ADPRE: Blood Pressure in Adolescents With PReclampsia and Eclampsia.

Sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid (Other)
Overall Status
Completed
CT.gov ID
NCT03360240
Collaborator
(none)
1,050
8
7.2
131.3
18.2

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    1050 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Cross-Sectional
    Official Title:
    Levels of Blood Pressure in Adolescents With Preclampsia and Eclampsia: Study of Cases and Controls.
    Actual Study Start Date :
    Aug 1, 2017
    Actual Primary Completion Date :
    Mar 8, 2018
    Actual Study Completion Date :
    Mar 8, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Levels of blood pressure [after 24 weeks of gestactión to delivery.]

      Level of blood pressure during pregnancy or delivery

    Secondary Outcome Measures

    1. severe hypertension [after 24 weeks of gestactión to delivery.]

      hypertension more thet 160 mmHg on systolic or 110 mmHg on diastolyc.

    2. parity [birth before actual pregancy]

      number of previous birth

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    12 Years to 19 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hospital del seguridad social La Paz La Paz Bolivia
    2 Hospital de Pereira Pereira Colombia
    3 Hospital de IGSS, Guatemala Guatemala Guatemala
    4 Hospial de Honduras Tegucigalpa Honduras
    5 Complejo Hospitalario CSS Panama Panama
    6 Santo Tomás Panamá Panama
    7 Hospital Regional de Cajamarca Cajamarca Peru
    8 Hospital Nacional Docente Madre Niño, San Bartolomé, Lima Peru

    Sponsors and Collaborators

    • Complejo Hospitalario Dr. Arnulfo Arias Madrid

    Investigators

    • Principal Investigator: Paulino Vigil, Complejo CSS

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Paulino Vigil-De Gracia, Gynecology and Obstetric, Complejo Hospitalario Dr. Arnulfo Arias Madrid
    ClinicalTrials.gov Identifier:
    NCT03360240
    Other Study ID Numbers:
    • Latin Adolescents
    First Posted:
    Dec 4, 2017
    Last Update Posted:
    Sep 18, 2018
    Last Verified:
    Sep 1, 2018
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Sep 18, 2018