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Active, Not Recruiting

NCT Number: NCT03167905

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

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Depression, Postpartum Agnosia Analgesia, Obstetrical Anesthesia, Obstetrical Depressive Disorder Female Urogenital Diseases and Pregnancy Complications Mental Disorders Mood Disorders Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Pregnancy Complications Puerperal Disorders Signs and Symptoms Urogenital Diseases

Age range

21 year–50 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

KK Women's and Children's Hospital

Singapore, 229899

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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).

Treatment and study plan

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.

Entonox

Drug

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

Other names: Laughing gas

Meperidine

Drug

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

Other names: Pethidine

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..

Other names: Remifentanil

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.

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.

Primary outcomes

  1. The incidence of major postnatal depression in both groups

    Time frame: 6-10 weeks after delivery

    Edinburgh Postnatal Depression Scale (EPDS) score>=13

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

    Time frame: 6-10 weeks after delivery

    Edinburgh Postnatal Depression Scale (EPDS) score>=10

Secondary outcomes

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

    Time frame: 6-10 weeks after delivery

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

  2. Pain vulnerability in both groups (1)

    Time frame: Upon recruitment until 6-10 weeks after delivery

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

  3. Pain vulnerability in both groups (2)

    Time frame: Upon recruitment until 6-10 weeks after delivery

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

  4. Pain vulnerability in both groups (3)

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

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

  5. Psychological vulnerability in both groups (1)

    Time frame: Upon recruitment until 5 days after delivery

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

  6. Psychological vulnerability in both groups (2)

    Time frame: Upon recruitment until 5 days after delivery

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

  7. Psychological vulnerability in both groups (3)

    Time frame: Upon recruitment until 5 days after delivery

    Assessment via Perceived Stress Scale (PSS) questionnaire before delivery

  8. Pain severity in both groups

    Time frame: During labour till one day after delivery

    Pain score>3 during labour

  9. Preferences for labor analgesia

    Time frame: Prior to labor and delivery

    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.

  10. Preferences for epidural analgesia

    Time frame: Prior to labor and delivery

    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.

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

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

    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.

Sponsors and collaborators

Lead sponsor

KK Women's and Children's Hospital

Other Gov

Registry information

Official study title

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

Acronym: CODEPAD

Important dates

Study start
2017
Primary completion
2021
Study completion
2026
First posted
May 30, 2017
Registry last updated
Apr 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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