Clinical trial NCT03167905: CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)
Official title: Comparison of the Role of Epidural Analgesia Versus Non-epidural Analgesia in Postnatal Depression and Persistent Pain Development: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Depression, Postpartum
Analgesia, Obstetrical
Anesthesia, Obstetrical
Keywords: Anesthesia, Obstetrical
Epidural anesthesia
Postnatal depression
Persistent pain
Lead sponsor: KK Women's and Children's Hospital
Sponsor class: OTHER_GOV
First posted: 2017-05-30
Enrollment: 881
Sex: FEMALE
Minimum age (years): 21
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cross over or switch to the other group of analgesia is allowed.
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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).

Primary outcomes:
measure: The incidence of major postnatal depression in both groups
timeFrame: 6-10 weeks after delivery
measure: The incidence of (clinically significant, probable) postnatal depression in both groups
timeFrame: 6-10 weeks after delivery
Secondary outcomes:
measure: The incidence of acquiring post-delivery persistent pain in both groups
timeFrame: 6-10 weeks after delivery
measure: Pain vulnerability in both groups (1)
timeFrame: Upon recruitment until 6-10 weeks after delivery
measure: Pain vulnerability in both groups (2)
timeFrame: Upon recruitment until 6-10 weeks after delivery
measure: Pain vulnerability in both groups (3)
timeFrame: Upon recruitment till end of first stage of labor (1 day)
measure: Psychological vulnerability in both groups (1)
timeFrame: Upon recruitment until 5 days after delivery
measure: Psychological vulnerability in both groups (2)
timeFrame: Upon recruitment until 5 days after delivery
measure: Psychological vulnerability in both groups (3)
timeFrame: Upon recruitment until 5 days after delivery
measure: Pain severity in both groups
timeFrame: During labour till one day after delivery
measure: Preferences for labor analgesia
timeFrame: Prior to labor and delivery
measure: Preferences for epidural analgesia
timeFrame: Prior to labor and delivery
measure: Chinese version of Angle Labor Pain Questionnaire (A-LPQ)
timeFrame: Upon recruitment till end of first stage of labor (1 day)
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: KK Women's and Children's Hospital
Study officials:
affiliation: KK Women's and Children's Hospital
name: Ban Leong Sng, FANZCA
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.