Nifedipine Dosing Daily vs Twice a Day for Pre-eclampsia With Severe Features (NOPPI)

NCT05096728 | Completed

• 1 other identifier: 2021H0292
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Preeclampsia With Severe Features

Keywords

preeclampsia severe; Nifedipine XL 60mg; Nifedipine XL 30mg

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  on day 2 (24 hour-48 hour) after the patient has been enrolled

• Evaluating concentration of Nifedipine in blood

  on day 2 (24 hour-48 hour) after the patient has been enrolled

• Evaluating number of route of delivery

  Through study completion, an average of 2 years

• Evaluating number of days in expectant management from enrollment

  Through study completion, an average of 2 years

• Evaluating frequency of indications for cesarean section

  Through study completion, an average of 2 years

Study Arms (2)

Once daily Nifedipine XL 60mg

Participants will receive Nifedipine XL once daily 60 mg for 48 hours.

Drug: Nifedipine XL

Twice daily Nifedipine XL 30mg

Participants will receive Nifedipine XL twice daily 30 mg for 48 hours.

Drug: Nifedipine XL

Interventions

Nifedipine XL DRUG

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

Once daily Nifedipine XL 60mg; Twice daily Nifedipine XL 30mg

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• 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. .

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University Wexner Medical Center OB/GYN Maternal and Fetal Medicine

Columbus, Ohio, 43210, United States

Location

MeSH Terms

Interventions

Nifedipine

Intervention Hierarchy (Ancestors)

Dihydropyridines; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Kara Rood, MD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: September 17, 2021
• First Posted: October 27, 2021
• Study Start: December 1, 2021
• Primary Completion: December 6, 2023
• Study Completion: December 15, 2023
• Last Updated: December 22, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)