HypertensionPhase 4NCT02902172
NSAID Use in Postpartum Hypertensive Women
A Phase 4 study testing Acetaminophen and NSAID in people with Hypertension, run by St. Louis University at 1 site in United States.
Trial summary
Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and deliver an infant via vaginal delivery will be placed into two groups in the postpartum period. One group will receive Ibuprofen for pain control and the other group will be given Tylenol. 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
- Hypertension
- What is being tested?
- Acetaminophen and NSAID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2017to 8 Oct 2017
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- vaginal delivery
- diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia
- preeclampsia without severe features
- preeclampsia with severe features gestational hypertension without severe range blood pressures
- gestational hypertension with severe range blood pressures
- singleton pregnancies
Who cannot join
- Cesarean Delivery
- no diagnosis of hypertensive disorder
- chronic or acute renal disease
- allergy to ibuprofen or acetaminophen
- lupus
- multiple order pregnancies (twins, triplets)
- Narcotic addiction/ in treatment for substance abuse/ current prescription drug user/ current use of illegal drugs
Trial locations and contacts
1 site in 1 country.
About this study
Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and deliver an infant via vaginal delivery will be placed into two groups in the postpartum period. One group will receive Ibuprofen for pain control and the other group will be given Tylenol. Blood pressures during the postpartum period will then be collected and compared in order to see if NSAIDs use increases blood pressure.
Read the detailed description
The patients who have a vaginal delivery and have the diagnosis of hypertension in pregnancy will be randomized to either Ibuprofen use or acetaminophen use during the postpartum period. Standard blood pressure monitoring in the postpartum period will be followed to help determine if there is a significant rise in the women who use NSAIDS in the postpartum period versus those that use acetaminophen.
Groups will be divided into women with chronic hypertension, women with chronic hypertension with superimposed preeclampsia, women with preeclampsia without severe features, women with preeclampsia with severe features, women with gestational hypertension without severe range blood pressures, and women with gestational hypertension with severe range blood pressures.
Recruitment will last 36 months. Patients will be monitored during their postpartum stay (typical 2 days) with blood pressure measurements. An additional 12 months will be needed for data analysis and publication.
- Conditions
- Hypertension
- Being tested
- Acetaminophen, NSAID
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcetaminophenDrug
Also called Tylenol
Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
NSAIDDrug
Also called Ibuprofen
Blood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements
| Study group | Role | What they receive |
|---|---|---|
| Acetaminophen | Other | Patients will be monitored for change in blood pressure Receives: Drug: Acetaminophen |
| NSAID | Other | Patients will be monitored during their postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements Receives: Drug: NSAID |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing systolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of systolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of systolic blood pressures from 24 hours to 47 hours after delivery.
Measured: 2 days
Secondary outcomes (1)
Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing diastolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of diastolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of diastolic blood pressures from 24 hours to 47 hours after delivery.
Measured: 2 days
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 start15 Mar 2017
- Primary completion8 Oct 2017
- Study completion8 Oct 2017
Why it stopped: Unable to recruit necessary number of patients
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HypertensionStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 36 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
- NCT02902172
- Sponsor's protocol ID
- 26976
- Status last verified
- Oct 2018
- First submitted
- 12 Sep 2016
- Last updated
- 31 Oct 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NSAID Use in Postpartum Hypertensive Women
- ClinicalTrials.gov ID
- NCT02902172
- Acronym / sponsor ID
- 26976
- Conditions
- Hypertension
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to recruit necessary number of patients
- Enrolment
- 36 participants (actual)
- Lead sponsor
- St. Louis UniversityUniversity, hospital or other
- Study start
- 15 Mar 2017 (actual)
- Primary completion
- 8 Oct 2017 (actual)
- Study completion
- 8 Oct 2017 (actual)
- First posted
- 15 Sep 2016 (estimated)
- Results
- Posted 31 Oct 2018
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Women who have the diagnosis of hypertension (pre-pregnancy and pregnancy induced) and deliver an infant via vaginal delivery will be placed into two groups in the postpartum period. One group will receive Ibuprofen for pain control and the other group will be given Tylenol. Blood pressures during the postpartum period will then be collected and compared in order to see if NSAIDs use increases blood pressure.
Detailed description
The patients who have a vaginal delivery and have the diagnosis of hypertension in pregnancy will be randomized to either Ibuprofen use or acetaminophen use during the postpartum period. Standard blood pressure monitoring in the postpartum period will be followed to help determine if there is a significant rise in the women who use NSAIDS in the postpartum period versus those that use acetaminophen.
Groups will be divided into women with chronic hypertension, women with chronic hypertension with superimposed preeclampsia, women with preeclampsia without severe features, women with preeclampsia with severe features, women with gestational hypertension without severe range blood pressures, and women with gestational hypertension with severe range blood pressures.
Recruitment will last 36 months. Patients will be monitored during their postpartum stay (typical 2 days) with blood pressure measurements. An additional 12 months will be needed for data analysis and publication.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acetaminophen | Other | Drug: AcetaminophenPatients will be monitored for change in blood pressure |
| NSAID | Other | Drug: NSAIDPatients will be monitored during their postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements |
Who may qualify
- Ages
- 14 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- vaginal delivery
- diagnosis of chronic hypertension, chronic hypertension with superimposed preeclampsia
- preeclampsia without severe features
- preeclampsia with severe features gestational hypertension without severe range blood pressures
- gestational hypertension with severe range blood pressures
Key exclusion criteria (7 listed)
- Cesarean Delivery
- no diagnosis of hypertensive disorder
- chronic or acute renal disease
- allergy to ibuprofen or acetaminophen
- lupus
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 |
|---|---|---|
| AcetaminophenAlso: TylenolBlood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements | Drug | Acetaminophen |
| NSAIDAlso: IbuprofenBlood pressure will be monitored during postpartum stay (typical 2 days) and then again at 1 week and 6 weeks (standard practice of care) with blood pressure measurements | Drug | NSAID |
Primary outcome
Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
Time frame: 2 days
To determine if NSAIDS in the postpartum period raise blood pressure in women with a hypertensive disorder. The mean increase and standard deviation of each group (acetaminophen and NSAID/Ibupforen) was calculated when compairing systolic blood pressures from the first postpartum day to the second postpartum day. Day 1 is the mean of systolic blood pressures from 0 hours to 23 hours after delivery, and Day 2 is the mean of systolic blood pressures from 24 hours to 47 hours after delivery.
1 secondary outcome
Change in the Mean Diastolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2.
Time frame: 2 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
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?
A Phase 4 study testing Acetaminophen and NSAID in people with Hypertension, 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 6 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: stopped early, as of the sponsor's last update on 31 Oct 2018. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in the Mean Systolic Blood Pressure From Postpartum Day 1 Versus Postpartum Day 2. (time frame: 2 days). 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 31 Oct 2018.