Preeclampsia With Severe FeaturesNCT05096728
Nifedipine Dosing Daily vs Twice a Day for Pre-eclampsia With Severe Features (NOPPI)
An observational study of Preeclampsia With Severe Features, run by Ohio State University at 1 site in United States.
Trial summary
The investigators propose a randomized controlled unblinded trial to evaluate rates of optimal blood pressure control between Nifedipine 60mg XL once daily vs. Nifedipine 30mg XL twice daily in patients admitted for expectant management with pre-eclampsia with severe features. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Preeclampsia With Severe Features
- What is being tested?
- Nifedipine XL
- How many people
- 56 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2021to 15 Dec 2023
- Phase
- Observational
- 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 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women undergoing expectant management for a diagnosis of preeclampsia with severe features already initiated on 30mg Nifedipine XL and the primary provider has made the decision to increase the patient's daily dose of Procardia XL from 30mg to 60mg. .
Who may be able to join
- Women age 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7 and 33 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria.
- Undergoing expectant management for a diagnosis of preeclampsia with severe features and already initiated on 30mg Nifedipine XL. The patient may or may not have already received acute treatment for severe blood pressures.
Who cannot join
- Known allergy or adverse reaction to Nifedipine or any medical condition where Nifedipine is contraindicated, such as galactose intolerance, severe GI stricture, and GI hypomotility disorder.
- Participation in another trial without prior approval
- Currently receiving a daily dose of Nifedipine XL of 60mg or greater
- Continuation of alternate long-acting anti-hypertensive medication on admission
- Physician/provider or patient refusal
- Triplet or higher order pregnancy
Trial locations and contacts
1 site in 1 country.
United States1 site
The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
Columbus, Ohio, 43210
About this study
Official title: Frequency and Dosing of Long Acting Anti-Hypertensive Agent in Women With Pre-eclampsia With Severe Features Undergoing Expectant Management: A Randomized Controlled Trial
The investigators propose a randomized controlled unblinded trial to evaluate rates of optimal blood pressure control between Nifedipine 60mg XL once daily vs. Nifedipine 30mg XL twice daily in patients admitted for expectant management with pre-eclampsia with severe features. Patients will be approached for consent when they are placed on 30mg of Nifedipine daily by their primary provider and will be enrolled in the study when the primary provider has made the decision to increase the patient's daily dose of Nifedipine XL from 30mg to 60mg.
Read the detailed description
This is a randomized controlled unblinded trial at The Ohio State University comparing Nifedipine XL 60mg daily to 30mg twice daily in patients admitted for expectant management for pre-eclampsia with severe features.
Potential study participants will be identified at the time of admission to the antepartum unit. Inclusion criteria must be met, namely patient's age, gestational age, diagnosis of preeclampsia with severe features.
Patients will be approached for consent when they are placed on 30mg of Nifedipine daily by their primary provider and will be enrolled in the study when the primary provider has made the decision to increase the patient's daily dose of Nifedipine XL from 30mg to 60mg. Participants will be randomized in to one of two groups:
- Once daily Nifedipine XL 60mg Vs.
- Twice daily Nifedipine XL 30mg
Once enrolled and randomized, blood pressures will be monitored every 4 hours as is standard on the antepartum unit. Blood pressures for the primary outcome will be collected 24 hours after the patient is randomized and initiated on their above regimen. This is to allow the medication to reach steady state prior to collected information on optimal blood pressures. The primary outcome will consist of blood pressure values collected q4 hours beginning 24h-48h after receiving their first dose of the randomized dose regimen.
Algorithms for the administration of intravenous labetalol, Nifedipine or hydralazine will be utilized by the primary provider at his or her discretion.
Women may take the medication concurrently with intravenous labetalol, hydralazine, or immediate release Nifedipine for the treatment of severe blood pressures as determined by their primary provider.
All other obstetric care will be at the discretion of the primary provider, including but not limited to addition of second long-acting hypertensive agents, decision to proceed with delivery, IV magnesium for seizure prophylaxis and recommendations regarding mode of delivery. Data will be collected on these components of routine obstetric care. Analysis will be by intent to treat.
A subset of patients will be enrolled for a pharmacokinetic study and blood will be collected at prespecified times following administration of the randomized Nifedipine XL regimen.
- Conditions
- Preeclampsia With Severe Features
- Being tested
- Nifedipine XL
- Keywords
- preeclampsia severe, Nifedipine XL 60mg, Nifedipine XL 30mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine XLDrug
Also called Procardia XL
Patients will be enrolled when the primary provider has made the decision to increase the patient's daily dose of Procardia XL from 30mg to 60mg. Participants will be randomized in to one of two groups
- Once daily Nifedipine XL 60mg Vs.
