Pethidine versus Diamorphine Study
| ISRCTN | ISRCTN14898678 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14898678 |
| Protocol serial number | 6895 |
| Sponsor | Poole Hospital NHS Foundation Trust (UK) |
| Funder | National Institute for Health Research (NIHR) (UK) - Research for Patient Benefit (RfPB) Programme |
- Submission date
- 12/05/2010
- Registration date
- 12/05/2010
- Last edited
- 17/04/2014
- 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
Miss Dawn Jackson
Scientific
Scientific
Poole Hospital NHS Foundation Trust
St Mary's Maternity Hospital
Poole
BH15 2JB
United Kingdom
Study information
| Primary study design | Observational |
|---|---|
| Study design | Multicentre randomised process of care cohort study |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | A two centre randomised controlled trial comparing intramuscular diamorphine and intramuscular pethidine for labour analgesia |
| Study acronym | IDvIP |
| Study objectives | Study objectives: To evaluate the maternal and neonatal efficacy and safety of intramuscular diamorphine 7.5 mg versus intramuscular pethidine 150 mg for labour pain. Evaluation of study: An intention to treat analysis will be used. Results will be presented with 95% confidence intervals whenever possible and will be reported using CONSORT guidelines. Duration of study period: 3 years |
| Ethics approval(s) | Southampton and SW Hampshire REC (B) approved on the 2nd March 2007 (ref: 07/Q1704/6) |
| Health condition(s) or problem(s) studied | Topic: Reproductive Health and Childb, Generic Health Relevance and Cross Cutting Themes, Primary Care Research Network for England; Subtopic: Not Assigned, Reproductive Health and Childb (all Subtopics), Generic Health Relevance (all Subtopics); Disease: |
| Intervention | Study Medicinal Products: 7.5 mg diamorphine and 150 mg pethidine up to a maximum of two doses with a minimal interval of 2 hours between doses. Total duration of treatment and follow-up will be the duration of the womens labour plus 24 hours after birth. As of 10/01/2011 this record was updated to include an extended anticipated end date; the initial anticipated end date was 01/05/2010. |
| Intervention type | Drug |
| Phase | Phase IV |
| Drug / device / biological / vaccine name(s) | Pethidine, diamorphine |
| Primary outcome measure(s) |
1. Change in pain intensity over 3 hours (AUC) |
| Key secondary outcome measure(s) |
1. Pain relief |
| Completion date | 01/02/2012 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target sample size at registration | 450 |
| Key inclusion criteria | 1. Active labour with a singleton pregnancy 2. Regular uterine contractions of at least two in 10 minutes 3. Cervical dilatation of at least 3 cm 4. Foetal gestational age of 37 - 42 weeks 5. Minimum weight of 60 kg 6. Multiparous and nulliparous women 7. Spontaneously gone into labour or have had an amniotomy and intravenous oxytocin to induce labour 8. Aged 18 years and over |
| Key exclusion criteria | 1. Allergy or previous severe reaction to opioid analgesia 2. Opioid dependency 3. History of foetal compromise 4. Maternal cardiorespiratory compromise 5. American Society of Anaesthesiologists (ASA) grade 3 and 4 6. Maternal weight greater than 120 kg |
| Date of first enrolment | 01/11/2008 |
| Date of final enrolment | 01/02/2012 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Poole Hospital NHS Foundation Trust
Poole
BH15 2JB
United Kingdom
BH15 2JB
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 | 01/03/2014 | Yes | No | |
| Protocol article | protocol | 08/07/2011 | Yes | No | |
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
