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Cesarean Section RatesCRADLINGNCT06090695

Cesarean Delivery in Uganda: A Mixed Methods Study

An observational study of Cesarean Section Rates, run by Massachusetts General Hospital at 14 sites in Uganda.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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%. Read more about this study

Who is it for?
Any age, women only
Conditions the study is for
Cesarean Section Rates
How many people
11,760 participants
Where
14 sitesUganda
Study dates
1 May 2021to 31 Dec 2023
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

Study population: All women admitted to the labor wards of participating institutions

Who may be able to join

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

Who cannot join

  • none

Trial locations and contacts

14 sites in 1 country.

14 sites in 1 country

Uganda14 sites
  • Fort Portal Regional Referral Hospital

    Fort Portal

  • Gulu Regional Referral Hospital

    Gulu

  • Hoima Regional Referral Hospital

    Hoima

  • Jinja Regional Referral Hospital

    Jinja

  • Kabale Regional Referral Hospital

    Kabale

  • Mengo Hospital

    Kampala, Central Region

  • Naguru General Hospital

    Kampala, Central Region

  • Uganda Martyrs' Hospital Lubaga

    Kampala, Central Region

  • Nsambya Hospital (St. Francis Hospital Nsambya)

    Kampala

  • Lira Regional Referral Hospital

    Lira

  • St Mary's Hospital

    Lira

  • Masaka Regional Referral Hospital

    Masaka

  • Mbale Regional Referral Hospital

    Mbale

  • Mbarara Regional Referral Hospital

    Mbarara

Other trials in Uganda

About this study

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.

Read the 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, the investigators 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.

Keywords
cesarean section rate, global surgery, quality of care

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Cesarean section rate

    as above

    Measured: 3 months

Secondary outcomes (2)
  1. Severe Maternal Outcome

    Composite of measure that includes WHO near miss morbidity criteria and maternal mortality

    Measured: up to hospital discharge, an average of 3 days

  2. Adverse Perinatal Outcome

    Composite measure of adverse perinatal outcomes including stillbirth, neonatal death, neonatal admission

    Measured: up to hospital discharge, an average of 3 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Oct 2023
  2. Study start1 May 2021
  3. Primary completion31 Aug 2022
  4. Study completion31 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
11,760 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06090695
Sponsor's protocol ID
2020P002530
Acronym
CRADLING
Status last verified
Jul 2026
First submitted
27 Jul 2021
Last updated
9 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Cesarean Section Rates, run by Massachusetts General Hospital at 14 sites in Uganda.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 14 sites in Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cesarean section rate (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2026.

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