Blood Pressure in Adolescents With PReclampsia and Eclampsia. (ADPRE)

Levels of Blood Pressure in Adolescents With Preclampsia and Eclampsia: Study of Cases and Controls.

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).

Study Overview

• Status: Completed
• Conditions: Adolescent Pregnancy; Preeclampsia and Eclampsia

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.

• Study Type: Observational
• Enrollment (Actual): 1050

Contacts and Locations

Study Locations

• Bolivia
  • La Paz, Bolivia
    • Hospital del seguridad social La Paz
• Colombia
  • Pereira, Colombia
    • Hospital de Pereira
• Guatemala
  • Guatemala, Guatemala
    • Hospital de IGSS, Guatemala
• Honduras
  • Tegucigalpa, Honduras
    • Hospial de Honduras
• Panama
  • Panama, Panama
    • Complejo Hospitalario CSS
  • Panamá, Panama
    • Santo Tomás
• Peru
  • Cajamarca, Peru
    • Hospital Regional de Cajamarca
  • Lima, Peru
    • Hospital Nacional Docente Madre Niño, San Bartolomé,

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years to 19 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Levels of blood pressure	Level of blood pressure during pregnancy or delivery	after 24 weeks of gestactión to delivery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
severe hypertension	hypertension more thet 160 mmHg on systolic or 110 mmHg on diastolyc.	after 24 weeks of gestactión to delivery.
parity	number of previous birth	birth before actual pregancy

Collaborators and Investigators

• Sponsor: Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Investigators: Principal Investigator: Paulino Vigil, Complejo CSS

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2017
• Primary Completion (Actual): March 8, 2018
• Study Completion (Actual): March 8, 2018

Study Registration Dates

• First Submitted: November 28, 2017
• First Submitted That Met QC Criteria: November 28, 2017
• First Posted (Actual): December 4, 2017

Study Record Updates

• Last Update Posted (Actual): September 18, 2018
• Last Update Submitted That Met QC Criteria: September 16, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pregnancy Complications; Hypertension, Pregnancy-Induced; Eclampsia; Pre-Eclampsia
• Other Study ID Numbers: Latin Adolescents

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No