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CompletedNCT03360240ADPREUpdated Sep 18, 2018

Blood Pressure in Adolescents With PReclampsia and Eclampsia.

An observational study in Adolescent Pregnancy and Preeclampsia and Eclampsia, sponsored by Complejo Hospitalario Dr. Arnulfo Arias Madrid. Completed at 8 sites in 6 countries. Open to female participants aged 12 Years to 19 Years. Per ClinicalTrials.gov, last updated 2018-09-18.

Sponsored by Complejo Hospitalario Dr. Arnulfo Arias Madrid · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
1,050
Ages
12 Years to 19 Years
Sex
Female
01

Study 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).

Read the 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.

02

Conditions studied

  • Adolescent Pregnancy
  • Preeclampsia and Eclampsia
03

Who can participate

Ages eligible
12 Years to 19 Years
Sexes eligible
Female
Accepts healthy volunteers
No
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.

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

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.
04

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
1,050 participants (actual)
Target follow-up
11 Months
Patient registry
Yes

Groups and 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.

05

What researchers measure

Primary outcomes

  1. Levels of blood pressure

    Level of blood pressure during pregnancy or delivery

    Time frame: after 24 weeks of gestactión to delivery.

Secondary outcomes

  1. severe hypertension

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

    Time frame: after 24 weeks of gestactión to delivery.

  2. parity

    number of previous birth

    Time frame: birth before actual pregancy

06

Study locations

8 sites
  • Hospital del seguridad social La Paz
    La Paz, Bolivia
  • Hospital de Pereira
    Pereira, Colombia
  • Hospital de IGSS, Guatemala
    Guatemala, Guatemala
  • Hospial de Honduras
    Tegucigalpa, Honduras
  • Complejo Hospitalario CSS
    Panama, Panama
  • Santo Tomás
    Panamá, Panama
  • Hospital Regional de Cajamarca
    Cajamarca, Peru
  • Hospital Nacional Docente Madre Niño, San Bartolomé,
    Lima, Peru
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03360240
Lead sponsor
Complejo Hospitalario Dr. Arnulfo Arias Madrid
Responsible party
Paulino Vigil-De Gracia (Gynecology and Obstetric, Complejo Hospitalario Dr. Arnulfo Arias Madrid) — Principal investigator
First posted
Dec 4, 2017
Start date
Aug 1, 2017
Primary completion
Mar 8, 2018
Completion
Mar 8, 2018
Last update
Sep 18, 2018

Study contacts

Paulino Vigil
principal investigator · Complejo CSS

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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