- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06090695
Cesarean Delivery in Uganda: A Mixed Methods Study (CRADLING)
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.
The 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.
Study Overview
Status
Conditions
Detailed Description
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.
Recent 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.
There 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%.
Benchmarking 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.
In 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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Locations
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Fort Portal, Uganda
- Fort Portal Regional Referral Hospital
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Gulu, Uganda
- Gulu Regional Referral Hospital
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Hoima, Uganda
- Hoima Regional referral Hospital
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Jinja, Uganda
- Jinja Regional Referral Hospital
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Kabale, Uganda
- Kabale Regional Referral Hospital
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Kampala, Uganda
- Nsambya Hospital (St. Francis Hospital Nsambya)
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Lira, Uganda
- Lira Regional Referral Hospital
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Lira, Uganda
- St Mary's Hospital
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Masaka, Uganda
- Masaka Regional Referral Hospital
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Mbale, Uganda
- Mbale Regional Referral Hospital
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Mbarara, Uganda
- Mbarara Regional Referral Hospital
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Central
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Kampala, Central, Uganda
- Mengo Hospital
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Central Region
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Kampala, Central Region, Uganda
- Naguru General Hospital
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Kampala, Central Region, Uganda
- Uganda Martyrs' Hospital Lubaga
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Delivery at a regional referral hospital or private not for profit hospital participating in the study
Exclusion Criteria:
- none
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cesarean section rate
Time Frame: 3 months
|
as above
|
3 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Severe Maternal Outcome
Time Frame: up to hospital discharge, an average of 3 days
|
Composite of measure that includes WHO near miss morbidity criteria and maternal mortality
|
up to hospital discharge, an average of 3 days
|
|
Adverse Perinatal Outcome
Time Frame: up to hospital discharge, an average of 3 days
|
Composite measure of adverse perinatal outcomes including stillbirth, neonatal death, neonatal admission
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up to hospital discharge, an average of 3 days
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Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- 2020P002530
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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