Ignite Creation Date:
2025-12-24 @ 3:30 PM
Ignite Modification Date:
2026-02-24 @ 4:10 AM
Study NCT ID:
NCT01406392
Status:
COMPLETED
Last Update Posted:
2019-09-18
First Post:
2011-07-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Sublingual Misoprostol for Induction of Labor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}], 'ancestors': [{'id': 'D011459', 'term': 'Prostaglandins E, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 150}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-15', 'studyFirstSubmitDate': '2011-07-29', 'studyFirstSubmitQcDate': '2011-07-29', 'lastUpdatePostDateStruct': {'date': '2019-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-08-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of taquissistoly', 'timeFrame': '48 hours', 'description': 'during 48 hours the presence of taquissistoly will be observed'}], 'secondaryOutcomes': [{'measure': 'Hyperstimulation Syndrome', 'timeFrame': '48 hours', 'description': 'during 48 hours the presence of hyperstimulation syndrome will be observed'}, {'measure': 'changes in the cervix at 12 and 24 hours', 'timeFrame': '12 and 24 hours', 'description': 'changes in the cervix'}, {'measure': 'failure to achieve vaginal delivery within 12 and 24 hours', 'timeFrame': '12 and 24 hours', 'description': 'failure to achieve vaginal delivery'}, {'measure': "the mother's preferred route of administration", 'timeFrame': 'after 48 hours', 'description': 'Ask to mother what route of administratios was the best for her'}, {'measure': 'time between the first dose and the onset of labour and delivery', 'timeFrame': 'after 48 hours', 'description': 'to avaluete the time between the first dose and the onset of labour and delivery'}, {'measure': 'duration of labour', 'timeFrame': 'after 48 hours', 'description': 'to avaluete the time of duration of labour'}, {'measure': 'need for oxytocin', 'timeFrame': 'after 48 hours', 'description': 'to avaluete the use of oxytocin during the labour'}, {'measure': 'failed induction of labour', 'timeFrame': 'after 48 hours', 'description': 'to avaluete the faliled induction of labor'}, {'measure': 'Caesarean section and the indications for this procedure', 'timeFrame': 'after 48 hours', 'description': 'to avaluete the number of Caesarean section and the indications for this procedure'}, {'measure': 'need for epidural anaesthesia', 'timeFrame': 'after 48 hours', 'description': 'to avaluete the need for epidural anaesthesia'}, {'measure': 'maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever);', 'timeFrame': 'after 48 hours', 'description': 'to avaluete if occurred any case of maternal side effects (nausea, vomiting, diarrhoea, postpartum haemorrhage and fever);'}, {'measure': 'severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death', 'timeFrame': '48 hours', 'description': 'to avaluete severe maternal morbidity (uterine rupture, sepsis and admission to intensive care unit) or maternal death'}, {'measure': 'meconium in the amniotic fluid', 'timeFrame': '48 hours', 'description': 'to avaluete meconium in the amniotic fluid'}, {'measure': 'non-reassuring foetal heart rate', 'timeFrame': '48 hours', 'description': 'non-reassuring foetal heart rate'}, {'measure': 'one- and five-minute Apgar scores <7', 'timeFrame': 'after 48 hours', 'description': 'to avaluete one- and five-minute Apgar scores \\<7'}, {'measure': 'admission of the newborn to a neonatal intensive care unit', 'timeFrame': 'after 48 hours', 'description': 'to avaluete admission of the newborn to a neonatal intensive care unit'}, {'measure': 'need for neonatal resuscitation', 'timeFrame': 'after 48 hours', 'description': 'to avaluete the need for neonatal resuscitation'}, {'measure': 'severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death.', 'timeFrame': 'after 48 hours', 'description': 'to avaluete severe neonatal morbidity (convulsions and neonatal asphyxiation) or perinatal death.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Misoprostol', 'Sublingual', 'Induced', 'Labor'], 'conditions': ['Labor', 'Induced']}, 'referencesModule': {'references': [{'pmid': '32272959', 'type': 'DERIVED', 'citation': 'Gattas DSMB, de Amorim MMR, Feitosa FEL, da Silva-Junior JR, Ribeiro LCG, Souza GFA, Souza ASR. Misoprostol administered sublingually at a dose of 12.5 mug versus vaginally at a dose of 25 mug for the induction of full-term labor: a randomized controlled trial. Reprod Health. 2020 Apr 10;17(1):47. doi: 10.1186/s12978-020-0901-8.'}, {'pmid': '29669596', 'type': 'DERIVED', 'citation': 'Gattas DSMB, da Silva Junior JR, Souza ASR, Feitosa FE, de Amorim MMR. Misoprostol administered sublingually at a dose of 12.5 mug versus vaginally at a dose of 25 mug for the induction of full-term labor: a randomized controlled trial protocol. Reprod Health. 2018 Apr 18;15(1):65. doi: 10.1186/s12978-018-0508-5.