Ignite Creation Date:
2025-12-24 @ 5:29 PM
Ignite Modification Date:
2025-12-24 @ 5:29 PM
Study NCT ID:
NCT04468568
Status:
COMPLETED
Last Update Posted:
2022-06-06
First Post:
2020-03-01
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008591', 'term': 'Meningomyelocele'}], 'ancestors': [{'id': 'D009436', 'term': 'Neural Tube Defects'}, {'id': 'D009421', 'term': 'Nervous System Malformations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C047046', 'term': 'atosiban'}, {'id': 'D013726', 'term': 'Terbutaline'}], 'ancestors': [{'id': 'D004983', 'term': 'Ethanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D000588', 'term': 'Amines'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-06-02', 'studyFirstSubmitDate': '2020-03-01', 'studyFirstSubmitQcDate': '2020-07-10', 'lastUpdatePostDateStruct': {'date': '2022-06-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-07-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-01-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maternal arterial blood pH at the start of surgery', 'timeFrame': 'Right after intubation', 'description': 'Arterial blood pH'}, {'measure': 'Maternal arterial blood pH at the end of surgery', 'timeFrame': 'Before extubation', 'description': 'Arterial blood pH'}, {'measure': 'Maternal arterial blood pH at 120 minutes after surgery', 'timeFrame': 'Two hours after the end of surgery', 'description': 'Arterial blood pH'}], 'secondaryOutcomes': [{'measure': 'Short-term fetal repercussions', 'timeFrame': 'In the end of the surgery, before extubation', 'description': 'Fetal heart rate in the immediate postoperative period'}, {'measure': 'Long-term fetal repercussions', 'timeFrame': 'At the birth', 'description': 'Gestational age at birth'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Myelomeningocele', 'Terbutaline Adverse Reaction', 'Pregnancy; Malformation Central Nervous System']}, 'referencesModule': {'references': [{'pmid': '23508219', 'type': 'RESULT', 'citation': 'Ferschl M, Ball R, Lee H, Rollins MD. Anesthesia for in utero repair of myelomeningocele. Anesthesiology. 2013 May;118(5):1211-23. doi: 10.1097/ALN.0b013e31828ea597.'}, {'pmid': '18481813', 'type': 'RESULT', 'citation': 'Boulet SL, Yang Q, Mai C, Kirby RS, Collins JS, Robbins JM, Meyer R, Canfield MA, Mulinare J; National Birth Defects Prevention Network. Trends in the postfortification prevalence of spina bifida and anencephaly in the United States. Birth Defects Res A Clin Mol Teratol. 2008 Jul;82(7):527-32. doi: 10.1002/bdra.20468.'}, {'pmid': '18417993', 'type': 'RESULT', 'citation': 'Fichter MA, Dornseifer U, Henke J, Schneider KT, Kovacs L, Biemer E, Bruner J, Adzick NS, Harrison MR, Papadopulos NA. Fetal spina bifida repair--current trends and prospects of intrauterine neurosurgery. Fetal Diagn Ther. 2008;23(4):271-86. doi: 10.1159/000123614. Epub 2008 Apr 14.'}, {'pmid': '21306277', 'type': 'RESULT', 'citation': "Adzick NS, Thom EA, Spong CY, Brock JW 3rd, Burrows PK, Johnson MP, Howell LJ, Farrell JA, Dabrowiak ME, Sutton LN, Gupta N, Tulipan NB, D'Alton ME, Farmer DL; MOMS Investigators. A randomized trial of prenatal versus postnatal repair of myelomeningocele. N Engl J Med. 2011 Mar 17;364(11):993-1004. doi: 10.1056/NEJMoa1014379. Epub 2011 Feb 9."}, {'pmid': '11605920', 'type': 'RESULT', 'citation': 'Fisk NM, Gitau R, Teixeira JM, Giannakoulopoulos X, Cameron AD, Glover VA. Effect of direct fetal opioid analgesia on fetal hormonal and hemodynamic stress response to intrauterine needling. Anesthesiology. 2001 Oct;95(4):828-35. doi: 10.1097/00000542-200110000-00008.'}, {'pmid': '11892506', 'type': 'RESULT', 'citation': 'Cauldwell CB. Anesthesia for fetal surgery. Anesthesiol Clin North Am. 2002 Mar;20(1):211-26. doi: 10.1016/s0889-8537(03)00062-2.'}, {'pmid': '28547209', 'type': 'RESULT', 'citation': 'Devoto JC, Alcalde JL, Otayza F, Sepulveda W. Anesthesia for myelomeningocele surgery in fetus. Childs Nerv Syst. 2017 Jul;33(7):1169-1175. doi: 10.1007/s00381-017-3437-7. Epub 2017 May 25.'