Ignite Creation Date:
2025-12-25 @ 12:06 AM
Ignite Modification Date:
2026-01-24 @ 10:17 PM
Study NCT ID:
NCT04025658
Status:
COMPLETED
Last Update Posted:
2022-01-28
First Post:
2019-07-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy
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': 'D010121', 'term': 'Oxytocin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Biased coin up-and-down design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-01', 'completionDateStruct': {'date': '2021-09-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-01-27', 'studyFirstSubmitDate': '2019-07-17', 'studyFirstSubmitQcDate': '2019-07-17', 'lastUpdatePostDateStruct': {'date': '2022-01-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-07-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Uterine tone 2 minutes: questionnaire', 'timeFrame': '3 minutes', 'description': 'Uterine tone, defined as satisfactory or unsatisfactory by the obstetrician at 2 minutes after completion of the oxytocin injection (3 minutes post delivery).'}], 'secondaryOutcomes': [{'measure': 'Need for uterine massage: questionnaire', 'timeFrame': '20 minutes', 'description': 'The obstetricians will be asked if there was any need for uterine massage beyond the initial 3 minute evaluation period following delivery.'}, {'measure': 'Intraoperative requirement for additional uterotonic medication', 'timeFrame': '2 hours', 'description': 'A request made by the obstetrician performing the cesarean delivery for additional uterotonic medication, due to bleeding or poor uterine tone.'}, {'measure': 'Calculated estimate of blood loss', 'timeFrame': '24 hours', 'description': "Blood loss will be calculated through the difference in hematocrit values assessed prior to and at the end of 48 hours after the cesarean delivery, according to the following formula:\n\nCalculated blood loss = EBV ((Pre-op Htc-Post-op Htc)/pre-op Htc). EBV (estimated blood volume) in ml: patient's weight in kg x 85"}, {'measure': 'Intravenous fluid administered during surgery', 'timeFrame': '2 hours', 'description': 'The total volume (ml) of fluid administered from entering the operating room to skin closure.'}, {'measure': 'Hypotension: systolic blood pressure less than 80% of baseline', 'timeFrame': '2 hours', 'description': 'Systolic blood pressure \\< 80% of baseline, from drug administration until end of surgery'}, {'measure': 'Tachycardia: heart rate greater than 130% of baseline', 'timeFrame': '2 hours', 'description': 'Heart rate \\> 130% of baseline, from drug administration until end of surgery'}, {'measure': 'Bradycardia: heart rate less than 70% of baseline', 'timeFrame': '2 hours', 'description': 'Heart rate \\< 70% of baseline or a heart rate \\< 50bpm, from drug administration until end of surgery'}, {'measure': 'Presence of ventricular tachycardia: ECG', 'timeFrame': '2 hours', 'description': 'Presence of ventricular tachycardia as recorded by ECG, from drug administration until end of surgery'}, {'measure': 'Presence of atrial fibrillation: ECG', 'timeFrame': '2 hours', 'description': 'Presence of atrial fibrillation as recorded by ECG, from drug administration until end of surgery'}, {'measure': 'Presence of atrial flutter: ECG', 'timeFrame': '2 hours', 'description': 'Presence of atrial flutter as recorded by ECG, from drug administration until end of surgery'}, {'measure': 'Presence of nausea: questionnaire', 'timeFrame': '2 hours', 'description': 'The presence of nausea and number of episodes, from drug administration until end of surgery, as reported by the patient'}, {'measure': 'Presence of vomiting: questionnaire', 'timeFrame': '2 hours', 'description': 'The presence of vomiting and number of episodes, from drug administration until end of surgery'}, {'measure': 'Presence of chest pain: questionnaire', 'timeFrame': '2 hours', 'description': 'Any presence of chest pain, from drug administration until end of surgery, as reported by the patient'}, {'measure': 'Presence of shortness of breath: questionnaire', 'timeFrame': '2 hours', 'description': 'Any presence of shortness of breath, from drug administration until end of surgery, as reported by the patient'}, {'measure': 'Presence of headache: questionnaire', 'timeFrame': '2 hours', 'description': 'Any presence of headache, from drug administration until end of surgery, as reported by the patient'}, {'measure': 'Presence of flushing: questionnaire', 'timeFrame': '2 hours', 'description': 'Any presence of flushing, from drug administration until end of surgery'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['pregnancy', 'twin', 'postpartum hemorrhage', 'oxytocin', 'Cesarean delivery'], 'conditions': ['Postpartum Hemorrhage', 'Twin']}, 'referencesModule': {'references': [{'pmid': '36480452', 'type': 'DERIVED', 'citation': 'Peska E, Balki M, Pfeifer W, Maxwell C, Ye XY, Downey K, Carvalho JCA. Oxytocin at Elective Cesarean Delivery: A Dose-Finding Study in Pregnant People With Twin Pregnancy. Anesth Analg. 2024 Apr 1;138(4):814-820. doi: 10.1213/ANE.0000000000006309. Epub 2022 Dec 8.'