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MOTHER trial: Efficacy and safety of low-dose intrathecal morphine following planned caesarean section - a randomised, blinded, clinical, controlled, multicentre trial.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2024-518678-16-00
Enrollment
1312
Registered
2025-05-05
Start date
2025-07-08
Completion date
Unknown
Last updated
2025-05-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caesarean section, acute postoperative pain

Brief summary

Level of pain when mobilising from supine to sitting position within 24 hours: Level of pain when mobilising from supine to sitting position within 24 hours, Maternal and neonatal safety: Binary composite outcome consisting of 1) participants with respiratory depression 2) participants with severe nausea/vomiting within 24 hours 3) neonatal admission within 48 hours 4) hospitalisation of participant or neonate within 7 days after discharge and 5) death of either participant or neonate within 7 days

Detailed description

Opioid consumption within 24 hours, Morphine associated adverse events within 24 hours: Vomiting, nausea, dizziness, pruritus and urinary retention, Obstetric quality of recovery score at 24 hours, Participants satisfaction with postoperative pain-treatment during the first 24 hours, Established breastfeeding at 30 days

Interventions

DRUGSodium chloride 9 mg/ml (solution for injection)

Sponsors

Region Sjaelland
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
Level of pain when mobilising from supine to sitting position within 24 hours: Level of pain when mobilising from supine to sitting position within 24 hours, Maternal and neonatal safety: Binary composite outcome consisting of 1) participants with respiratory depression 2) participants with severe nausea/vomiting within 24 hours 3) neonatal admission within 48 hours 4) hospitalisation of participant or neonate within 7 days after discharge and 5) death of either participant or neonate within 7 days

Secondary

MeasureTime frame
Opioid consumption within 24 hours, Morphine associated adverse events within 24 hours: Vomiting, nausea, dizziness, pruritus and urinary retention, Obstetric quality of recovery score at 24 hours, Participants satisfaction with postoperative pain-treatment during the first 24 hours, Established breastfeeding at 30 days

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026