Pethidine versus Diamorphine Study
Completed
- Conditions
- Topic: Reproductive Health and Childb, Generic Health Relevance and Cross Cutting Themes, Primary Care Research Network for EnglandSubtopic: Not Assigned, Reproductive Health and Childb (all Subtopics), Generic Health Relevance (all Subtopics)Disease:Pregnancy and ChildbirthLabour
- Registration Number
- ISRCTN14898678
- Lead Sponsor
- Poole Hospital NHS Foundation Trust (UK)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 450
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
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
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Change in pain intensity over 3 hours (AUC)<br>2. Side effects: <br>2.1. Need for neonatal resuscitation<br>2.2. Apgar score less than 7 at 1 minute
- Secondary Outcome Measures
Name Time Method 1. Pain relief<br>2. Maternal sedation<br>3. Nausea and vomiting<br>4. CTG<br>5. Patient satisfaction<br>6. % choosing analgesia for next pregnancy<br>7. Meconium staining<br>8. UApH<br>9. UVpH<br>10. Apgar scores<br>11. Naloxone<br>12. Neonatal SpO2<br>13. Feeding behaviour