Blood Pressure in Adolescents With PReclampsia and Eclampsia.

NCT ID: NCT03360240

Last Updated: 2018-09-18

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

1050 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-08-01

Study Completion Date

2018-03-08

Brief Summary

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Levels of blood pressure in adolescents with preeclampsia and eclampsia:

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).

Detailed Description

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Levels of blood pressure in adolescents with preeclampsia and eclampsia: cases and controls study.

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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Adolescent Pregnancy Preeclampsia and Eclampsia

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

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

* Criteria for inclusion cases: Patients with pregnancy that starts before the age of 19 that develops preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that has 24 and more weeks of pregnancy with prenatal control started before 20 weeks of age. pregnancy. That you get the data of the termination of your pregnancy.

Exclusion Criteria

* Patients with pregnancy that starts before 19 years of age that does NOT develop preeclampsia (mild), severe preeclampsia, gestational hypertension and eclampsia, that has 24 and more weeks of pregnancy with prenatal control started before 20 weeks of pregnancy. That you get the data of the termination of your pregnancy.
Minimum Eligible Age

12 Years

Maximum Eligible Age

19 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Complejo Hospitalario Dr. Arnulfo Arias Madrid

OTHER

Sponsor Role lead

Responsible Party

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Paulino Vigil-De Gracia

Gynecology and Obstetric

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Hospital de Pereira

Pereira, , Colombia

Site Status

Hospital de IGSS, Guatemala

Guatemala City, , Guatemala

Site Status

Hospial de Honduras

Tegucigalpa, , Honduras

Site Status

Complejo Hospitalario CSS

Panama City, , Panama

Site Status

Santo Tomás

Panama City, , Panama

Site Status

Hospital Regional de Cajamarca

Cajamarca, , Peru

Site Status

Hospital Nacional Docente Madre Niño, San Bartolomé,

Lima, , Peru

Site Status

Countries

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Bolivia Colombia Guatemala Honduras Panama Peru

Other Identifiers

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Latin Adolescents

Identifier Type: -

Identifier Source: org_study_id

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