Tocolysis With NifedipineNCT02902354
Changes in Central Arterial Pressure of Normotensive Women Taking Nifedipine for Tocolysis
A study testing Nifedipine for tocolysis in people with Tocolysis With Nifedipine, run by St. Louis University.
Trial summary
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for uterine contraction suppression Read more about this study
- Who is it for?
- Ages 14 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tocolysis With Nifedipine
- What is being tested?
- Nifedipine for tocolysis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Jan 2017
- Phase
- Interventional
- 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 50 years
- Women only
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Singleton pregnancy
- Currently receiving tocolysis with nifedipine (10 or 20mg q4-6 hours)
Who cannot join
- Multiple pregnancy
- Diagnosis of hypertensive disorder in pregnancy or blood pressures 140/90 or higher on -more than 2 occasions.
- Currently on antihypertensive medications (Nifedipine XL, labetalol, hydralazine, methyl-dopa, etc)
- Currently on other tocolytic medications (exp: magnesium, Indocin)
- Narcotic use
- Renal diseaseI
Show all 18Show fewer
- Irregular heart rhythms or arrhythmias
- Peripheral arterial disease, leg artery disease
- Reynaud's phenomena
- Intense cold/hypothermia
- If there is a wound at location of where central arterial cuff would be placed or tonometer for carotid assessment
- Severe tachycardia (>120)
- Greater than 1st degree heart block
- Severe asthma
- Congestive heart failure or heart disease
- Lupus, rheumatoid arthritis
- Inability to adequately monitor BP
- Magnesium treatment
About this study
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for uterine contraction suppression
Read the detailed description
Only women whom have been prescribed nifedipine tocolysis by their covering obstetrician will be approached to participate in the study.
The patient will take their nifedipine as scheduled, we will attain central arterial pressure reading in addition to arterial waveform measurements. These will be collected:
Before administration of the medication Every 20 minutes for 3 hours (total of 10 measurements)
-This timing will allow measurements through approximately 2 half lives Routine sphygmomanometry will also be completed at the testing times All of these measurements will be collected for study purposes, although the nurses will have the opportunity to record the routine blood pressure measurements for their charting/vital signs assessment if they desire.
Once the patient has been monitored for 3 hours, her participation in the study is considered complete and no additional information will be collected. Each patient will serve as her own control (blood pressure prior to administration of medication), no randomization will occur.
- Conditions
- Tocolysis With Nifedipine
- Being tested
- Nifedipine for tocolysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine for tocolysisOther
Also called Standard of care
observational
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine for tocolysis | Other | Only women receiving nifedipine (as standard of care) for tocolysis Receives: Other: Nifedipine for tocolysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.
Measured: every 20 min for 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2016 (estimated)
- Study startSep 2016
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tocolysis With NifedipineStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- 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
- NCT02902354
- Sponsor's protocol ID
- 27468
- Status last verified
- Nov 2017
- First submitted
- 12 Sep 2016
- Last updated
- 13 Nov 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 13 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changes in Central Arterial Pressure of Normotensive Women Taking Nifedipine for Tocolysis
- ClinicalTrials.gov ID
- NCT02902354
- Acronym / sponsor ID
- 27468
- Conditions
- Tocolysis With Nifedipine
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 15 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.
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for uterine contraction suppression
Detailed description
Only women whom have been prescribed nifedipine tocolysis by their covering obstetrician will be approached to participate in the study.
The patient will take their nifedipine as scheduled, we will attain central arterial pressure reading in addition to arterial waveform measurements. These will be collected:
Before administration of the medication Every 20 minutes for 3 hours (total of 10 measurements)
-This timing will allow measurements through approximately 2 half lives Routine sphygmomanometry will also be completed at the testing times All of these measurements will be collected for study purposes, although the nurses will have the opportunity to record the routine blood pressure measurements for their charting/vital signs assessment if they desire.
Once the patient has been monitored for 3 hours, her participation in the study is considered complete and no additional information will be collected. Each patient will serve as her own control (blood pressure prior to administration of medication), no randomization will occur.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Nifedipine for tocolysis | Other | Other: Nifedipine for tocolysisOnly women receiving nifedipine (as standard of care) for tocolysis |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Singleton pregnancy
- Currently receiving tocolysis with nifedipine (10 or 20mg q4-6 hours)
Key exclusion criteria (18 listed)
- Multiple pregnancy
- Diagnosis of hypertensive disorder in pregnancy or blood pressures 140/90 or higher on -more than 2 occasions.
- Currently on antihypertensive medications (Nifedipine XL, labetalol, hydralazine, methyl-dopa, etc)
- Currently on other tocolytic medications (exp: magnesium, Indocin)
- Narcotic use
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nifedipine for tocolysisAlso: Standard of careobservational | Other | Nifedipine for tocolysis |
Primary outcome
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.
Time frame: every 20 min for 3 hours
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis.
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 13 Nov 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
Questions about this trial
What is this clinical trial studying?
A study testing Nifedipine for tocolysis in people with Tocolysis With Nifedipine, run by St. Louis University.
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 18 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 13 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
To determine the central blood pressure changes in normotensive women who are receiving nifedipine for tocolysis. (time frame: every 20 min for 3 hours). 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 13 Nov 2017.