Blood Pressure in Adolescents With PReclampsia and Eclampsia.

Preeclampsia and Eclampsia Clinical Trial

— ADPRE  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03360240
• Other study ID #: Latin Adolescents
• Status: Completed
• Start date: August 1, 2017
• Est. completion date: March 8, 2018

Study information

• Verified date: September 2018
• Source: Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1050
• Est. completion date: March 8, 2018
• Est. primary completion date: March 8, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 12 Years to 19 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Pregnancy
• Eclampsia
• Pre-Eclampsia
• Preeclampsia and Eclampsia

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Complejo Hospitalario Dr. Arnulfo Arias Madrid

Countries where clinical trial is conducted

Bolivia,  Colombia,  Guatemala,  Honduras,  Panama,  Peru, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Levels of blood pressure	Level of blood pressure during pregnancy or delivery	after 24 weeks of gestactión to delivery.
Secondary	severe hypertension	hypertension more thet 160 mmHg on systolic or 110 mmHg on diastolyc.	after 24 weeks of gestactión to delivery.
Secondary	parity	number of previous birth	birth before actual pregancy