FindTrial
Sign In

Application for the detection of the risk of increased blood pressure at the beginning of pregnancy

Assistance Application for Prediction of Preeclampsia in the First Trimester Gestational Quarter: Randomized Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-5vcmzfs
Enrollment
Unknown
Registered
2024-08-21
Start date
2024-08-10
Completion date
Unknown
Last updated
2025-10-27

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

Conditions

Preeclampsia

Interventions

It is an experimental study, a randomized clinical trial (RCT) of two groups (intervention and control), double-blind to be implemented in 3 moments: capture, telemonitoring and outcome
In order to evaluate the effectiveness of the PREApp? assistance application in predicting preeclampsia in the first gestational trimester (11+0 to 13+6 weeks) in clinical practice. Thus, the Interven
And, the Control Group (CG) by pregnant women who will be accompanied by the standard prenatal consultation combined with risk assessment according to the American College of Obstetricians and Gynecol
As well as arterial pressures, for measurement of the mean arterial pressure (MAP) of the first trimester, but specifically between 11weeks 0 days and 13 weeks and 6 days of gestational age (11+0 to 1
I01.320
V03.175.250.500.500
L01.224.900.685

Sponsors

Universidade Federal do Ceará
Lead Sponsor
Universidade Federal do Ceará
Collaborator
Hospital Geral Dr César Cals
Collaborator
Maternidade Escola Assis Chateaubrinand da Universidade Federal do Ceará
Collaborator

Eligibility

Sex/Gender
Female

Inclusion criteria

Inclusion criteria: Pregnant women over 18 or under 18 who are accompanied by a legal guardian; Unique pregnancy; Pregnancy between 11+0 and 13+6 weeks of evolution

Exclusion criteria

Exclusion criteria: prior kidney disease; Committed physical or mental health that makes interaction with researchers unfeasible at any time of study data collection

Design outcomes

Primary

MeasureTime frame
Women in the intervention group are expected to have a positive prediction rate of pre-eclampsia of up to 70% compared to the control group in which a positive prediction rate of around 40% is expected.—

Secondary

MeasureTime frame
It is expected that women who participated in the intervention group will present better obstetric and neonatal outcomes compared to those who participated in the control group, who will present worse obstetric and neonatal outcomes.—

Countries

Brazil

Contacts

Public ContactJoão Teixeira

Universidade Federal do Ceará

joadsond@yahoo.com.br+55(85)999034026

Outcome results

None listed

Source: REBEC (via WHO ICTRP)