Hypertension in PregnancyPhase 4NCT04349124
Persistent Postpartum Hypertension Pilot Trial
A Phase 4 study testing Nifedipine Extended-Release Tablets in people with Hypertension in Pregnancy, run by Duke University at 1 site in United States.
Trial summary
This study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the study to provide data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women only
- Conditions the study is for
- Hypertension in Pregnancy
- What is being tested?
- Nifedipine Extended-Release Tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Aug 2020to 4 Mar 2021
- 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 18 to 60 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Antepartum diagnosis of gestational hypertension
- preeclampsia
- superimposed preeclampsia without antepartum chronic hypertension medication
- Delivery at 23 weeks or greater
- Persistent elevation in BP >24 hours postpartum (>140/90 mm Hg) (2 or more BP >4 hours apart)
- 18 years or older
- English speaking
Who cannot join
- Need for continuation of antepartum antihypertensive medication
- Contraindication of calcium channel blocker use
- Severe range (160/110 mm Hg) blood pressure requiring treatment >24 hours after delivery
- Requires a 2nd oral antihypertensive medication for blood pressure control inpatient
- Acute cardiomyopathy or heart failure
- Creatinine ≥1.5
- Blood pressure <90/60 within 24 hours of discharge
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Treatment of Persistent Non-Severe Postpartum Hypertension
This study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the study to provide data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. There are limited guidelines for best practice with persistent, non-severe hypertension, and treatment in this situation is usually at the provider's discretion.
Read the detailed description
Study groups will include a treatment with nifedipine extended release or no treatment. Subjects will be randomized 1:1. Subjects randomized to the treatment group will be provided the study drug (nifedipine extended release) at an initial dose of 30mg daily in 1-month supply. The control group will not receive any drug for blood pressure control. the primary outcome is systolic blood pressure at 1 week postpartum.
Subjects in both groups will be scheduled for a 1-week postpartum blood pressure check and routine 4 week postpartum visit. Medication compliance in the treatment group will be assessed via validated questionnaire. The primary outcome of this study is average systolic blood pressure at 1 week postpartum. Patients will be given instructions on blood pressure ranges and specific symptoms when they should contact study staff.
- Conditions
- Hypertension in Pregnancy
- Being tested
- Nifedipine Extended-Release Tablets
- Medical subject headings
- Hypertension, Pregnancy-Induced
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine Extended-Release TabletsDrug
Antihypertensive
| Study group | Role | What they receive |
|---|---|---|
| Treatment Group | Other | The treatment group will be provided with month supply of 30mg tablets of nifedipine extended release prior to discharge from the delivery admission. Dose increases in clinic will be at the discretion of providers, however a treatment algorithm will be provided for guidance.Treatment group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. Receives: Drug: Nifedipine Extended-Release Tablets |
| Control Group | No intervention | The control group will not receive any medications at discharge. Providers will be instructed to only prescribe new blood pressure medication at subsequent postpartum visits if the blood pressure is in the severe range (>/=160/110). The control group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average Systolic Blood Pressure at 1 Week Postpartum
Measured: 1 week postpartum
Secondary outcomes (11)
Average Systolic Blood Pressure at 4 Weeks Postpartum
Measured: 4 weeks postpartum
Average Diastolic Blood Pressure at 1 Week Postpartum
Measured: 1 week postpartum
Average Diastolic Blood Pressure at 4 Weeks Postpartum
Measured: 4 weeks postpartum
Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum
Measured: 1 week postpartum
Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum
Measured: 4 weeks postpartum
Method of Feeding
Measured: up to 4 weeks postpartum
Number of Participants With ED/Triage Visits
Measured: up to 4 weeks postpartum
Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum
Measured: 1 week postpartum
Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum
Measured: 1 week postpartum
Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum
Measured: 1 week postpartum
Number of Participants With Hospital Readmission
Measured: up to 4 weeks postpartum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start25 Aug 2020
- Primary completion12 Feb 2021
- Study completion4 Mar 2021
Why it stopped: Unable to continue recruiting
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 Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Treatment Arm vs Active Control Arm
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Brenna Hughes, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04349124
- Sponsor's protocol ID
- Pro00104425
- Status last verified
- Mar 2023
- First submitted
- 14 Apr 2020
- Last updated
- 3 Apr 2023
- 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 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Treatment of Persistent Non-Severe Postpartum Hypertension
- ClinicalTrials.gov ID
- NCT04349124
- Acronym / sponsor ID
- Pro00104425
- Conditions
- Hypertension in Pregnancy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Unable to continue recruiting
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 25 Aug 2020 (actual)
- Primary completion
- 12 Feb 2021 (actual)
- Study completion
- 4 Mar 2021 (actual)
- First posted
- 16 Apr 2020 (actual)
- Results
- Posted 3 Apr 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the study to provide data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. There are limited guidelines for best practice with persistent, non-severe hypertension, and treatment in this situation is usually at the provider's discretion.
