NCT04232137

Brief 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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
439

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2015

Status
completed

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

April 8, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2015

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2016

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

January 14, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
4 months until next milestone

Results Posted

Study results publicly available

May 7, 2020

Completed
Last Updated

May 7, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

January 14, 2020

Results QC Date

April 23, 2020

Last Update Submit

April 23, 2020

Conditions

Birth SettingMaternal Health

Keywords

Coffee ceremonyHospital-based deliveriesMaternal healthEthiopia

Outcome Measures

Primary Outcomes (1)

  • Hospital-based Delivery Rate

    Percentage of antenatal care patients that deliver in the hospital

    Up to 9 months

Secondary Outcomes (1)

  • Health Center or Health Post-delivery Rate

    Up to 9 months

Study Arms (2)

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

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

Interventions

Postpartum coffee ceremonyBEHAVIORAL

The promise of a postpartum coffee ceremony

Coffee ceremony

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Pregnant patient
  • First visit to antenatal care clinic

You may not qualify if:

  • Non-viable pregnancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Results Point of Contact

Title
Dr. Tobias Limperg
Organization
Vanderbilt University Medical Center
tobias.limperg@vumc.org
(615) 343-6710

Study Officials

  • Tobias Limperg, MD MSc

    Vanderbilt University Medical Center

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
No masking
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 14, 2020

First Posted

January 18, 2020

Study Start

April 8, 2015

Primary Completion

December 15, 2015

Study Completion

September 30, 2016

Last Updated

May 7, 2020

Results First Posted

May 7, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will share

All collected individual deidentified participant data will be shared.

Shared Documents
STUDY PROTOCOL
Time Frame
Plan: immediately following publication. End date to be determined.
Access Criteria
Anyone who wishes to access the data. For any type of purpose.