Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2025-12-25 @ 9:51 PM
Study NCT ID:
NCT04993651
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2021-06-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of CPAP on Fetal pH at Scheduled C-section in Morbidly Obese Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D045422', 'term': 'Continuous Positive Airway Pressure'}], 'ancestors': [{'id': 'D011175', 'term': 'Positive-Pressure Respiration'}, {'id': 'D012121', 'term': 'Respiration, Artificial'}, {'id': 'D058109', 'term': 'Airway Management'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D012138', 'term': 'Respiratory Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 66}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2023-06-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-17', 'studyFirstSubmitDate': '2021-06-21', 'studyFirstSubmitQcDate': '2021-07-30', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-08-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Umbilical Cord Arterial pH', 'timeFrame': 'At delivery', 'description': 'We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.'}], 'secondaryOutcomes': [{'measure': 'Patient satisfaction with use of CPAP', 'timeFrame': 'Within 4 days following delivery (prior to discharge from hospital)', 'description': 'Survey will be used to determine patient experience and satisfaction'}, {'measure': 'Effect of CPAP on maternal acid base status with analysis of venous blood gas', 'timeFrame': 'At time of uterine incision', 'description': 'Maternal venous blood gas will be analyzed at the time of uterine incision to measure the acid base status'}, {'measure': 'Effect of maternal CPAP use on neonatal Apgar scores', 'timeFrame': 'At delivery', 'description': 'Apgar scores will be compared between 2 groups'}, {'measure': 'Effect of maternal CPAP use on composite neonatal outcome', 'timeFrame': 'At delivery', 'description': 'Perinatal death, respiratory support, Apgar score \\<=3 at 5 min, hypoxic ischemic encephalopathy, hypotension requiring vasopressor support'}, {'measure': 'Effect of duration in supine position prior to delivery on neonatal acid base status', 'timeFrame': 'At delivery', 'description': 'Neonatal venous blood gas will be analyzed to determine the acid base status as it correlates to length of time in maternal supine position'}, {'measure': 'Effect of duration in supine position prior to delivery on maternal acid base status', 'timeFrame': 'At delivery', 'description': 'Maternal venous blood gas will be analyzed to determine the acid base status as it correlates to length of time in supine position'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Fetal pH', 'CPAP', 'Continuous Positive Airway Pressure'], 'conditions': ['Morbid Obesity', 'Cesarean Delivery Affecting Fetus']}, 'referencesModule': {'references': [{'pmid': '27272580', 'type': 'BACKGROUND', 'citation': 'Flegal KM, Kruszon-Moran D, Carroll MD, Fryar CD, Ogden CL. Trends in Obesity Among Adults in the United States, 2005 to 2014. JAMA. 2016 Jun 7;315(21):2284-91. doi: 10.1001/jama.2016.6458.'}, {'pmid': '17716296', 'type': 'BACKGROUND', 'citation': 'Chu SY, Kim SY, Schmid CH, Dietz PM, Callaghan WM, Lau J, Curtis KM. Maternal obesity and risk of cesarean delivery: a meta-analysis. Obes Rev. 2007 Sep;8(5):385-94. doi: 10.1111/j.1467-789X.2007.00397.x.'}, {'pmid': '15118648', 'type': 'BACKGROUND', 'citation': "Weiss JL, Malone FD, Emig D, Ball RH, Nyberg DA, Comstock CH, Saade G, Eddleman K, Carter SM, Craigo SD, Carr SR, D'Alton ME; FASTER Research Consortium. Obesity, obstetric complications and cesarean delivery rate--a population-based screening study. Am J Obstet Gynecol. 2004 Apr;190(4):1091-7. doi: 10.1016/j.ajog.2003.09.058."}, {'pmid': '16816066', 'type': 'BACKGROUND', 'citation': "Hibbard JU, Gilbert S, Landon MB, Hauth JC, Leveno KJ, Spong CY, Varner MW, Caritis SN, Harper M, Wapner RJ, Sorokin Y, Miodovnik M, Carpenter M, Peaceman AM, O'Sullivan MJ, Sibai BM, Langer O, Thorp JM, Ramin SM, Mercer BM, Gabbe SG; National Institute of Child Health and Human Development Maternal-Fetal Medicine Units Network. Trial of labor or repeat cesarean delivery in women with morbid obesity and previous cesarean delivery. Obstet Gynecol. 2006 Jul;108(1):125-33. doi: 10.1097/01.AOG.0000223871.69852.31."}, {'pmid': '23969793', 'type': 'BACKGROUND', 'citation': 'Edwards RK, Cantu J, Cliver S, Biggio JR Jr, Owen J, Tita ATN. The association of maternal obesity with fetal pH and base deficit at cesarean delivery. Obstet Gynecol. 