Birth SettingNCT04232137
Traditional Ethiopian Coffee Ceremony in a Rural Ethiopian Hospital to Increase Hospital-based Delivery Rates
A study testing Postpartum coffee ceremony in people with Birth Setting and Maternal Health, run by Vanderbilt University Medical Center.
Trial summary
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. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Birth Setting, Maternal Health
- What is being tested?
- Postpartum coffee ceremony
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 439 participants
- Where
- No sites listed yet
- Study dates
- 8 Apr 2015to 30 Sep 2016
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Who may be able to join
- Pregnant patient
- First visit to antenatal care clinic
Who cannot join
- Non-viable pregnancy
About this study
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.
Read the 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.
- Conditions
- Birth Setting, Maternal Health
- Being tested
- Postpartum coffee ceremony
- Keywords
- Coffee ceremony, Hospital-based deliveries, Maternal health, Ethiopia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postpartum coffee ceremonyBehavioural
The promise of a postpartum coffee ceremony
| Study group | Role | What they receive |
|---|---|---|
| Coffee ceremony | Experimental | 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 Receives: Behavioral: Postpartum coffee ceremony |
| NO Coffee ceremony | No intervention | Antenatal care patients will be told that they will NOT receive a postpartum coffee ceremony, as is the current status quo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital-based Delivery Rate
Percentage of antenatal care patients that deliver in the hospital
Measured: Up to 9 months
Secondary outcomes (1)
Health Center or Health Post-delivery Rate
Percentage of antenatal care patients that deliver in an associated health center or health post
Measured: Up to 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start8 Apr 2015
- Primary completion15 Dec 2015
- Study completion30 Sep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Birth SettingStudies of the same condition, open and under way.
- More trials run by Vanderbilt University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 439 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Gambo General Rural Hospital, University of Missouri, Kansas City
- Responsible party
- Principal investigator, Tobias Limperg, Vanderbilt University Medical Center
- Investigators
- Tobias Limperg, MD MSc, Principal investigator, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04232137
- Sponsor's protocol ID
- GH/LUC/909
- Status last verified
- Apr 2020
- First submitted
- 14 Jan 2020
- Last updated
- 7 May 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected individual deidentified participant data will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Traditional Ethiopian Coffee Ceremony in a Rural Ethiopian Hospital to Increase Hospital-based Delivery Rates
- ClinicalTrials.gov ID
- NCT04232137
- Acronym / sponsor ID
- GH/LUC/909
- Conditions
- Birth Setting, Maternal Health
- Keywords
- Coffee ceremony, Hospital-based deliveries, Maternal health, Ethiopia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 439 participants (actual)
- Lead sponsor
- Vanderbilt University Medical CenterUniversity, hospital or other
- Collaborators
- Gambo General Rural Hospital, University of Missouri, Kansas City
- Study start
- 8 Apr 2015 (actual)
- Primary completion
- 15 Dec 2015 (actual)
- Study completion
- 30 Sep 2016 (actual)
- First posted
- 18 Jan 2020 (actual)
- Results
- Posted 7 May 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Coffee ceremony | Experimental | Behavioral: Postpartum coffee ceremonyAntenatal 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 |
| NO Coffee ceremony | No intervention | –Antenatal care patients will be told that they will NOT receive a postpartum coffee ceremony, as is the current status quo |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Pregnant patient
- First visit to antenatal care clinic
Key exclusion criteria (1 listed)
- Non-viable pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postpartum coffee ceremonyThe promise of a postpartum coffee ceremony | Behavioural | Coffee ceremony |
Primary outcome
Hospital-based Delivery Rate
Time frame: Up to 9 months
Percentage of antenatal care patients that deliver in the hospital
1 secondary outcome
Health Center or Health Post-delivery Rate
Time frame: Up to 9 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. All collected individual deidentified participant data will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Tobias Limperg, MD MSc principal investigator
Vanderbilt University Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Postpartum coffee ceremony in people with Birth Setting and Maternal Health, run by Vanderbilt University Medical Center.
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 2 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 7 May 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Yes. Results are posted in the registry (first posted 7 May 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Hospital-based Delivery Rate (time frame: Up to 9 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 7 May 2020.