Preeclampsia SeverePhase 4NCT04392375
Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
A Phase 4 study testing Nifedipine 30 MG in people with Preeclampsia Severe, run by Ohio State University at 1 site in United States.
Trial summary
This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia 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 Severe
- What is being tested?
- Nifedipine 30 MG
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 110 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Jun 2020to 10 May 2022
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- Women aged 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by The American College of Obstetricians and Gynecologists (ACOG) criteria.
- Diagnosis of preeclampsia with severe features with decision made to induce labor. 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 gastrointestinal (GI) structure, and GI hypomotility disorder.
- Currently receiving Nifedipine XL as part of hypertension management prior to induction of labor
- Participation in another trial that affects the primary outcome without prior approval
- Physician/provider or patient refusal
- Participation in this trial in a prior pregnancy
- 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
This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.
Read the detailed description
This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.
After diagnosis of preeclampsia with severe features and decision made to proceed with induction of labor. Patients were approached about study and if consented then were then randomized to placebo or nifedipine 30XL daily until delivery occurred.
- Conditions
- Preeclampsia Severe
- Being tested
- Nifedipine 30 MG, Placebos
- Keywords
- preeclampsia severe, Nifedipine 30MG, placebo controlled
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nifedipine 30 MGDrug
Nifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure.
PlacebosDrug
At the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo.
| Study group | Role | What they receive |
|---|---|---|
| Nifedipine 30MG | Active comparator | Oral administration of 30mg Nifedipine XL q24 hours until delivery Receives: Drug: Nifedipine 30 MG |
| Placebo | Placebo comparator | Matching placebo group q24hrs until delivery Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo
Measured acute antihypertension therapy between enrollment and delivery
Measured: Between enrollment and delivery, assessed up to 18 weeks
Secondary outcomes (4)
Number of Participants Stratified by Route of Delivery
Measured: At delivery
Number of Participants With Various Indications for Cesarean Delivery
Some participants could have more than one indication for Cesarean Delivery.
Measured: Between enrollment and delivery, assessed up to 18 weeks
Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy
Measured: Between enrollment and delivery, assessed up to 18 weeks
Number of Participants Who Required Acute Antihypertension Treatments Postpartum
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start9 Jun 2020
- Primary completion20 Apr 2022
- Study completion10 May 2022
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 Preeclampsia SevereStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 110 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392375
- Sponsor's protocol ID
- 2019H0431
- Status last verified
- Jul 2023
- First submitted
- 2 May 2020
- Last updated
- 24 Jul 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cleary EM, Racchi NW, Patton KG, Kudrimoti M, Costantine MM, Rood KM. Trial of Intrapartum Extended-Release Nifedipine to Prevent Severe Hypertension Among Pregnant Individuals With Preeclampsia With Severe Features. Hypertension. 2023 Feb;80(2):335-342. doi: 10.1161/HYPERTENSIONAHA.122.19751. Epub 2022 Oct 3.
PubMed 36189646
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nifedipine XL Versus Placebo for the Treatment of Preeclampsia With Severe Features During Induction of Labor
- ClinicalTrials.gov ID
- NCT04392375
- Acronym / sponsor ID
- 2019H0431
- Conditions
- Preeclampsia Severe
- Keywords
- preeclampsia severe, Nifedipine 30MG, placebo controlled
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Ohio State UniversityUniversity, hospital or other
- Study start
- 9 Jun 2020 (actual)
- Primary completion
- 20 Apr 2022 (actual)
- Study completion
- 10 May 2022 (actual)
- First posted
- 18 May 2020 (actual)
- Results
- Posted 24 Jul 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.
Detailed description
This is a randomized double blind placebo controlled trial comparing Nifedipine 30mg XL to placebo in 110 patients after decision has been made to proceed with induction of labor for the diagnosis of preeclampsia with severe features.
After diagnosis of preeclampsia with severe features and decision made to proceed with induction of labor. Patients were approached about study and if consented then were then randomized to placebo or nifedipine 30XL daily until delivery occurred.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
- Model description
- Patients are enrolled and randomly selected to receive Nifedipine or placebo through delivery of her infant.
| Arm | Type | Receives |
|---|---|---|
| Nifedipine 30MG | Active comparator | Drug: Nifedipine 30 MGOral administration of 30mg Nifedipine XL q24 hours until delivery |
| Placebo | Placebo comparator | Drug: PlacebosMatching placebo group q24hrs until delivery |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Women aged 18-45 with a viable single or twin intrauterine pregnancy between 22 0/7 and 41 6/7 weeks gestation based on the best obstetric estimate by The American College of Obstetricians and Gynecologists (ACOG) criteria.
- Diagnosis of preeclampsia with severe features with decision made to induce labor. 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 gastrointestinal (GI) structure, and GI hypomotility disorder.
- Currently receiving Nifedipine XL as part of hypertension management prior to induction of labor
- Participation in another trial that affects the primary outcome without prior approval
- Physician/provider or patient refusal
- Participation in this trial in a prior pregnancy
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 30 MGNifedipine XL is a long-acting medication used to lower blood pressure. The investigators want to learn whether women who receive the study drug will experience fewer severe-range blood pressure readings, and therefore need fewer intravenous (IV) medications to safely lower blood pressure. | Drug | Nifedipine 30MG |
| PlacebosAt the time of enrollment, patients will be randomized to either the study drug (oral Nifedipine XL 30mg) or identical placebo. | Drug | Placebo |
Primary outcome
Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo
Time frame: Between enrollment and delivery, assessed up to 18 weeks
Measured acute antihypertension therapy between enrollment and delivery
4 secondary outcomes
Number of Participants Stratified by Route of Delivery
Time frame: At delivery
Number of Participants With Various Indications for Cesarean Delivery
Time frame: Between enrollment and delivery, assessed up to 18 weeks
Number of Participants With Hypotension of ≥30% Decrease in Blood Pressure From Baseline Following Acute Antihypertensive Therapy
Time frame: Between enrollment and delivery, assessed up to 18 weeks
Number of Participants Who Required Acute Antihypertension Treatments Postpartum
Time frame: At delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 36189646Cleary EM, Racchi NW, Patton KG, Kudrimoti M, Costantine MM, Rood KM. Trial of Intrapartum Extended-Release Nifedipine to Prevent Severe Hypertension Among Pregnant Individuals With Preeclampsia With Severe Features. Hypertension. 2023 Feb;80(2):335-342. doi: 10.1161/HYPERTENSIONAHA.122.19751. Epub 2022 Oct 3.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
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 30 MG in people with Preeclampsia Severe, 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 24 Jul 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. Some participants in this study may receive a placebo. 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 24 Jul 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?
Number of Participants With the Change in Blood Pressure (Both Systolic and Diastolic) Under the Treatment of NIfedipine 30mg XL Versus Placebo (time frame: Between enrollment and delivery, assessed up to 18 weeks). 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 NCT04392375, 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 24 Jul 2023.