Ignite Creation Date:
2025-12-24 @ 7:48 PM
Ignite Modification Date:
2026-01-05 @ 1:07 AM
Study NCT ID:
NCT06469203
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-08-13
First Post:
2024-06-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxytocin Effectiveness in First Trimester Dilatation and Curettage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000030', 'term': 'Abortion, Missed'}, {'id': 'D014592', 'term': 'Uterine Hemorrhage'}, {'id': 'D004108', 'term': 'Dilatation, Pathologic'}], 'ancestors': [{'id': 'D000022', 'term': 'Abortion, Spontaneous'}, {'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D014591', 'term': 'Uterine Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006470', 'term': 'Hemorrhage'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'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'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'randomization will be done by hospitals pharmacy. A total of 160 patients will be included in the sample size resulting in a net total of 80 patients per group as described below. Patients who choose to withdraw from the study will still be analyzed as intention-to-treat patients.'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage.\n\nGroup 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-06', 'completionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-12', 'studyFirstSubmitDate': '2024-06-17', 'studyFirstSubmitQcDate': '2024-06-17', 'lastUpdatePostDateStruct': {'date': '2024-08-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative Blood Loss Assessment', 'timeFrame': '14 days', 'description': 'We will assess perioperative blood loss by:\n\n* Measuring the content collected in the vacuum apparatus after the procedure.\n* Recording hemoglobin and hematocrit levels prior to the procedure.\n* Measuring hemoglobin and hematocrit levels immediately after the procedure.\n* Monitoring hemoglobin and hematocrit levels two weeks post-procedure.'}], 'secondaryOutcomes': [{'measure': 'perioperative complications according to the Dindo-Clavien scale', 'timeFrame': '30 days', 'description': 'perioperative complications according to the Dindo-Clavien scale'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['missed abortion', 'vaginal bleeding', 'dilation and curretage', 'pregnancy termination', 'oxytocin'], 'conditions': ['Missed Abortion']}, 'descriptionModule': {'briefSummary': "The aim of this study is to investigate the impact of oxytocin on perioperative blood loss during the D\\&C procedure, as well as to assess early and late complications associated with it's use.", 'detailedDescription': 'Study Design\n\nThis study is a prospective randomized placebo-controlled double-blind trial. Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage.\n\nGroup 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.\n\nThe medication bags will be prepared by the Assuta Ashdod University Hospital Pharmacy, coded with serial numbers, and randomized using computerized software. Both the investigators and patients will remain unaware of the composition of the distension medium to ensure blinding.\n\nA total of 160 patients will be included in the sample size resulting in a net total of 80 patients per group as described below. Patients who choose to withdraw from the study will still be analyzed as intention-to-treat patients.\n\nInclusion Criteria:\n\nAll patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks.\n\nPatients aged 18 years and older who are capable to provide informed consent.\n\nExclusion criteria\n\n* individual intolerance to oxytocin\n* mullerian anomalies\n* Fibroid uterus\n* thrombophilia or coagulation disorders\n* cardiovascular disease\n\nPrimary outcome\n\nPerioperative Blood Loss Assessment:\n\nWe will assess perioperative blood loss by:\n\n* Measuring the content collected in the vacuum apparatus after the procedure.\n* Recording hemoglobin and hematocrit levels prior to the procedure.\n* Measuring hemoglobin and hematocrit levels immediately after the procedure.\n* Monitoring hemoglobin and hematocrit levels two weeks post-procedure.\n\nSecondary outcomes\n\n-perioperative complications according to the Dindo-Clavien scale'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'including pregnant women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients admitted to the OBGYN Assuta Ashdod Hospital for elective surgical termination of pregnancy due to missed miscarriages in the first trimester, with gestational age range of 6.0 to 11.6 weeks.\n\nPatients aged 18 years and older who are capable to provide informed consent.\n\nExclusion Criteria:\n\n* individual intolerance to oxytocin\n* mullerian anomalies\n* Fibroid uterus\n* thrombophilia or coagulation disorders\n* cardiovascular disease'}, 'identificationModule': {'nctId': 'NCT06469203', 'briefTitle': 'Oxytocin Effectiveness in First Trimester Dilatation and Curettage', 'organization': {'class': 'OTHER', 'fullName': 'Assuta Ashdod Hospital'}, 'officialTitle': 'Oxytocin Effectiveness in First Trimester Dilatation and Curettage', 'orgStudyIdInfo': {'id': '0127-23-AAA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants will receive 100 ml of saline alone.', 'interventionNames': ['Drug: Sodium Chloride 0.9% Inj']}, {'type': 'EXPERIMENTAL', 'label': 'Oxytocin', 'description': 'Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.', 'interventionNames': ['Drug: Oxytocin', 'Drug: Sodium Chloride 0.9% Inj']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'description': 'Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage.\n\nGroup 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.', 'armGroupLabels': ['Oxytocin']}, {'name': 'Sodium Chloride 0.9% Inj', 'type': 'DRUG', 'description': 'Women undergoing dilation and curettage, who meet the eligibility criteria for the study, will be divided into two groups. They will receive the assigned medication at the beginning of the procedure, after cervical dilation but before using suction curettage.\n\nGroup 1: Participants will receive 100 ml of saline alone. Group 2: Participants will receive an intravenous infusion of 8 units of oxytocin diluted in 100 ml of saline.', 'armGroupLabels': ['Oxytocin', 'Placebo']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Assuta Ashdod Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}