- Twice daily Nifedipine XL 30mg
| Study group | Role | What they receive |
|---|---|---|
| Once daily Nifedipine XL 60mg | Participants will receive Nifedipine XL once daily 60 mg for 48 hours. Receives: Drug: Nifedipine XL | |
| Twice daily Nifedipine XL 30mg | Participants will receive Nifedipine XL twice daily 30 mg for 48 hours. Receives: Drug: Nifedipine XL |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparing the rates of suboptimal blood pressure
Comparing the rates of suboptimal blood pressure, defined as frequency of systolic >150 mmHg and/or diastolic >100 mmHg blood pressure. Blood pressure measurements will be measured every 4 hours on day 2 (24 hour-48 hour) after the patient has been enrolled, randomized, and initiated on either once daily Nifedipine XL 60mg or twice daily Nifedipine XL 30mg.
Measured: on day 2 (24 hour-48 hour) after the patient has been enrolled
Secondary outcomes (8)
Evaluating mean systolic and diastolic blood pressure and mean arterial pressure
Evaluating mean systolic and diastolic blood pressure and mean arterial pressure measured on day 2 (24h-48h) after the patient has been enrolled, randomized, and initiated on Nifedipine regimen
Measured: on day 2 (24 hour-48 hour) after the patient has been enrolled
Evaluating concentration of Nifedipine in blood
Evaluating concentration of Nifedipine in blood measured at prespecified times taken on day 2 (24 hour-48 hour) after the patient has been enrolled, randomized, and initiated on a Nifedipine regimen
Measured: on day 2 (24 hour-48 hour) after the patient has been enrolled
Evaluating number of route of delivery
Measured: Through study completion, an average of 2 years
Evaluating number of days in expectant management from enrollment
Measured: Through study completion, an average of 2 years
Evaluating frequency of indications for cesarean section
Measured: Through study completion, an average of 2 years
Evaluating frequency of need for acute acting anti-hypertensive treatment (IR Nifedipine, IV labetalol, or IV hydralazine)
Measured: on day 2 (24 hour-48 hour) after the patient has been enrolled
Evaluating number of delivery less than 34 weeks
Measured: Through study completion, an average of 2 years
Evaluating gestational age at delivery
Measured: Through study completion, an average of 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start1 Dec 2021
- Primary completion6 Dec 2023
- Study completion15 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preeclampsia With Severe FeaturesStudies of the same condition, open and under way.
- More trials run by Ohio State 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ohio State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kara M Rood, MD, Ohio State University
- Investigators
- Kara Rood, MD, Principal investigator, Ohio State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05096728
- Sponsor's protocol ID
- 2021H0292
- Status last verified
- Dec 2023
- First submitted
- 17 Sep 2021
- Last updated
- 22 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Frequency and Dosing of Long Acting Anti-Hypertensive Agent in Women With Pre-eclampsia With Severe Features Undergoing Expectant Management: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05096728
- Acronym / sponsor ID
- 2021H0292
- Conditions
- Preeclampsia With Severe Features
- Keywords
- preeclampsia severe, Nifedipine XL 60mg, Nifedipine XL 30mg
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 6 Dec 2023 (actual)
- Study completion
- 15 Dec 2023 (actual)
- First posted
- 27 Oct 2021 (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.
The investigators propose a randomized controlled unblinded trial to evaluate rates of optimal blood pressure control between Nifedipine 60mg XL once daily vs. Nifedipine 30mg XL twice daily in patients admitted for expectant management with pre-eclampsia with severe features. Patients will be approached for consent when they are placed on 30mg of Nifedipine daily by their primary provider and will be enrolled in the study when the primary provider has made the decision to increase the patient's daily dose of Nifedipine XL from 30mg to 60mg.
Detailed description
This is a randomized controlled unblinded trial at The Ohio State University comparing Nifedipine XL 60mg daily to 30mg twice daily in patients admitted for expectant management for pre-eclampsia with severe features.
Potential study participants will be identified at the time of admission to the antepartum unit. Inclusion criteria must be met, namely patient's age, gestational age, diagnosis of preeclampsia with severe features.
Patients will be approached for consent when they are placed on 30mg of Nifedipine daily by their primary provider and will be enrolled in the study when the primary provider has made the decision to increase the patient's daily dose of Nifedipine XL from 30mg to 60mg. Participants will be randomized in to one of two groups:
- Once daily Nifedipine XL 60mg Vs.
