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SMS Maama Project COVID-19

mHealth for Improvement of Access to Maternal Health Services in the Era of COVID-19 Pandemic (SMS Maama Project)

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04739462
Enrollment
248
Registered
2021-02-04
Start date
2021-09-28
Completion date
2021-10-21
Last updated
2022-04-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Birth Injuries, Pregnancy Complications

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; 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.

Interventions

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.

Sponsors

Makerere University
CollaboratorOTHER
University of Minnesota
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Change in Pre- to Post-Intervention Knowledgeup to 18 weeksOutcome 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

MeasureTime frameDescription
Rate of COVID Testingup to 18 weeksOutcome is reported as the percent of pregnant participants who were tested for SARS-CoV-2 during pregnancy.
Change in Pregnancy Risk Knowledgeup to 18 weeksOutcome 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 Knowledgeup to 18 weeksOutcome 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.
Change in Knowledge on COVID-19up to 18 weeksOutcome 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.
Skilled Birth Attendance Rateup to 18 weeksOutcome is reported as the percent of pregnant participants who give birth at a hospital.
Rate of Negative Pregnancy Outcomesup to 18 weeksOutcome 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).
Antenatal Care Rateup to 18 weeksOutcome is reported as the percent of pregnant participants who attend at least 4 antenatal care visits.

Countries

Uganda, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026