Hypertension in PregnancyPhase 4NCT04236258
Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
A Phase 4 study testing NIFEdipine ER and Enalapril in people with Hypertension in Pregnancy and Preeclampsia Severe, run by Brigham and Women's Hospital at 1 site in United States.
Trial summary
This study evaluates whether nifedipine or enalapril is better at decreasing the amount of medical resources used in the postpartum period by women who have high blood pressure in pregnancy and the postpartum period. Half of participants will receive enalapril while the other half will receive enalapril. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Hypertension in Pregnancy, Preeclampsia Severe, Gestational Hypertension
- What is being tested?
- NIFEdipine ER and Enalapril
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2020to 30 Jun 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- diagnosis of any hypertensive disorder of pregnancy/postpartum period or chronic hypertension
- provider wanting to initiate antihypertensive in the postpartum period
- the patient is not currently on >1 antihypertensive
- plans to receive postpartum care at the hospital or affiliated clinic
Who cannot join
- sustained pulse <60 or >120 BPM over four hours
- allergy to any of the antihypertensives
- creatinine greater than or equal to 1.5
- strict contraindication to any of the antihypertensives
- history of failed treatment with any of the antihypertensives
Trial locations and contacts
1 site in 1 country.
United States1 site
Brigham and Women's Hospital
Boston, Massachusetts, 02115
About this study
Official title: A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
This study evaluates whether nifedipine or enalapril is better at decreasing the amount of medical resources used in the postpartum period by women who have high blood pressure in pregnancy and the postpartum period. Half of participants will receive enalapril while the other half will receive enalapril. We will compare the two groups in the amount of medical resources used which we are defining as prolonged hospitalizations, unscheduled medical visits and/or hospital readmissions in the postpartum period.
Read the detailed description
This is randomized controlled trial to investigate if enalapril is superior to nifedipine in terms of medical resources used in postpartum women with hypertension. These are both antihypertensives we commonly use in the postpartum period for women with hypertension in pregnancy but we do not know which medication works better at decreasing prolonged hospitalizations, the number of unscheduled medical visits and/or readmissions to the hospital.
Nifedipine is more traditionally used and well-validated by current medical literature. However, enalapril's mechanism of action is better suited to the dysregulation of blood pressure that can occur with hypertensive disorders of pregnancy. Therefore, we hypothesize that enalapril is superior to nifedipine in terms of medical resources used in the postpartum period.
- Conditions
- Hypertension in Pregnancy, Preeclampsia Severe, Gestational Hypertension, Postpartum Preeclampsia, Postpartum
- Being tested
- NIFEdipine ER, Enalapril
- 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 ERDrug
Postpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive.
EnalaprilDrug
Postpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive.
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine | Active comparator | This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. Receives: Drug: NIFEdipine ER |
| Enalapril | Active comparator | This arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. Receives: Drug: Enalapril |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prolonged Hospitalization
Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery
Measured: up to six weeks postpartum
Unscheduled Clinic Appointment
Participants who have any additional clinic appointments for any clinical reason in the postpartum period beyond the two appointments (around 1 week and 6 weeks postpartum) that are routinely scheduled
Measured: up to six weeks postpartum
Visit to Labor and Delivery Triage for Evaluation
Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason
Measured: up to six weeks postpartum
Postpartum Readmission
Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period
Measured: up to six weeks postpartum
Secondary outcomes (9)
Time to Blood Pressure Control
Time to sustained blood pressure control (defined as no need for changes to antihypertensive regimen for >24 hours)
Measured: up to six weeks postpartum
Number of Participants Who Needed for Additional Antihypertensives
Any time a patient needs a second or third agent added to her antihypertensive regimen
Measured: up to six weeks postpartum
Time to Discharge
The days a patient stays in the hospital after delivery or after readmission for postpartum hypertension
Measured: up to six weeks postpartum
Clinically Significant Hypotension or Hypertension
Any time a patient became symptomatic from her blood pressure as noted by her providers
Measured: up to six weeks postpartum
Creatinine Values at 1-2 Weeks After Discharge
Creatinine measured at 1-2 weeks after discharge from the randomization hospitalization (not all study patients attended their appointments and had their blood drawn)
Measured: 1-2 weeks
Continued Need for Antihypertensive
If a patient still needs the prescribed antihypertensives one week after discharge and six weeks after delivery to control her blood pressure as determined by her provider during her clinic visit
Measured: up to six weeks postpartum
Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received
A patient will complete a survey that will report any side effect the patient attributes to the antihypertension medication
Measured: up to six weeks postpartum
Patient Self-reported Compliance With Their Antihypertensive Regimen
The patient will complete a survey that self-assesses how compliant she has been with taking the prescribed antihypertensives ("difficulty remembering to take the medication")
Measured: up to six weeks postpartum
Creatinine Level Around 6 Weeks After Delivery
Creatinine level drawn at 6 week postpartum visit (not all study patients attended their appointments and had their blood drawn)
Measured: 6 weeks after delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2020
- Study start24 Jan 2020
- Primary completion30 Jun 2021
- Study completion30 Jun 2021
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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension in PregnancyStudies of the same condition, open and under way.
- More trials run by Brigham and Women's HospitalThe 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
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Brigham and Women's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thomas Frederick McElrath, M.D.,Ph.D., Brigham and Women's Hospital
- Investigators
- Thomas McElrath, MD, PhD, Principal investigator, Brigham and Women's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04236258
- Sponsor's protocol ID
- 2019P002981
- Status last verified
- Nov 2022
- First submitted
- 16 Jan 2020
- Last updated
- 30 Nov 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data will be made available to other researchers for all primary and secondary outcomes as well as demographic data.
