Hypertension in PregnancyPhase 4PEACENCT07023003
Postpartum Evaluation of Nifedipine and Enalapril for Hypertension
A Phase 4 study testing Enalapril 10mg QD and Nifedipine 30mg XL BID in people with Hypertension in Pregnancy, run by Nebraska Methodist Health System at 1 site in United States.
Trial summary
This is an open label, randomized controlled trial designed to compare nifedipine and enalapril in the management of postpartum hypertension. This is an equivalence study- meaning it is not expected one medication is better than the other. Read more about this study
- Who is it for?
- Ages 19 years and older, women only
- Conditions the study is for
- Hypertension in Pregnancy
- What is being tested?
- Enalapril 10mg QD and Nifedipine 30mg XL BID
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 850 participants
- Where
- 1 siteUnited States
- Study dates
- 11 Jul 2025to Dec 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 19 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admitted for delivery by cesarean or vaginal delivery
- 24 weeks gestation or greater
- Pregnancy related hypertension(HTN) or chronic hypertension. Pregnancy related hypertension will be defined during the study as either a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hours apart. This definition is consistent with the ACOG definition for pregnancy related HTN in patients without CHTN.
Who cannot join
- Absolute contraindication to either nifedipine or enalapril Relative contraindications will be reviewed with PI.
- Persistent HR <60 or >110
- Native language other than English
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Methodist Women's Hospital
Omaha, Nebraska, 68022
Todd Lovgren, 4028151970, todd.lovgren@nmhs.org
Joshua Dahlke, MD, 4028151970, joshua.dahlke@nmhs.org
About this study
Official title: Postpartum Evaluation of Antihypertensives for Control of Hypertension: A Randomized Controlled Equivalence Study
This is an open label, randomized controlled trial designed to compare nifedipine and enalapril in the management of postpartum hypertension. This is an equivalence study- meaning it is not expected one medication is better than the other. Nifedipine has been shown to be better than another common blood pressure medicine, labetalol, for postpartum hypertension but enalapril which is also used worldwide to manage blood pressure postpartum, has not yet been evaluated or compared to nifedipine.
Investigators will identify and offer enrollment to women who are admitted for delivery with documented hypertension- participants with either chronic hypertension or pregnancy related hypertension will be included. Our hypothesis is both medications are safe and effective in managing blood pressure and preventing readmission for hypertensive complications during the postpartum period so evaluating the rate of readmission is the primary goal of the study.
The only intervention of the trial will be to assign which medication the participant starts taking. Any decisions after that point- stopping medication, changing doses, additional medications, discharge from the hospital, etc, will all be at the discretion of the participant's primary provider.
- Conditions
- Hypertension in Pregnancy
- Being tested
- Enalapril 10mg QD, Nifedipine 30mg XL BID
- Keywords
- Hypertension, Postpartum, Enalapril, Nifedipine, Readmission
- Medical subject headings
- Hypertension, Pregnancy-Induced, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enalapril 10mg QDDrug
Also called vasotec, enalaprilat, epaned
Enalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
Nifedipine 30mg XL BIDDrug
Also called adalat, procardia
Nifedipine 30mg XL BID will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider.
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine XR | Active comparator | Patients will be randomized to receive nifedipine 30mg XR BID. Any additional changes in treatment will be at the discretion of their provider. Receives: Drug: Nifedipine 30mg XL BID |
| Enalapril 10mg QD | Experimental | Patients will be administered 10mg enalapril daily. Any additional intervention or changes in management of their hypertension will be at the discretion of their primary provider. Receives: Drug: Enalapril 10mg QD |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Readmission
Number of participants meeting criteria for hospital admission.
