NCT06090695

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
9,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2021

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2021

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

July 27, 2021

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 31, 2022

Completed
1.1 years until next milestone

First Posted

Study publicly available on registry

October 19, 2023

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 19, 2023

Status Verified

October 1, 2023

Enrollment Period

1.3 years

First QC Date

July 27, 2021

Last Update Submit

October 18, 2023

Conditions

Keywords

cesarean section rateglobal surgeryquality of care

Outcome Measures

Primary Outcomes (1)

  • Cesarean section rate

    as above

    3 months

Secondary Outcomes (2)

  • Severe Maternal Outcome

    up to hospital discharge, an average of 3 days

  • Adverse Perinatal Outcome

    up to hospital discharge, an average of 3 days

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All women admitted to the labor wards of participating institutions

You may qualify if:

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

You may not qualify if:

  • none

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Mengo Hospital

Kampala, Central Region, Uganda

Location

Naguru General Hospital

Kampala, Central Region, Uganda

Location

Uganda Martyrs' Hospital Lubaga

Kampala, Central Region, Uganda

Location

Fort Portal Regional Referral Hospital

Fort Portal, Uganda

Location

Gulu Regional Referral Hospital

Gulu, Uganda

Location

Hoima Regional Referral Hospital

Hoima, Uganda

Location

Jinja Regional Referral Hospital

Jinja, Uganda

Location

Kabale Regional Referral Hospital

Kabale, Uganda

Location

Nsambya Hospital (St. Francis Hospital Nsambya)

Kampala, Uganda

Location

Lira Regional Referral Hospital

Lira, Uganda

Location

St Mary's Hospital

Lira, Uganda

Location

Masaka Regional Referral Hospital

Masaka, Uganda

Location

Mbale Regional Referral Hospital

Mbale, Uganda

Location

Mbarara Regional Referral Hospital

Mbarara, Uganda

Location

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor of OB/GYN

Study Record Dates

First Submitted

July 27, 2021

First Posted

October 19, 2023

Study Start

May 1, 2021

Primary Completion

August 31, 2022

Study Completion

December 31, 2023

Last Updated

October 19, 2023

Record last verified: 2023-10

Data Sharing

IPD Sharing
Will not share

Locations