- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03167905
CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery) (CODEPAD)
Comparison of the Role of Epidural Analgesia Versus Non-epidural Analgesia in Postnatal Depression and Persistent Pain Development: a Randomized Controlled Trial
Study Overview
Status
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 3
Contacts and Locations
Study Locations
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Singapore, Singapore, 229899
- KK Women's and Children's Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Epidural group
Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option.
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Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.
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Active Comparator: Non-epidural group
Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.
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Entonox will be given upon request in non-epidural group.
Other Names:
Intramuscular pethidine (75mg/1.5ml)
will be given upon request in non-epidural group.
Other Names:
Intravenous patient controlled remifentanil (20-40mcg/ml) is only given when the patient rejects or cannot receive pethidine and entonox in non-epidural group..
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of major postnatal depression in both groups
Time Frame: 6-10 weeks after delivery
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Edinburgh Postnatal Depression Scale (EPDS) score>=13
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6-10 weeks after delivery
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The incidence of (clinically significant, probable) postnatal depression in both groups
Time Frame: 6-10 weeks after delivery
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Edinburgh Postnatal Depression Scale (EPDS) score>=10
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6-10 weeks after delivery
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The incidence of acquiring post-delivery persistent pain in both groups
Time Frame: 6-10 weeks after delivery
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Pain score>3 in the perineal, surgical scar or abdomen region that lasts for at least 6 weeks post-delivery
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6-10 weeks after delivery
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Pain vulnerability in both groups (1)
Time Frame: Upon recruitment until 6-10 weeks after delivery
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Assessment via Pain Catastrophizing Scale (PCS) questionnaire before and after delivery
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Upon recruitment until 6-10 weeks after delivery
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Pain vulnerability in both groups (2)
Time Frame: Upon recruitment until 6-10 weeks after delivery
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Assessment via Central Sensitisation Inventory (CSI) questionnaire before and after delivery
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Upon recruitment until 6-10 weeks after delivery
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Pain vulnerability in both groups (3)
Time Frame: Upon recruitment till end of first stage of labor (1 day)
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Assessment via Angle Labor Pain Questionnaire (A-LPQ) during first stage of labor when the participants experience labor pain
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Upon recruitment till end of first stage of labor (1 day)
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Psychological vulnerability in both groups (1)
Time Frame: Upon recruitment until 5 days after delivery
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Assessment via Fear-Avoidance Components Scale (FACS) questionnaire before delivery
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Upon recruitment until 5 days after delivery
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Psychological vulnerability in both groups (2)
Time Frame: Upon recruitment until 5 days after delivery
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Assessment via State Trait Anxiety Inventory (STAI) questionnaire before delivery
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Upon recruitment until 5 days after delivery
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Psychological vulnerability in both groups (3)
Time Frame: Upon recruitment until 5 days after delivery
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Assessment via Perceived Stress Scale (PSS) questionnaire before delivery
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Upon recruitment until 5 days after delivery
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Pain severity in both groups
Time Frame: During labour till one day after delivery
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Pain score>3 during labour
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During labour till one day after delivery
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Preferences for labor analgesia
Time Frame: Prior to labor and delivery
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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.
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Prior to labor and delivery
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Preferences for epidural analgesia
Time Frame: Prior to labor and delivery
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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.
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Prior to labor and delivery
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Chinese version of Angle Labor Pain Questionnaire (A-LPQ)
Time Frame: Upon recruitment till end of first stage of labor (1 day)
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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.
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Upon recruitment till end of first stage of labor (1 day)
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Collaborators and Investigators
Investigators
- Principal Investigator: Ban Leong Sng, FANZCA, KK Women's and Children's Hospital
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Behavioral Symptoms
- Mental Disorders
- Mood Disorders
- Pregnancy Complications
- Puerperal Disorders
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Depression
- Depressive Disorder
- Depression, Postpartum
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics, Intravenous
- Anesthetics, General
- Anesthetics
- Analgesics, Non-Narcotic
- Analgesics, Opioid
- Narcotics
- Adjuvants, Anesthesia
- Anesthetics, Local
- Anesthetics, Inhalation
- Anesthetics, Combined
- Remifentanil
- Fentanyl
- Nitrous Oxide
- Ropivacaine
- Meperidine
- Entonox
Other Study ID Numbers
- 2017/2090
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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