HealthyNCT00452647
Comparison of Blood Pressure Throughout Pregnancy
An observational study of Healthy, run by Drexel University College of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to observe and analyze variation of diastolic blood pressure measurements at third trimester of pregnancy and when they present for delivery in comparison to healthy volunteers. When patients present for delivery, we expect blood pressure to be lower than normal. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women only
- Conditions the study is for
- Healthy
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2007to Feb 2010
- 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 18 to 40 years
- Women only
- No healthy volunteers
- Adult
Study population: Population defined as parturients who present for delivery. See Eligibility Criteria.
Who may be able to join
- Females age 18-40
- Parturients who present for delivery who are not yet in labor
Who cannot join
- Patients with hypertension, cardiac disease, diabetes, or thyroid disorders
- Parturients who are already in labor upon presentation to the labor floor
Trial locations and contacts
1 site in 1 country.
United States1 site
Hahnemann University Hospital
Philadelphia, Pennsylvania, 19102
About this study
The purpose of this study is to observe and analyze variation of diastolic blood pressure measurements at third trimester of pregnancy and when they present for delivery in comparison to healthy volunteers.
When patients present for delivery, we expect blood pressure to be lower than normal. However this is not the case. We aim to determine where this trend occurs throughout to duration of pregnancy, and propose possible explanation as to the source of this event.
After discharge, the information recorded includes each patient's blood pressure upon admission to the labor floor, and several blood pressure measurements from prior clinical visits.
- Conditions
- Healthy
- Keywords
- Condition: No specific disease is being studied, few procedures are excluded., Focus: To obtain blood pressure data and detect any trends to a statistically significant degree.
What is being measured
The primary outcome is the main question the study is designed to answer.
Measurment of blood pressure throught pregnancy
Measured: 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2007 (estimated)
- Study startFeb 2007
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: data did not indicate any meaningful information
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University College of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marcus Zebrower, Drexel University
- Investigators
- Jay Horrow, MD, Study chair, Drexel University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00452647
- Sponsor's protocol ID
- 16807
- Status last verified
- Sep 2013
- First submitted
- 26 Mar 2007
- Last updated
- 9 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Blood Pressure Throughout Pregnancy
- ClinicalTrials.gov ID
- NCT00452647
- Acronym / sponsor ID
- 16807
- Conditions
- Healthy
- Keywords
- Condition: No specific disease is being studied, few procedures are excluded., Focus: To obtain blood pressure data and detect any trends to a statistically significant degree.
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: data did not indicate any meaningful information
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Drexel University College of MedicineUniversity, hospital or other
- Study start
- Feb 2007
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 27 Mar 2007 (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.
The purpose of this study is to observe and analyze variation of diastolic blood pressure measurements at third trimester of pregnancy and when they present for delivery in comparison to healthy volunteers.
When patients present for delivery, we expect blood pressure to be lower than normal. However this is not the case. We aim to determine where this trend occurs throughout to duration of pregnancy, and propose possible explanation as to the source of this event.
After discharge, the information recorded includes each patient's blood pressure upon admission to the labor floor, and several blood pressure measurements from prior clinical visits.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Population defined as parturients who present for delivery. See Eligibility Criteria.
Key inclusion criteria (2 listed)
- Females age 18-40
- Parturients who present for delivery who are not yet in labor
Key exclusion criteria (2 listed)
- Patients with hypertension, cardiac disease, diabetes, or thyroid disorders
- Parturients who are already in labor upon presentation to the labor floor
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
Measurment of blood pressure throught pregnancy
Time frame: 9 months
Results and safety
The study was stopped early (reason given: data did not indicate any meaningful information). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2013.
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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.
Jay Horrow, MD study chair
Drexel University College of Medicine
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 Healthy, run by Drexel University College of Medicine at 1 site in United States.
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: stopped early, as of the sponsor's last update on 9 Sep 2013. 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 United States. 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?
The study was stopped early (reason given: data did not indicate any meaningful information). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measurment of blood pressure throught pregnancy (time frame: 9 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 9 Sep 2013.