Blood Pressure in Adolescents With PReclampsia and Eclampsia.
NCT ID: NCT03360240
Last Updated: 2018-09-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1050 participants
OBSERVATIONAL
2017-08-01
2018-03-08
Brief Summary
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Multicenter case-control study (Latin America). Maternities in Latin America: Two hospitals in Panama, one hospital in Mexico, one hospital in El Salvador, one hospital in Guatemala, two hospitals in Honduras, one hospital in Colombia, two hospitals in Peru and two hospitals in Bolivia.
The objective is to evaluate the basal levels of blood pressure during pregnancy and determine if there is any increase that is associated with the development of preeclampsia and eclampsia without reaching the known values of 140/90 mm Hg.
The sample is 1050: (350 Cases and 700 Controls).
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Detailed Description
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It is unknown whether the blood pressure levels used for the diagnosis of preeclampsia have the same impact in adolescents as in older women, however for the diagnosis of preeclampsia and severe hypertension the same criteria of hypertension are used regardless of age maternal.
It is necessary to do research to determine the values of blood pressure with which adolescents convulse and also to validate if slight increases in baseline blood pressure in adolescents are associated with prediction of preeclampsia and eclampsia.
Unfortunately, 85% of teenage pregnancies occur in non-industrialized countries such as those in Latin America, and it is estimated that 25% of maternal deaths occur in adolescents
Cases: patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that is 24 and more weeks pregnant with prenatal control started before 20 weeks of pregnancy. Controls are patients with the same criteria but WITHOUT hypertension during this pregnancy.
The statistical analyzes are based on comparing blood pressure levels between the two groups, in addition blood pressure levels like 30/15 on the systolic and diastolic basal levels will be created and compared between the two groups, especially when it is not possible to have 140 / 90 mm Hg.
Conditions
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Study Design
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CASE_CONTROL
CROSS_SECTIONAL
Study Groups
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Cases
Cases: patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that is 24 and more weeks pregnant with prenatal control started before 20 weeks of pregnancy.
No interventions assigned to this group
controls
Are patients with pregnancy that starts before the age of 19 that without develops (preeclampsia mild), severe preeclampsia, gestational hypertension or eclampsia) that is 24 and more weeks pregnant with prenatal control started before 20 weeks of pregnancy.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
12 Years
19 Years
FEMALE
No
Sponsors
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Complejo Hospitalario Dr. Arnulfo Arias Madrid
OTHER
Responsible Party
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Paulino Vigil-De Gracia
Gynecology and Obstetric
Principal Investigators
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Paulino Vigil
Role: PRINCIPAL_INVESTIGATOR
Complejo CSS
Locations
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Hospital del seguridad social La Paz
La Paz, , Bolivia
Hospital de Pereira
Pereira, , Colombia
Hospital de IGSS, Guatemala
Guatemala City, , Guatemala
Hospial de Honduras
Tegucigalpa, , Honduras
Complejo Hospitalario CSS
Panama City, , Panama
Santo Tomás
Panama City, , Panama
Hospital Regional de Cajamarca
Cajamarca, , Peru
Hospital Nacional Docente Madre Niño, San Bartolomé,
Lima, , Peru
Countries
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Other Identifiers
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Latin Adolescents
Identifier Type: -
Identifier Source: org_study_id
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