Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity

January 1, 2015 updated by: Osvaldo A. Reyes T., Saint Thomas Hospital, Panama

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

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.

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

110

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Panama
      • Panama, Panama, 1439 zona 9A
        • Recruiting
        • Saint Thomas Hospital
        • Principal Investigator:
          • Leisa Rosas, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients < 19 years old who delivered in our institution.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
Two months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maternal complications
Time Frame: Two months
Presence of a complication related to preeclampsia: abruptio placenta, HELLP syndrome, eclampsia.
Two months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Saint Thomas Hospital, Panama

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (ANTICIPATED)

December 1, 2015

Study Completion (ANTICIPATED)

January 1, 2016

Study Registration Dates

First Submitted

June 14, 2011

First Submitted That Met QC Criteria

June 15, 2011

First Posted (ESTIMATE)

June 16, 2011

Study Record Updates

Last Update Posted (ESTIMATE)

January 5, 2015

Last Update Submitted That Met QC Criteria

January 1, 2015

Last Verified

January 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MHST2011-05

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Preeclampsia

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe