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Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity

This study is currently recruiting participants.
Verified June 2012 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 7, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

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: October 2012
Estimated Primary Completion Date: September 2012 (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
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 7, 2012
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
Eclampsia
Polyhydramnios
Pregnancy, Ectopic
 Vascular Diseases
Cardiovascular Diseases
Hypertension, Pregnancy-Induced
Pregnancy Complications

ClinicalTrials.gov processed this record on May 23, 2013