SMS Maama Project COVID-19

Pregnancy Complications Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04739462
• Other study ID #: STUDY00010582
• Status: Completed
• Phase: N/A
• Start date: September 28, 2021
• Est. completion date: October 21, 2021

Study information

• Verified date: April 2022
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 248
• Est. completion date: October 21, 2021
• Est. primary completion date: October 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Birth Injuries
• Pregnancy Complications

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.

Locations

Country	Name	City	State
Uganda	Makerere University	Kampala
United States	University of Minnesota	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	Makerere University

Countries where clinical trial is conducted

United States,  Uganda, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	up to 18 weeks
Secondary	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.	up to 18 weeks
Secondary	Rate of COVID Testing	Outcome is reported as the percent of pregnant participants who were tested for SARS-CoV-2 during pregnancy.	up to 18 weeks
Secondary	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.	up to 18 weeks
Secondary	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.	up to 18 weeks
Secondary	Antenatal Care Rate	Outcome is reported as the percent of pregnant participants who attend at least 4 antenatal care visits.	up to 18 weeks
Secondary	Skilled Birth Attendance Rate	Outcome is reported as the percent of pregnant participants who give birth at a hospital.	up to 18 weeks
Secondary	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).	up to 18 weeks