}]}, 'descriptionModule': {'briefSummary': 'Myelomeningocele is a malformation with high incidence, and it consists in a neural tube defect. Fetal intrauterine surgery is an alternative for correction, and it improves the prognosis of the fetus, but has an increased risk of maternal complications and premature labor, as it can occur due to uterine stimulation. It is therefore essential that tocolysis is performed before, during and after surgery, and the most commonly used tocolytics are terbutaline and atosiban. Terbutaline has no specificity and may have several adverse effects such as maternal acidosis.', 'detailedDescription': 'The objective of the study was to evaluate maternal blood gas alterations among cases that used atosiban tocolytic agent and cases with terbutaline in in utero repair of myelomeningocele. It consists of a retrospective cohort study. It included 25 patients, who were divided into two groups, depending on which agent they received as main tocolytic agent during the intrauterine fetal myelomeningocele repair: terbutalineor atosiban. The primary outcome was maternal arterial pH at the end of surgery.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients who underwent intrauterine myelomeningocele surgical repair in a tertiary obstetrical center (Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo), from November of 2017 to January of 2020.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Pregnant women over 18 years\n* Single fetus pregnancy\n* Fetus with myelomeningocele\n* Gestational age from 19 to 26\n* Fetus with normal karyotype\n\nExclusion Criteria:\n\n* Multiple pregnancy\n* Fetal abnormality not related to myelomeningocele\n* Kyphosis greater than or equal to 30 degrees\n* Placenta previa\n* Maternal disease that increases the risk of pregnancy (insulin-dependent DM, hypertension poorly controlled)\n* History of incompetent cervix\n* Carrier of HIV, hepatitis B or hepatitis C\n* Maternal-fetal isoimmunization\n* Uterine Alteration\n* Obesity (IMC greater than 30)'}, 'identificationModule': {'nctId': 'NCT04468568', 'briefTitle': 'In Utero Repair of Myelomeningocele: Atosiban Versus Terbutaline', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo General Hospital'}, 'officialTitle': 'Assessment of Maternal Blood Gas Changes When Using Atosiban and Terbutaline as Tocolytic Agents, During in Utero Repair of Myelomeningocele', 'orgStudyIdInfo': {'id': '00607219.4.0030.0099'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Atosiban', 'description': 'Intravenous Atosiban as main tocolytic agent', 'interventionNames': ['Drug: Atosiban']}, {'label': 'Terbutaline', 'description': 'Intravenous Terbutaline as main tocolytic agent', 'interventionNames': ['Drug: Terbutaline']}], 'interventions': [{'name': 'Atosiban', 'type': 'DRUG', 'description': 'Atosiban intravenous. Dose: attack of 6.75 mg, and maintenance of 300 mcg / min for 3 hours, and 100 mcg / min for 21 hours.', 'armGroupLabels': ['Atosiban']}, {'name': 'Terbutaline', 'type': 'DRUG', 'description': 'Terbutaline intravenous. Dose: 2.5 mg in 500 mL saline, infusion rate of 30 mL / hr (150 mcg / h) during the surgery and for 24 hours.', 'armGroupLabels': ['Terbutaline']}]}, 'contactsLocationsModule': {'locations': [{'city': 'São Paulo', 'country': 'Brazil', 'facility': 'Faculdade de Medicina da Universidade de São Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Elaine I Moura, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital das Clinicas'}, {'name': 'Hermann S Fernandes, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital das Clinicas'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'From October/2017 until January/2021', 'ipdSharing': 'YES', 'description': 'The IPD sharing plan includes informations about the demographic sample, the results of the study and the statistical analysis', 'accessCriteria': 'Contact through email'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Attending Anesthetist', 'investigatorFullName': 'Hermann dos Santos Fernandes', 'investigatorAffiliation': 'University of Sao Paulo General Hospital'}}}}