Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2025-12-29 @ 10:51 AM
Study NCT ID:
NCT06159959
Status:
COMPLETED
Last Update Posted:
2023-12-07
First Post:
2023-11-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Carbetocin in the Prevention of Primary Postpartum Haemorrhage
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006473', 'term': 'Postpartum Hemorrhage'}, {'id': 'D009765', 'term': 'Obesity'}], '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'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C020731', 'term': 'carbetocin'}, {'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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 244}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-05', 'studyFirstSubmitDate': '2023-11-25', 'studyFirstSubmitQcDate': '2023-12-05', 'lastUpdatePostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Post postpartum bleeding', 'timeFrame': 'first 6 hours after the Cesarean Section', 'description': 'To compare the incidence of primary postpartum hemorrhage in both groups receiving carbetocin'}], 'secondaryOutcomes': [{'measure': 'Sever PPH as bleeding is >1000 cc', 'timeFrame': 'first 24 hours after Cesarean Section', 'description': 'Outcome of the study will be measured in terms of assessment of Hemoglobin level and Hematocrit level post operatively.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Obesity', 'PPH', 'BMI', 'Carbetocin', 'Oxytocin', 'Uterotonic'], 'conditions': ['Post Partum Hemorrhage']}, 'descriptionModule': {'briefSummary': 'Postpartum haemorrhage (PPH) ranks as the first cause of maternal mortality in developing countries and it is the cause of 25% of maternal deaths worldwide.\n\nCarbetocin is a long-acting synthetic octapeptide analogue of oxytocin with agonist properties. Like oxytocin, carbetocin binds to oxytocin receptors present on the smooth musculature of the uterus, resulting in rhythmic contractions of the uterus, increased frequency of existing contractions and increased uterine tone.', 'detailedDescription': 'Postpartum hemorrhage is defined as a blood loss more than 500 ml, and serious PPH as a blood loss more than 1,000 ml.\n\nIt is a common maternal morbidity in high-resource countries and is trending upward and prevention of postpartum haemorrhage is, therefore, of great importance for improved maternal health care.\n\nAlthough two-thirds of the PPH cases occur in women without predisposing factors, there are several risk factors for PPH. The most frequent cause of PPH is uterine atony, contributing up to 80 % of the PPH cases .\n\nStudies investigating effect of increased BMI on birth outcomes in a general obstetric population revealed an association between obesity and PPH. The overall increased risk of postpartum hemorrhage among obese women was 8-13%, depending on obesity class.\n\nThe risk of postpartum haemorrhage is much higher for women undergoing Cesarean section, particularly in developing countries, where the majority of operations are carried out as an emergency procedure.\n\nMaternal obesity is associated with an elevated risk of intrapartum cesarean section, mainly due to reduced uterine contractility culminating in failure to progress in labor .\n\nUp to date, which uterotonic agent suitable for prophylactic use is being debated and literature lacks of clear endpoints on this item .\n\nThe most routinely and widely used uterotonic agent for preventing postpartum haemorrhage is oxytocin, but it only has a half-life of 4-10 min. So, it must be administered as a continuous intravenous infusion to achieve sustained uterotonic activity, which is inconvenient and makes dosing errors a possibility.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'To assess the effectiveness of single IV bolus dose of carbetocin in the prevention of primary PPH in obese versus non obese women undergoing elective cesarean section.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age: 20-40years.\n* Body mass index (BMI): Obese ≥30 kg/m2 and non-obese women \\<30 kg/m2 calculated using maternal height and weight measured to the nearest centimeter and kilogram, respectively, at time of admission to labor word.\n* Gestational age: Gestational age ≥37 weeks (gestational age will be recorded according to the last menstrual period and confirmed by ultrasound). In case of discrepancy, a 1st trimesteric ultrasound will be taken as the actual gestational age.\n* Singleton pregnancy.\n\nExclusion Criteria:\n\nPatients who have any factors that might increase the risk of postpartum haemorrhage will be excluded as anemic patients (Hb\\<10.5g%), antepartum haemorrhage ( placenta previa, placental abruption ), uterine myomata, multiple gestation, polyhydramnios.\n\n* Patients with pre-existing bleeding or thromboembolic disorder.\n* Patients with chronic medical diseases (cardiac, hepatic, renal)'}, 'identificationModule': {'nctId': 'NCT06159959', 'briefTitle': 'Carbetocin in the Prevention of Primary Postpartum Haemorrhage', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Ministry of Health and Population, Egypt'}, 'officialTitle': 'Carbetocin in the Prevention of Primary Postpartum Haemorrhage in Obese Versus Non-obese Women Undergoing Elective Cesarean Section', 'orgStudyIdInfo': {'id': 'Dina Sanad Tawfik'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group A: Obese Pregnant Females', 'description': 'About 122 Pregnant women candidate for elective cesarean section suffering from obesity where as Body mass index (BMI) is ≥30 kg/m2', 'interventionNames': ['Drug: Carbetocin']}, {'label': 'Group B: Non-Obese Pregnant Females', 'description': 'About 122 Pregnant women candidate for elective cesarean section and not obese obesity where as Body mass index (BMI) is \\< 30 kg/m2', 'interventionNames': ['Drug: Carbetocin']}], 'interventions': [{'name': 'Carbetocin', 'type': 'DRUG', 'otherNames': ['Oxytocin'], 'description': 'To assess the effectiveness of single IV bolus dose of carbetocin in the prevention of primary PPH in obese versus non obese women undergoing elective cesarean section.', 'armGroupLabels': ['Group A: Obese Pregnant Females', 'Group B: Non-Obese Pregnant Females']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr- Alainy Hospitals', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'overallOfficials': [{'name': 'Abdallah Y Elkateb, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Cairo University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ministry of Health and Population, Egypt', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Specialist of Obstetrics and Gynecology at AlSahelTeaching Hospital', 'investigatorFullName': 'Dina Sanad Tawfik Allam', 'investigatorAffiliation': 'Ministry of Health and Population, Egypt'}}}}