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Pregnancy ComplicationsNCT04739462

SMS Maama Project COVID-19

A study testing mHealth Platform in people with Pregnancy Complications and Birth Injuries, run by University of Minnesota at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older, women onlyHealthy volunteers can take part
Conditions the study is for
Pregnancy Complications, Birth Injuries
What is being tested?
mHealth Platform
Could I receive a placebo?
No, everyone receives an active treatment
How many people
248 participants
Where
2 sitesin 2 countries
Study dates
28 Sep 2021to 21 Oct 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • Women only
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • Females who plan to travel out of Uganda during the study period

Trial locations and contacts

2 sites in 2 countries.

2 sites in 2 countries

United States1 site

  • University of Minnesota

    Minneapolis, Minnesota, 55455

Other trials in United States

Uganda1 site

  • Makerere University

    Kampala

Other trials in Uganda

About this study

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

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.

Read the 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.
Being tested
mHealth Platform
Medical subject headings
Pregnancy Complications, Birth Injuries

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • mHealth PlatformBehavioural

    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.

Study groups in NCT04739462
Study groupRoleWhat they receive
InterventionExperimentalParticipants in this arm will receive the study intervention.
Receives: Behavioral: mHealth Platform
Routine Antenatal CareNo interventionParticipants in this arm will receive no intervention.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: up to 18 weeks

Secondary outcomes (7)

  1. 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.

    Measured: up to 18 weeks

  2. Rate of COVID Testing

    Outcome is reported as the percent of pregnant participants who were tested for SARS-CoV-2 during pregnancy.

    Measured: up to 18 weeks

  3. 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.

    Measured: up to 18 weeks

  4. 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.

    Measured: up to 18 weeks

  5. Antenatal Care Rate

    Outcome is reported as the percent of pregnant participants who attend at least 4 antenatal care visits.

    Measured: up to 18 weeks

  6. Skilled Birth Attendance Rate

    Outcome is reported as the percent of pregnant participants who give birth at a hospital.

    Measured: up to 18 weeks

  7. 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).

    Measured: up to 18 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2021
  2. Study start28 Sep 2021
  3. Primary completion21 Oct 2021
  4. Study completion21 Oct 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
248 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04739462
Sponsor's protocol ID
STUDY00010582
Status last verified
Apr 2022
First submitted
1 Feb 2021
Last updated
14 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing mHealth Platform in people with Pregnancy Complications and Birth Injuries, run by University of Minnesota at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, Uganda. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in Pre- to Post-Intervention Knowledge (time frame: up to 18 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04739462.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2022.

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