CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)
- Conditions
- Depression, PostpartumAnesthesia, ObstetricalAnalgesia, Obstetrical
- Interventions
- Drug: EntonoxDevice: Epidural delivery system
- Registration Number
- NCT03167905
- Lead Sponsor
- KK Women's and Children's Hospital
- 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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 881
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Epidural group Ropivacaine Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option. Non-epidural group Entonox Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option. Epidural group Epidural delivery system Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option. Epidural group Fentanyl Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option. Non-epidural group Meperidine Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option. Non-epidural group Ultiva Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.
- Primary Outcome Measures
Name Time Method The incidence of major postnatal depression in both groups 6-10 weeks after delivery Edinburgh Postnatal Depression Scale (EPDS) score\>=13
The incidence of (clinically significant, probable) postnatal depression in both groups 6-10 weeks after delivery Edinburgh Postnatal Depression Scale (EPDS) score\>=10
- Secondary Outcome Measures
Name Time Method Pain vulnerability in both groups (1) Upon recruitment until 6-10 weeks after delivery Assessment via Pain Catastrophizing Scale (PCS) questionnaire before and after delivery
The incidence of acquiring post-delivery persistent pain in both groups 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
Pain vulnerability in both groups (2) Upon recruitment until 6-10 weeks after delivery Assessment via Central Sensitisation Inventory (CSI) questionnaire before and after delivery
Pain vulnerability in both groups (3) 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
Psychological vulnerability in both groups (1) Upon recruitment until 5 days after delivery Assessment via Fear-Avoidance Components Scale (FACS) questionnaire before delivery
Psychological vulnerability in both groups (2) Upon recruitment until 5 days after delivery Assessment via State Trait Anxiety Inventory (STAI) questionnaire before delivery
Psychological vulnerability in both groups (3) Upon recruitment until 5 days after delivery Assessment via Perceived Stress Scale (PSS) questionnaire before delivery
Pain severity in both groups During labour till one day after delivery Pain score\>3 during labour
Preferences for labor analgesia 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.
Preferences for epidural analgesia 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.
Chinese version of Angle Labor Pain Questionnaire (A-LPQ) 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.
Trial Locations
- Locations (1)
KK Women's and Children's Hospital
đŸ‡¸đŸ‡¬Singapore, Singapore