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

Study Overview
=================
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.

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

Conditions
-----------------
Anesthesia, Obstetrical, Depression, Postpartum, Analgesia, Obstetrical

Intervention / Treatment
-----------------
* Device: Epidural delivery system
* Drug: Entonox
* Drug: Meperidine
* Drug: Ultiva
* Drug: Fentanyl
* Drug: Ropivacaine


Participation Criteria
=================
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).

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Cross over or switch to the other group of analgesia is allowed.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epidural group<br>Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option. | Device: Epidural delivery system<br>* Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.<br>Drug: Fentanyl<br>* Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.<br>Drug: Ropivacaine<br>* Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.<br>|
| Active Comparator: Non-epidural group<br>Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option. | Drug: Entonox<br>* Entonox will be given upon request in non-epidural group.<br>* Other names: Laughing gas;Drug: Meperidine<br>* Intramuscular pethidine (75mg/1.5ml) will be given upon request in non-epidural group.<br>* Other names: Pethidine;Drug: Ultiva<br>* Intravenous patient controlled remifentanil (20-40mcg/ml) is only given when the patient rejects or cannot receive pethidine and entonox in non-epidural group..<br>* Other names: Remifentanil;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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) | 
| Psychological vulnerability in both groups (1) | Assessment via Fear-Avoidance Components Scale (FACS) questionnaire before delivery | Upon recruitment until 5 days after delivery | 
| Psychological vulnerability in both groups (2) | Assessment via State Trait Anxiety Inventory (STAI) questionnaire before delivery | Upon recruitment until 5 days after delivery | 
| Psychological vulnerability in both groups (3) | Assessment via Perceived Stress Scale (PSS) questionnaire before delivery | Upon recruitment until 5 days after delivery | 
| Pain severity in both groups | Pain score>3 during labour | During labour till one day after delivery | 
| 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 | 
| 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 | 
| 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) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anesthesia, Obstetrical, Epidural anesthesia, Postnatal depression, Persistent pain