SMS Maama Project COVID-19
Primary Purpose
Pregnancy Complications, Birth Injuries
Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
mHealth Platform
Sponsored by
About this trial
This is an interventional prevention trial for Pregnancy Complications
Eligibility Criteria
Inclusion Criteria:
- Own a personal mobile phone
- Attend ANC at Kisenyi Health Centre IV, Kawempe Hospital or Rubaga Hospital
- Are at least 24-26 weeks estimated gestational age
- Literate in English or Luganda
- Capable of sending/receiving text messages
Exclusion Criteria:
- Females who plan to travel out of Uganda during the study period
Sites / Locations
- University of Minnesota
- Makerere University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention
Routine Antenatal Care
Arm Description
Participants in this arm will receive the study intervention.
Participants in this arm will receive no intervention.
Outcomes
Primary Outcome Measures
Change in Pre- to Post-Intervention Knowledge
Outcome is reported as the percent of pregnant participants who recognize key danger signs during pregnancy, labor and childbirth, and postpartum period. Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks.
Secondary Outcome Measures
Change in Knowledge on COVID-19
Outcome reported as the percent of pregnant participants who identify key symptoms, modes of transmission, and measures to prevent SARS-CoV-2 infection (COVID-19). Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks.
Rate of COVID Testing
Outcome is reported as the percent of pregnant participants who were tested for SARS-CoV-2 during pregnancy.
Change in Pregnancy Risk Knowledge
Outcome is reported as the percent of pregnant participants who believe pregnant females are at increased risk for COVID-19. Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks.
Change in Breastfeeding Knowledge
Outcome is reported as the percent of pregnant participants who believe it is safe to breastfeed their newborn if they have or have had COVID-19. Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks.
Antenatal Care Rate
Outcome is reported as the percent of pregnant participants who attend at least 4 antenatal care visits.
Skilled Birth Attendance Rate
Outcome is reported as the percent of pregnant participants who give birth at a hospital.
Rate of Negative Pregnancy Outcomes
Outcome is reported as the percent of pregnant participants who experience a negative pregnancy outcome (e.g. maternal/neonatal complications, miscarriage, stillbirth, and/or neonatal death).
Full Information
NCT ID
NCT04739462
First Posted
February 1, 2021
Last Updated
April 13, 2022
Sponsor
University of Minnesota
Collaborators
Makerere University
1. Study Identification
Unique Protocol Identification Number
NCT04739462
Brief Title
SMS Maama Project COVID-19
Official Title
mHealth for Improvement of Access to Maternal Health Services in the Era of COVID-19 Pandemic (SMS Maama Project)
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Completed
Study Start Date
September 28, 2021 (Actual)
Primary Completion Date
October 21, 2021 (Actual)
Study Completion Date
October 21, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
Makerere University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
The study's purpose is to demonstrate the ability of an mHealth platform as a feasible way of sharing information in a time of restricted movement in order to inform future studies.
Detailed Description
The primary objective of this trial is to assess whether an mHealth platform increases maternal health knowledge in the areas of birth preparedness, pregnancy, and birth complications as measured by the pre- and post-surveys in comparison to routine antenatal care.
The secondary objectives of this trial are;
To provide knowledge of COVID-19 symptoms, transmission, diagnosis, and treatment, in a time of social distancing and learning.
To improve access and linkages to maternal health services and information as well as provide appropriate referrals for pregnant females.
Inform the adoption of mHealth into future health delivery plans.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pregnancy Complications, Birth Injuries
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
248 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention
Arm Type
Experimental
Arm Description
Participants in this arm will receive the study intervention.
Arm Title
Routine Antenatal Care
Arm Type
No Intervention
Arm Description
Participants in this arm will receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
mHealth Platform
Intervention Description
All participants randomized to the intervention group will receive 2-4 informational texts each week and will also receive interactive health screening questions throughout enrollment. A participant will also receive appointment reminder texts. All SMS text messages will be transmitted through a local organization known as The Medical Concierge Group (TMCG) via an electronic system that allows for bulk messaging. TMCG also staffs a 24-hour call line for those using TMCG services to call in for medical related questions. This call line is staffed by doctors and nurses; SMS Maama participants randomized to the interventional group will be able to access this call line free of charge as part of their enrollment in SMS Maama.
Primary Outcome Measure Information:
Title
Change in Pre- to Post-Intervention Knowledge
Description
Outcome is reported as the percent of pregnant participants who recognize key danger signs during pregnancy, labor and childbirth, and postpartum period. Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks.
Time Frame
up to 18 weeks
Secondary Outcome Measure Information:
Title
Change in Knowledge on COVID-19
Description
Outcome reported as the percent of pregnant participants who identify key symptoms, modes of transmission, and measures to prevent SARS-CoV-2 infection (COVID-19). Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks.
Time Frame
up to 18 weeks
Title
Rate of COVID Testing
Description
Outcome is reported as the percent of pregnant participants who were tested for SARS-CoV-2 during pregnancy.
Time Frame
up to 18 weeks
Title
Change in Pregnancy Risk Knowledge
Description
Outcome is reported as the percent of pregnant participants who believe pregnant females are at increased risk for COVID-19. Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks.
Time Frame
up to 18 weeks
Title
Change in Breastfeeding Knowledge
Description
Outcome is reported as the percent of pregnant participants who believe it is safe to breastfeed their newborn if they have or have had COVID-19. Knowledge is measured pre-intervention (approximately 24-26 weeks gestation) and post-intervention (approximately 2 weeks following delivery). The timeframe is calculated to be 16-18 weeks.
Time Frame
up to 18 weeks
Title
Antenatal Care Rate
Description
Outcome is reported as the percent of pregnant participants who attend at least 4 antenatal care visits.
Time Frame
up to 18 weeks
Title
Skilled Birth Attendance Rate
Description
Outcome is reported as the percent of pregnant participants who give birth at a hospital.
Time Frame
up to 18 weeks
Title
Rate of Negative Pregnancy Outcomes
Description
Outcome is reported as the percent of pregnant participants who experience a negative pregnancy outcome (e.g. maternal/neonatal complications, miscarriage, stillbirth, and/or neonatal death).
Time Frame
up to 18 weeks
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Own a personal mobile phone
Attend ANC at Kisenyi Health Centre IV, Kawempe Hospital or Rubaga Hospital
Are at least 24-26 weeks estimated gestational age
Literate in English or Luganda
Capable of sending/receiving text messages
Exclusion Criteria:
- Females who plan to travel out of Uganda during the study period
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Betty Nakabuye, MBChB, MMed
Organizational Affiliation
Lubaga Hospital and School of Public Health, Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jolly Beyeza
Organizational Affiliation
Mulago Specialised Women's Hospital and School of Medicine, Makerere University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Katelyn Pastick
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Cheryl Robertson
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Makerere University
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Learn more about this trial
SMS Maama Project COVID-19
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