Ignite Creation Date:
2025-12-24 @ 10:57 PM
Ignite Modification Date:
2025-12-30 @ 9:17 PM
Study NCT ID:
NCT05326269
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2022-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Acute Tocolysis With Terbutaline for Suspected Fetal Distress
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005316', 'term': 'Fetal Distress'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The participants are randomly assigned a number (generated using an online random number generator) and given an opaque envelope containing instructions for study drug or placebo administration. The envelope will be opened by a nurse who prepared the injection in a treatment room, separated from the Labour Suite. The doctors managing the cases, the surgeons who performed the surgeries, the anaesthetists and the patients themselves were blinded against the injection given'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-05', 'studyFirstSubmitDate': '2022-03-22', 'studyFirstSubmitQcDate': '2022-04-05', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Neonatal acidosis', 'timeFrame': 'within 1 hour of delivery', 'description': 'Umbilical artery acidosis'}], 'secondaryOutcomes': [{'measure': 'Neonatal acid base status', 'timeFrame': 'within 1 hour of delivery', 'description': 'Mean umbilical artery pH \\& base excess'}, {'measure': 'Neonatal Apgar score', 'timeFrame': '5 minutes after delivery', 'description': 'Mean Apgar score at 5 minutes of life'}, {'measure': 'Neonatal intensive care unit admission', 'timeFrame': 'Within 24 hours of delivery', 'description': 'Number of babies admitted to neonatal intensive care unit'}, {'measure': 'Maternal blood pressure', 'timeFrame': 'Within 1 hours after drug administration', 'description': 'Mean maternal arterial pressure (before and after drug or placebo administration)'}, {'measure': 'Maternal heart rate', 'timeFrame': 'Within 1 hours after drug administration', 'description': 'Mean maternal heart rate changes (before and after drug or placebo administration)'}, {'measure': 'Blood loss', 'timeFrame': 'Within 24 hours of delivery', 'description': 'Mean estimated blood loss'}, {'measure': 'Hematocrit change', 'timeFrame': 'Within 24 hours of delivery', 'description': 'Mean hematocrit changes before and after cesarean section'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['fetal resuscitation', 'acute tocolysis', 'fetal distress', 'cesarean section'], 'conditions': ['Nonreassuring Fetal Status']}, 'referencesModule': {'references': [{'pmid': '3303936', 'type': 'BACKGROUND', 'citation': 'Patriarco MS, Viechnicki BM, Hutchinson TA, Klasko SK, Yeh SY. A study on intrauterine fetal resuscitation with terbutaline. Am J Obstet Gynecol. 1987 Aug;157(2):384-7. doi: 10.1016/s0002-9378(87)80178-3.'}, {'pmid': '4073156', 'type': 'BACKGROUND', 'citation': 'Ingemarsson I, Arulkumaran S, Ratnam SS. Single injection of terbutaline in term labor. I. Effect on fetal pH in cases with prolonged bradycardia. Am J Obstet Gynecol. 1985 Dec 15;153(8):859-65. doi: 10.1016/0002-9378(85)90690-8.'}, {'pmid': '29971813', 'type': 'BACKGROUND', 'citation': 'Leathersich SJ, Vogel JP, Tran TS, Hofmeyr GJ. Acute tocolysis for uterine tachysystole or suspected fetal distress. Cochrane Database Syst Rev. 2018 Jul 4;7(7):CD009770. doi: 10.1002/14651858.CD009770.pub2.'}, {'pmid': '17904983', 'type': 'BACKGROUND', 'citation': 'Pullen KM, Riley ET, Waller SA, Taylor L, Caughey AB, Druzin ML, El-Sayed YY. Randomized comparison of intravenous terbutaline vs nitroglycerin for acute intrapartum fetal resuscitation. Am J Obstet Gynecol. 2007 Oct;197(4):414.e1-6. doi: 10.1016/j.ajog.2007.06.063.'}, {'pmid': '32378185', 'type': 'RESULT', 'citation': 'Buckley VA, Wu J, De Vries B. Outcomes following acute tocolysis prior to emergency caesarean section. Aust N Z J Obstet Gynaecol. 