Clinical trial NCT03360240: Blood Pressure in Adolescents With PReclampsia and Eclampsia.
Official title: Levels of Blood Pressure in Adolescents With Preclampsia and Eclampsia: Study of Cases and Controls.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Adolescent Pregnancy
Preeclampsia and Eclampsia
Lead sponsor: Complejo Hospitalario Dr. Arnulfo Arias Madrid
Sponsor class: OTHER
First posted: 2017-12-04
Enrollment: 1050
Sex: FEMALE
Minimum age (years): 12
Maximum age (years): 19
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Pregnant patients who are 19 years of age or younger and more than 23 weeks pregnant, where the cases are those that develop preeclampsia (mild), severe preclampsia, gestational hypertension and eclampsia; and the controls patients of the same age and with more than 23 weeks of pregnancy without hypertension.

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Levels of blood pressure
timeFrame: after 24 weeks of gestactión to delivery.
Secondary outcomes:
measure: severe hypertension
timeFrame: after 24 weeks of gestactión to delivery.
measure: parity
timeFrame: birth before actual pregancy
Other outcomes:
Locations:
city: La Paz
country: Bolivia
facility: Hospital del seguridad social La Paz
city: Pereira
country: Colombia
facility: Hospital de Pereira
city: Guatemala
country: Guatemala
facility: Hospital de IGSS, Guatemala
city: Tegucigalpa
country: Honduras
facility: Hospial de Honduras
city: Panama
country: Panama
facility: Complejo Hospitalario CSS
city: Panamá
country: Panama
facility: Santo Tomás
city: Cajamarca
country: Peru
facility: Hospital Regional de Cajamarca
city: Lima
country: Peru
facility: Hospital Nacional Docente Madre Niño, San Bartolomé,
Study officials:
affiliation: Complejo CSS
name: Paulino Vigil
role: PRINCIPAL_INVESTIGATOR
References: