Blood Pressure in Adolescents With PReclampsia and Eclampsia.

NCT03360240 | Completed

• 1 other identifier: Latin Adolescents
• Study Type: observational
• Target: 1,050
• Locations: 6 countries
• Sites: 8

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).

Conditions

Adolescent Pregnancy; Preeclampsia and Eclampsia

Outcome Measures

Primary Outcomes (1)

• Levels of blood pressure

  Level of blood pressure during pregnancy or delivery

  after 24 weeks of gestactión to delivery.

Secondary Outcomes (2)

• severe hypertension

  after 24 weeks of gestactión to delivery.

• parity

  birth before actual pregancy

Study Arms (2)

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.

Eligibility Criteria

• Age: 12 Years - 19 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Complejo Hospitalario Dr. Arnulfo Arias Madrid: lead

Study Sites (8)

Hospital del seguridad social La Paz

La Paz, Bolivia

Location

Hospital de Pereira

Pereira, Colombia

Location

Hospital de IGSS, Guatemala

Guatemala City, Guatemala

Location

Hospial de Honduras

Tegucigalpa, Honduras

Location

Complejo Hospitalario CSS

Panama City, Panama

Location

Santo Tomás

Panama City, Panama

Location

Hospital Regional de Cajamarca

Cajamarca, Peru

Location

Hospital Nacional Docente Madre Niño, San Bartolomé,

Lima, Peru

Location

MeSH Terms

Conditions

Pre-Eclampsia; Eclampsia

Condition Hierarchy (Ancestors)

Hypertension, Pregnancy-Induced; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Paulino Vigil

  Complejo CSS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 11 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Gynecology and Obstetric

Study Record Dates

• First Submitted: November 28, 2017
• First Posted: December 4, 2017
• Study Start: August 1, 2017
• Primary Completion: March 8, 2018
• Study Completion: March 8, 2018
• Last Updated: September 18, 2018

Record last verified: 2018-09

Data Sharing

• IPD Sharing: Will not share

Locations

PE (2); BO (1); CO (1); HO (1); PA (2); GU (1)