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare effectiveness and safety of a sublingual misoprostol 12,5 mcg with vaginal misoprostol 25 mcg for induction of labour with an alive and term fetus.', 'detailedDescription': 'Several methods for induction of labour are available. However, the most effective and with less frequency of adverse effects is still unknown. Vaginal misoprostol has been used frequently to induce labour but other routes of administrations have been proposed, such as oral and sublingual. The purpose of this study is to compare effectiveness and safety of sublingual misoprostol 12,5 mcg with vaginal misoprostol 25 mcg administration for induction of labour with an alive and term fetus. A randomized controlled double-blind trial will be carried in two hospitals: Instituto de Medicina Integral Prof. Fernando Figueira and Universidade Federal do Ceará and Instituto de Saúde Elpídio de Almeida, from July 2014 to November 2016. A total of 150 patients must be enrolled. Inclusion criteria are: a) indication for labour induction; b) term pregnancy with alive fetus; Bishop score less than six. Exclusion criteria are: a) previous uterine scar; b) nonvertex presentation; c) non-reassuring fetal status; d) fetal anomalies; e) fetal growth restriction; f) genital bleeding; g) tumors, malformations and/or ulcers of vulva, perineum or vagina. They will be randomized to receive a sublingual misoprostol 12,5 mcg with vaginal placebo tablet or sublingual placebo with vaginal misoprostol 25 mcg tablet. Vaginal tablets will have 25mcg of misoprostol or placebo. Sublingual tablet will have 12,5mcg or placebo. Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets. Primary outcome will be the frequency of tachysystole. Secondary outcomes will be vaginal delivery within 24 hours, hyperstimulation syndrome, cesarean section, severe neonatal morbidity or perinatal death, serious maternal morbidity or maternal death, need of oxytocin for augmentation of labour, number of misoprostol doses needed to bring on labour, interval from first dose to labour and first dose to delivery, failed induction, uterine rupture, need of labour analgesia, instrumental delivery, side effects, maternal death, meconium, non-reassuring fetal heart rate, Apgar scores less than seven at 1st and 5th minutes, admission at neonatal intensive care unit, neonatal encephalopaty, perinatal death and women not satisfied.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '45 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Indication for labour induction\n* Term pregnancy with alive fetus\n* Bishop score less than six\n\nExclusion Criteria:\n\n* Previous uterine scar\n* Nonvertex presentation\n* Non-reassuring fetal status\n* Fetal anomalies\n* Fetal growth restriction\n* Genital bleeding\n* Tumors, malformations and/or ulcers of vulva, perineum or vagina'}, 'identificationModule': {'nctId': 'NCT01406392', 'acronym': 'SUBMISO', 'briefTitle': 'Sublingual Misoprostol for Induction of Labor', 'organization': {'class': 'OTHER', 'fullName': 'Professor Fernando Figueira Integral Medicine Institute'}, 'officialTitle': 'Sublingual Misoprostol 12,5 mcg Versus Vaginal Misoprostol 25 mcg for Induction of Labour of Alive and Term Fetus : Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SUBMISO'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Sublingual Misoprostol 12,5mcg', 'description': 'Sublingual misoprostol or placebo tablete will be administered for each six hours until the maximum dose of 100mcg or eight tablets.', 'interventionNames': ['Drug: Sublingual Misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Vaginal Misoprostol 25 mcg', 'description': 'Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets. Each pacient will receve at the same time a sublingual placebo tablet and vaginal misoprostol or sublingual misoprostol and vaginal placebo tablet. It will depend of the randomization.', 'interventionNames': ['Drug: Misoprostol 25mcg']}], 'interventions': [{'name': 'Misoprostol 25mcg', 'type': 'DRUG', 'otherNames': ['Prostokos Cytotec'], 'description': 'Vaginal misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 200mcg or eight tablets.', 'armGroupLabels': ['Vaginal Misoprostol 25 mcg']}, {'name': 'Sublingual Misoprostol', 'type': 'DRUG', 'otherNames': ['Prostokos', 'Cytotec'], 'description': 'Sublingual misoprostol or placebo tablets will be administered for each six hours until the maximum dose of 100mcg or eight tablets', 'armGroupLabels': ['Sublingual Misoprostol 12,5mcg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '50070-550', 'city': 'Recife', 'state': 'Pernambuco', 'country': 'Brazil', 'facility': 'Instituto de Medicina Integral Professor Fernando Figueira (IMIP)', 'geoPoint': {'lat': -8.05389, 'lon': -34.88111}}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL'], 'timeFrame': 'After publication in scientific journal', 'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Professor Fernando Figueira Integral Medicine Institute', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maternidade Escola Assis Chateaubriand', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PhD', 'investigatorFullName': 'Daniele Sofia de Moraes Barros Gattas', 'investigatorAffiliation': 'Professor Fernando Figueira Integral Medicine Institute'}}}}