Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity

Preeclampsia Clinical Trial

Official title:

Hypertensive Disorders of Pregnancy in Adolescence and the Primipaternity Concept. Cases and Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01374477
• Other study ID #: MHST2011-05
• Status: Recruiting
• Phase: N/A
• First received: June 14, 2011
• Last updated: January 1, 2015
• Start date: June 2012
• Est. completion date: January 2016

Study information

• Verified date: January 2015
• Source: Saint Thomas Hospital, Panama
• Contact: Leisa Rosas, MD
• Phone: 66146306
• Email: lcr10[@]hotmail.com
• Is FDA regulated: No
• Health authority: Panama: Ministry of Health
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 110
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 19 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Hypertension
• Pre-Eclampsia
• Preeclampsia
• Pregnancy Complications

Locations

Country	Name	City	State
Panama	Saint Thomas Hospital	Panama

Sponsors (1)

Lead Sponsor	Collaborator
Saint Thomas Hospital, Panama

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of a primipaternity factor	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).	Two months	No
Secondary	Maternal complications	Presence of a complication related to preeclampsia: abruptio placenta, HELLP syndrome, eclampsia.	Two months	No