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

NCT03167905 | Active Not Recruiting Phase 2

• 1 other identifier: 2017/2090
• Study Type: interventional
• Target: 881
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Depression, Postpartum; Analgesia, Obstetrical; Anesthesia, Obstetrical

Keywords

Anesthesia, Obstetrical; Epidural anesthesia; Postnatal depression; Persistent pain

Outcome Measures

Primary Outcomes (2)

• The incidence of major postnatal depression in both groups

  Edinburgh Postnatal Depression Scale (EPDS) score\>=13

  6-10 weeks after delivery

• The incidence of (clinically significant, probable) postnatal depression in both groups

  Edinburgh Postnatal Depression Scale (EPDS) score\>=10

  6-10 weeks after delivery

Secondary Outcomes (11)

• The incidence of acquiring post-delivery persistent pain in both groups

  6-10 weeks after delivery

• Pain vulnerability in both groups (1)

  Upon recruitment until 6-10 weeks after delivery

• Pain vulnerability in both groups (2)

  Upon recruitment until 6-10 weeks after delivery

• Pain vulnerability in both groups (3)

  Upon recruitment till end of first stage of labor (1 day)

• Psychological vulnerability in both groups (1)

  Upon recruitment until 5 days after delivery

Study Arms (2)

Epidural group

EXPERIMENTAL

Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option.

Device: Epidural delivery system; Drug: Fentanyl; Drug: Ropivacaine

Non-epidural group

ACTIVE COMPARATOR

Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.

Drug: Entonox; Drug: Meperidine; Drug: Ultiva

Interventions

Epidural delivery system DEVICE

Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Epidural group

Entonox DRUG

Entonox will be given upon request in non-epidural group.

Also known as: Laughing gas

Non-epidural group

Meperidine DRUG

Intramuscular pethidine (75mg/1.5ml) will be given upon request in non-epidural group.

Also known as: Pethidine

Non-epidural group

Ultiva DRUG

Intravenous patient controlled remifentanil (20-40mcg/ml) is only given when the patient rejects or cannot receive pethidine and entonox in non-epidural group..

Also known as: Remifentanil

Non-epidural group

Fentanyl DRUG

Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Epidural group

Ropivacaine DRUG

Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.

Epidural group

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients at term (36 weeks gestation or more) (nulliparous and multiparous);
• With a singleton fetus.

You may not qualify if:

• Multiple pregnancies;
• Non-cephalic fetal presentation;
• Obstetric complications (e.g. pre-eclampsia, uncontrolled hypertension, uncontrolled diabetes);
• Elective and urgent caesarean section (not from delivery suite).

Sponsors & Collaborators

• KK Women's and Children's Hospital: lead

Study Sites (1)

KK Women's and Children's Hospital

Singapore, 229899, Singapore

Location

Related Publications (4)

• Tan HS, Tan CW, Sultana R, Chen HY, Chua T, Rahman N, Gandhi M, Sia ATH, Sng BL. The association between epidural labour analgesia and postpartum depression: a randomised controlled trial. Anaesthesia. 2024 Apr;79(4):357-367. doi: 10.1111/anae.16178. Epub 2023 Nov 21.

  PMID: 37990597 RESULT

• Chan JCY, Sultana R, Mathur D, Tan CW, Sng BL. The association of pain and psychological vulnerabilities with postpartum pain catastrophizing: a secondary analysis of a randomized controlled trial. Can J Anaesth. 2025 Apr;72(4):603-614. doi: 10.1007/s12630-025-02920-8. Epub 2025 Mar 20.

  PMID: 40113655 DERIVED

• Ayuby NA, Ang MQ, Sultana R, Tan CW, Sng BL. Investigating the association between labor pain and cessation of breastfeeding. Sci Rep. 2024 Dec 28;14(1):31361. doi: 10.1038/s41598-024-82850-5.

  PMID: 39732915 DERIVED

• Tan CW, Tan NY, Sultana R, Tan HS, Sng BL. Investigating the association factors of acute postpartum pain: a cohort study. BMC Anesthesiol. 2023 Jul 25;23(1):252. doi: 10.1186/s12871-023-02214-w.

  PMID: 37491196 DERIVED

Related Links

• Published data on the primary outcome on epidural labour analgesia and postnatal depression

MeSH Terms

Conditions

Depression, Postpartum; Agnosia

Interventions

Entonox; Nitrous Oxide; Meperidine; Remifentanil; Fentanyl; Ropivacaine

Condition Hierarchy (Ancestors)

Puerperal Disorders; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Depressive Disorder; Mood Disorders; Mental Disorders; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Nitrogen Oxides; Gases; Inorganic Chemicals; Nitrogen Compounds; Oxides; Oxygen Compounds; Isonipecotic Acids; Acids, Heterocyclic; Heterocyclic Compounds; Piperidines; Heterocyclic Compounds, 1-Ring; Propionates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines

Study Officials

• Ban Leong Sng, FANZCA

  KK Women's and Children's Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Cross over or switch to the other group of analgesia is allowed.

Study Record Dates

• First Submitted: May 2, 2017
• First Posted: May 30, 2017
• Study Start: June 15, 2017
• Primary Completion: July 19, 2021
• Study Completion (Estimated): December 31, 2026
• Last Updated: April 18, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)