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SMS Maama Project COVID-19

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04739462
Recruitment Status : Completed
First Posted : February 4, 2021
Last Update Posted : April 14, 2022
Sponsor:
Collaborator:
Makerere University
Information provided by (Responsible Party):
University of Minnesota

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.

Condition or disease Intervention/treatment Phase
Pregnancy Complications Birth Injuries Behavioral: mHealth Platform Not Applicable

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;

  1. To provide knowledge of COVID-19 symptoms, transmission, diagnosis, and treatment, in a time of social distancing and learning.
  2. To improve access and linkages to maternal health services and information as well as provide appropriate referrals for pregnant females.
  3. Inform the adoption of mHealth into future health delivery plans.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 248 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: mHealth for Improvement of Access to Maternal Health Services in the Era of COVID-19 Pandemic (SMS Maama Project)
Actual Study Start Date : September 28, 2021
Actual Primary Completion Date : October 21, 2021
Actual Study Completion Date : October 21, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intervention
Participants in this arm will receive the study intervention.
Behavioral: mHealth Platform
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.

No Intervention: Routine Antenatal Care
Participants in this arm will receive no intervention.



Primary Outcome Measures :
  1. Change in Pre- to Post-Intervention Knowledge [ Time Frame: up to 18 weeks ]
    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 :
  1. Change in Knowledge on COVID-19 [ Time Frame: up to 18 weeks ]
    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.

  2. Rate of COVID Testing [ Time Frame: up to 18 weeks ]
    Outcome is reported as the percent of pregnant participants who were tested for SARS-CoV-2 during pregnancy.

  3. Change in Pregnancy Risk Knowledge [ Time Frame: up to 18 weeks ]
    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.

  4. Change in Breastfeeding Knowledge [ Time Frame: up to 18 weeks ]
    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.

  5. Antenatal Care Rate [ Time Frame: up to 18 weeks ]
    Outcome is reported as the percent of pregnant participants who attend at least 4 antenatal care visits.

  6. Skilled Birth Attendance Rate [ Time Frame: up to 18 weeks ]
    Outcome is reported as the percent of pregnant participants who give birth at a hospital.

  7. Rate of Negative Pregnancy Outcomes [ Time Frame: up to 18 weeks ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04739462


Locations
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United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Uganda
Makerere University
Kampala, Uganda
Sponsors and Collaborators
University of Minnesota
Makerere University
Investigators
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Principal Investigator: Betty Nakabuye, MBChB, MMed Lubaga Hospital and School of Public Health, Makerere University
Principal Investigator: Jolly Beyeza Mulago Specialised Women's Hospital and School of Medicine, Makerere University
Principal Investigator: Katelyn Pastick University of Minnesota
Principal Investigator: Cheryl Robertson University of Minnesota
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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT04739462    
Other Study ID Numbers: STUDY00010582
First Posted: February 4, 2021    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pregnancy Complications
Birth Injuries
Infant, Newborn, Diseases
Wounds and Injuries