An interventional study of mHealth Platform in Pregnancy Complications and Birth Injuries, sponsored by University of Minnesota. Completed at 2 sites in 2 countries. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-04-14.
Sponsored by University of Minnesota · Not applicable, Interventional, and Prevention
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.
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;
437 studies on the registry are indexed under Pregnancy Complications; 119 are open to participants now.
This study's enrollment of 248 is above the median of 147 across 220 interventional studies indexed under Pregnancy Complications.
Browse Pregnancy Complications studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants in this arm will receive the study intervention.
Behavioral: mHealth Platform
Participants in this arm will receive no intervention.
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.
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.
Time frame: up to 18 weeks
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.
Time frame: up to 18 weeks
Rate of COVID Testing
Outcome is reported as the percent of pregnant participants who were tested for SARS-CoV-2 during pregnancy.
Time frame: up to 18 weeks
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.
Time frame: up to 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.
Time frame: up to 18 weeks
Antenatal Care Rate
Outcome is reported as the percent of pregnant participants who attend at least 4 antenatal care visits.
Time frame: up to 18 weeks
Skilled Birth Attendance Rate
Outcome is reported as the percent of pregnant participants who give birth at a hospital.
Time frame: up to 18 weeks
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).
Time frame: up to 18 weeks
This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
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