Cesarean Delivery in Uganda: A Mixed Methods Study (CRADLING)

October 18, 2023 updated by: Adeline A Boatin, Massachusetts General Hospital

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

Active, not recruiting

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

Observational

Enrollment (Estimated)

9000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Fort Portal, Uganda
        • Fort Portal Regional Referral Hospital
      • Gulu, Uganda
        • Gulu Regional Referral Hospital
      • Hoima, Uganda
        • Hoima Regional referral Hospital
      • Jinja, Uganda
        • Jinja Regional Referral Hospital
      • Kabale, Uganda
        • Kabale Regional Referral Hospital
      • Kampala, Uganda
        • Nsambya Hospital (St. Francis Hospital Nsambya)
      • Lira, Uganda
        • Lira Regional Referral Hospital
      • Lira, Uganda
        • St Mary's Hospital
      • Masaka, Uganda
        • Masaka Regional Referral Hospital
      • Mbale, Uganda
        • Mbale Regional Referral Hospital
      • Mbarara, Uganda
        • Mbarara Regional Referral Hospital
    • Central
      • Kampala, Central, Uganda
        • Mengo Hospital
    • Central Region
      • Kampala, Central Region, Uganda
        • Naguru General Hospital
      • Kampala, Central Region, Uganda
        • Uganda Martyrs' Hospital Lubaga

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

All women admitted to the labor wards of participating institutions

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • none

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

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
up to hospital discharge, an average of 3 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2021

Primary Completion (Actual)

August 31, 2022

Study Completion (Estimated)

December 31, 2023

Study Registration Dates

First Submitted

July 27, 2021

First Submitted That Met QC Criteria

October 18, 2023

First Posted (Actual)

October 19, 2023

Study Record Updates

Last Update Posted (Actual)

October 19, 2023

Last Update Submitted That Met QC Criteria

October 18, 2023

Last Verified

October 1, 2023

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)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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