Clinical trial NCT06090695: Cesarean Delivery in Uganda: A Mixed Methods Study
Official title: Cesarean Delivery in Uganda: A Mixed Methods Study
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Cesarean Section Rates
Keywords: cesarean section rate
global surgery
quality of care
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: Mbarara University of Science and Technology
First posted: 2023-10-19
Enrollment: 9000
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: All women admitted to the labor wards of participating institutions

Brief summary: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Delivery at a regional referral hospital or private not for profit hospital participating in the study

Exclusion Criteria:

* none

Primary outcomes:
measure: Cesarean section rate
timeFrame: 3 months
Secondary outcomes:
measure: Severe Maternal Outcome
timeFrame: up to hospital discharge, an average of 3 days
measure: Adverse Perinatal Outcome
timeFrame: up to hospital discharge, an average of 3 days
Other outcomes:
Locations:
city: Kampala
country: Uganda
facility: Naguru General Hospital
state: Central Region
city: Kampala
country: Uganda
facility: Uganda Martyrs' Hospital Lubaga
state: Central Region
city: Kampala
country: Uganda
facility: Mengo Hospital
state: Central
city: Fort Portal
country: Uganda
facility: Fort Portal Regional Referral Hospital
city: Gulu
country: Uganda
facility: Gulu Regional Referral Hospital
city: Hoima
country: Uganda
facility: Hoima Regional Referral Hospital
city: Jinja
country: Uganda
facility: Jinja Regional Referral Hospital
city: Kabale
country: Uganda
facility: Kabale Regional Referral Hospital
city: Kampala
country: Uganda
facility: Nsambya Hospital (St. Francis Hospital Nsambya)
city: Lira
country: Uganda
facility: Lira Regional Referral Hospital
city: Lira
country: Uganda
facility: St Mary's Hospital
city: Masaka
country: Uganda
facility: Masaka Regional Referral Hospital
city: Mbale
country: Uganda
facility: Mbale Regional Referral Hospital
city: Mbarara
country: Uganda
facility: Mbarara Regional Referral Hospital
Study officials:
References: