University of Plymouth
Maternity Unit
Derriford Hospital
Plymouth
PL6 8DH
United Kingdom
| Phone | +44 1752 763631 |
|---|---|
| k.greene@plymouth.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | Randomised controlled trial of the clinical impact of an intelligent decision making support tool for labour management using the cardiotocogram |
| Study objectives | To determine whether an intelligent support system can improve outcomes for mother and baby for current foetal monitoring by reducing human error. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Obstetrics and gynaecology |
| Intervention | EFM with and without decision support Delivery - operative (Caesarean section or forceps) or spontaneous Added 19/08/09: Follow-up: One month in first instance. Longer term follow-up will almost certainly occur as part of a paediatric developmental study. |
| Intervention type | Other |
| Primary outcome measure(s) |
Operative delivery rates for mother. Cord blood gas analysis, admissions to NICU, neonatal encephalopathy and perinatal mortality rates for baby. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 31/05/2004 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target sample size at registration | 15000 |
| Key inclusion criteria | All consented pregnancies after 34 weeks gestation with no gross foetal anomaly undergoing electronic foetal monitoring (EFM) in labour |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/06/1999 |
| Date of final enrolment | 31/05/2004 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Perinatal Research Group
Plymouth
PL6 8DH
United Kingdom
PL6 8DH
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 |
Editorial Notes
28/02/2018: No publications found, verifying study status with principal investigator.
