Persistent Postpartum Hypertension Pilot Trial

• Sponsor: Duke University (Other)
• Overall Status: Terminated
• CT.gov ID: NCT04349124
• Collaborator: (none)
• Enrollment: 12
• Location: 1
• Arms: 2
• Actual Duration (Months): 6.3
• Patients Per Site Per Month: 1.9

Study Details

Study Description

Brief Summary

This study is a pilot, open-label, randomized controlled trial of postpartum women with hypertensive disorders pregnancy and persistent non-severe blood pressure. The purpose of the study to provide data that may provide guidance regarding blood pressure management of patients with non-severe postpartum hypertension. There are limited guidelines for best practice with persistent, non-severe hypertension, and treatment in this situation is usually at the provider's discretion.

Condition or Disease	Intervention/Treatment	Phase
Hypertension in Pregnancy	Drug: Nifedipine Extended-Release Tablets; Other: No Antihypertensive Medication	Phase 4

Detailed Description

Study groups will include a treatment with nifedipine extended release or no treatment. Subjects will be randomized 1:1. Subjects randomized to the treatment group will be provided the study drug (nifedipine extended release) at an initial dose of 30mg daily in 1-month supply. The control group will not receive any drug for blood pressure control. the primary outcome is systolic blood pressure at 1 week postpartum.

Subjects in both groups will be scheduled for a 1-week postpartum blood pressure check and routine 4 week postpartum visit. Medication compliance in the treatment group will be assessed via validated questionnaire. The primary outcome of this study is average systolic blood pressure at 1 week postpartum. Patients will be given instructions on blood pressure ranges and specific symptoms when they should contact study staff.

Study Design

• Study Type: Interventional
• Actual Enrollment: 12 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: Treatment Arm vs Active Control ArmTreatment Arm vs Active Control Arm
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Pilot Treatment of Persistent Non-Severe Postpartum Hypertension
• Actual Study Start Date: Aug 25, 2020
• Actual Primary Completion Date: Feb 12, 2021
• Actual Study Completion Date: Mar 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Other: Treatment Group The treatment group will provided with month supply of 30mg tablets of nifedipine extended release prior to discharge from the delivery admission. Dose increases in clinic will be at the discretion of providers, however a treatment algorithm will be provided for guidance.Treatment group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal.	Drug: Nifedipine Extended-Release Tablets; Antihypertensive
Placebo Comparator: Control Group The control group will not receive any medications at discharge. Providers will be instructed to only prescribe new blood pressure medication at subsequent postpartum visits if the blood pressure is in the sever range (>/=160/110). The control group will be given a home blood pressure cuff prior to discharge with instructions for use. They will also be scheduled for a 1 week blood pressure check and 4 week postpartum clinic appointment which standard for these patients outside of this proposal.	Other: No Antihypertensive Medication; Control (no intervention)

Outcome Measures

Primary Outcome Measures

1. Number of Women with Systolic Blood Pressure of less than 140 [1 Week Postpartum]

2. Number of participants enrolled as measured by randomization to arm [1 Year]

   Target enrollment reached.

3. Number of participants who completed the study as measured by completion logs [1 Year]

Secondary Outcome Measures

1. Average diastolic blood pressure [1 Week Postpartum]

2. Average Systolic and Diastolic Blood Pressure [4 Weeks Postpartum]

3. Change in Percentage of Patients with Blood Pressure Less Than 130/80 [1 Week Postpartum and 4 Weeks Postpartum]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 60 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Antepartum diagnosis of gestational hypertension

• preeclampsia

• superimposed preeclampsia without antepartum chronic hypertension medication

• Delivery at 23 weeks or greater

• Persistent elevation in BP >24 hours postpartum (>140/90 mm Hg) (2 or more BP >4 hours apart)

• 18 years or older

• English speaking

Exclusion Criteria:

• Need for continuation of antepartum antihypertensive medication

• Contraindication of calcium channel blocker use

• Severe range (160/110 mm Hg) blood pressure requiring treatment >24 hours after delivery

• Requires a 2nd oral antihypertensive medication for blood pressure control inpatient

• Acute cardiomyopathy or heart failure

• Creatinine ≥1.5

• Blood pressure <90/60 within 24 hours of discharge

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke University	Durham	North Carolina	United States	27705

Sponsors and Collaborators

• Duke University

Investigators

• Principal Investigator: Brenna Hughes, MD, Duke University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Duke University
• ClinicalTrials.gov Identifier: NCT04349124
• Other Study ID Numbers: Pro00104425
• First Posted: Apr 16, 2020
• Last Update Posted: Feb 2, 2022
• Last Verified: Feb 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes
• Additional relevant MeSH terms: Hypertension, Pregnancy-Induced; Hypertension; Antihypertensive Agents; Nifedipine

Study Results

No Results Posted as of Feb 2, 2022