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Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Osvaldo A. Reyes T., Saint Thomas Hospital, Panama.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01374477
First Posted: June 16, 2011
Last Update Posted: January 5, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
  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 Osvaldo A. Reyes T., Saint Thomas Hospital, Panama:

Primary Outcome Measures:
  • 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:
  • Maternal complications [ Time Frame: Two months ]
    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 2016
Estimated Primary Completion Date: December 2015 (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

Information from the National Library of Medicine

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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
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
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: Osvaldo Reyes, MD         
Sponsors and Collaborators
Saint Thomas Hospital, Panama
Investigators
Principal Investigator: Osvaldo Reyes, MD Saint Thomas Hospital, Panama
  More Information

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 Submitted: June 14, 2011
First Posted: June 16, 2011
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:
Pre-Eclampsia
Hypertension
Hypertension, Pregnancy-Induced
Pregnancy Complications
Vascular Diseases
Cardiovascular Diseases