Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT03140033
Status:
UNKNOWN
Last Update Posted:
2017-05-04
First Post:
2017-04-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D016595', 'term': 'Misoprostol'}, {'id': 'D011899', 'term': 'Ranitidine'}], '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'}, {'id': 'D005663', 'term': 'Furans'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 158}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-05', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-02', 'studyFirstSubmitDate': '2017-04-24', 'studyFirstSubmitQcDate': '2017-05-02', 'lastUpdatePostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-05-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood loss during cesarean sections', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Blood loss will be estimated by the anesthesiologist Using soaked towels and suction set after delivery of placenta'}], 'secondaryOutcomes': [{'measure': 'Vaginal bleeding', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Calculation of the amount of vaginal bleeding according to the number of soaked pads used after cesarea section for the 1st 6 hrs. Each soaked pad equal 50 cc'}, {'measure': 'Change in blood pressure and pulse', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Change in blood pressure and pulse before and after the cesarean section'}, {'measure': 'Blood loss after 24 hr.', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'The allowable blood loss (ABL) =\\[ estimated blood volume ( EBV ) x (intial hematocrit (HI ) - final hematocrit (HF) \\] / HI ( initial hematocrit)'}, {'measure': 'Need for additional uterotonic agent', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Need for additional uterotonic agent e.g oxytocin - methyl ergotamine'}, {'measure': 'Need for blood transfusion', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'number of patients receiving blood transfusion'}, {'measure': 'Need for surgical measures to stop bleeding', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Need for surgical measures to stop bleeding e.g uterine artery ligation , B-lynch sutures or Hysterectomy'}, {'measure': 'Side effects of misoprostol', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Nausea, Vomiting or Diarrhea'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hemorrhage Postpartum']}, 'descriptionModule': {'briefSummary': 'Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Trial', 'detailedDescription': 'This study aims to evaluate efficacy and safety of subligual misoprostol in reducing blood loss during cesarean section , a randomized double blinded prospective controlled trial conducted at Ain Shams maternity hospital . 158 women who fulfilled the inclusion criteria enrolled in this study .the patients randomized into two groups one of them will receive sublingual misoprostol 400 micrograms ( misotac )and the other will receive placebo( Ranitak ),all patients will subjected to history,physical examination,and investigations.preparation of patients (preload and antibiotics )according to hospital protocol.All C.S will be perfomed using spinal anaesthesia ,pfannenstiel incision of the skin ,open of abdomen in layers ,at cord clamping the patients will receive the medication sublingual and 20IU of oxytocin intravenous infusion simultaneous by the anesthesiologist,then close in anatomical layers.blood loss during C.S will be calculated following placental delivery to the end of surgery,and from the end of the operation to 6h after birth.the need for additional uterotonics agents,blood transfusion and adverse effects of the study drug will be recorded.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '19 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* singleton pregnancies\n* women booked for elective C.S\n* full term pregnancies\n* primi gravida or previous one delivery ( either by spontaneous vaginal delivery or C.S )\n\nExclusion Criteria:\n\n* blood disorders\n* multiple pregnancy\n* placenta previa\n* polyhydramnios\n* marked maternal anemia\n* contraindications to prostaglandin e.g history of asthma , allergy to misoprostol\n* previous 2 or more C.S'}, 'identificationModule': {'nctId': 'NCT03140033', 'briefTitle': 'Sublingual Misoprostol to Reduce Blood Loss During Elective Cesarean Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Ain Shams Maternity Hospital'}, 'officialTitle': 'Sublingual Misoprostol Versus Placebo to Reduce Blood Loss During Elective Cesarean Delivery : A Randomized Controlled Study', 'orgStudyIdInfo': {'id': 'MFathy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Misoprostol oral tablets', 'description': '79 women will recieve 400 micrograms of misoprostol ( misotac) sublingually and 20 IU of oxytocin at cord clamping', 'interventionNames': ['Drug: Misoprostol Oral Tablet']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Ranitidine oral tablets', 'description': '79 women will recieve ranitidine oral tablets sublingually and 20 IU of oxytocin at cord clamping', 'interventionNames': ['Drug: Ranitidine Oral Tablet']}], 'interventions': [{'name': 'Misoprostol Oral Tablet', 'type': 'DRUG', 'otherNames': ['Misotac'], 'description': 'at cord clamping the patient will recieve 400 micrograms of misoprostol sublingually', 'armGroupLabels': ['Misoprostol oral tablets']}, {'name': 'Ranitidine Oral Tablet', 'type': 'DRUG', 'otherNames': ['Ranitak'], 'description': 'at cord clamping the patient will recieve ranitidine sublingually', 'armGroupLabels': ['Ranitidine oral tablets']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mohamed Fathy, M.B.B.Ch', 'role': 'CONTACT', 'email': 'Mohamedfathy31085@gmail.com', 'phone': '00201099984100'}, {'name': 'AMR Helmy, MD.MRCOG', 'role': 'CONTACT', 'email': 'am_helmy77@hotmail.com', 'phone': '00201227900014'}], 'facility': 'Ain shams maternity hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mohamed H Fathy, M.B.B.Ch', 'role': 'CONTACT', 'email': 'Mohamedfathy31085@gmail.com', 'phone': '00201099984100'}, {'name': 'Amr YEHIA, MD,MRCOG', 'role': 'CONTACT', 'email': 'am_helmy77@hotmail.com', 'phone': '00201227900014'}], 'overallOfficials': [{'name': 'Amr H YEHIA, MD,MRCOG', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Ain Shams University-Maternity Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ain Shams Maternity Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Resident of obstetrics and gynecology', 'investigatorFullName': 'Mohamed Fathy', 'investigatorAffiliation': 'Ain Shams Maternity Hospital'}}}}