Publications
Yoselevsky EM, Seely EW, Celi AC, Robinson JN, McElrath TF. A randomized controlled trial comparing the efficacy of nifedipine and enalapril in the postpartum period. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101178. doi: 10.1016/j.ajogmf.2023.101178. Epub 2023 Oct 6.
PubMed 37806651
Study at a glance
From the registry record, last updated by the sponsor on 30 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial Comparing Nifedipine and Enalapril in Medical Resources Used in the Postpartum Period
- ClinicalTrials.gov ID
- NCT04236258
- Acronym / sponsor ID
- 2019P002981
- Conditions
- Hypertension in Pregnancy, Preeclampsia Severe, Gestational Hypertension, Postpartum Preeclampsia, Postpartum
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Brigham and Women's HospitalUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 30 Jun 2021 (actual)
- Study completion
- 30 Jun 2021 (actual)
- First posted
- 22 Jan 2020 (actual)
- Results
- Posted 30 Nov 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates whether nifedipine or enalapril is better at decreasing the amount of medical resources used in the postpartum period by women who have high blood pressure in pregnancy and the postpartum period. Half of participants will receive enalapril while the other half will receive enalapril. We will compare the two groups in the amount of medical resources used which we are defining as prolonged hospitalizations, unscheduled medical visits and/or hospital readmissions in the postpartum period.
Detailed description
This is randomized controlled trial to investigate if enalapril is superior to nifedipine in terms of medical resources used in postpartum women with hypertension. These are both antihypertensives we commonly use in the postpartum period for women with hypertension in pregnancy but we do not know which medication works better at decreasing prolonged hospitalizations, the number of unscheduled medical visits and/or readmissions to the hospital.
Nifedipine is more traditionally used and well-validated by current medical literature. However, enalapril's mechanism of action is better suited to the dysregulation of blood pressure that can occur with hypertensive disorders of pregnancy. Therefore, we hypothesize that enalapril is superior to nifedipine in terms of medical resources used in the postpartum period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nifedipine | Active comparator | Drug: NIFEdipine ERThis arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start nifedipine extended release 30 mg daily as their starting antihypertensive. |
| Enalapril | Active comparator | Drug: EnalaprilThis arm will be postpartum women with high blood pressure who need an antihypertensive and have been assigned to start enalapril 10 mg daily as their starting antihypertensive. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- diagnosis of any hypertensive disorder of pregnancy/postpartum period or chronic hypertension
- provider wanting to initiate antihypertensive in the postpartum period
- the patient is not currently on >1 antihypertensive
- plans to receive postpartum care at the hospital or affiliated clinic
Key exclusion criteria (5 listed)
- sustained pulse <60 or >120 BPM over four hours
- allergy to any of the antihypertensives
- creatinine greater than or equal to 1.5
- strict contraindication to any of the antihypertensives
- history of failed treatment with any of the antihypertensives
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 ERPostpartum women with high blood pressure will be randomized to receive nifedipine extended release 30mg daily as their starting antihypertensive. | Drug | Nifedipine |
| EnalaprilPostpartum women with high blood pressure will be randomized to receive enalapril 10 mg daily as their starting antihypertensive. | Drug | Enalapril |
Primary outcome
Prolonged Hospitalization
Time frame: up to six weeks postpartum
Participants who have any postpartum hospitalization that extends beyond the normal length of stay after delivery
Unscheduled Clinic Appointment
Time frame: up to six weeks postpartum
Participants who have any additional clinic appointments for any clinical reason in the postpartum period beyond the two appointments (around 1 week and 6 weeks postpartum) that are routinely scheduled
Visit to Labor and Delivery Triage for Evaluation
Time frame: up to six weeks postpartum
Participants who have any visit to triage on Labor and Delivery for evaluation in the postpartum period for any clinical reason
Postpartum Readmission
Time frame: up to six weeks postpartum
Participants who have any postpartum readmission after being discharged from the delivery hospitalization in the postpartum period
9 secondary outcomes
Time to Blood Pressure Control
Time frame: up to six weeks postpartum
Number of Participants Who Needed for Additional Antihypertensives
Time frame: up to six weeks postpartum
Time to Discharge
Time frame: up to six weeks postpartum
Clinically Significant Hypotension or Hypertension
Time frame: up to six weeks postpartum
Creatinine Values at 1-2 Weeks After Discharge
Time frame: 1-2 weeks
Continued Need for Antihypertensive
Time frame: up to six weeks postpartum
Number of Participants With Self-reported Side Effects Attributed to the Antihypertensive They Received
Time frame: up to six weeks postpartum
Patient Self-reported Compliance With Their Antihypertensive Regimen
Time frame: up to six weeks postpartum
Creatinine Level Around 6 Weeks After Delivery
Time frame: 6 weeks after delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Nov 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 37806651Yoselevsky EM, Seely EW, Celi AC, Robinson JN, McElrath TF. A randomized controlled trial comparing the efficacy of nifedipine and enalapril in the postpartum period. Am J Obstet Gynecol MFM. 2023 Dec;5(12):101178. doi: 10.1016/j.ajogmf.2023.101178. Epub 2023 Oct 6.
- Individual participant dataSharing planned: Yes. De-identified individual participant data will be made available to other researchers for all primary and secondary outcomes as well as demographic data.
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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.
Thomas McElrath, MD, PhD principal investigator
Brigham and Women's Hospital
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 ER and Enalapril in people with Hypertension in Pregnancy and Preeclampsia Severe, run by Brigham and Women's Hospital 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 4 inclusion and 5 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: finished, as of the sponsor's last update on 30 Nov 2022. 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 30 Nov 2022). 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?
Prolonged Hospitalization (time frame: up to six weeks postpartum). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04236258, which also lists 1 linked publication.
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 30 Nov 2022.