Ignite Creation Date:
2025-12-24 @ 12:22 PM
Ignite Modification Date:
2025-12-31 @ 11:05 PM
Study NCT ID:
NCT04860661
Status:
COMPLETED
Last Update Posted:
2024-08-06
First Post:
2021-04-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Esketamine on Postpartum Depression in Cesarean Section Women
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': 'D000077330', 'term': 'Saline Solution'}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': '1. Assign a researcher to determine the order of patients and coordinate the relationship between researchers;\n2. For each patient, an anesthesiologist was assigned to manage anesthesia and collect intraoperative data;\n3. A researcher who was not aware of the protocol was assigned to conduct preoperative evaluation and postoperative follow-up, and received training on evaluation methods before the study.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'The incidence of PPD: the EPDS scale was assessed by face-to-face or telephone interview of the Puerpera 7 d, 30 d, 60 d and 90 d after delivery. EPDS score ≥ 10 was defined as antenatal depression or postpartum emotional disorder.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 336}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-08', 'completionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-08-04', 'studyFirstSubmitDate': '2021-04-20', 'studyFirstSubmitQcDate': '2021-04-25', 'lastUpdatePostDateStruct': {'date': '2024-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Edinburgh Postnatal Depression Scale(EPDS） scores', 'timeFrame': 'up to 90 days after surgery', 'description': 'EPDS score is 0-30，and ≥ 10 to indicate depression'}], 'secondaryOutcomes': [{'measure': 'Numeric Rating Scale (NRS) score', 'timeFrame': '1 Day before operation', 'description': 'NRS score is 0-10，and ≥ 4 to indicate the pain needs treatment'}, {'measure': 'total number of patient-controlled analgesia (PCA) compressions', 'timeFrame': 'up to 24 hours after operation', 'description': 'the total number of PCA compressions which the patients pressed'}, {'measure': 'total volume of PCA', 'timeFrame': 'up to 24 hours after operation', 'description': 'the total volume of PCA drugs which the patients needed in 24h after surgery'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Esketamine', 'Postpartum Depression']}, 'descriptionModule': {'briefSummary': 'This study was to explore the preventive effect of esketamine on postpartum depression (PPD) in cesarean section, and to evaluate the safety of the drug', 'detailedDescription': "Studies have shown that esketamine can treat clinical refractory depression, the drug takes effect quickly, can quickly eliminate the patient's suicide intention, low-dose maintenance treatment is conducive to the stability of the patient's condition, and less adverse reactions, is the current hot spot of antidepressant drug research. Esketamine has been approved by FDA for the treatment of refractory and suicidal depression, but can it effectively prevent and treat postpartum depression? It is not clear. Based on this, this study aims to explore the preventive effect of prophylactic administration of esketamine on postpartum depression in cesarean section, and evaluate the safety of the drug."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The objects of this observation were puerpera with cesarean section', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Elective cesarean section;\n* 18-40 years;\n* Primipara;\n* Singleton pregnancy;\n* Sign informed consent.\n\nExclusion Criteria:\n\n* American Society of Anesthesiologists (ASA) grade III and above;\n* Intracranial hypertension;\n* Hypertension;\n* Severe heart disease;\n* Hyperthyroidism patients without treatment or insufficient treatment;\n* Liver and kidney dysfunction;\n* Preeclampsia or eclampsia;\n* Mental disorder, mental retardation;\n* Drug abuse and alcoholism;\n* Contraindication of intraspinal anesthesia;\n* The preoperative EPDS score ≥10;\n* Participated in other clinical studies.'}, 'identificationModule': {'nctId': 'NCT04860661', 'acronym': 'EKET', 'briefTitle': 'Esketamine on Postpartum Depression in Cesarean Section Women', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'Effect of Prophylactic Esketamine on Postpartum Depression in Cesarean Section: A Multicenter, Prospective, Randomized, Controlled Study', 'orgStudyIdInfo': {'id': 'EKET'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'N group', 'description': '15 minutes after umbilical cord amputation, the patient was intravenously injected with 10 ml normal saline', 'interventionNames': ['Drug: Normal saline']}, {'type': 'EXPERIMENTAL', 'label': 'Es group', 'description': '15 minutes after umbilical cord amputation, the patient was intravenously injected with 0.25mg/kg esketamine, PCIA regimen: sufentanil 100 μ g, esketamine 80 mg, diluted to 100 ml with 0.9% normal saline, set analgesia pump background infusion dose 2 ml/h, single bolus dose 2 ml, locking time 8 minutes.', 'interventionNames': ['Drug: Esketamine']}], 'interventions': [{'name': 'Esketamine', 'type': 'DRUG', 'otherNames': ['Es group'], 'description': 'After delivery, the parturient was given a loading dose of esketamine, and then a small dose of esketamine was added into PCIA analgesia pump', 'armGroupLabels': ['Es group']}, {'name': 'Normal saline', 'type': 'DRUG', 'otherNames': ['Ns group'], 'description': '10 ml normal saline', 'armGroupLabels': ['N group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430000', 'city': 'Wuhan', 'state': 'Hubei', 'country': 'China', 'facility': 'Tongji Hospital', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'overallOfficials': [{'name': 'Ailin luo, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Anesthesiology of Tongji Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ailin Luo', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maternal and Child Health Hospital of Hubei Province', 'class': 'OTHER'}, {'name': "Jingmen No.1 People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Ailin Luo', 'investigatorAffiliation': 'Tongji Hospital'}}}}