2013 Aug;122(2 Pt 1):262-267. doi: 10.1097/AOG.0b013e31829b1e62.'}, {'pmid': '21864821', 'type': 'BACKGROUND', 'citation': 'Vricella LK, Louis JM, Mercer BM, Bolden N. Impact of morbid obesity on epidural anesthesia complications in labor. Am J Obstet Gynecol. 2011 Oct;205(4):370.e1-6. doi: 10.1016/j.ajog.2011.06.085. Epub 2011 Jun 29.'}, {'pmid': '15270963', 'type': 'BACKGROUND', 'citation': 'von Ungern-Sternberg BS, Regli A, Bucher E, Reber A, Schneider MC. Impact of spinal anaesthesia and obesity on maternal respiratory function during elective Caesarean section. Anaesthesia. 2004 Aug;59(8):743-9. doi: 10.1111/j.1365-2044.2004.03832.x.'}, {'pmid': '9038445', 'type': 'BACKGROUND', 'citation': 'Kelly MC, Fitzpatrick KT, Hill DA. Respiratory effects of spinal anaesthesia for caesarean section. Anaesthesia. 1996 Dec;51(12):1120-2. doi: 10.1111/j.1365-2044.1996.tb15046.x.'}, {'pmid': '27100522', 'type': 'BACKGROUND', 'citation': 'Turan OM, Rosenbloom J, Galey JL, Kahntroff SL, Bharadwaj S, Turner SM, Malinow AM. The Relationship between Rostral Retraction of the Pannus and Outcomes at Cesarean Section. Am J Perinatol. 2016 Aug;33(10):951-6. doi: 10.1055/s-0036-1581054. Epub 2016 Apr 21.'}, {'pmid': '29649034', 'type': 'BACKGROUND', 'citation': 'Dominguez JE, Krystal AD, Habib AS. Obstructive Sleep Apnea in Pregnant Women: A Review of Pregnancy Outcomes and an Approach to Management. Anesth Analg. 2018 Nov;127(5):1167-1177. doi: 10.1213/ANE.0000000000003335.'}, {'pmid': '29747728', 'type': 'BACKGROUND', 'citation': 'Dominguez JE, Street L, Louis J. Management of Obstructive Sleep Apnea in Pregnancy. Obstet Gynecol Clin North Am. 2018 Jun;45(2):233-247. doi: 10.1016/j.ogc.2018.01.001.'}, {'pmid': '31110031', 'type': 'BACKGROUND', 'citation': 'MacIntyre NR. Physiologic Effects of Noninvasive Ventilation. Respir Care. 2019 Jun;64(6):617-628. doi: 10.4187/respcare.06635.'}, {'pmid': '31617693', 'type': 'BACKGROUND', 'citation': 'Corcione N, Karim H, Mina B, Pisano A, Dikmen Y, Kondili E, Nicolini A, Fiorentino G, Caldeira V, Ubeda A, Papadakos P, Wittenstein J, Singha S, Sovani M, Panda C, Tani C, Khatib M, Perren A, Ho K, Esquinas A. Non-invasive ventilation during surgery under neuraxial anaesthesia: a pathophysiological perspective on application and benefits and a systematic literature review. Anaesthesiol Intensive Ther. 2019;51(4):289-298. doi: 10.5114/ait.2019.88572.'}, {'pmid': '20702082', 'type': 'BACKGROUND', 'citation': 'Erdogan G, Okyay DZ, Yurtlu S, Hanci V, Ayoglu H, Koksal B, Turan IO. Non-invasive mechanical ventilation with spinal anesthesia for cesarean delivery. Int J Obstet Anesth. 2010 Oct;19(4):438-40. doi: 10.1016/j.ijoa.2010.04.005. Epub 2010 Aug 10.'}, {'pmid': '25936783', 'type': 'BACKGROUND', 'citation': 'Polin CM, Hale B, Mauritz AA, Habib AS, Jones CA, Strouch ZY, Dominguez JE. Anesthetic management of super-morbidly obese parturients for cesarean delivery with a double neuraxial catheter technique: a case series. Int J Obstet Anesth. 2015 Aug;24(3):276-80. doi: 10.1016/j.ijoa.2015.04.001. Epub 2015 Apr 8.'}, {'pmid': '23771818', 'type': 'BACKGROUND', 'citation': 'Chung F, Yang Y, Liao P. Predictive performance of the STOP-Bang score for identifying obstructive sleep apnea in obese patients. Obes Surg. 2013 Dec;23(12):2050-7. doi: 10.1007/s11695-013-1006-z.'}, {'pmid': '31053210', 'type': 'BACKGROUND', 'citation': 'Pearson F, Batterham AM, Cope S. The STOP-Bang Questionnaire as a Screening Tool for Obstructive Sleep Apnea in Pregnancy. J Clin Sleep Med. 2019 May 15;15(5):705-710. doi: 10.5664/jcsm.7754.'}, {'pmid': '28838010', 'type': 'BACKGROUND', 'citation': 'Simon VB, Fong A, Nageotte MP. Supplemental Oxygen Study: A Randomized Controlled Study on the Effect of Maternal Oxygen Supplementation during Planned Cesarean Delivery on Umbilical Cord Gases. Am J Perinatol. 2018 Jan;35(1):84-89. doi: 10.1055/s-0037-1606184. Epub 2017 Aug 24.'}, {'pmid': '27906196', 'type': 'BACKGROUND', 'citation': 'Skiold B, Petersson G, Ahlberg M, Stephansson O, Johansson S. Population-based reference curve for umbilical cord arterial pH in infants born at 28 to 42 weeks. J Perinatol. 2017 Mar;37(3):254-259. doi: 10.1038/jp.2016.207. Epub 2016 Dec 1.'}, {'pmid': '29915374', 'type': 'BACKGROUND', 'citation': 'Johansson S, Sandstrom A, Cnattingius S. Maternal overweight and obesity increase the risk of fetal acidosis during labor. J Perinatol. 2018 Sep;38(9):1144-1150. doi: 10.1038/s41372-018-0144-5. Epub 2018 Jun 19.'