An observational study in Preeclampsia With Severe Features, sponsored by Ohio State University. Completed at 1 site in United States. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2023-12-22.
Sponsored by Ohio State University · Observational
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.
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 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.
882 studies on the registry are indexed under Pre-Eclampsia; 237 are open to participants now.
This study's enrollment of 56 is below the median of 163 across 380 observational studies indexed under Pre-Eclampsia.
Browse Pre-Eclampsia studies →Ohio State University is the lead sponsor of 640 studies on the registry; 144 are open to participants now.
Of its 60 completed or terminated interventional studies of FDA-regulated products, 45 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
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. .
Exclusion Criteria:
Participants will receive Nifedipine XL once daily 60 mg for 48 hours.
Drug: Nifedipine XL
Participants will receive Nifedipine XL twice daily 30 mg for 48 hours.
Drug: Nifedipine 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
Also known as: Procardia XL
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.
Time frame: on day 2 (24 hour-48 hour) after the patient has been enrolled
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
Time frame: 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
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
Plan to share: No
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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Ohio State University