Topic: Reproductive Health and Childb, Generic Health Relevance and Cross Cutting Themes, Primary Care Research Network for England
Conditions
Interventions
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
the initial anticipated end date was 01/05/2010.
Sponsors
Poole Hospital NHS Foundation Trust (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. Change in pain intensity over 3 hours (AUC) 2. Side effects: 2.1. Need for neonatal resuscitation 2.2. Apgar score less than 7 at 1 minute | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain relief 2. Maternal sedation 3. Nausea and vomiting 4. CTG 5. Patient satisfaction 6. % choosing analgesia for next pregnancy 7. Meconium staining 8. UApH 9. UVpH 10. Apgar scores 11. Naloxone 12. Neonatal SpO2 13. Feeding behaviour | — |
Countries
United Kingdom
Outcome results
None listed