}]}, 'descriptionModule': {'briefSummary': 'The objective of our study is to evaluate the effect of CPAP on umbilical cord acid base status in morbidly obese women at the time of scheduled cesarean delivery. We hypothesize that neonates born to mothers wearing CPAP during the cesarean section will have a higher umbilical artery pH.', 'detailedDescription': 'This is a randomized control trial comparing CPAP to routine airway management in morbidly obese patients undergoing scheduled cesarean delivery. Morbidly obese women meeting criteria for inclusion will be approached for participation. Women who are scheduled for cesarean delivery at Sentara Norfolk General Hospital will be approached at a prenatal appointment prior to scheduled date of delivery. If a woman agrees to participate in the study, she will be counseled and consented at that time.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women between the ages of 18-45\n* Body mass index of 40 kg/m2 or greater at the time patient is scheduled for cesarean delivery\n* Singleton gestation\n* Scheduled for primary or repeat cesarean delivery at Sentara Norfolk General Hospital\n* Gestational age between 37+0 and 41+0 weeks at the time of delivery\n* Non-stress test on admission with moderate variability, without repetitive late or variable decelerations\n* Negative SARS-CoV-2 PCR test within 72 hours of procedure\n\nExclusion Criteria:\n\n* Fetal growth restriction\n* Active pulmonary diseases to include pneumonia, sarcoidosis, pulmonary hypertension, moderate or severe persistent asthma\n* Suspected placenta accreta based on prenatal sonographic evaluation\n* Active maternal infection to include pyelonephritis, appendicitis, upper respiratory tract infection, urinary tract infection or suspected intra-amniotic infection\n* SARS-CoV-2 positive test within past 10 days or ongoing symptoms of SARS-CoV-2 to include cough, fever or shortness of breath with positive test greater than 10 days prior, or history of hospitalization for SARS-CoV-2 infection\n* Fetus with aneuploidy or major anomaly\n* Enrolled in another trial that may affect outcome'}, 'identificationModule': {'nctId': 'NCT04993651', 'briefTitle': 'Effect of CPAP on Fetal pH at Scheduled C-section in Morbidly Obese Women', 'organization': {'class': 'OTHER', 'fullName': 'Eastern Virginia Medical School'}, 'officialTitle': 'Effect of Continuous Positive Airway Pressure on Fetal pH at Time of Scheduled Cesarean Delivery in Morbidly Obese Women', 'orgStudyIdInfo': {'id': 'CPAP on Fetal pH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Continuous Positive Airway Pressure', 'description': 'Those randomized to CPAP will be fitted with CPAP face mask or nasal device by the respiratory therapist and permitted to trial the machine to ensure proper use and fit. CPAP settings: CPAP AUTO 5-20 cm H20 will be utilized. The CPAP device will then be removed. The subject will then be placed in the supine position with a standard roll placed under the right maternal hip. Those randomized to CPAP will have the device applied and machine turned on. For those randomized to routine airway management, nasal cannula with oxygen 2L/min will be applied and this will be titrated to achieve a maternal SpO2 \\> 95%. End tidal CO2 monitors will be applied to both patient groups.', 'interventionNames': ['Device: CPAP']}, {'type': 'NO_INTERVENTION', 'label': 'Nasal Cannula', 'description': 'For those randomized to routine airway management, nasal cannula with oxygen 2L/min will be applied and this will be titrated to achieve a maternal SpO2 \\> 95%. End tidal CO2 monitors will be applied to both patient groups.'}], 'interventions': [{'name': 'CPAP', 'type': 'DEVICE', 'otherNames': ['Continuous Positive Airway Pressure'], 'description': 'CPAP is a form of noninvasive positive pressure ventilation (NPPV). CPAP works to maintain adequate levels of PO2 and PCO2 through improved alveolar ventilation and maintenance of upper-airway patency.', 'armGroupLabels': ['Continuous Positive Airway Pressure']}]}, 'contactsLocationsModule': {'locations': [{'zip': '23507', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Department of Obstetrics and Gynecology, Division of Maternal-Fetal Medicine, Eastern Virginia Medical School', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}], 'overallOfficials': [{'name': 'Tracey DeYoung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Eastern Virginia Medical School'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Eastern Virginia Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}