Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity
This study is currently recruiting participants.
Verified June 2012 by Saint Thomas Hospital, Panama
Sponsor:
Saint Thomas Hospital, Panama
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
| Tracking Information | |||||||||
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| First Received Date ICMJE | June 14, 2011 | ||||||||
| Last Updated Date | June 7, 2012 | ||||||||
| Start Date ICMJE | June 2012 | ||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
Presence of a primipaternity factor [ Time Frame: Two months ] [ Designated as safety issue: No ] The presence of primipaternity factor. They include:
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01374477 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
Maternal complications [ Time Frame: Two months ] [ Designated as safety issue: No ] Presence of a complication related to preeclampsia: abruptio placenta, HELLP syndrome, eclampsia. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity | ||||||||
| Official Title ICMJE | Hypertensive Disorders of Pregnancy in Adolescence and the Primipaternity Concept. Cases and Control Trial | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case Control Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Probability Sample | ||||||||
| Study Population | Patients < 19 years old who delivered in our institution. |
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| Condition ICMJE | Preeclampsia | ||||||||
| Intervention ICMJE | Not Provided | ||||||||
| Study Group/Cohort (s) |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 110 | ||||||||
| Estimated Completion Date | October 2012 | ||||||||
| Estimated Primary Completion Date | September 2012 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||||||
| Ages | up to 19 Years | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Panama | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01374477 | ||||||||
| Other Study ID Numbers ICMJE | MHST2011-05 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| Responsible Party | Osvaldo A. Reyes T., Saint Thomas Hospital, Panama | ||||||||
| Study Sponsor ICMJE | Saint Thomas Hospital, Panama | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE | Not Provided | ||||||||
| Information Provided By | Saint Thomas Hospital, Panama | ||||||||
| Verification Date | June 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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