}]}, 'descriptionModule': {'briefSummary': 'Postpartum hemorrhage (PPH) due to uterine atony is a major cause of maternal morbidity and mortality. Uterotonic drugs are used to improve the muscle tone of the uterus after birth and these are effective at reducing the incidence of PPH. Large doses of this drug are associated with adverse effects like lower blood pressure, nausea, vomiting, abnormal heart rhythms and changes on ECG. Various international bodies recommend varying and high doses of oxytocin in elective cesarean sections. A study performed at Mount Sinai Hospital showed that a much smaller doses of oxytocin is required (ED95 being 0.35IU). Women who had twins were excluded from this study. It is known that women with a twin pregnancy have a higher risk of poor tone and postpartum hemorrhage.\n\nThe investigators seek to find the best dose of oxytocin for the patients with a twin pregnancy. A higher dose may be needed to contract the uterus adequately.', 'detailedDescription': 'Postpartum hemorrhage (PPH) is one of the leading causes of death during childbirth and accounts for an estimated 140,000 deaths per year worldwide. Furthermore, recent evidence has shown that the rate of PPH secondary to uterine atony is increasing.\n\nMultiple pregnancy is a well-recognized risk factor for PPH. Compared with singleton pregnancy, women with a multiple pregnancy have an increased risk of PPH, severe PPH, transfusion, uterine atony, hysterectomy, prolonged hospital stay and death. This is true in both high- and low-income countries. Uterine atony as a cause of PPH is more likely in multiple pregnancy compared with singleton pregnancy.\n\nProphylactic uterotonic drugs administered after the delivery have been demonstrated to reduce the incidence of PPH by up to 40%. Oxytocin is the most commonly administered uterotonic drug used to prevent PPH in North America but is associated with adverse effects such as hypotension, nausea, vomiting, dysrhythmias, ST segment abnormalities, and severe water intoxication that may lead to pulmonary edema and convulsions.\n\nPrevious dose finding studies have excluded women with twin pregnancies. Therefore, the investigators wish to perform a double blinded dose finding study using the biased coin flip up-and-down sequential allocation technique to determine the ED 90 of oxytocin at cesarean section in those women with a twin pregnancy.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Twin pregnancy\n* Elective cesarean delivery under regional anesthesia\n* Gestational age ≥36 weeks\n* No known additional risk factors for postpartum hemorrhage\n* Written informed consent to participate in this study\n\nExclusion Criteria:\n\n* Refusal to give written informed consent\n* Allergy or hypersensitivity to oxytocin\n* Conditions that may predispose to uterine atony and postpartum hemorrhage such as placenta previa, severe preeclampsia (as defined by SOGC guidelines (25)), polyhydramnios, uterine fibroids, previous history of uterine atony resulting in PPH, or bleeding diathesis and obesity, defined as pre-pregnancy BMI \\>40\n* Hepatic, renal, and vascular disease\n* Use of general anesthesia prior to the administration of the study drug'}, 'identificationModule': {'nctId': 'NCT04025658', 'briefTitle': 'Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital'}, 'officialTitle': 'Oxytocin at Elective Cesarean Deliveries: A Dose-finding Study in Women With Twin Pregnancy', 'orgStudyIdInfo': {'id': '19-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin 0.5IU', 'description': 'Patient is given 0.5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin 1IU', 'description': 'Patient is given 1IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin 2IU', 'description': 'Patient is given 2IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin 3IU', 'description': 'Patient is given 3IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin 4IU', 'description': 'Patient is given 4IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.', 'interventionNames': ['Drug: Oxytocin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Oxytocin 5IU', 'description': 'Patient is given 5IU of oxytocin intravenously over 1 minute, immediately upon delivery of the fetal head.', 'interventionNames': ['Drug: Oxytocin']}], 'interventions': [{'name': 'Oxytocin', 'type': 'DRUG', 'otherNames': ['pitocin'], 'description': 'Oxytocin administered intravenously, over 1 minute following delivery of the fetal head', 'armGroupLabels': ['Oxytocin 0.5IU', 'Oxytocin 1IU', 'Oxytocin 2IU', 'Oxytocin 3IU', 'Oxytocin 4IU', 'Oxytocin 5IU']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1X5', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Mount Sinai Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Jose Carvalho, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'MOUNT SINAI HOSPITAL'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Samuel Lunenfeld Research Institute, Mount Sinai Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}