Ignite Creation Date:
2025-12-25 @ 5:00 AM
Ignite Modification Date:
2025-12-26 @ 4:00 AM
Study NCT ID:
NCT04560218
Status:
COMPLETED
Last Update Posted:
2021-09-13
First Post:
2020-09-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sublingual vs Intrauterine MISOPROSTOL Plus Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Placebo RCT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}], 'ancestors': [{'id': 'D007744', 'term': 'Obstetric Labor Complications'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011644', 'term': 'Puerperal Disorders'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 135}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-10-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-09-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-09-10', 'studyFirstSubmitDate': '2020-09-17', 'studyFirstSubmitQcDate': '2020-09-17', 'lastUpdatePostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-09-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss', 'timeFrame': 'operation time', 'description': 'total blood loss estimated by Anesthesiologist team'}], 'secondaryOutcomes': [{'measure': 'Hemoglobin/Hematocrit change', 'timeFrame': 'until 24 hours post-operation', 'description': 'compare before/after operation'}, {'measure': 'need of uterotonic agents', 'timeFrame': 'until 24 hours post-operation', 'description': 'number of uterotonic agents need and type of drug'}, {'measure': 'need of blood transfusion', 'timeFrame': 'until 24 hours post-operation', 'description': 'number of blood transfusion need'}, {'measure': 'adverse drug event', 'timeFrame': 'until 24 hours post-operation', 'description': 'adverse drug event of Misoprostol and Oxytocin'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postpartum hemorrhage, Cesarean section, Sublingual Misoprostol, Intrauterine Misoprostol'], 'conditions': ['To Compare Efficacy Intrauterine vs Sublingual MISOPROSTOL in Addition to Oxytocin in Reducing Blood Loss of Post-cesarean Section in High Risk Women']}, 'descriptionModule': {'briefSummary': 'Research Objective:\n\nPrimary outcome\n\n-To compare efficacy Intrauterine vs Sublingual MISOPROSTOL in addition to Oxytocin in reducing blood loss of post-cesarean section in high risk women\n\nSecondary outcome\n\n-To study Hemoglobin/Hematocrit change, need of uterotonic agents, need of blood transfusion, adverse drug event of Intrauterine vs Sublingual Misoprostol plus Oxytocin compare to Oxytocin alone\n\nHypothesis:\n\n-Intrauterine MISOPROSTOL plus Oxytocin is not inferior to Sublingual MISOPROSTOL plus Oxytocin in reducing blood loss of post-cesarean section in high risk women', 'detailedDescription': 'Research Design: Double-blind Randomized Placebo Controlled Trial\n\nSubject: Singleton pregnancy GA 34 wk or more with high risk for postpartum hemorrhage undergo cesarean section with spinal anesthesia in Rajavithi Hospital\n\nAllocated to 3 groups\n\n* group1: Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab\n* group2: Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab\n* group3: Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'genderBased': True, 'genderDescription': 'Pregnant women', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* ≥35 ปี\n* Previous PPH\n* Morbid obesity\n* Fetal macrosomia\n* Polyhydramnios\n* Induction/Augmentation of Labour\n* Prolonged Labour\n* Grand multiparity\n* Preeclampsia\n* Myoma Uteri\n\nExclusion Criteria:\n\n* Asthma\n* Maternal fever/ Tripple I can't excluded\n* coagulopathy\n* Placenta previa/ adherens/ abruptio placenta\n* Allergy to Prostaglandins/Oxytocin"}, 'identificationModule': {'nctId': 'NCT04560218', 'briefTitle': 'Sublingual vs Intrauterine MISOPROSTOL Plus Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Placebo RCT', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Department of Medical Services Ministry of Public Health of Thailand'}, 'officialTitle': 'Sublingual Versus Intrauterine MISOPROSTOL in Addition to Oxytocin Infusion for Prevention of Post-cesarean Hemorrhage in High Risk Pregnant Women: A Double-blind Randomized Placebo Controlled Trial', 'orgStudyIdInfo': {'id': '122/2563'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Uterotonic agents group A', 'description': 'Misoprostol sublingually 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab', 'interventionNames': ['Drug: sublingual Misoprostol']}, {'type': 'EXPERIMENTAL', 'label': 'Uterotonic agents group B', 'description': 'Misoprostol Intrauterine 2 tab (400 mcg) + Oxytocin 20 IU Intravenous + Placebo sublingually 2 tab', 'interventionNames': ['Drug: Intrauterine Misoprostol']}, {'type': 'NO_INTERVENTION', 'label': 'Uterotonic agents group C', 'description': 'Oxytocin 20 IU Intravenous + Placebo Intrauterine 2 tab + Placebo sublingually 2 tab'}], 'interventions': [{'name': 'sublingual Misoprostol', 'type': 'DRUG', 'description': 'apply drug by Anesthesiologist', 'armGroupLabels': ['Uterotonic agents group A']}, {'name': 'Intrauterine Misoprostol', 'type': 'DRUG', 'description': 'apply drug by surgeon at uterine cornu', 'armGroupLabels': ['Uterotonic agents group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10400', 'city': 'Bangkok', 'country': 'Thailand', 'facility': 'Rajavithi hospital', 'geoPoint': {'lat': 13.75398, 'lon': 100.50144}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Department of Medical Services Ministry of Public Health of Thailand', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'SPONSOR'}}}}