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Laura-obst study: using technology to improve pregnancy care and maternal and baby health in four cities in ceará brazil

Laura-obst study: implementation of digital health tools to improve prenatal care quality and gestational outcomes in four municipalities in the state of ceará brazil

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-3y5v567
Enrollment
1152
Registered
2026-07-09
Start date
2026-07-15
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Pregnancy Maternal Health

Interventions

This is a prospective implementation study using a cluster-randomized clinical trial design. Pregnant women enrolled during the first trimester of pregnancy in participating Family Health Strategy pre

Sponsors

Faculdade de Ciências Médicas - UNICAMP
Lead Sponsor
Saúde, Alegria e Sustentabilidade Brasil
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Women of any age with pregnancy confirmed by clinical and/or laboratory methods; women enrolled in the SUS Prenatal Care Program during the first trimester of pregnancy, up to 20 weeks; women with gestational age determined by the date of the last menstrual period (LMP); women assigned to a Family Health Unit (USF) participating in the study; women who sign the written informed consent form

Exclusion criteria

Exclusion criteria: Women who are unable to understand or access the digital health tools; women without self-care capacity; women with neurological disabilities that prevent full understanding of the guidance provided by the study team; women who move to a municipality outside the project’s coverage area; women who express the wish not to participate in the study at any time

Design outcomes

Primary

MeasureTime frame
It is expected to find improvements in prenatal care quality and pregnancy outcomes associated with the implementation of a package of digital health interventions in four municipalities in Ceará with limited access to medical specialists

Secondary

MeasureTime frame
It is expected to observe high acceptance and utilization of digital health tools among pregnant women and health professionals during routine prenatal care;It is expected to find increased adherence to prenatal care recommendations and improvements in prenatal care quality indicators following the implementation of a package of digital health interventions;It is expected to observe an increased capacity for early diagnosis of major first-trimester pregnancy conditions, including ectopic pregnancy, molar pregnancy, and fetal malformations, as well as common gestational conditions such as gestational diabetes mellitus, hypertensive disorders of pregnancy, and risk of prematurity, following the implementation of a package of digital health interventions;It is expected to find an increased prevalence of diagnosed pathological conditions during pregnancy as a result of expanded access to digital health tools for screening and diagnosis;It is expected to observe improved pregnancy-related clinical outcomes following the implementation of a package of digital health interventions, including higher gestational age at birth, lower prevalence of prematurity, higher birth weight, lower prevalence of small-for-gestational-age newborns, fewer hospitalization days, and fewer lost workdays during pregnancy;It is expected to observe that the implementation costs of the digital health intervention package will be partially or fully offset by reductions in patient travel required to access health care services

Countries

BR

Contacts

Public ContactAdriana Mallet

SAS Brasil

adriana@sasbrasil.org.br+55(19)98111-6060

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Sep 19, 2026