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

Depression, Postpartum Clinical Trial

— CODEPAD  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03167905
• Other study ID #: 2017/2090
• Status: Active, not recruiting
• Phase: Phase 2/Phase 3
• Start date: June 15, 2017
• Est. completion date: December 31, 2025

Study information

• Verified date: January 2024
• Source: KK Women's and Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 881
• Est. completion date: December 31, 2025
• Est. primary completion date: July 19, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 50 Years

Eligibility

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).

Related Conditions & MeSH terms

• Analgesia, Obstetrical
• Anesthesia, Obstetrical
• Depression
• Depression, Postpartum
• Depressive Disorder

Intervention

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

Locations

Country	Name	City	State
Singapore	KK Women's and Children's Hospital	Singapore

Sponsors (1)

Lead Sponsor	Collaborator
KK Women's and Children's Hospital

Country where clinical trial is conducted

Singapore, 

References & Publications (1)

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. 2023 Nov 21. doi: 10.1111/anae.16178. Online ahead of — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of major postnatal depression in both groups	Edinburgh Postnatal Depression Scale (EPDS) score>=13	6-10 weeks after delivery
Primary	The incidence of (clinically significant, probable) postnatal depression in both groups	Edinburgh Postnatal Depression Scale (EPDS) score>=10	6-10 weeks after delivery
Secondary	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	6-10 weeks after delivery
Secondary	Pain vulnerability in both groups (1)	Assessment via Pain Catastrophizing Scale (PCS) questionnaire before and after delivery	Upon recruitment until 6-10 weeks after delivery
Secondary	Pain vulnerability in both groups (2)	Assessment via Central Sensitisation Inventory (CSI) questionnaire before and after delivery	Upon recruitment until 6-10 weeks after delivery
Secondary	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	Upon recruitment till end of first stage of labor (1 day)
Secondary	Psychological vulnerability in both groups (1)	Assessment via Fear-Avoidance Components Scale (FACS) questionnaire before delivery	Upon recruitment until 5 days after delivery
Secondary	Psychological vulnerability in both groups (2)	Assessment via State Trait Anxiety Inventory (STAI) questionnaire before delivery	Upon recruitment until 5 days after delivery
Secondary	Psychological vulnerability in both groups (3)	Assessment via Perceived Stress Scale (PSS) questionnaire before delivery	Upon recruitment until 5 days after delivery
Secondary	Pain severity in both groups	Pain score>3 during labour	During labour till one day after delivery
Secondary	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.	Prior to labor and delivery
Secondary	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.	Prior to labor and delivery
Secondary	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.	Upon recruitment till end of first stage of labor (1 day)