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Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity

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ClinicalTrials.gov Identifier: NCT01374477
Recruitment Status : Unknown
Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was:  Recruiting
First Posted : June 16, 2011
Last Update Posted : January 5, 2015
Sponsor:
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

Study Description
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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
Preeclampsia

Study Design
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Study Type : Observational
Estimated 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 : June 2012
Estimated Primary Completion Date : December 2015
Estimated Study Completion Date : January 2016

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. Presence of a primipaternity factor [ Time Frame: Two months ]

    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 :
  1. Maternal complications [ Time Frame: Two months ]
    Presence of a complication related to preeclampsia: abruptio placenta, HELLP syndrome, eclampsia.


Eligibility Criteria
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Ages Eligible for Study:   up to 19 Years   (Child, Adult)
Sexes 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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01374477


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

Locations
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Panama
Saint Thomas Hospital Recruiting
Panama, Panama, 1439 zona 9A
Principal Investigator: Leisa Rosas, MD         
Principal Investigator: Osvaldo Reyes, MD         
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
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Principal Investigator: Osvaldo Reyes, MD Saint Thomas Hospital, Panama
More Information
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Responsible Party: Osvaldo A. Reyes T., MD, Saint Thomas Hospital, Panama
ClinicalTrials.gov Identifier: NCT01374477     History of Changes
Other Study ID Numbers: MHST2011-05
First Posted: June 16, 2011    Key Record Dates
Last Update Posted: January 5, 2015
Last Verified: January 2015
Keywords provided by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:
Preeclampsia in Adolescence
Adolescent
Primipaternity
Additional relevant MeSH terms:
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Toxemia
Pre-Eclampsia
Hypertension
Hypertension, Pregnancy-Induced
 Pregnancy Complications
Vascular Diseases
Cardiovascular Diseases
Infection