Ignite Creation Date:
2025-12-24 @ 11:04 PM
Ignite Modification Date:
2026-02-26 @ 2:15 AM
Study NCT ID:
NCT03858569
Status:
COMPLETED
Last Update Posted:
2024-01-09
First Post:
2019-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Uterine Massage After Vaginal 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-07', 'studyFirstSubmitDate': '2019-02-27', 'studyFirstSubmitQcDate': '2019-02-27', 'lastUpdatePostDateStruct': {'date': '2024-01-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-09-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Postpartum hemorrhage', 'timeFrame': 'during procedure', 'description': 'The amount of blood loss after delivery of the fetus'}], 'secondaryOutcomes': [{'measure': 'Duration of third stage of the labor', 'timeFrame': 'during procedure', 'description': 'Delivery of the fetus and delivery of the placenta interval'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Postpartum Hemorrhage']}, 'referencesModule': {'references': [{'pmid': '37698604', 'type': 'DERIVED', 'citation': 'Kadirogullari P, Aslan Cetin B, Goksu M, Cetin Arslan H, Seckin KD. The effect of uterine massage after vaginal delivery on the duration of placental delivery and amount of postpartum hemorrhage. Arch Gynecol Obstet. 2024 Jun;309(6):2689-2695. doi: 10.1007/s00404-023-07211-5. Epub 2023 Sep 12.'}]}, 'descriptionModule': {'briefSummary': 'The participants will be randomized into an oxytocin plus uterine massage group and an oxytocin-only group in the third stage of the labor. Women allocated to the uterine massage group will be provided with trans-abdominal uterine massage starting promptly after delivery of the fetus until delivery of the placenta. The amount of postpartum hemorrhage and placental delivery time will be recorded and compared between the groups.', 'detailedDescription': "Women allocated to oxytocin only group will be given 10 units of oxytocin intramuscularly immediately after delivery of the fetus. Women allocated to the oxytocin plus uterine massage group will be will be given 10 units of oxytocin intramuscularly immediately after delivery of the fetus and will be provided with trans-abdominal uterine massage starting promptly after delivery of the fetus until delivery of the placenta. Collection of blood loss will be initiated immediately after delivery of the fetus by putting a drape under the woman's buttocks. Collected blood will be weighed and the amount will be recorded in grams."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18-40 years old women delivering vaginally\n\nExclusion Criteria:\n\n* women with bleeding disorder'}, 'identificationModule': {'nctId': 'NCT03858569', 'briefTitle': 'Uterine Massage After Vaginal Delivery', 'organization': {'class': 'OTHER', 'fullName': 'Kanuni Sultan Suleyman Training and Research Hospital'}, 'officialTitle': 'Effect of Uterine Massage on Postpartum Hemorrhage After Vaginal Delivery', 'orgStudyIdInfo': {'id': '2018/11/42'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin', 'description': '10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus', 'interventionNames': ['Procedure: active management of third stage of labor']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin plus uterine massage', 'description': '10 units of oxytocin will be given intramuscularly immediately after delivery of the fetus and transabdominal uterine massage will be performed.', 'interventionNames': ['Procedure: active management of third stage of labor']}], 'interventions': [{'name': 'active management of third stage of labor', 'type': 'PROCEDURE', 'description': 'Active management of the third stage of the labor will be done administering oxytocin and cord traction.', 'armGroupLabels': ['Oxytocin', 'Oxytocin plus uterine massage']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34150', 'city': 'Istanbul', 'country': 'Turkey (Türkiye)', 'facility': 'Kanuni SSTRH', 'geoPoint': {'lat': 41.01384, 'lon': 28.94966}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kanuni Sultan Suleyman Training and Research Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Md, ObGYN, Principal Investigator', 'investigatorFullName': 'Berna Aslan Cetin', 'investigatorAffiliation': 'Kanuni Sultan Suleyman Training and Research Hospital'}}}}