Normotensive Postpartum Cesarean Section PatientsNCT02912403
Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum
An observational study of Normotensive Postpartum Cesarean Section Patients, run by St. Louis University at 1 site in United States.
Trial summary
Investigators plan to study blood pressure trends on days 3 to 6 of the postpartum period. Investigators will use a home blood pressure monitor that stays on the arm, and takes blood pressures hourly. Participants will record any symptoms that they feel are attributed to high blood pressure and pain medication use. Read more about this study
- Who is it for?
- Ages 14 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Normotensive Postpartum Cesarean Section Patients
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to Aug 2018
- 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 14 to 40 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Study population: postpartum women
Who may be able to join
- Normotensive postpartum women
- Singleton pregnancy
- Cesarean delivery
Who cannot join
- Chronic medical conditions that would put the patient at increased risk for hypertension (diabetes, lupus, renal disease)
- Current diagnosis of hypertensive disease
- Skin rash in location of cuff placement
- Tobacco user
- Chronic narcotic user
- Vaginal delivery
- cognitively impaired persons
Trial locations and contacts
1 site in 1 country.
About this study
Investigators plan to study blood pressure trends on days 3 to 6 of the postpartum period. Investigators will use a home blood pressure monitor that stays on the arm, and takes blood pressures hourly. Participants will record any symptoms that they feel are attributed to high blood pressure and pain medication use.
Read the detailed description
Participants will be screened postpartum for inclusion. Only women with cesarean deliveries will be included as they are kept for 3 days in the hospital as opposed to 2 days for vaginal deliveries. If they meet inclusion criteria they will be asked to participate in the study, and consented. Each patient will receive routine postpartum care. The ambulatory blood pressure cuff will be introduced and validated on the particpant prior to discharge. Particpants will then be given specific instructions on when to place the cuff on their am and when to remove it. The ambulatory cuff will take blood pressure measurements every hour. The Particpant will be asked to keep a log of actives, symptoms, and pain medication use for the 72 hour period that her blood pressures are being recorded. The BP device will be returned to the department of OB/GYN at St. Mary's after completion of her 72 hours of monitoring. This will occur at her first post op visit. Particpants will be asked to complete a survey about comfort of device and return with the device. Information pertaining to their pregnancy and delivery will be collected while the patient is in the hospital. Particpants are not responsible for damage or loss of equipment.
All of these procedures are part of the study.
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 |
|---|---|---|
| Postpartum Cesarean Section | We will be including postpartum women as this study idea is pertaining to recent pregnancy |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood pressure changes on days 3 to 6 of the postpartum period
To determine the normal blood pressure trends for women with uncomplicated pregnancies during days 3 to 6 of the postpartum period. These days are historically considered the "at risk days" for rising blood pressures.
Measured: days 3 to 6 of the postpartum period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2016 (estimated)
- Study startAug 2016 (estimated)
- Primary completionAug 2017 (estimated)
- Study completionAug 2018 (estimated)
Why it stopped: Unable to enroll
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Normotensive Postpartum Cesarean Section PatientsStudies 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 only
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Louis University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jennifer Goldkamp, MD, St. Louis University
- Investigators
- Jennifer Goldkamp, MD, Principal investigator, St. Louis University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02912403
- Sponsor's protocol ID
- 27285
- Status last verified
- Mar 2017
- First submitted
- 22 Aug 2016
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ambulatory Blood Pressure and the Normal Increase in Maternal Blood Pressure Postpartum
- ClinicalTrials.gov ID
- NCT02912403
- Acronym / sponsor ID
- 27285
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Unable to enroll
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Aug 2016 (estimated)
- Primary completion
- Aug 2017 (estimated)
- Study completion
- Aug 2018 (estimated)
- First posted
- 23 Sep 2016 (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.
Investigators plan to study blood pressure trends on days 3 to 6 of the postpartum period. Investigators will use a home blood pressure monitor that stays on the arm, and takes blood pressures hourly. Participants will record any symptoms that they feel are attributed to high blood pressure and pain medication use.
Detailed description
Participants will be screened postpartum for inclusion. Only women with cesarean deliveries will be included as they are kept for 3 days in the hospital as opposed to 2 days for vaginal deliveries. If they meet inclusion criteria they will be asked to participate in the study, and consented. Each patient will receive routine postpartum care. The ambulatory blood pressure cuff will be introduced and validated on the particpant prior to discharge. Particpants will then be given specific instructions on when to place the cuff on their am and when to remove it. The ambulatory cuff will take blood pressure measurements every hour. The Particpant will be asked to keep a log of actives, symptoms, and pain medication use for the 72 hour period that her blood pressures are being recorded. The BP device will be returned to the department of OB/GYN at St. Mary's after completion of her 72 hours of monitoring. This will occur at her first post op visit. Particpants will be asked to complete a survey about comfort of device and return with the device. Information pertaining to their pregnancy and delivery will be collected while the patient is in the hospital. Particpants are not responsible for damage or loss of equipment.
All of these procedures are part of the study.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Postpartum Cesarean Section | – | –We will be including postpartum women as this study idea is pertaining to recent pregnancy |
Who may qualify
- Ages
- 14 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- postpartum women
Key inclusion criteria (3 listed)
- Normotensive postpartum women
- Singleton pregnancy
- Cesarean delivery
Key exclusion criteria (7 listed)
- Chronic medical conditions that would put the patient at increased risk for hypertension (diabetes, lupus, renal disease)
- Current diagnosis of hypertensive disease
- Skin rash in location of cuff placement
- Tobacco user
- Chronic narcotic user
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
blood pressure changes on days 3 to 6 of the postpartum period
Time frame: days 3 to 6 of the postpartum period
To determine the normal blood pressure trends for women with uncomplicated pregnancies during days 3 to 6 of the postpartum period. These days are historically considered the "at risk days" for rising blood pressures.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2017.
- Individual participant dataSharing planned: No
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.
Jennifer Goldkamp, MD principal investigator
St. Louis University
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 Normotensive Postpartum Cesarean Section Patients, run by St. Louis University 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 3 inclusion and 7 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: withdrawn, as of the sponsor's last update on 6 Mar 2017. 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 withdrawn before enrolling participants, so there are no results.
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?
blood pressure changes on days 3 to 6 of the postpartum period (time frame: days 3 to 6 of the postpartum period). 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 6 Mar 2017.