Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2026-01-01 @ 12:18 AM
Study NCT ID:
NCT04649593
Status:
COMPLETED
Last Update Posted:
2022-03-31
First Post:
2020-11-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Study of Giving Birth, a Study About Treatment of Labor Dystocia
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004420', 'term': 'Dystocia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': "According to the clinic's memo, when the labor is found to be dystocic, the woman is asked about her participation in the study. If the woman admits participation, she is included in the project. This is also noted in her journal."}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2000}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-03', 'completionDateStruct': {'date': '2022-02-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-03-28', 'studyFirstSubmitDate': '2020-11-22', 'studyFirstSubmitQcDate': '2020-11-25', 'lastUpdatePostDateStruct': {'date': '2022-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Labor outcome', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Labor outcome in the different groups (spontaneous vaginal, VE or caesarean section)'}, {'measure': 'AFL values', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'AFL-values to be at different times during labor'}], 'secondaryOutcomes': [{'measure': 'The use of oxytocin', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Oxytocin stimulation (number of hours of stimulation and amount of oxytocin given),'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Dystocia']}, 'descriptionModule': {'briefSummary': 'Labor dystocia is an intransigent, high-profile issue in obstetric care, which causes significant maternal morbidity in low resource settings and maternal dissatisfaction, and increased healthcare costs worldwide. Amniotic fluid lactate, (AFL), values have recently been shown to reflect the metabolic status of the uterus and high levels have a strong association with subsequent need for operative intervention due to dystocia. In sports medicine, it is known that lactic acid can affect muscular performance but be decreased by bicarbonate given orally before physical activity. Main Outcome Measures: If an intake of bicarbonate, one hour before stimulation with oxytocin in cases with a high AFL value, changes the AFL levels and enhances delivery outcome in dystocic deliveries.\n\nDesign: Randomized controlled trial', 'detailedDescription': "Primary question: whether high AFL values (\\>12mmol/l) in women with observed dystocic labor are best treated by\n\n1. to handle childbirth according to the clinic's current guidelines in case of labor dystocia, i.e. with oxytocin stimulation\n2. an intake of bicarbonate (Samarin) dissolved in water given 1 hour before the oxytocin is started Primary outcome variable A comparison of the frequency of spontaneous vaginal delivery in the observed two described intervention groups."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The study is about labor. It means only women is the possible inclusion', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* dystocic labor with a need of oxytocin \\>=34w of gestation\n\nExclusion Criteria:\n\n* Nondystocic labors.\n* Women who don't understand Swedish or English\n* Premature deliveries (\\<34w)"}, 'identificationModule': {'nctId': 'NCT04649593', 'acronym': 'GB', 'briefTitle': 'The Study of Giving Birth, a Study About Treatment of Labor Dystocia', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'The Giving Birth Project, a Study of Labor Dystocia', 'orgStudyIdInfo': {'id': 'GB1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'according to clinical guidlines', 'description': 'Dystocic progress and an observed low AFL value (\\< 12.0 mmol/l).'}, {'type': 'EXPERIMENTAL', 'label': 'intevention', 'description': "At dystocic labor and an observed high AFL value, the woman is randomized to one of the intended two study groups.\n\nGroup 1) Delivery according to the clinic's guidelines in case labor dystocia, i.e., oxytocin stimulation Group 2) Two bags of Samarin mixed in a glass of water. After an hour, In case of lack of progress, oxytocin stimulation is started.", 'interventionNames': ['Dietary Supplement: Samarin']}], 'interventions': [{'name': 'Samarin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Half of the group with a high AFL value will have a glass of Samarin to drink', 'armGroupLabels': ['intevention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18239', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'Eva Wiberg-Itzel', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Eva Wiberg-Itzel', 'investigatorAffiliation': 'Karolinska Institutet'}}}}