PreeclampsiaNCT01374477
Hypertensive Disorders of Pregnancy in Adolescence and Primipaternity
An observational study of Preeclampsia, run by Saint Thomas Hospital, Panama at 1 site in Panama.
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… Read more about this study
- Who is it for?
- Ages Up to 19 years, women only
- Conditions the study is for
- Preeclampsia
- How many people
- 110 participants
- Where
- 1 sitePanama
- Study dates
- Jun 2012to Jan 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Study population: Patients < 19 years old who delivered in our institution.
Who may be able to join
- 19 year old or less
- Pregnancy > 24 weeks at the moment of delivery
Who cannot join
- 20 years old or more.
- Pregnancy < 24 weeks at the moment of delivery
Trial locations and contacts
1 site in 1 country.
Panama1 site, 1 recruiting
- Recruiting
Saint Thomas Hospital
Panama City, Provincia de Panamá, 1439 zona 9A
Leisa Rosas, MD
Osvaldo Reyes, MD
About this study
Official title: 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.
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia in Adolescence, Adolescent, Primipaternity
- Medical subject headings
- Pre-Eclampsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Two months
Secondary outcomes (1)
Maternal complications
Presence of a complication related to preeclampsia: abruptio placenta, HELLP syndrome, eclampsia.
Measured: Two months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2011 (estimated)
- Study startJun 2012
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PreeclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Saint Thomas Hospital, Panama
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Osvaldo A. Reyes T., Saint Thomas Hospital, Panama
- Investigators
- Osvaldo Reyes, MD, Principal investigator, Saint Thomas Hospital, Panama
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01374477
- Sponsor's protocol ID
- MHST2011-05
- Status last verified
- Jan 2015
- First submitted
- 14 Jun 2011
- Last updated
- 5 Jan 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hypertensive Disorders of Pregnancy in Adolescence and the Primipaternity Concept. Cases and Control Trial
- ClinicalTrials.gov ID
- NCT01374477
- Acronym / sponsor ID
- MHST2011-05
- Conditions
- Preeclampsia
- Keywords
- Preeclampsia in Adolescence, Adolescent, Primipaternity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Saint Thomas Hospital, PanamaUniversity, hospital or other
- Study start
- Jun 2012
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 16 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- Up to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients < 19 years old who delivered in our institution.
Key inclusion criteria (2 listed)
- 19 year old or less
- Pregnancy > 24 weeks at the moment of delivery
Key exclusion criteria (2 listed)
- 20 years old or more.
- Pregnancy < 24 weeks at the moment of delivery
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
1 secondary outcome
Maternal complications
Time frame: Two months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Osvaldo Reyes, MD principal investigator
Saint Thomas Hospital, Panama
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia, run by Saint Thomas Hospital, Panama at 1 site in Panama.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Panama. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Leisa Rosas, MD (66146306, lcr10@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Presence of a primipaternity factor (time frame: Two months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2015.