Clinical trial NCT05096728: Nifedipine Dosing Daily vs Twice a Day for Pre-eclampsia With Severe Features (NOPPI)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Preeclampsia With Severe Features
Keywords: preeclampsia severe
Nifedipine XL 60mg
Nifedipine XL 30mg
Lead sponsor: Ohio State University
Sponsor class: OTHER
First posted: 2021-10-27
Enrollment: 56
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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. .

Brief 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. 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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

Primary outcomes:
measure: Comparing the rates of suboptimal blood pressure
timeFrame: on day 2 (24 hour-48 hour) after the patient has been enrolled
Secondary outcomes:
measure: Evaluating mean systolic and diastolic blood pressure and mean arterial pressure
timeFrame: on day 2 (24 hour-48 hour) after the patient has been enrolled
measure: Evaluating concentration of Nifedipine in blood
timeFrame: on day 2 (24 hour-48 hour) after the patient has been enrolled
measure: Evaluating number of route of delivery
timeFrame: Through study completion, an average of 2 years
measure: Evaluating number of days in expectant management from enrollment
timeFrame: Through study completion, an average of 2 years
measure: Evaluating frequency of indications for cesarean section
timeFrame: Through study completion, an average of 2 years
measure: Evaluating frequency of need for acute acting anti-hypertensive treatment (IR Nifedipine, IV labetalol, or IV hydralazine)
timeFrame: on day 2 (24 hour-48 hour) after the patient has been enrolled
measure: Evaluating number of delivery less than 34 weeks
timeFrame: Through study completion, an average of 2 years
measure: Evaluating gestational age at delivery
timeFrame: Through study completion, an average of 2 years
Other outcomes:
Locations:
city: Columbus
country: United States
facility: The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine
state: Ohio
Study officials:
affiliation: Ohio State University
name: Kara Rood, MD
role: PRINCIPAL_INVESTIGATOR
References: