Ignite Creation Date:
2025-12-25 @ 3:18 AM
Ignite Modification Date:
2026-02-01 @ 7:08 PM
Study NCT ID:
NCT03167905
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-18
First Post:
2017-05-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D000377', 'term': 'Agnosia'}], 'ancestors': [{'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C001147', 'term': 'Entonox'}, {'id': 'D009609', 'term': 'Nitrous Oxide'}, {'id': 'D008614', 'term': 'Meperidine'}, {'id': 'D000077208', 'term': 'Remifentanil'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D000077212', 'term': 'Ropivacaine'}], 'ancestors': [{'id': 'D009589', 'term': 'Nitrogen Oxides'}, {'id': 'D005740', 'term': 'Gases'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017672', 'term': 'Nitrogen Compounds'}, {'id': 'D010087', 'term': 'Oxides'}, {'id': 'D017601', 'term': 'Oxygen Compounds'}, {'id': 'D007540', 'term': 'Isonipecotic Acids'}, {'id': 'D000147', 'term': 'Acids, Heterocyclic'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D011422', 'term': 'Propionates'}, {'id': 'D000144', 'term': 'Acids, Acyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Cross over or switch to the other group of analgesia is allowed.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 881}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-15', 'studyFirstSubmitDate': '2017-05-02', 'studyFirstSubmitQcDate': '2017-05-24', 'lastUpdatePostDateStruct': {'date': '2025-04-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-19', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The incidence of major postnatal depression in both groups', 'timeFrame': '6-10 weeks after delivery', 'description': 'Edinburgh Postnatal Depression Scale (EPDS) score\\>=13'}, {'measure': 'The incidence of (clinically significant, probable) postnatal depression in both groups', 'timeFrame': '6-10 weeks after delivery', 'description': 'Edinburgh Postnatal Depression Scale (EPDS) score\\>=10'}], 'secondaryOutcomes': [{'measure': 'The incidence of acquiring post-delivery persistent pain in both groups', 'timeFrame': '6-10 weeks after delivery', 'description': 'Pain score\\>3 in the perineal, surgical scar or abdomen region that lasts for at least 6 weeks post-delivery'}, {'measure': 'Pain vulnerability in both groups (1)', 'timeFrame': 'Upon recruitment until 6-10 weeks after delivery', 'description': 'Assessment via Pain Catastrophizing Scale (PCS) questionnaire before and after delivery'}, {'measure': 'Pain vulnerability in both groups (2)', 'timeFrame': 'Upon recruitment until 6-10 weeks after delivery', 'description': 'Assessment via Central Sensitisation Inventory (CSI) questionnaire before and after delivery'}, {'measure': 'Pain vulnerability in both groups (3)', 'timeFrame': 'Upon recruitment till end of first stage of labor (1 day)', 'description': 'Assessment via Angle Labor Pain Questionnaire (A-LPQ) during first stage of labor when the participants experience labor pain'}, {'measure': 'Psychological vulnerability in both groups (1)', 'timeFrame': 'Upon recruitment until 5 days after delivery', 'description': 'Assessment via Fear-Avoidance Components Scale (FACS) questionnaire before delivery'}, {'measure': 'Psychological vulnerability in both groups (2)', 'timeFrame': 'Upon recruitment until 5 days after delivery', 'description': 'Assessment via State Trait Anxiety Inventory (STAI) questionnaire before delivery'}, {'measure': 'Psychological vulnerability in both groups (3)', 'timeFrame': 'Upon recruitment until 5 days after delivery', 'description': 'Assessment via Perceived Stress Scale (PSS) questionnaire before delivery'}, {'measure': 'Pain severity in both groups', 'timeFrame': 'During labour till one day after delivery', 'description': 'Pain score\\>3 during labour'}, {'measure': 'Preferences for labor analgesia', 'timeFrame': 'Prior to labor and delivery', 'description': '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.'}, {'measure': 'Preferences for epidural analgesia', 'timeFrame': 'Prior to labor and delivery', 'description': '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.'}, {'measure': 'Chinese version of Angle Labor Pain Questionnaire (A-LPQ)', 'timeFrame': 'Upon recruitment till end of first stage of labor (1 day)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Anesthesia, Obstetrical', 'Epidural anesthesia', 'Postnatal depression', 'Persistent pain'], 'conditions': ['Depression, Postpartum', 'Analgesia, Obstetrical', 'Anesthesia, Obstetrical']}, 'referencesModule': {'references': [{'pmid': '37990597', 'type': 'RESULT', '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.'