NCT03167905

CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)

Comparison of the Role of Epidural Analgesia Versus Non-epidural Analgesia in Postnatal Depression and Persistent Pain Development: a Randomized Controlled Trial

• Status: Active Not Recruiting
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 881 (actual)
• Sponsor: KK Women's and Children's Hospital · Other Government
• Sex: Female
• Age: 21 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

Postnatal depression affects about 10-15% of women after childbirth. Approximately 3-5% of women experience a moderate-to-severe depression that requires medical attention. This study aims to investigate the implication of pain relief choice in reducing the postnatal depression of women who deliver their babies.

Detailed description

If the patients have not decided on which pain relief method to be used, and would like to take part in this study, they will be assigned to either epidural or non-epidural pain relief for labour based on the study randomization result. Blood samples will be drawn to study the presence of known functional polymorphisms in candidate genes associated with depression, pain, stress and anxiety. Patients will be followed up with study questionnaires related to pain and postnatal depression screening during the study. For some of the patients, a discrete choice experiment (DCE) on pain relief choice will be conducted, and their preferences on epidural analgesia will be asked. During any time of the labour period, the patient is allowed to switch the pain relief option upon request.

Conditions

• Depression, Postpartum
• Analgesia, Obstetrical
• Anesthesia, Obstetrical

Interventions

Type	Name	Description
DEVICE	Epidural delivery system	Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
DRUG	Entonox	Entonox will be given upon request in non-epidural group.
DRUG	Meperidine	Intramuscular pethidine (75mg/1.5ml) will be given upon request in non-epidural group.
DRUG	Ultiva	Intravenous patient controlled remifentanil (20-40mcg/ml) is only given when the patient rejects or cannot receive pethidine and entonox in non-epidural group..
DRUG	Fentanyl	Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
DRUG	Ropivacaine	Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Timeline

• Start date: 2017-06-15
• Primary completion: 2021-07-19
• Completion: 2026-12-31
• First posted: 2017-05-30
• Last updated: 2025-04-18

Locations

1 site across 1 country: Singapore