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Trial record 4 of 10 for:    Open Studies | "Pregnancy in Adolescence"

Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity

This study is currently recruiting participants. (see Contacts and Locations)
Verified June 2013 by Saint Thomas Hospital, Panama
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier:
NCT01374477
First received: June 14, 2011
Last updated: June 30, 2013
Last verified: June 2013
  Purpose

Hypertensive disorders of pregnancy are one of the most frequent complications of pregnancy, being a serious health problem around the world.

Previous studies have suggested that there is an association between a short period of exposure to paternal sperm of a new sexual partner and the development of an immunological reaction that could trigger a hypertensive disorder of pregnancy. For this reason we want to study the relationship between the primipaternity concept (exposure to male antigens present in semen over a short period of time previous to the pregnancy) and the development of preeclampsia in adolescents.


Condition
Preeclampsia

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Hypertensive Disorders of Pregnancy in Adolescence and the Primipaternity Concept. Cases and Control Trial

Resource links provided by NLM:


Further study details as provided by Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • Presence of a primipaternity factor [ Time Frame: Two months ] [ Designated as safety issue: No ]

    The presence of primipaternity factor. They include:

    1. Sexual Cohabitation (timeframe between first sexual intercourse and pregnancy < 4 months)without the use of a barrier contraceptive.
    2. Oral sex with ejaculation (previous to pregnancy < 4 months).


Secondary Outcome Measures:
  • Maternal complications [ Time Frame: Two months ] [ Designated as safety issue: No ]
    Presence of a complication related to preeclampsia: abruptio placenta, HELLP syndrome, eclampsia.


Estimated Enrollment: 110
Study Start Date: June 2012
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Adolescent with preeclampsia
Patients < 19 years old who delivered in our institution (vaginal birth or cesarean) that developed a hypertensive disorder of pregnancy.
Normal adolescent
Patients < 19 years old who delivered in our institution (vaginal birth or cesarean) without developing a hypertensive disorder of pregnancy.

  Eligibility

Ages Eligible for Study:   up to 19 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients < 19 years old who delivered in our institution.

Criteria

Inclusion Criteria:

  • 19 year old or less
  • Pregnancy > 24 weeks at the moment of delivery

Exclusion Criteria:

  • 20 years old or more.
  • Pregnancy < 24 weeks at the moment of delivery
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01374477

Contacts
Contact: Leisa Rosas, MD 66146306 lcr10@hotmail.com
Contact: Osvaldo Reyes, MD 65655041 investigacionmaternidadhst@yahoo.com

Locations
Panama
Saint Thomas Hospital Recruiting
Panama, Panama, 1439 zona 9A
Principal Investigator: Leisa Rosas, MD         
Principal Investigator: Osvalldo Reyes, MD         
Sponsors and Collaborators
Saint Thomas Hospital, Panama
  More Information

No publications provided

Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01374477     History of Changes
Other Study ID Numbers: MHST2011-05
Study First Received: June 14, 2011
Last Updated: June 30, 2013
Health Authority: Panama: Ministry of Health

Keywords provided by Saint Thomas Hospital, Panama:
Preeclampsia in Adolescence
Adolescent
Primipaternity

Additional relevant MeSH terms:
Hypertension
Pre-Eclampsia
Pregnancy Complications
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Vascular Diseases

ClinicalTrials.gov processed this record on November 20, 2014