Blood Pressure in Adolescents With PReclampsia and Eclampsia. (ADPRE)
|ClinicalTrials.gov Identifier: NCT03360240|
Recruitment Status : Completed
First Posted : December 4, 2017
Last Update Posted : September 18, 2018
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|
|Adolescent Pregnancy Preeclampsia and Eclampsia|
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]|
|Actual Enrollment :||1050 participants|
|Target Follow-Up Duration:||11 Months|
|Official Title:||Levels of Blood Pressure in Adolescents With Preclampsia and Eclampsia: Study of Cases and Controls.|
|Actual Study Start Date :||August 1, 2017|
|Actual Primary Completion Date :||March 8, 2018|
|Actual Study Completion Date :||March 8, 2018|
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.
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.
- Levels of blood pressure [ Time Frame: after 24 weeks of gestactión to delivery. ]Level of blood pressure during pregnancy or delivery
- 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
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03360240
|Hospital del seguridad social La Paz|
|La Paz, Bolivia|
|Hospital de Pereira|
|Hospital de IGSS, Guatemala|
|Hospial de Honduras|
|Complejo Hospitalario CSS|
|Hospital Regional de Cajamarca|
|Hospital Nacional Docente Madre Niño, San Bartolomé,|
|Principal Investigator:||Paulino Vigil||Complejo CSS|