2020 Dec;60(6):884-889. doi: 10.1111/ajo.13170. Epub 2020 May 6.'}, {'pmid': '8179541', 'type': 'RESULT', 'citation': 'Magann EF, Cleveland RS, Dockery JR, Chauhan SP, Martin JN Jr, Morrison JC. Acute tocolysis for fetal distress: terbutaline versus magnesium sulphate. Aust N Z J Obstet Gynaecol. 1993 Nov;33(4):362-4. doi: 10.1111/j.1479-828x.1993.tb02109.x.'}]}, 'descriptionModule': {'briefSummary': 'The trial was to determine the effect of administrating subcutaneous terbutaline prior to emergency caesarean delivery for suspected fetal distress', 'detailedDescription': 'The trial was a double-blinded, placebo-controlled study using subcutaneous terbutaline for acute tocolysis prior to emergency caesarean delivery in suspected fetal distress. The intervention (subcutaneous terbutaline) was compared to placebo looking at the neonatal and maternal outcomes.\n\nThe primary outcome was the proportion of babies with neonatal acidosis (based on umbilical artery blood sampling at delivery). Other outcome of interest were the mean cord pH and base excess, the Apgar score at 5 minutes after delivery, he proportion of babies requiring intubation and admission to the Neonatal Intensive Care Unit. The maternal outcomes of interest were the changes in mean arterial pressure (before and after the drug or placebo injection), the maternal heart rate changes, the estimated blood loss, and the hematocrit changes.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* term singleton pregnancy\n* cephalic presentation\n* in labour with cervix dilatation \\> 4cm and regular uterine contractions of 3 or more 10 min\n* abnormal fetal heart rate status diagnosed using standard electronic FHR according to NICE guideline (2014)\n* acceptance of participation by the signing of a written consent.\n\nExclusion Criteria\n\n* maternal cardiopathy\n* hyperthyroidism\n* abruptio placentae or other placental accidents\n* hypertensive disease of pregnancy\n* hyperstimulation with oxytocin\n* multiple gestation\n* abnormal fetus planned for conservative management\n* evidence of intrauterine growth restriction\n* patient on medication which will interact with terbutaline (tricyclic antidepressants, beta-blockers, diuretics and sympathomimetic medicine).'}, 'identificationModule': {'nctId': 'NCT05326269', 'briefTitle': 'Acute Tocolysis With Terbutaline for Suspected Fetal Distress', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Kemaman'}, 'officialTitle': 'Acute Tocolysis With Terbutaline vs Placebo Prior to Emergency Caesarean Delivery for Suspected Intrauterine Fetal Compromise', 'orgStudyIdInfo': {'id': 'NMRR-16-1985-331'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Intervention group', 'description': 'Terbutaline 0.5 mls (0.25 mg) , subcutaneously', 'interventionNames': ['Drug: Terbutaline']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'Placebo (normal saline) 0.5 mls , subcutaneously', 'interventionNames': ['Drug: Terbutaline']}], 'interventions': [{'name': 'Terbutaline', 'type': 'DRUG', 'otherNames': ['beta mimetic'], 'description': 'Subcutaneous injection', 'armGroupLabels': ['Control group', 'Intervention group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '24000', 'city': 'Kuala Terengganu', 'state': 'Terengganu', 'country': 'Malaysia', 'facility': 'Hospital Kemaman', 'geoPoint': {'lat': 5.3302, 'lon': 103.1408}}], 'overallOfficials': [{'name': 'Zahar A Zakaria, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital Kemaman'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Kemaman', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal investigator, Consultant Obstetrician', 'investigatorFullName': 'Zahar Azuar Zakaria', 'investigatorAffiliation': 'Hospital Kemaman'}}}}