Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03360240
Recruitment Status : Completed
First Posted : December 4, 2017
Last Update Posted : September 18, 2018
Sponsor:
Information provided by (Responsible Party):
Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid

Tracking Information
First Submitted Date November 28, 2017
First Posted Date December 4, 2017
Last Update Posted Date September 18, 2018
Actual Study Start Date August 1, 2017
Actual Primary Completion Date March 8, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 28, 2017)
Levels of blood pressure [ Time Frame: after 24 weeks of gestactión to delivery. ]
Level of blood pressure during pregnancy or delivery
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03360240 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: November 28, 2017)
  • severe hypertension [ Time Frame: after 24 weeks of gestactión to delivery. ]
    hypertension more thet 160 mmHg on systolic or 110 mmHg on diastolyc.
  • parity [ Time Frame: birth before actual pregancy ]
    number of previous birth
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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.
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration 11 Months
Biospecimen Not Provided
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.
Condition
  • Adolescent Pregnancy
  • Preeclampsia and Eclampsia
Intervention Not Provided
Study Groups/Cohorts
  • 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 16, 2018)
1050
Original Estimated Enrollment
 (submitted: November 28, 2017)
718
Actual Study Completion Date March 8, 2018
Actual Primary Completion Date March 8, 2018   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: Female
Ages 12 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Peru,   Bolivia,   Colombia,   Guatemala,   Honduras,   Panama
Removed Location Countries Mexico
 
Administrative Information
NCT Number NCT03360240
Other Study ID Numbers Latin Adolescents
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid
Study Sponsor Complejo Hospitalario Dr. Arnulfo Arias Madrid
Collaborators Not Provided
Investigators
Principal Investigator: Paulino Vigil Complejo CSS
PRS Account Complejo Hospitalario Dr. Arnulfo Arias Madrid
Verification Date September 2018