Topic: Reproductive Health and Childbirth
Conditions
Interventions
Women will be randomly allocated to either:
1. Intervention group: Remifentanil via PCA pump (PCA bolus remifentanil 40 µg) administered intravenously
PCA pump programm
Sponsors
University of Birmingham (UK)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: Current inclusion criteria as of 23/04/2015: 1. Requesting systemic opioid analgesia 2. 16 years of age or older 3. Beyond 37+0 weeks' gestation 4. In established labour (defined as regular painful contractions, irrespective of cervical dilatation) with vaginal birth intended 5. Able to understand all information (written and oral) presented (using an interpreter if necessary) and provide signed consent 6. Not participating in any other clinical trial of a medicinal product 7. Live, singleton pregnancy with cephalic presentation Previous inclusion criteria: 1. Requesting systemic opioid analgesia 2. 16 years of age or older 3. Beyond 30+0 weeks' gestation 4. In established labour with vaginal birth intended 5. Able to understand all information (written and oral) presented (using an interpreter if necessary) and provide signed consent 6. Not participating in any other clinical trial of a medicinal product 7. Singleton pregnancy with cephalic presentation
Exclusion criteria
Exclusion criteria: Exclusion criteria as of 21/12/2015: 1. Contraindication to epidural analgesia 2. Contraindication to intramuscular injection 3. History of a previous adverse reaction to pethidine or remifentanil 4. Patients taking any long-term opioid drug therapy including Methadone 5. Systemic opioid pain relief in last 4 hours administered by intravenous or intramuscular injection. (Oral medications comprising opioids alone or in combination preparations, administered in this 4 hour period, are permitted). Previous exclusion criteria as of 23/04/2015: 1. Contraindication to epidural analgesia 2. Contraindication to intramuscular injection 3. History of drug sensitivity to pethidine or remifentanil 4. Patients taking any long-term opioid drug therapy including Methadone 5. Systemic opioid pain relief in last 4 hours Previous exclusion criteria: 1. Contraindication to epidural analgesia 2. Contraindication to intramuscular injection 3. History of drug sensitivity to pethidine or remifentanil 4. Patients taking any long-term opioid drug therapy including Methadone
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of women who have an epidural placed for pain relief in labour, in each group | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome measures as of 21/12/2015: 1. The effectiveness of pain relief provided by each technique, quantified by Visual Analogue Scale taken every 30 minutes after time zero, until delivery or transfer to theatre. 2. The incidence of maternal side effects, up to the end of 3rd stage, including: 2.1. Excessive sedation score 2.2. Oxygen Saturation <94% whilst breathing room air 2.3. Nausea requiring anti-emetic administration 2.4. Requirement and indication for supplemental oxygen 2.5. Respiratory depression (respiratory rate < 8 breaths/minute) 3. Delivery mode (Spontaneous, Instrumental Vaginal, Caesarean Section) 4. Incidence of foetal distress requiring delivery 5. Neonatal status at delivery: 5.1. APGAR score at 5 minutes 5.2. Incidence of foetal acidosis determined by umbilical cord gas analysis 5.3. Requirement for neonatal resuscitation 5.4. Incidence of and indication for admission to neonatal care 6. Rate of initiation of breastfeeding within the first hour of birth 7. Maternal satisfaction with childbirth experience determined by postpartum questionnaire prior to discharge from the delivery ward 8. Explore and compare women’s birth experiences, perceptions of pain relief and infant feeding behaviours up to six weeks postpartum (RESPITE Post-Natal Sub-Study) Previous secondary outcome measures: 1. The effectiveness of pain relief provided by each technique, quantified by Visual Analogue Scale taken every 30 minutes after time zero, until delivery or transfer to theatre. 2. The incidence of maternal side effects, up to the end of 3rd stage, including: 2.1. Excessive sedation score 2.2. Oxygen Saturatio | — |
Countries
United Kingdom
Outcome results
None listed