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Depression, PostpartumPhase 2/3CODEPADNCT03167905

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

A Phase 2/3 study testing Epidural delivery system, Entonox and Meperidine in people with Depression, Postpartum and Analgesia, Obstetrical, run by KK Women's and Children's Hospital at 1 site in Singapore.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 50 years, women only
What is being tested?
Epidural delivery system, Entonox and Meperidine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
881 participants
Where
1 siteSingapore
Study dates
15 Jun 2017to 31 Dec 2027
Phase
Phase 2/3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 50 years
  • Women only
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

1 site in 1 country.

Singapore1 site

  • KK Women's and Children's Hospital

    Singapore, 229899

Other trials in Singapore

About this study

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

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.

Read the 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.

Being tested
Epidural delivery system, Entonox, Meperidine, Ultiva, Fentanyl
Keywords
Anesthesia, Obstetrical, Epidural anesthesia, Postnatal depression, Persistent pain
Medical subject headings
Depression, Postpartum, Agnosia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Epidural delivery systemDevice

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

  • EntonoxDrug

    Also called Laughing gas

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

  • MeperidineDrug

    Also called Pethidine

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

  • UltivaDrug

    Also called Remifentanil

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

  • FentanylDrug

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

  • RopivacaineDrug

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

Study groups in NCT03167905
Study groupRoleWhat they receive
Epidural groupExperimentalPatients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option.
Receives: Device: Epidural delivery system; Drug: Fentanyl; Drug: Ropivacaine
Non-epidural groupActive comparatorPatients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.
Receives: Drug: Entonox; Drug: Meperidine; Drug: Ultiva

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The incidence of major postnatal depression in both groups

    Edinburgh Postnatal Depression Scale (EPDS) score>=13

    Measured: 6-10 weeks after delivery

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

    Edinburgh Postnatal Depression Scale (EPDS) score>=10

    Measured: 6-10 weeks after delivery

Secondary outcomes (11)

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

    Pain score>3 in the perineal, surgical scar or abdomen region that lasts for at least 6 weeks post-delivery

    Measured: 6-10 weeks after delivery

  2. Pain vulnerability in both groups (1)

    Assessment via Pain Catastrophizing Scale (PCS) questionnaire before and after delivery

    Measured: Upon recruitment until 6-10 weeks after delivery

  3. Pain vulnerability in both groups (2)

    Assessment via Central Sensitisation Inventory (CSI) questionnaire before and after delivery

    Measured: Upon recruitment until 6-10 weeks after delivery

  4. Pain vulnerability in both groups (3)

    Assessment via Angle Labor Pain Questionnaire (A-LPQ) during first stage of labor when the participants experience labor pain

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

  5. Psychological vulnerability in both groups (1)

    Assessment via Fear-Avoidance Components Scale (FACS) questionnaire before delivery

    Measured: Upon recruitment until 5 days after delivery

  6. Psychological vulnerability in both groups (2)

    Assessment via State Trait Anxiety Inventory (STAI) questionnaire before delivery

    Measured: Upon recruitment until 5 days after delivery

  7. Psychological vulnerability in both groups (3)

    Assessment via Perceived Stress Scale (PSS) questionnaire before delivery

    Measured: Upon recruitment until 5 days after delivery

  8. Pain severity in both groups

    Pain score>3 during labour

    Measured: During labour till one day after delivery

  9. Preferences for labor analgesia

    Recruited patients will be administered a survey on Discrete Choice Experiment (DCE) and other questions on their preferences for labor analgesia. For DCE, nine tasks will be included in which parturients will choose one of four hypothetical forms of labor analgesia: 1) epidural analgesia, 2) pethidine, 3) Entonox (nitrous oxide-oxygen mixture), and 4) no labor analgesia, which varies with regards to six attributes: 1) pain intensity following treatment, 2) duration of second stage of labor, 3) risk of instrumental delivery, 4) risk of back pain, 5) risk of permanent nerve injury, and 6) out-of-pocket cost.

    Measured: Prior to labor and delivery

  10. Preferences for epidural analgesia

    Recruited patients will be administered a survey on their preferences and opinions on epidural analgesia, including their concerns on possible risk of epidural analgesia e.g. instrumental delivery, prolonged duration of second stage of labor, back pain etc.

    Measured: Prior to labor and delivery

  11. Chinese version of Angle Labor Pain Questionnaire (A-LPQ)

    Assessment via Angle Labor Pain Questionnaire (A-LPQ) during first stage of labor when the participants experience labor pain. The tool comprises 22 items divided into five subscales on the childbirth pain experience: the enormity of the pain, the fear and anxiety, uterine contraction pain, birthing pain, and the back pain/ long haul. Each item is scaled from 0 to 10, implying a range from non to worst possible or extremely (where applicable), and therefore has a total score ranged from 0 to 220. The higher the score, the greater the labor pain.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 May 2017
  2. Study start15 Jun 2017
  3. Primary completion19 Jul 2021
  4. Study completion31 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Cross over or switch to the other group of analgesia is allowed.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
881 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03167905
Sponsor's protocol ID
2017/2090
Acronym
CODEPAD
Status last verified
Aug 2026
First submitted
2 May 2017
Last updated
6 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 37990597

  • Tan CW, Wang S, Sultana R, Sia ATH, Sng BL. Associations of Pain, Analgesia Technique, and Psychological Factors with Central Sensitization after Childbirth. Anaesth Crit Care Pain Med. 2026 Jun 18:101881. doi: 10.1016/j.accpm.2026.101881. Online ahead of print.

    PubMed 42314868

  • Tan CW, Liu Y, Sultana R, Sia ATH, Sng BL. Understanding maternal pain and psychological vulnerabilities associated with the development of sub-acute pain after childbirth. BMC Anesthesiol. 2026 May 7;26(1):385. doi: 10.1186/s12871-026-03885-x.

    PubMed 42092800

  • Tan CW, Sultana R, Chen HY, Chua TE, Ku CW, Sng BL. Investigating the association between pain and psychological vulnerabilities and postpartum depression. Sci Rep. 2026 Apr 28;16(1):19691. doi: 10.1038/s41598-026-50140-x.

    PubMed 42049811

  • 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.

    PubMed 40113655

  • 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.

    PubMed 39732915

  • 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.

    PubMed 37491196

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing Epidural delivery system, Entonox and Meperidine in people with Depression, Postpartum and Analgesia, Obstetrical, run by KK Women's and Children's Hospital at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The incidence of major postnatal depression in both groups (time frame: 6-10 weeks after delivery). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03167905, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2026.

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