Ignite Creation Date:
2025-12-24 @ 1:29 PM
Ignite Modification Date:
2025-12-29 @ 12:14 AM
Study NCT ID:
NCT06090695
Status:
UNKNOWN
Last Update Posted:
2023-10-19
First Post:
2021-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cesarean Delivery in Uganda: A Mixed Methods Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 9000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-18', 'studyFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2023-10-18', 'lastUpdatePostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Cesarean section rate', 'timeFrame': '3 months', 'description': 'as above'}], 'secondaryOutcomes': [{'measure': 'Severe Maternal Outcome', 'timeFrame': 'up to hospital discharge, an average of 3 days', 'description': 'Composite of measure that includes WHO near miss morbidity criteria and maternal mortality'}, {'measure': 'Adverse Perinatal Outcome', 'timeFrame': 'up to hospital discharge, an average of 3 days', 'description': 'Composite measure of adverse perinatal outcomes including stillbirth, neonatal death, neonatal admission'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cesarean section rate', 'global surgery', 'quality of care'], 'conditions': ['Cesarean Section Rates']}, 'descriptionModule': {'briefSummary': 'Recent data indicate that 1 in 5 women worldwide undergo Caesarean sections (CS) and in most regions CS rates are increasing. Sub-Saharan Africa has the lowest CS rate at 3.5%, compared to a global average of 19.1%. However, there is emerging evidence for a double burden in low-income countries, with low national CS rates masking both overuse and underuse. While national CS rates may remain stagnant, disaggregation by wealth, location, and education level reveal disparities in rate.\n\nThe purpose of this study is to understand the Caesarean delivery in Uganda by examining CS rates, factors associated with CS and maternal and neonatal outcomes across institutions using the Robson classification.', 'detailedDescription': 'Caesarean sections (CS) are an essential component of obstetric care and the most common surgical procedures performed in women. At the population level, the ideal CS rate is challenging to determine, however, in the past the World Health Organization has recommended a national population level rate of 10-15% and more recently updated its recommendation to state that no benefit is seen in maternal and neonatal mortality above this population level rate.\n\nRecent data indicate that 1 in 5 women worldwide undergo CS and in most regions worldwide CS rates are increasing. However, stark disparities exist globally with national rates ranging from as low as 1.4% in Niger to as high as 56.4% in the Dominican Republic. At the regional level, sub-Saharan Africa (SSA) has the lowest CS rate at 3.5% (compared to a global average of 19.1%) and over the last two decades demonstrated the least increases in this rate.\n\nThere is, however, emerging evidence for a double burden in low income countries, with low national CS rates masking both overuse and underuse. While national CS rates may remain stagnant, disaggregation by wealth, location, and education level reveal disparities in rate. In Uganda, for example, national CS rates remain low with a national rate of 6% in 2016, up from 3% in 2006, indicating that at the national level there is likely a lack of access to CS for many women in need of this procedure. However, disaggregation by wealth reveals rates of 3% in the in the poorest fifth of the population in compared to 15 % in the richest fifth; 5% in rural vs 11% in urban and 3-8% among less educated compared to 22% in more educated women. There is also striking variation in CS rates in hospitals of the same cadre. For example, Nsambya Hospital has a CS rate of 50.3% compared to Gulu regional referral hospital with a CS rate of 12.3%. Moreover, strikingly higher rates of CS are seen in some private institutions. In recent newspaper publications, some national newspaper reports, some private institutions are cited as having CS rates as high as 70%.\n\nBenchmarking of CS rates between facilities and across time can help demonstrate where CS rates may not be optimal (either underuse or overuse) and provide the basis to motivate change. The Robson Classification has been recommended by both the WHO and the International Federation of Gynaecology and Obstetrics (FIGO) as a global standard for assessing, monitoring, and comparing c-section rates within heath care facilities, over time and between facilities. In this system, deliveries are categorized into 10 groups based on obstetric history, onset of labour, fetal presentation, number of neonates and gestational age. This system benefits from parameters that are prospective, mutually exclusive, and totally inclusive. There are a few studies using the Robson Classification to understand facility-based rates in SSA, however to date, none have been in Uganda.\n\nIn this study, our goal is to examine CS rates using the Robson classification through a cross-Sectional Clinical Record Review of women delivering at regional referral hospitals (RRHs) and large private non-profit hospitals (PNFPs) in Uganda.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'All women admitted to the labor wards of participating institutions', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Delivery at a regional referral hospital or private not for profit hospital participating in the study\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT06090695', 'acronym': 'CRADLING', 'briefTitle': 'Cesarean Delivery in Uganda: A Mixed Methods Study', 'organization': {'class': 'OTHER', 'fullName': 'Massachusetts General Hospital'}, 'officialTitle': 'Cesarean Delivery in Uganda: A Mixed Methods Study', 'orgStudyIdInfo': {'id': '2020P002530'}}, 'contactsLocationsModule': {'locations': [{'city': 'Kampala', 'state': 'Central Region', 'country': 'Uganda', 'facility': 'Mengo Hospital', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Kampala', 'state': 'Central Region', 'country': 'Uganda', 'facility': 'Naguru General Hospital', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Kampala', 'state': 'Central Region', 'country': 'Uganda', 'facility': "Uganda Martyrs' Hospital Lubaga", 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Fort Portal', 'country': 'Uganda', 'facility': 'Fort Portal Regional Referral Hospital', 'geoPoint': {'lat': 0.66174, 'lon': 30.2748}}, {'city': 'Gulu', 'country': 'Uganda', 'facility': 'Gulu Regional Referral Hospital', 'geoPoint': {'lat': 2.77457, 'lon': 32.29899}}, {'city': 'Hoima', 'country': 'Uganda', 'facility': 'Hoima Regional Referral Hospital', 'geoPoint': {'lat': 1.43314, 'lon': 31.35241}}, {'city': 'Jinja', 'country': 'Uganda', 'facility': 'Jinja Regional Referral Hospital', 'geoPoint': {'lat': 0.43902, 'lon': 33.20317}}, {'city': 'Kabale', 'country': 'Uganda', 'facility': 'Kabale Regional Referral Hospital', 'geoPoint': {'lat': -1.24857, 'lon': 29.98993}}, {'city': 'Kampala', 'country': 'Uganda', 'facility': 'Nsambya Hospital (St. Francis Hospital Nsambya)', 'geoPoint': {'lat': 0.31628, 'lon': 32.58219}}, {'city': 'Lira', 'country': 'Uganda', 'facility': 'Lira Regional Referral Hospital', 'geoPoint': {'lat': 2.2499, 'lon': 32.89985}}, {'city': 'Lira', 'country': 'Uganda', 'facility': "St Mary's Hospital", 'geoPoint': {'lat': 2.2499, 'lon': 32.89985}}, {'city': 'Masaka', 'country': 'Uganda', 'facility': 'Masaka Regional Referral Hospital', 'geoPoint': {'lat': -0.33379, 'lon': 31.73409}}, {'city': 'Mbale', 'country': 'Uganda', 'facility': 'Mbale Regional Referral Hospital', 'geoPoint': {'lat': 1.08209, 'lon': 34.17503}}, {'city': 'Mbarara', 'country': 'Uganda', 'facility': 'Mbarara Regional Referral Hospital', 'geoPoint': {'lat': -0.60467, 'lon': 30.64851}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Massachusetts General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Mbarara University of Science and Technology', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of OB/GYN', 'investigatorFullName': 'Adeline A Boatin', 'investigatorAffiliation': 'Massachusetts General Hospital'}}}}