Ignite Creation Date:
2025-12-25 @ 5:12 AM
Ignite Modification Date:
2025-12-26 @ 4:17 AM
Study NCT ID:
NCT05826327
Status:
RECRUITING
Last Update Posted:
2024-08-20
First Post:
2023-03-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression in Parturients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019052', 'term': 'Depression, Postpartum'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000629870', 'term': 'Esketamine'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 364}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-05', 'completionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-17', 'studyFirstSubmitDate': '2023-03-19', 'studyFirstSubmitQcDate': '2023-04-20', 'lastUpdatePostDateStruct': {'date': '2024-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of depression', 'timeFrame': 'Day 42 after completion of labour', 'description': 'The incidence (MINI-6.0 for the diagnosis of postnatal depression) and severity of depression on day 42 after delivery in both groups.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Esketamine', 'Epidural labor analgesia', 'Postpartum depression'], 'conditions': ['Postpartum Depression']}, 'descriptionModule': {'briefSummary': 'Postpartum depression is a common psychological abnormality during the puerperium, which seriously affects maternal and neonatal health. Esketamine, the S-enantiomer of ketamine, is twice as potent as ketamine and can be safely used for cesarean section and labor analgesia. However, it is not clear whether esketamine used for epidural labor analgesia can significantly reduce the incidence of postpartum depression. This study intends to explore the incidence of maternal prenatal depression and to investigate the effect of esketamine for epidural labor analgesia on postpartum depression and maternal and neonatal outcomes in parturients with prenatal depression through a multi-center, large-scale and high-quality clinical trail, in order to provide a clinical basis and theoretical basis for the application of esketamine used for epidural labor analgesia in postpartum depression and further reduce the incidence of postpartum depression, promote maternal and infant health, and ensure maternal and infant safety .', 'detailedDescription': 'The study include women who meet the inclusion criteria for antenatal EPDS score ≥10 for labour analgesia while signing informed consent. The women will be randomized into two groups, one for esketamine group and the other for the control group. Follow-up visits will be conducted at 1 day, 7 days and 42 days after delivery. The primary endpoint of the study was the incidence (MINI-6.0 for diagnosis of postnatal depression) and severity of maternal depression at day 42 postpartum. The secondary endpoints of the study are maternal EPDS scores at 7 and 42 days postpartum; pain scores and impact at 1, 7 and 42 days postpartum; breastfeeding at 1, 7 and 42 days postpartum; length of postpartum stay; maternal complications at 42 days postpartum and neonatal illnesses at 42 days postpartum.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Full-term pregnancy; Antenatal depressive state (EPDS score ≥10 and non-depressive diagnosis by a psychiatrist); Epidural labor analgesia； Signed informed consent.\n\nExclusion Criteria:\n\n* Pre-existing history of definite psychiatric disorders (depression, schizophrenia, etc.) or communication disorders；Presence of severe preoperative pregnancy complications (e.g., severe preeclampsia, placental implantation, HELLP syndrome, placenta praevia, placenta abruptio)；ASA classification ≥ grade III；Contraindications to ketamine/S-ketamine (e.g., intractable, refractory hypertension, severe cardiovascular disease \\[cardiac function class ≥ III\\], hyperthyroidism); Refusal to participate in the study.'}, 'identificationModule': {'nctId': 'NCT05826327', 'briefTitle': 'Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression in Parturients', 'organization': {'class': 'OTHER', 'fullName': "Women's Hospital School Of Medicine Zhejiang University"}, 'officialTitle': 'Effects of Epidural Labor Analgesia With Esketamine on the Incidence of Postpartum Depression and Maternal and Neonatal Outcomes in Parturients With Prenatal Depression', 'orgStudyIdInfo': {'id': 'IRB-20230021-R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Esketamine Group', 'description': 'The epidural analgesic drug mix for labour analgesia is ropivacaine 0.08mg/mL compounded with esketamine 0.3mg/mL.', 'interventionNames': ['Drug: Esketamine']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control Group', 'description': 'The epidural analgesic drug mix for labour analgesia is ropivacaine 0.08mg/mL compounded with sufentanil 0.3ug/mL.', 'interventionNames': ['Drug: Sufentanil']}], 'interventions': [{'name': 'Esketamine', 'type': 'DRUG', 'otherNames': ['E'], 'description': 'The drug esketamine will be added to the experimental group as opposed to the control group.', 'armGroupLabels': ['Esketamine Group']}, {'name': 'Sufentanil', 'type': 'DRUG', 'otherNames': ['C'], 'description': 'Sufentanil for labour analgesia in the control group', 'armGroupLabels': ['Control Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '331000', 'city': 'Hangzhou', 'state': 'Zhejiang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xinzhong Chen, Dr', 'role': 'CONTACT', 'email': 'chenxinz@zju.edu.cn', 'phone': '13575738058'}], 'facility': "Women's hospital, school of medicine, Zhejiang university", 'geoPoint': {'lat': 30.29365, 'lon': 120.16142}}], 'centralContacts': [{'name': 'Xinzhong Chen, Dr', 'role': 'CONTACT', 'email': 'chenxinz@zju.edu.cn', 'phone': '0571-8999100'}], 'overallOfficials': [{'name': 'Weiguo Lyv, Dr', 'role': 'STUDY_DIRECTOR', 'affiliation': "Women's Hospital School Of Medicine Zhejiang University"}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Women's Hospital School Of Medicine Zhejiang University", 'class': 'OTHER'}, 'collaborators': [{'name': 'Peking University First Hospital', 'class': 'OTHER'}, {'name': 'Obstetrics & Gynecology Hospital of Fudan University', 'class': 'OTHER'}, {'name': 'Beijing Obstetrics and Gynecology Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}