Trials Sponsors Conditions Drugs Pricing

Conditions

Preeclampsia With Severe Features

Keywords

preeclampsia severeNifedipine XL 60mgNifedipine 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
+3 more secondary outcomes

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 XLDrug

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 60mgTwice daily Nifedipine XL 30mg

Eligibility Criteria

Age18 Years - 45 Years

Sexfemale(Gender-based eligibility)

Healthy VolunteersNo

Age GroupsAdult (18-64)

Sampling MethodProbability 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.

Sponsors & Collaborators

Ohio State University
Otherlead

Study Sites (1)

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

Columbus, Ohio, 43210, United States

MeSH Terms

Interventions

Nifedipine

Intervention Hierarchy (Ancestors)

DihydropyridinesPyridinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

Kara Rood, MD
Ohio State University
PRINCIPAL INVESTIGATOR

Enrollment

56 participants (actual enrollment reported by the registry).

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

Actual (reported)

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Once daily Nifedipine XL 60mg

Twice daily Nifedipine XL 30mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (8)

Study Arms (2)

Once daily Nifedipine XL 60mg

Twice daily Nifedipine XL 30mg

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Data Sharing

Source record

Locations