Analgesia, Obstetrical, Anesthesia, Obstetrical, Depression, Postpartum
Conditions
Keywords
Anesthesia, Obstetrical, Epidural anesthesia, Postnatal depression, Persistent pain
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.
Interventions
DEVICEEpidural 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.
DRUGEntonox
Entonox will be given upon request in non-epidural group.
DRUGMeperidine
Intramuscular pethidine (75mg/1.5ml) will be given upon request in non-epidural group.
DRUGUltiva
Intravenous patient controlled remifentanil (20-40mcg/ml) is only given when the patient rejects or cannot receive pethidine and entonox in non-epidural group..
DRUGFentanyl
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
DRUGRopivacaine
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Sponsors
KK Women's and Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Intervention model description
Cross over or switch to the other group of analgesia is allowed.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to 50 Years
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 (1) | Upon recruitment until 6-10 weeks after delivery | Assessment via Pain Catastrophizing Scale (PCS) questionnaire before and after 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. |
Countries
Singapore
Contacts
PRINCIPAL_INVESTIGATORBan Leong Sng, FANZCA
KK Women's and Children's Hospital
Outcome results
None listed