Ignite Creation Date:
2025-12-24 @ 4:56 PM
Ignite Modification Date:
2026-03-06 @ 2:04 PM
Study NCT ID:
NCT02495350
Status:
COMPLETED
Last Update Posted:
2017-11-17
First Post:
2015-06-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlation Between Prelabor Analgesic Plan and Actual Labor Analgesia With Satisfaction, Postpartum Depression, and Breast Feeding Success
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'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1954}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-11', 'completionDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-11-16', 'studyFirstSubmitDate': '2015-06-17', 'studyFirstSubmitQcDate': '2015-07-10', 'lastUpdatePostDateStruct': {'date': '2017-11-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-07-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Assessment of postpartum depression using Edinborough Postnatal Depression scale', 'timeFrame': 'One year'}], 'secondaryOutcomes': [{'measure': 'Assessment of breast feeding duration in women undergoing vaginal deliveries', 'timeFrame': 'one year'}, {'measure': 'Increases in labor satisfaction defined as a vas (visual analog scale) satisfaction over 7 in women undergoing vaginal deliveries', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Depression, Postpartum']}, 'referencesModule': {'references': [{'pmid': '14995921', 'type': 'BACKGROUND', 'citation': 'Hiltunen P, Raudaskoski T, Ebeling H, Moilanen I. Does pain relief during delivery decrease the risk of postnatal depression? Acta Obstet Gynecol Scand. 2004 Mar;83(3):257-61. doi: 10.1111/j.0001-6349.2004.0302.x.'}, {'pmid': '24797120', 'type': 'BACKGROUND', 'citation': 'Ding T, Wang DX, Qu Y, Chen Q, Zhu SN. Epidural labor analgesia is associated with a decreased risk of postpartum depression: a prospective cohort study. Anesth Analg. 2014 Aug;119(2):383-392. doi: 10.1213/ANE.0000000000000107.'}, {'pmid': '18818022', 'type': 'BACKGROUND', 'citation': "Eisenach JC, Pan PH, Smiley R, Lavand'homme P, Landau R, Houle TT. Severity of acute pain after childbirth, but not type of delivery, predicts persistent pain and postpartum depression. Pain. 2008 Nov 15;140(1):87-94. doi: 10.1016/j.pain.2008.07.011. Epub 2008 Sep 24."}, {'pmid': '24894732', 'type': 'BACKGROUND', 'citation': 'Mauri PA, Contini NN, Giliberti S, Barretta F, Consonni D, Negri M, Di Benedetto I. Intrapartum epidural analgesia and onset of lactation: a prospective study in an Italian birth centre. Matern Child Health J. 2015 Mar;19(3):511-8. doi: 10.1007/s10995-014-1532-x.'}, {'pmid': '14717315', 'type': 'BACKGROUND', 'citation': 'Henderson JJ, Dickinson JE, Evans SF, McDonald SJ, Paech MJ. Impact of intrapartum epidural analgesia on breast-feeding duration. Aust N Z J Obstet Gynaecol. 2003 Oct;43(5):372-7. doi: 10.1046/j.0004-8666.2003.t01-1-00117.x.'}, {'pmid': '10763834', 'type': 'BACKGROUND', 'citation': 'Sheiner E, Shoham-Vardi I, Sheiner EK, Press F, Hackmon-Ram R, Mazor M, Katz M. A comparison between the effectiveness of epidural analgesia and parenteral pethidine during labor. Arch Gynecol Obstet. 2000 Feb;263(3):95-8. doi: 10.1007/s004040050003.'}, {'pmid': '14712952', 'type': 'BACKGROUND', 'citation': 'Dickinson JE, Paech MJ, McDonald SJ, Evans SF. Maternal satisfaction with childbirth and intrapartum analgesia in nulliparous labour. Aust N Z J Obstet Gynaecol. 2003 Dec;43(6):463-8. doi: 10.1046/j.0004-8666.2003.00152.x.'}, {'pmid': '11561269', 'type': 'BACKGROUND', 'citation': 'Kannan S, Jamison RN, Datta S. Maternal satisfaction and pain control in women electing natural childbirth. Reg Anesth Pain Med. 2001 Sep-Oct;26(5):468-72. doi: 10.1053/rapm.2001.24260.'}, {'pmid': '15321184', 'type': 'BACKGROUND', 'citation': 'Shapiro A, Fredman B, Zohar E, Olsfanger D, Jedeikin R. Delivery room analgesia: an analysis of maternal satisfaction. Int J Obstet Anesth. 1998 Oct;7(4):226-30. doi: 10.1016/s0959-289x(98)80043-5.'}, {'pmid': '10955108', 'type': 'BACKGROUND', 'citation': 'Glasser S, Barell V. [Depression scale for research in and identification of postpartum depression]. Harefuah. 1999 May 16;136(10):764-8, 844, 843. Hebrew.'}, {'pmid': '9844846', 'type': 'BACKGROUND', 'citation': 'Glasser S, Barell V, Shoham A, Ziv A, Boyko V, Lusky A, Hart S. Prospective study of postpartum depression in an Israeli cohort: prevalence, incidence and demographic risk factors. J Psychosom Obstet Gynaecol. 1998 Sep;19(3):155-64. doi: 10.3109/01674829809025693.'}, {'pmid': '31425221', 'type': 'DERIVED', 'citation': 'Orbach-Zinger S, Landau R, Davis A, Oved O, Caspi L, Fireman S, Fein S, Ioscovich A, Bracco D, Hoshen M, Eidelman LA. The Effect of Labor Epidural Analgesia on Breastfeeding Outcomes: A Prospective Observational Cohort Study in a Mixed-Parity Cohort. Anesth Analg. 2019 Sep;129(3):784-791. doi: 10.1213/ANE.0000000000003442.'