Ignite Creation Date:
2025-12-24 @ 2:14 PM
Ignite Modification Date:
2026-02-06 @ 3:46 AM
Study NCT ID:
NCT03381495
Status:
UNKNOWN
Last Update Posted:
2018-07-13
First Post:
2017-12-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Association Between Epidural Labor Analgesia and Pregnancy Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D048949', 'term': 'Labor Pain'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D019052', 'term': 'Depression, Postpartum'}, {'id': 'D009043', 'term': 'Motor Activity'}], 'ancestors': [{'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'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': 'D001519', 'term': 'Behavior'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077212', 'term': 'Ropivacaine'}, {'id': 'D017409', 'term': 'Sufentanil'}], 'ancestors': [{'id': 'D000813', 'term': 'Anilides'}, {'id': 'D000577', 'term': 'Amides'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000814', 'term': 'Aniline Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D005283', 'term': 'Fentanyl'}, {'id': 'D010880', 'term': 'Piperidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-05-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2018-07-11', 'studyFirstSubmitDate': '2017-12-02', 'studyFirstSubmitQcDate': '2017-12-17', 'lastUpdatePostDateStruct': {'date': '2018-07-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Labor duration', 'timeFrame': 'At the end of the delivery', 'description': 'Duration of three stages of labor.'}], 'secondaryOutcomes': [{'measure': '1 minute Apgar index', 'timeFrame': '1 minute after the infant is born', 'description': "The index indicates the infant s' conditions, including heart rate, breathing, muscle tone, reflex response, color. Each characteristic is given an individual score; two points for each of the five categories if all is completely well; then all scores are totaled. The score is from 0 to 10."}, {'measure': '5 minute Apgar index', 'timeFrame': '5 minutes after the infant is born', 'description': "The index indicates the infant s' conditions, including heart rate, breathing, muscle tone, reflex response, color. Each characteristic is given an individual score; two points for each of the five categories if all is completely well; then all scores are totaled. The score is from 0 to 10."}, {'measure': 'Visual Analogue Scores(VAS)', 'timeFrame': '5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.', 'description': 'VAS is the most common pain scale for quantification. The score is from 0 to 10. The score is higher, the patient will be more painful. That will indicate if the analgesia is effective.'}, {'measure': 'Modified Bromage scores', 'timeFrame': '5min before analgesia;5min,15min, 30min,60min after analgesia; at the time of latent phase, active phase, full dilation of the cervix, crowning of head, and laceration repair.', 'description': "The modified Bromage score is the most frequently used measure of motor block. The scores is from 0 to 3. In this scale, the intensity of motor block is assessed by the patient's ability to move their lower extremities (0: no motor paralysis; 1: inability to raise extended leg, but able to move knee and foot; 2: inability to raise extended leg and to move knee, but able to move foot; 3: inability to raise extended leg or to move knee and foot). That will indicate if the analgesia block the patient motor too much."}, {'measure': 'Postpartum depression', 'timeFrame': '3 days after delivery,6 weeks after delivery, 3 months after delivery, 6 months after delivery, 1 year after delivery.', 'description': 'Assess the risk of postpartum depression among all participants using EPDS，HAMA.'}, {'measure': 'The mode of delivery', 'timeFrame': 'At the end of delivery', 'description': 'Including spontaneous vaginal delivery, vacuum- and forceps-assisted delivery, cesarean delivery.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Epidural Labor Analgesia', 'length of labor stage', 'fetal outcomes', 'maternal outcomes', 'postpartum depression', 'exercise'], 'conditions': ['Labor Pain', 'Pregnancy Outcomes', 'Psychological Disorder']}, 'referencesModule': {'references': [{'pmid': '33655955', 'type': 'DERIVED', 'citation': 'Zha Y, Gong X, Yang C, Deng D, Feng L, Luo A, Wan L, Qiao F, Zeng W, Chen S, Wu Y, Han D, Liu H. Epidural analgesia during labor and its optimal initiation time-points: A real-world study on 400 Chinese nulliparas. Medicine (Baltimore). 2021 Mar 5;100(9):e24923. doi: 10.1097/MD.0000000000024923.'}]}, 'descriptionModule': {'briefSummary': 'Labor analgesia can alleviate intrapartum pain, in the importance of the delivery is very obvious.But some researches think labor analgesia may affect the progress of labor, increase the cesarean section rate.This research adopts the epidural anesthesia to study labor analgesia effects on delivery outcomes and long-term emotional and psychological effects on the mothers. Besides, we also want to study the effect of exercise during pregnancy on the mode of delivery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '50 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nhealthy and full term pregnant women\n\nExclusion Criteria:\n\nthe pregnant women with complications'}, 'identificationModule': {'nctId': 'NCT03381495', 'briefTitle': 'The Association Between Epidural Labor Analgesia and Pregnancy Outcomes', 'organization': {'class': 'OTHER', 'fullName': 'Tongji Hospital'}, 'officialTitle': 'The Association Between Epidural Labor Analgesia and Pregnancy Outcomes', 'orgStudyIdInfo': {'id': 'TJ-C20171201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Epidural analgesia during labor', 'description': 'The epidural analgesia technique was used to maintain analgesia for parturients who request labor analgesia.First, we injected a test dose of 5ml 1% lidocaine . If not adverse effects were observed 10 minutes after the test dose, the parturient then received a bolus injection of an initial dose of 8-10 ml mixed liquids of 0.075% ropivacaine and 0.2ug/ml sufentanil citrate. We then connected the epidural catheter with a patient-controlled epidural analgesia (PCA) pump, which provided patients the same mixed solution at 8-10ml/h until the delivery of neonates.', 'interventionNames': ['Drug: Ropivacaine Hydrochloride, Sufentanil']}, {'type': 'NO_INTERVENTION', 'label': 'Non-epidural analgesia during labor', 'description': "Women who refused epidural labor analgesia were included in the non-epidural analgesia group, and they don't receive epidural analgesia during labor"}], 'interventions': [{'name': 'Ropivacaine Hydrochloride, Sufentanil', 'type': 'DRUG', 'description': 'In this research one group will receive epidural analgesia(Ropivacaine Hydrochloride, Sufentanil), data will be collected and analyzed between this group and non-epidural analgesia group.', 'armGroupLabels': ['Epidural analgesia during labor']}]}, 'contactsLocationsModule': {'locations': [{'zip': '430030', 'city': 'Wuhan', 'state': 'Hubei', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xun Gong, M.D.', 'role': 'CONTACT', 'email': 'gongxun4019@163.com', 'phone': '+8613886174675'}, {'name': 'Dongji Han, M.D.', 'role': 'CONTACT', 'email': 'handongjihospital@163.com', 'phone': '+8618971583899'}, {'name': 'Haiyi Liu, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}], 'centralContacts': [{'name': 'Xun Gong', 'role': 'CONTACT', 'email': 'gongxun4019@163.com', 'phone': '+8613886174675'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Deng Dongrui', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'professor,chief doctor', 'investigatorFullName': 'Deng Dongrui', 'investigatorAffiliation': 'Tongji Hospital'}}}}