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
• Sponsor: Complejo Hospitalario Dr. Arnulfo Arias Madrid
• Information provided by (Responsible Party): Paulino Vigil-De Gracia, Complejo Hospitalario Dr. Arnulfo Arias Madrid

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
Adolescent Pregnancy; Preeclampsia and Eclampsia

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
• 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

Groups and Cohorts

Group/Cohort
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 [ Time Frame: after 24 weeks of gestactión to delivery. ]
   Level of blood pressure during pregnancy or delivery

Secondary Outcome Measures :

1. severe hypertension [ Time Frame: after 24 weeks of gestactión to delivery. ]
   hypertension more thet 160 mmHg on systolic or 110 mmHg on diastolyc.
2. parity [ Time Frame: birth before actual pregancy ]
   number of previous birth

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 19 Years (Child, Adult)
• Sexes Eligible for Study: 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.

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.

Contacts and Locations

Locations

Bolivia

Hospital del seguridad social La Paz

La Paz, Bolivia

Colombia

Hospital de Pereira

Pereira, Colombia

Guatemala

Hospital de IGSS, Guatemala

Guatemala, Guatemala

Honduras

Hospial de Honduras

Tegucigalpa, Honduras

Panama

Complejo Hospitalario CSS

Panama, Panama

Santo Tomás

Panamá, Panama

Peru

Hospital Regional de Cajamarca

Cajamarca, Peru

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

More Information

Additional Information:

• 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: December 4, 2017
• Last Update Posted: September 18, 2018
• Last Verified: September 2018

Individual Participant Data (IPD) Sharing Statement:

• 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:

Pre-Eclampsia; Eclampsia; Hypertension, Pregnancy-Induced; Pregnancy Complications