Ignite Creation Date:
2025-12-25 @ 2:45 AM
Ignite Modification Date:
2026-01-09 @ 6:22 PM
Study NCT ID:
NCT03054233
Status:
COMPLETED
Last Update Posted:
2017-02-16
First Post:
2017-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2016-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-15', 'studyFirstSubmitDate': '2017-02-13', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of successful spinal needle placement in the first attempt', 'timeFrame': '2 months', 'description': 'The number of successful spinal needle placement in the first attempt was recorded in yes/no method.'}, {'measure': 'The number of needle-bone contact', 'timeFrame': '2 months', 'description': 'The number of spinal needle-bone contact'}], 'secondaryOutcomes': [{'measure': 'The number of blood vessel puncture incidence.', 'timeFrame': '2 months', 'description': 'The number of blood vessel puncture incidence by the spinal needle during insertion.'}]}, 'conditionsModule': {'keywords': ['spinal anesthesia', 'spinal-bone contact', 'caesarian section', 'crossed leg sitting position'], 'conditions': ['Caesarian Section']}, 'referencesModule': {'references': [{'pmid': '20641146', 'type': 'BACKGROUND', 'citation': 'Davies GA, Maxwell C, McLeod L, Gagnon R, Basso M, Bos H, Delisle MF, Farine D, Hudon L, Menticoglou S, Mundle W, Murphy-Kaulbeck L, Ouellet A, Pressey T, Roggensack A, Leduc D, Ballerman C, Biringer A, Duperron L, Jones D, Lee LS, Shepherd D, Wilson K; Society of Obstetricians and Gynaecologists of Canada. SOGC Clinical Practice Guidelines: Obesity in pregnancy. No. 239, February 2010. Int J Gynaecol Obstet. 2010 Aug;110(2):167-73. doi: 10.1016/j.ijgo.2010.03.008.'}, {'pmid': '23262963', 'type': 'BACKGROUND', 'citation': 'American College of Obstetricians and Gynecologists. ACOG Committee opinion no. 549: obesity in pregnancy. Obstet Gynecol. 2013 Jan;121(1):213-7. doi: 10.1097/01.aog.0000425667.10377.60.'}, {'pmid': '21334503', 'type': 'BACKGROUND', 'citation': 'Rodrigues FR, Brandao MJ. Regional anesthesia for cesarean section in obese pregnant women: a retrospective study. Rev Bras Anestesiol. 2011 Jan-Feb;61(1):13-20. doi: 10.1016/S0034-7094(11)70002-2.'}, {'pmid': '24790901', 'type': 'BACKGROUND', 'citation': 'Soltani Mohammadi S, Hassani M, Marashi SM. Comparing the squatting position and traditional sitting position for ease of spinal needle placement: a randomized clinical trial. Anesth Pain Med. 2014 Apr 5;4(2):e13969. doi: 10.5812/aapm.13969. eCollection 2014 May.'}, {'pmid': '20552952', 'type': 'BACKGROUND', 'citation': 'Watanabe S, Kobara K, Ishida H, Eguchi A. Influence of trunk muscle co-contraction on spinal curvature during sitting cross-legged. Electromyogr Clin Neurophysiol. 2010 Apr-Jun;50(3-4):187-92.'}, {'pmid': '11477502', 'type': 'BACKGROUND', 'citation': 'Sebire NJ, Jolly M, Harris JP, Wadsworth J, Joffe M, Beard RW, Regan L, Robinson S. Maternal obesity and pregnancy outcome: a study of 287,213 pregnancies in London. Int J Obes Relat Metab Disord. 2001 Aug;25(8):1175-82. doi: 10.1038/sj.ijo.0801670.'}, {'pmid': '17215699', 'type': 'BACKGROUND', 'citation': 'Mhyre JM. Anesthetic management for the morbidly obese pregnant woman. Int Anesthesiol Clin. 2007 Winter;45(1):51-70. doi: 10.1097/AIA.0b013e31802b8a90. No abstract available.'}, {'pmid': '20673866', 'type': 'BACKGROUND', 'citation': 'Vricella LK, Louis JM, Mercer BM, Bolden N. Anesthesia complications during scheduled cesarean delivery for morbidly obese women. Am J Obstet Gynecol. 2010 Sep;203(3):276.e1-5. doi: 10.1016/j.ajog.2010.06.022. Epub 2010 Jul 31.'}, {'pmid': '11069342', 'type': 'BACKGROUND', 'citation': 'Broadbent CR, Maxwell WB, Ferrie R, Wilson DJ, Gawne-Cain M, Russell R. Ability of anaesthetists to identify a marked lumbar interspace. Anaesthesia. 2000 Nov;55(11):1122-6. doi: 10.1046/j.1365-2044.2000.01547-4.x.'}, {'pmid': '25878618', 'type': 'BACKGROUND', 'citation': 'Gulay U, Meltem T, Nadir SS, Aysin A. Ultrasound-guided evaluation of the lumbar subarachnoid space in lateral and sitting positions in pregnant patients to receive elective cesarean operation. Pak J Med Sci. 2015 Jan-Feb;31(1):76-81. doi: 10.12669/pjms.311.5647.'}, {'pmid': '25302094', 'type': 'BACKGROUND', 'citation': "Kim SH, Kim DY, Han JI, Baik HJ, Park HS, Lee GY, Kim JH. Vertebral level of Tuffier's line measured by ultrasonography in parturients in the lateral decubitus position. Korean J Anesthesiol. 2014 Sep;67(3):181-5. doi: 10.4097/kjae.2014.67.3.181. Epub 2014 Sep 24."}, {'pmid': '19809292', 'type': 'BACKGROUND', 'citation': 'Reinius H, Jonsson L, Gustafsson S, Sundbom M, Duvernoy O, Pelosi P, Hedenstierna G, Freden F. Prevention of atelectasis in morbidly obese patients during general anesthesia and paralysis: a computerized tomography study. Anesthesiology. 2009 Nov;111(5):979-87. doi: 10.1097/ALN.0b013e3181b87edb.'}, {'pmid': '15527629', 'type': 'BACKGROUND', 'citation': 'Collins JS, Lemmens HJ, Brodsky JB, Brock-Utne JG, Levitan RM. Laryngoscopy and morbid obesity: a comparison of the "sniff" and "ramped" positions. Obes Surg. 2004 Oct;14(9):1171-5. doi: 10.1381/0960892042386869.'