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Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity

Sponsor
Saint Thomas Hospital, Panama (Other)
Overall Status
Unknown status
CT.gov ID
NCT01374477
Collaborator
(none)
110
Enrollment
1
Location
43
Duration (Months)
2.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    110 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Hypertensive Disorders of Pregnancy in Adolescence and the Primipaternity Concept. Cases and Control Trial
    Study Start Date :
    Jun 1, 2012
    Anticipated Primary Completion Date :
    Dec 1, 2015
    Anticipated Study Completion Date :
    Jan 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    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.

    Outcome Measures

    Primary Outcome Measures

    1. Presence of a primipaternity factor [Two months]

      The presence of primipaternity factor. They include: Sexual Cohabitation (timeframe between first sexual intercourse and pregnancy < 4 months)without the use of a barrier contraceptive. Oral sex with ejaculation (previous to pregnancy < 4 months).

    Secondary Outcome Measures

    1. Maternal complications [Two months]

      Presence of a complication related to preeclampsia: abruptio placenta, HELLP syndrome, eclampsia.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 19 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    No
    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

    Locations

    Site City State Country Postal Code
    1 Saint Thomas Hospital Panama Panama 1439 zona 9A

    Sponsors and Collaborators

    • Saint Thomas Hospital, Panama

    Investigators

    • Principal Investigator: Osvaldo Reyes, MD, Saint Thomas Hospital, Panama

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
    ClinicalTrials.gov Identifier:
    NCT01374477
    Other Study ID Numbers:
    • MHST2011-05
    First Posted:
    Jun 16, 2011
    Last Update Posted:
    Jan 5, 2015
    Last Verified:
    Jan 1, 2015
    Keywords provided by Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
    Preeclampsia in Adolescence
    Adolescent
    Primipaternity
    Additional relevant MeSH terms:
    Toxemia
    Pre-Eclampsia
    Hypertension

    Study Results

    No Results Posted as of Jan 5, 2015