- Twice daily Nifedipine XL 30mg
Once enrolled and randomized, blood pressures will be monitored every 4 hours as is standard on the antepartum unit. Blood pressures for the primary outcome will be collected 24 hours after the patient is randomized and initiated on their above regimen. This is to allow the medication to reach steady state prior to collected information on optimal blood pressures. The primary outcome will consist of blood pressure values collected q4 hours beginning 24h-48h after receiving their first dose of the randomized dose regimen.
Algorithms for the administration of intravenous labetalol, Nifedipine or hydralazine will be utilized by the primary provider at his or her discretion.
Women may take the medication concurrently with intravenous labetalol, hydralazine, or immediate release Nifedipine for the treatment of severe blood pressures as determined by their primary provider.
All other obstetric care will be at the discretion of the primary provider, including but not limited to addition of second long-acting hypertensive agents, decision to proceed with delivery, IV magnesium for seizure prophylaxis and recommendations regarding mode of delivery. Data will be collected on these components of routine obstetric care. Analysis will be by intent to treat.
A subset of patients will be enrolled for a pharmacokinetic study and blood will be collected at prespecified times following administration of the randomized Nifedipine XL regimen.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Once daily Nifedipine XL 60mg | – | Drug: Nifedipine XLParticipants will receive Nifedipine XL once daily 60 mg for 48 hours. |
| Twice daily Nifedipine XL 30mg | – | Drug: Nifedipine XLParticipants will receive Nifedipine XL twice daily 30 mg for 48 hours. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women undergoing expectant management for a diagnosis of preeclampsia with severe features already initiated on 30mg Nifedipine XL and the primary provider has made the decision to increase the patient's daily dose of Procardia XL from 30mg to 60mg. .
Key inclusion criteria (2 listed)
- Women age 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7 and 33 6/7 weeks gestation based on the best obstetric estimate by ACOG criteria.
- Undergoing expectant management for a diagnosis of preeclampsia with severe features and already initiated on 30mg Nifedipine XL. The patient may or may not have already received acute treatment for severe blood pressures.
Key exclusion criteria (6 listed)
- Known allergy or adverse reaction to Nifedipine or any medical condition where Nifedipine is contraindicated, such as galactose intolerance, severe GI stricture, and GI hypomotility disorder.
- Participation in another trial without prior approval
- Currently receiving a daily dose of Nifedipine XL of 60mg or greater
- Continuation of alternate long-acting anti-hypertensive medication on admission
- Physician/provider or patient refusal
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 XLAlso: Procardia XLPatients will be enrolled when the primary provider has made the decision to increase the patient's daily dose of Procardia XL from 30mg to 60mg. Participants will be randomized in to one of two groups * Once daily Nifedipine XL 60mg Vs. * Twice daily Nifedipine XL 30mg | Drug | Once daily Nifedipine XL 60mg, Twice daily Nifedipine XL 30mg |
Primary outcome
Comparing the rates of suboptimal blood pressure
Time frame: on day 2 (24 hour-48 hour) after the patient has been enrolled
Comparing the rates of suboptimal blood pressure, defined as frequency of systolic >150 mmHg and/or diastolic >100 mmHg blood pressure. Blood pressure measurements will be measured every 4 hours on day 2 (24 hour-48 hour) after the patient has been enrolled, randomized, and initiated on either once daily Nifedipine XL 60mg or twice daily Nifedipine XL 30mg.
8 secondary outcomes
Evaluating mean systolic and diastolic blood pressure and mean arterial pressure
Time frame: on day 2 (24 hour-48 hour) after the patient has been enrolled
Evaluating concentration of Nifedipine in blood
Time frame: on day 2 (24 hour-48 hour) after the patient has been enrolled
Evaluating number of route of delivery
Time frame: Through study completion, an average of 2 years
Evaluating number of days in expectant management from enrollment
Time frame: Through study completion, an average of 2 years
Evaluating frequency of indications for cesarean section
Time frame: Through study completion, an average of 2 years
Evaluating frequency of need for acute acting anti-hypertensive treatment (IR Nifedipine, IV labetalol, or IV hydralazine)
Time frame: on day 2 (24 hour-48 hour) after the patient has been enrolled
Evaluating number of delivery less than 34 weeks
Time frame: Through study completion, an average of 2 years
Evaluating gestational age at delivery
Time frame: Through study completion, an average of 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Dec 2023.
- 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.
Kara Rood, MD principal investigator
Ohio State University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Preeclampsia With Severe Features, run by Ohio State 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 2 inclusion and 6 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 22 Dec 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Comparing the rates of suboptimal blood pressure (time frame: on day 2 (24 hour-48 hour) after the patient has been enrolled). 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 Dec 2023.