Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2025-12-26 @ 6:42 PM
Study NCT ID:
NCT00116350
Status:
COMPLETED
Last Update Posted:
2009-03-19
First Post:
2005-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Misoprostol for the Treatment of Postpartum Hemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Brazil', 'Senegal']}, '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': 'D010121', 'term': 'Oxytocin'}], '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': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1786}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2005-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-03', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2009-03-17', 'studyFirstSubmitDate': '2005-06-28', 'studyFirstSubmitQcDate': '2005-06-28', 'lastUpdatePostDateStruct': {'date': '2009-03-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-06-29', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Need for additional treatment after initial PPH study treatment', 'timeFrame': 'all additional interventions recorded following initial uterotonic treatment'}], 'secondaryOutcomes': [{'measure': 'Mean blood loss after PPH treatment', 'timeFrame': 'blood loss measured for minimum of 1 hour or until active bleeding ceases'}, {'measure': 'Change in hemoglobin from pre-delivery to postpartum', 'timeFrame': 'Pe-delivery hemoblogin measured upon entry into labor ward; postpartum Hb measured 12-24 hrs after removal of IV'}, {'measure': 'Time to bleeding cessation', 'timeFrame': 'Time to bleeding cessation recorded'}, {'measure': 'Blood transfusion', 'timeFrame': 'any blood transfusion recorded after delivery and prior to discharge'}, {'measure': 'Side effects', 'timeFrame': 'any observed or reported side effects recorded following treatment and prior to discharge'}, {'measure': 'Acceptability for women', 'timeFrame': 'Exit interview conducted prior to discharge'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Postpartum hemorrhage', 'Misoprostol', 'Developing countries', 'Maternal morbidity', 'Randomized controlled trial'], 'conditions': ['Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '33232518', 'type': 'DERIVED', 'citation': 'Parry Smith WR, Papadopoulou A, Thomas E, Tobias A, Price MJ, Meher S, Alfirevic Z, Weeks AD, Hofmeyr GJ, Gulmezoglu AM, Widmer M, Oladapo OT, Vogel JP, Althabe F, Coomarasamy A, Gallos ID. Uterotonic agents for first-line treatment of postpartum haemorrhage: a network meta-analysis. Cochrane Database Syst Rev. 2020 Nov 24;11(11):CD012754. doi: 10.1002/14651858.CD012754.pub2.'}, {'pmid': '20060162', 'type': 'DERIVED', 'citation': 'Blum J, Winikoff B, Raghavan S, Dabash R, Ramadan MC, Dilbaz B, Dao B, Durocher J, Yalvac S, Diop A, Dzuba IG, Ngoc NT. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women receiving prophylactic oxytocin: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):217-23. doi: 10.1016/S0140-6736(09)61923-1. Epub 2010 Jan 6.'}, {'pmid': '20060161', 'type': 'DERIVED', 'citation': 'Winikoff B, Dabash R, Durocher J, Darwish E, Nguyen TN, Leon W, Raghavan S, Medhat I, Huynh TK, Barrera G, Blum J. Treatment of post-partum haemorrhage with sublingual misoprostol versus oxytocin in women not exposed to oxytocin during labour: a double-blind, randomised, non-inferiority trial. Lancet. 2010 Jan 16;375(9710):210-6. doi: 10.1016/S0140-6736(09)61924-3. Epub 2010 Jan 6.'}], 'seeAlsoLinks': [{'url': 'http://www.gynuity.org', 'label': 'Gynuity Health Projects website'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether misoprostol is as effective as oxytocin for treating primary postpartum hemorrhage (PPH) with uterine atony as the suspected cause in two circumstances: 1) where women have received prophylactic uterotonics in the third stage of labor; and 2) where no prophylactic uterotonics have been given in the third stage of labor.', 'detailedDescription': 'Postpartum hemorrhage (PPH) remains a major cause of maternal deaths worldwide. Misoprostol offers several advantages over oxytocin and ergometrine, the drugs currently used to treat PPH. For example, misoprostol is stable at high temperatures and has a shelf life of several years, it is easy to administer, it can be given to hypertensive patients, and it is inexpensive. This randomized, double-blind placebo-controlled trial will test whether misoprostol is as effective as oxytocin in treating primary PPH in hospital births, both when women have received prophylactic uterotonics in the third stage of labor and when they have not.