Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity
1 other identifier
observational
110
1 country
1
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.
Trial Health
Trial Health Score
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participants targeted
Target at P50-P75 for all trials
Started Jun 2012
Typical duration for all trials
1 active site
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Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2011
CompletedFirst Posted
Study publicly available on registry
June 16, 2011
CompletedStudy Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2016
CompletedJanuary 5, 2015
January 1, 2015
3.5 years
June 14, 2011
January 1, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Presence of a primipaternity factor
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).
Two months
Secondary Outcomes (1)
Maternal complications
Two months
Study Arms (2)
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 Criteria
Patients \< 19 years old who delivered in our institution.
You may qualify if:
- year old or less
- Pregnancy \> 24 weeks at the moment of delivery
You may not qualify if:
- years old or more.
- Pregnancy \< 24 weeks at the moment of delivery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Saint Thomas Hospital
Panama City, Provincia de Panamá, 1439 zona 9A, Panama
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Osvaldo Reyes, MD
Saint Thomas Hospital, Panama
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
June 14, 2011
First Posted
June 16, 2011
Study Start
June 1, 2012
Primary Completion
December 1, 2015
Study Completion
January 1, 2016
Last Updated
January 5, 2015
Record last verified: 2015-01