Measured: Within 6 weeks of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2025
- Study start11 Jul 2025
- Primary completionJul 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension in PregnancyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Open Label Randomized Controlled Equivalence Study
- Masking
- None (open label)
- Enrolment
- 850 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nebraska Methodist Health System
- Sponsor type
- University, hospital or other
- Collaborators
- Methodist Hospital Foundation
- Responsible party
- Principal investigator, Todd Lovgren, Nebraska Methodist Health System
- Investigators
- Todd Lovgren, MD, Principal investigator, Nebraska Methodist Health System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07023003
- Sponsor's protocol ID
- IRB 1551
- Acronym
- PEACE
- Status last verified
- Oct 2025
- First submitted
- 8 Jun 2025
- Last updated
- 22 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Requests for data sharing will be reviewed on a case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postpartum Evaluation of Antihypertensives for Control of Hypertension: A Randomized Controlled Equivalence Study
- ClinicalTrials.gov ID
- NCT07023003
- Acronym / sponsor ID
- PEACE / IRB 1551
- Conditions
- Hypertension in Pregnancy
- Keywords
- Hypertension, Postpartum, Enalapril, Nifedipine, Readmission
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 850 participants (estimated)
- Lead sponsor
- Nebraska Methodist Health SystemUniversity, hospital or other
- Collaborators
- Methodist Hospital Foundation
- Study start
- 11 Jul 2025 (actual)
- Primary completion
- Jul 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 15 Jun 2025 (actual)
- 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.
This is an open label, randomized controlled trial designed to compare nifedipine and enalapril in the management of postpartum hypertension. This is an equivalence study- meaning it is not expected one medication is better than the other. Nifedipine has been shown to be better than another common blood pressure medicine, labetalol, for postpartum hypertension but enalapril which is also used worldwide to manage blood pressure postpartum, has not yet been evaluated or compared to nifedipine.
Investigators will identify and offer enrollment to women who are admitted for delivery with documented hypertension- participants with either chronic hypertension or pregnancy related hypertension will be included. Our hypothesis is both medications are safe and effective in managing blood pressure and preventing readmission for hypertensive complications during the postpartum period so evaluating the rate of readmission is the primary goal of the study.
The only intervention of the trial will be to assign which medication the participant starts taking. Any decisions after that point- stopping medication, changing doses, additional medications, discharge from the hospital, etc, will all be at the discretion of the participant's primary provider.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Label Randomized Controlled Equivalence Study
| Arm | Type | Receives |
|---|---|---|
| Nifedipine XR | Active comparator | Drug: Nifedipine 30mg XL BIDPatients will be randomized to receive nifedipine 30mg XR BID. Any additional changes in treatment will be at the discretion of their provider. |
| Enalapril 10mg QD | Experimental | Drug: Enalapril 10mg QDPatients will be administered 10mg enalapril daily. Any additional intervention or changes in management of their hypertension will be at the discretion of their primary provider. |
Who may qualify
- Ages
- 19 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- admitted for delivery by cesarean or vaginal delivery
- 24 weeks gestation or greater
- Pregnancy related hypertension(HTN) or chronic hypertension. Pregnancy related hypertension will be defined during the study as either a systolic blood pressure ≥140mmHg or diastolic blood pressure ≥90mmHg on two occasions at least 4 hours apart. This definition is consistent with the ACOG definition for pregnancy related HTN in patients without CHTN.
Key exclusion criteria (3 listed)
- Absolute contraindication to either nifedipine or enalapril Relative contraindications will be reviewed with PI.
- Persistent HR <60 or >110
- Native language other than English
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 |
|---|---|---|
| Enalapril 10mg QDAlso: vasotec, enalaprilat, epanedEnalapril 10mg PO QD will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider. | Drug | Enalapril 10mg QD |
| Nifedipine 30mg XL BIDAlso: adalat, procardiaNifedipine 30mg XL BID will be given to manage postpartum hypertension. Duration of treatment to be dictated by primary provider. | Drug | Nifedipine XR |
Primary outcome
Hospital Readmission
Time frame: Within 6 weeks of delivery
Number of participants meeting criteria for hospital admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2025.
- Individual participant dataSharing planned: Yes. Requests for data sharing will be reviewed on a case by case basis.
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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.
Todd Lovgren, MD principal investigator
Nebraska Methodist Health System
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 Enalapril 10mg QD and Nifedipine 30mg XL BID in people with Hypertension in Pregnancy, run by Nebraska Methodist Health System 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 3 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: looking for participants now, as of the sponsor's last update on 22 Oct 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Todd Lovgren, MD (14028151970, todd.lovgren@nmhs.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital Readmission (time frame: Within 6 weeks of delivery). 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 22 Oct 2025.