\n\nBlood loss will be measured for all consenting women who deliver vaginally. If PPH occurs and uterine atony is the suspected cause, women will be randomized to receive either: a) four 200 µg pills of misoprostol sublingually and an IV of saline (resembling oxytocin) or b) four placebo tablets resembling misoprostol sublingually and 40 IU oxytocin by IV. This study seeks to answer the following questions:\n\n* Is misoprostol as effective as oxytocin for treatment of primary PPH for women who do and do not receive oxytocin prophylaxis in the third stage of labor?\n* Does misoprostol have an acceptable safety profile when given as an 800 µg sublingual dose to treat PPH?\n* Is the side effect profile of misoprostol acceptable to women?\n\nThis study will take place in hospitals located in Burkina Faso, Ecuador, Egypt, Turkey, and Vietnam.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Vaginal delivery\n* Postpartum hemorrhage due to suspected uterine atony\n* Depending on study group: administration of prophylactic uterotonics in third stage of labor\n\nExclusion Criteria:\n\n* Known allergy to misoprostol or other prostaglandin\n* C-section for current delivery'}, 'identificationModule': {'nctId': 'NCT00116350', 'briefTitle': 'Misoprostol for the Treatment of Postpartum Hemorrhage', 'organization': {'class': 'OTHER', 'fullName': 'Gynuity Health Projects'}, 'officialTitle': 'Misoprostol for the Treatment of Primary Postpartum Hemorrhage', 'orgStudyIdInfo': {'id': '2.4.1'}, 'secondaryIdInfos': [{'id': 'WIRB #20041878/1063615'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Misoprostol', 'description': '800 mcg sublingual misoprostol', 'interventionNames': ['Drug: Misoprostol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin', 'description': '40 IU Oxytocin IV', 'interventionNames': ['Drug: Oxytocin']}], 'interventions': [{'name': 'Misoprostol', 'type': 'DRUG', 'description': '800 mcg sublingual misoprostol', 'armGroupLabels': ['Misoprostol']}, {'name': 'Oxytocin', 'type': 'DRUG', 'description': '40 IU Oxytocin IV', 'armGroupLabels': ['Oxytocin']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Bobo Diolasso', 'country': 'Burkina Faso', 'facility': 'Centre Hospitalier Universitaire Souro Sanou de Bobo Dioulasso'}, {'city': 'Quito', 'country': 'Ecuador', 'facility': 'Hospital Gineco-Obstetrico Isidro Ayora', 'geoPoint': {'lat': -0.22985, 'lon': -78.52495}}, {'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria University Hospital, Shatby Maternity Hospital', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}, {'city': 'Cairo', 'country': 'Egypt', 'facility': 'El-Galaa Teaching Hospital', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}, {'zip': '06010', 'city': 'Ankara', 'country': 'Turkey (Türkiye)', 'facility': 'Ministry of Health Ankara Etlik Maternity and Teaching-Research Hospital', 'geoPoint': {'lat': 39.91987, 'lon': 32.85427}}, {'city': 'Ho Chi Minh City and Binh Duong Province', 'country': 'Vietnam', 'facility': 'Cu Chi Hospital, Tu Du Hospital, Hocmon Hospital, Binh Duong Hospital'}], 'overallOfficials': [{'name': 'Beverly Winikoff, MD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Jennifer Blum, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Rasha Dabash, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Sheila Raghavan, M.Sc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Ayisha Diop, MPH', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Ilana Dzuba, M.H.Sc.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}, {'name': 'Jill Durocher', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Gynuity Health Projects'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Gynuity Health Projects', 'class': 'OTHER'}, 'collaborators': [{'name': 'Family Care International', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Gynuity Health Projects', 'oldOrganization': 'Gynuity Health Projects'}}}}