}, {'pmid': '40113655', 'type': 'DERIVED', 'citation': 'Chan JCY, Sultana R, Mathur D, Tan CW, Sng BL. The association of pain and psychological vulnerabilities with postpartum pain catastrophizing: a secondary analysis of a randomized controlled trial. Can J Anaesth. 2025 Apr;72(4):603-614. doi: 10.1007/s12630-025-02920-8. Epub 2025 Mar 20.'}, {'pmid': '39732915', 'type': 'DERIVED', 'citation': 'Ayuby NA, Ang MQ, Sultana R, Tan CW, Sng BL. Investigating the association between labor pain and cessation of breastfeeding. Sci Rep. 2024 Dec 28;14(1):31361. doi: 10.1038/s41598-024-82850-5.'}, {'pmid': '37491196', 'type': 'DERIVED', 'citation': 'Tan CW, Tan NY, Sultana R, Tan HS, Sng BL. Investigating the association factors of acute postpartum pain: a cohort study. BMC Anesthesiol. 2023 Jul 25;23(1):252. doi: 10.1186/s12871-023-02214-w.'}], 'seeAlsoLinks': [{'url': 'https://pubmed.ncbi.nlm.nih.gov/37990597/', 'label': 'Published data on the primary outcome on epidural labour analgesia and postnatal depression'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nDuring any time of the labour period, the patient is allowed to switch the pain relief option upon request.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy adult (American Society of Anesthesiologists physical status 1 and 2) parturients at term (36 weeks gestation or more) (nulliparous and multiparous);\n* With a singleton fetus.\n\nExclusion Criteria:\n\n* Multiple pregnancies;\n* Non-cephalic fetal presentation;\n* Obstetric complications (e.g. pre-eclampsia, uncontrolled hypertension, uncontrolled diabetes);\n* Elective and urgent caesarean section (not from delivery suite).'}, 'identificationModule': {'nctId': 'NCT03167905', 'acronym': 'CODEPAD', 'briefTitle': 'CODEPAD (Collaborative Outcomes of DEpression and Pain Associated With Delivery)', 'organization': {'class': 'OTHER_GOV', 'fullName': "KK Women's and Children's Hospital"}, 'officialTitle': 'Comparison of the Role of Epidural Analgesia Versus Non-epidural Analgesia in Postnatal Depression and Persistent Pain Development: a Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2017/2090'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epidural group', 'description': 'Patients are assigned to receive epidural delivery system (fentanyl and ropivacaine) for labour as pain relief option.', 'interventionNames': ['Device: Epidural delivery system', 'Drug: Fentanyl', 'Drug: Ropivacaine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Non-epidural group', 'description': 'Patients are assigned to receive entonox (laughing gas), meperidine (pethidine) or remifentanil (Ultiva) for labour as pain relief option.', 'interventionNames': ['Drug: Entonox', 'Drug: Meperidine', 'Drug: Ultiva']}], 'interventions': [{'name': 'Epidural delivery system', 'type': 'DEVICE', 'description': 'Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.', 'armGroupLabels': ['Epidural group']}, {'name': 'Entonox', 'type': 'DRUG', 'otherNames': ['Laughing gas'], 'description': 'Entonox will be given upon request in non-epidural group.', 'armGroupLabels': ['Non-epidural group']}, {'name': 'Meperidine', 'type': 'DRUG', 'otherNames': ['Pethidine'], 'description': 'Intramuscular pethidine (75mg/1.5ml) will be given upon request in non-epidural group.', 'armGroupLabels': ['Non-epidural group']}, {'name': 'Ultiva', 'type': 'DRUG', 'otherNames': ['Remifentanil'], 'description': 'Intravenous patient controlled remifentanil (20-40mcg/ml) is only given when the patient rejects or cannot receive pethidine and entonox in non-epidural group..', 'armGroupLabels': ['Non-epidural group']}, {'name': 'Fentanyl', 'type': 'DRUG', 'description': 'Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.', 'armGroupLabels': ['Epidural group']}, {'name': 'Ropivacaine', 'type': 'DRUG', 'description': 'Epidural delivery system for maintenance of labour epidural analgesia using 0.1% ropivacaine (amide local anaesthetic) with 2mcg/ml fentanyl (opioid) as maintenance solution.', 'armGroupLabels': ['Epidural group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '229899', 'city': 'Singapore', 'country': 'Singapore', 'facility': "KK Women's and Children's Hospital", 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}], 'overallOfficials': [{'name': 'Ban Leong Sng, FANZCA', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "KK Women's and Children's Hospital"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "KK Women's and Children's Hospital", 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}