- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04232137
Traditional Ethiopian Coffee Ceremony in a Rural Ethiopian Hospital to Increase Hospital-based Delivery Rates
April 23, 2020 updated by: Tobias Limperg, Vanderbilt University Medical Center
This study evaluates if organizing a postpartum traditional Ethiopian coffee ceremony will provide an incentive for our antenatal care patients to eventually deliver in our hospital.
Patients are randomized to either receiving, or not receiving, a postpartum coffee ceremony for them and their relatives.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Ethiopia has one of the highest maternal mortality rates in the world, with an estimated maternal mortality ratio of 497 per 100,000 live births.
Cultural factors contribute to the underutilization of maternal health services.
In 2014, only 20% of our antenatal care patients delivered in our hospital.
In order to increase health facility-based delivery rates, government-funded hospitals and health centers facilitate traditional Ethiopian coffee ceremonies after delivery.
We hypothesized that organizing postpartum coffee ceremonies would motivate our antenatal care patients to deliver in our hospital and would thus increase the hospital-based delivery rate.
Study Type
Interventional
Enrollment (Actual)
439
Phase
- Not Applicable
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
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Pregnant patient
- First visit to antenatal care clinic
Exclusion Criteria:
- Non-viable pregnancy
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
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Coffee ceremony
Antenatal care patients will be told on their first antenatal care visit that a postpartum coffee ceremony will be organized for them and up to 4 relatives
|
The promise of a postpartum coffee ceremony
|
No Intervention: NO Coffee ceremony
Antenatal care patients will be told that they will NOT receive a postpartum coffee ceremony, as is the current status quo
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hospital-based Delivery Rate
Time Frame: Up to 9 months
|
Percentage of antenatal care patients that deliver in the hospital
|
Up to 9 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Health Center or Health Post-delivery Rate
Time Frame: Up to 9 months
|
Percentage of antenatal care patients that deliver in an associated health center or health post
|
Up to 9 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Tobias Limperg, MD MSc, Vanderbilt University Medical Center
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)
April 8, 2015
Primary Completion (Actual)
December 15, 2015
Study Completion (Actual)
September 30, 2016
Study Registration Dates
First Submitted
January 14, 2020
First Submitted That Met QC Criteria
January 14, 2020
First Posted (Actual)
January 18, 2020
Study Record Updates
Last Update Posted (Actual)
May 7, 2020
Last Update Submitted That Met QC Criteria
April 23, 2020
Last Verified
April 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- GH/LUC/909
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
All collected individual deidentified participant data will be shared.
IPD Sharing Time Frame
Plan: immediately following publication.
End date to be determined.
IPD Sharing Access Criteria
Anyone who wishes to access the data.
For any type of purpose.
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
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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