}]}, 'descriptionModule': {'briefSummary': 'In this study the investigators would like to evaluate how prelabor analgesic plan and actual labor analgesia effects the labor satisfaction, breastfeeding success, and whether or not it reduces postpartum depression.\n\nAlthough postpartum depression has been researched and reviewed, there is little information on how satisfaction during labor affects postpartum outcomes. The relationship between epidural analgesia is also complex, and there has yet to be found a valid correlation between the two parameters.\n\nIn addition although an attempt has been made to evaluate relationship between breastfeeding and epidural analgesia, results are unclear and further research is needed.', 'detailedDescription': "This is a prospective, single center study, which will be conducted at the Rabin Medical Center (Beilinson Campus), Petach Tikva, Israel, a tertiary university hospital.\n\nAll women undergoing vaginal delivery on the first day postpartum will be enrolled after filling out an informed consent.\n\nThey will be given out a labor satisfaction questionnaire detailing initial desire for epidural analgesia, final desire for epidural analgesia, adequacy of pain relief during labor and satisfaction with labor. (see appendix 1).\n\nThe investigators will evaluate breastfeeding success according to the latch scoring system in the first day postpartum which is routinely administered by nurses/ lactation consultants in the maternity ward.\n\nAccording to their initial desire verses final analgesic choice they will be divided into four groups:\n\n1. Women who initially didn't want and didn't receive one.\n2. Initially didn't want and did receive one.\n3. Initially wanted an epidural and didn't received one\n4. Initially wanted an epidural and did receive one.\n\nOn the third day postoperatively the parturients will be called and assessed for mood and signs of postpartum depression using Edinborough Postnatal Depression scale validated into Hebrew (10) , and the investigators will assess whether or not they are breastfeeding.\n\nAt 6 weeks the investigators will follow-up to assess breastfeeding duration ,and postpartum depression using the Edinborough Postnatal Depression scale.\n\nThe investigators' comparison will include average pain scores, breast feeding success, and postpartum depression assessment."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Women above 18 undergoing vaginal delivery in Beilinson Hospital', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women above 18 undergoing vaginal delivery in Beilinson Hospital\n* following obtaining written informed consents\n* ability to comply with the study requirements will be included in the investigators' study\n\nExclusion Criteria:\n\n* Women undergoing cesareans sections."}, 'identificationModule': {'nctId': 'NCT02495350', 'briefTitle': 'The Correlation Between Prelabor Analgesic Plan and Actual Labor Analgesia With Satisfaction, Postpartum Depression, and Breast Feeding Success', 'organization': {'class': 'OTHER', 'fullName': 'Rabin Medical Center'}, 'officialTitle': 'The Correlation Between Prelabor Analgesic Plan and Actual Labor Analgesia With Satisfaction, Postpartum Depression, and Breast Feeding Success', 'orgStudyIdInfo': {'id': '0666-14-RMC'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Initially didn't want an epidural and didn't receive one."}, {'label': "Initially didn't want an epidural and did receive one."}, {'label': "Initially wanted an epidural and didn't received one", 'interventionNames': ['Other: Questionarie']}, {'label': 'Initially wanted an epidural and did receive one.', 'interventionNames': ['Other: Questionarie']}], 'interventions': [{'name': 'Questionarie', 'type': 'OTHER', 'description': 'Parturients will be asked to fill out a labor satisfaction questionnaire detailing initial desire for epidural analgesia, final desire for epidural analgesia, adequacy of pain relief during labor and satisfaction with laborOn the third day postoperatively the parturients will be called and assessed for mood and signs of postpartum depression using Edinborough Postnatal Depression scale validated into Hebrew (10) , and we will assess whether or not they are breastfeeding.\n\nAt 6 weeks we will follow-up to assess breastfeeding duration ,and postpartum depression using the Edinborough Postnatal Depression scale.\n\nOur comparison will include average pain scores, breast feeding success, and postpartum depression assessment.', 'armGroupLabels': ['Initially wanted an epidural and did receive one.', "Initially wanted an epidural and didn't received one"]}]}, 'contactsLocationsModule': {'locations': [{'city': 'Petach Tikvah', 'country': 'Israel', 'facility': 'Beilinson hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rabin Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr. Sharon Orbach', 'investigatorFullName': 'sharonorbach', 'investigatorAffiliation': 'Rabin Medical Center'}}}}