Skip to main content
OpenTrials
Completed

NCT Number: NCT04739462

SMS Maama Project COVID-19

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Pregnancy Complications Birth Injuries Congenital, Hereditary, and Neonatal Diseases and Abnormalities Female Urogenital Diseases and Pregnancy Complications Infant, Newborn, Diseases Urogenital Diseases Wounds and Injuries

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Makerere University, Kampala, Uganda

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

mHealth Platform

Behavioral

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 outcomes

  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 outcomes

  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).

Sponsors and collaborators

Lead sponsor

University of Minnesota

Other

Collaborators

  • Makerere University

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Feb 4, 2021
Registry last updated
Apr 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.