}, {'pmid': '18407943', 'type': 'BACKGROUND', 'citation': 'Cadi P, Guenoun T, Journois D, Chevallier JM, Diehl JL, Safran D. Pressure-controlled ventilation improves oxygenation during laparoscopic obesity surgery compared with volume-controlled ventilation. Br J Anaesth. 2008 May;100(5):709-16. doi: 10.1093/bja/aen067.'}, {'pmid': '20037150', 'type': 'BACKGROUND', 'citation': 'McKay RE, Malhotra A, Cakmakkaya OS, Hall KT, McKay WR, Apfel CC. Effect of increased body mass index and anaesthetic duration on recovery of protective airway reflexes after sevoflurane vs desflurane. Br J Anaesth. 2010 Feb;104(2):175-82. doi: 10.1093/bja/aep374. Epub 2009 Dec 26.'}, {'pmid': '14676412', 'type': 'BACKGROUND', 'citation': 'Anuurad E, Shiwaku K, Nogi A, Kitajima K, Enkhmaa B, Shimono K, Yamane Y. The new BMI criteria for asians by the regional office for the western pacific region of WHO are suitable for screening of overweight to prevent metabolic syndrome in elder Japanese workers. J Occup Health. 2003 Nov;45(6):335-43. doi: 10.1539/joh.45.335.'}]}, 'descriptionModule': {'briefSummary': 'The study aimed to compare successful spinal needle insertion between obese and non-obese pregnant women in crossed leg sitting position undergoing cesarean section', 'detailedDescription': "Approval from Ethical Committee of Faculty of Medicine University of Indonesia was acquired prior conducting the study. Subjects were given informed consent before enrolling the study.Subjects sat in cross leg sitting position: patients sit with both thighs abducted, knees flexed medially, each feet soles were under their contralateral thighs. The back was flexed maximally, subjects' chin approaching the sternum, and subjects hugged a pillow. Lumbal puncture was done using Quincke needle 25G/27G at L4-5 intervertebral gap until the it reached subarachnoid space (confirmed by free flow cerebrospinal fluid). Data recorded were the number of attempt for the successful spinal puncture, the number of spinal needle-bone contact and blood vessel puncture incidence. Data was analyzed by using Statistical Package for Social Scientist (SPSS), for numerical data using unpaired T-test or Mann-Whitney-U test, for categorical data using Chi-square test or Fischer Exact's Test. Data normality was tested by Kolmogorov-Smirnov test. Significant value is p\\<0.05."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects aged 18-45 years old, with American Society of Anesthesiologists (ASA) physical status I-III who were planned to undergo caesarian section with spinal anesthesia in crossed leg sitting position.\n* Subjects have been explained about the study, have agreed to enroll and have signed the informed consent form\n\nExclusion Criteria:\n\n* Subjects with contraindications for spinal anesthesia\n* Subjects with fetal's head trapped, umbilical prolapse, and foot presentation\n* Subjects with pre-eclampsia\n* Subjects with cardiovascular diseases\n* Subjects with scoliosis\n* Subjects with recent lumbal surgery history\n* Subjects who cannot sit in crossed leg sitting position.\n\nDrop out criteria:\n\n* Subjects with worsening conditions before spinal anesthesia\n* Subjects with failed spinal needle insertion and thus received general anesthesia\n* Subjects with twin pregnancy\n* Subjects drop out the study."}, 'identificationModule': {'nctId': 'NCT03054233', 'briefTitle': 'Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women', 'organization': {'class': 'OTHER', 'fullName': 'Indonesia University'}, 'officialTitle': 'Comparison of Successful Spinal Needle Insertion Between Obese and Non-obese Pregnant Women in Crossed Leg Sitting Position Undergoing Caesarean Section', 'orgStudyIdInfo': {'id': 'IndonesiaUAnes010'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Obese', 'description': 'Obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section', 'interventionNames': ['Procedure: Crossed leg sitting position']}, {'type': 'EXPERIMENTAL', 'label': 'Non-obese', 'description': 'Non-obese pregnant women received spinal anesthesia using Quincke Needle 25G/27G in crossed leg sitting position for caesarean section', 'interventionNames': ['Procedure: Crossed leg sitting position']}], 'interventions': [{'name': 'Crossed leg sitting position', 'type': 'PROCEDURE', 'description': 'Spinal anesthesia done in crossed leg sitting position', 'armGroupLabels': ['Non-obese', 'Obese']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10430', 'city': 'Central Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Central National Hospital'}, {'zip': '10430', 'city': 'Jakarta', 'state': 'DKI Jakarta', 'country': 'Indonesia', 'facility': 'Cipto Mangunkusumo Cental National Hospital', 'geoPoint': {'lat': -6.21462, 'lon': 106.84513}}], 'overallOfficials': [{'name': 'Susilo Chandra', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Indonesia University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Indonesia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Anesthesiologist Consultant', 'investigatorFullName': 'Susilo Chandra', 'investigatorAffiliation': 'Indonesia University'}}}}