Detailed description
Study groups will include a treatment with nifedipine extended release or no treatment. Subjects will be randomized 1:1. Subjects randomized to the treatment group will be provided the study drug (nifedipine extended release) at an initial dose of 30mg daily in 1-month supply. The control group will not receive any drug for blood pressure control. the primary outcome is systolic blood pressure at 1 week postpartum.
Subjects in both groups will be scheduled for a 1-week postpartum blood pressure check and routine 4 week postpartum visit. Medication compliance in the treatment group will be assessed via validated questionnaire. The primary outcome of this study is average systolic blood pressure at 1 week postpartum. Patients will be given instructions on blood pressure ranges and specific symptoms when they should contact study staff.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Treatment Arm vs Active Control Arm
| Arm | Type | Receives |
|---|---|---|
| Treatment Group | Other | Drug: Nifedipine Extended-Release TabletsThe treatment group will be provided with month supply of 30mg tablets of nifedipine extended release prior to discharge from the delivery admission. Dose increases in clinic will be at the discretion of providers, however a treatment algorithm will be provided for guidance.Treatment group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. |
| Control Group | No intervention | –The control group will not receive any medications at discharge. Providers will be instructed to only prescribe new blood pressure medication at subsequent postpartum visits if the blood pressure is in the severe range (>/=160/110). The control group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Antepartum diagnosis of gestational hypertension
- preeclampsia
- superimposed preeclampsia without antepartum chronic hypertension medication
- Delivery at 23 weeks or greater
- Persistent elevation in BP >24 hours postpartum (>140/90 mm Hg) (2 or more BP >4 hours apart)
Key exclusion criteria (7 listed)
- Need for continuation of antepartum antihypertensive medication
- Contraindication of calcium channel blocker use
- Severe range (160/110 mm Hg) blood pressure requiring treatment >24 hours after delivery
- Requires a 2nd oral antihypertensive medication for blood pressure control inpatient
- Acute cardiomyopathy or heart failure
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 Extended-Release TabletsAntihypertensive | Drug | Treatment Group |
Primary outcome
Average Systolic Blood Pressure at 1 Week Postpartum
Time frame: 1 week postpartum
11 secondary outcomes
Average Systolic Blood Pressure at 4 Weeks Postpartum
Time frame: 4 weeks postpartum
Average Diastolic Blood Pressure at 1 Week Postpartum
Time frame: 1 week postpartum
Average Diastolic Blood Pressure at 4 Weeks Postpartum
Time frame: 4 weeks postpartum
Number of Participants With Blood Pressure < 130/80 mm Hg at 1 Week Postpartum
Time frame: 1 week postpartum
Number of Participants With Blood Pressure < 130/80 mm Hg at 4 Weeks Postpartum
Time frame: 4 weeks postpartum
Method of Feeding
Time frame: up to 4 weeks postpartum
Number of Participants With ED/Triage Visits
Time frame: up to 4 weeks postpartum
Number of Participants With an Increase in Blood Pressure Medication at 1 Week Postpartum
Time frame: 1 week postpartum
Number of Participants in the no Treatment Group With Initiation of Blood Pressure Medication at 1 Week Postpartum
Time frame: 1 week postpartum
Number of Participants Who Added a 2nd Blood Pressure Medication at 1 Week Postpartum
Time frame: 1 week postpartum
Number of Participants With Hospital Readmission
Time frame: up to 4 weeks postpartum
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- 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.
Brenna Hughes, MD principal investigator
Duke 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 Nifedipine Extended-Release Tablets in people with Hypertension in Pregnancy, run by Duke 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 7 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 3 Apr 2023. 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 3 Apr 2023). 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?
Average Systolic Blood Pressure at 1 Week Postpartum (time frame: 1 week postpartum). 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 3 Apr 2023.