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Feasibility and Acceptability of Risk Stratification in the Fourth Trimester to Reduce Maternal Morbidity and Mortality

Primary Purpose

Hypertensive Disorder of Pregnancy

Status
Recruiting
Phase
Not Applicable
Locations
Nigeria
Study Type
Interventional
Intervention
Remote blood pressure monitoring
NT proBNP assessment
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Hypertensive Disorder of Pregnancy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria: Adults >18 years of age Admitted for delivery Clinical diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia) Control participants: Adults >18 years of age Admitted for delivery with an uncomplicated pregnancy and delivery Exclusion Criteria: Unable to provide consent Unable to check blood pressure at home

Sites / Locations

  • University of Abuja Teaching HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

BP monitoring arm

Control arm

Arm Description

Participants will be adults >18 years of age admitted for delivery with a diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia) per the American College of Obstetricians and Gynecologists Criteria.

Control participants will be adults >18 years of age with an uncomplicated pregnancy and delivery, and without a diagnosis of HDP.

Outcomes

Primary Outcome Measures

Rate of recruitment
Number of participants recruited

Secondary Outcome Measures

Fidelity
10 daily home BP checks per participant during 2-week study period
Retention
Proportion (95% CI) of participants who remained with the home BP monitoring pilot study for the 14-day period

Full Information

First Posted
September 14, 2022
Last Updated
November 29, 2022
Sponsor
Washington University School of Medicine
Collaborators
University of Abuja Teaching Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT05631067
Brief Title
Feasibility and Acceptability of Risk Stratification in the Fourth Trimester to Reduce Maternal Morbidity and Mortality
Official Title
Feasibility and Acceptability of Remote Blood Pressure Monitoring and Risk Stratification in the Fourth Trimester to Reduce Maternal Cardiovascular Morbidity and Mortality in Nigeria
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 15, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Anticipated)
Study Completion Date
June 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Washington University School of Medicine
Collaborators
University of Abuja Teaching Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Hypertensive disorders of pregnancy (HDP) are major causes of maternal morbidity and mortality globally and are associated with peripartum and future cardiovascular disease, including stroke, heart failure, and myocardial infarction. About 1 out of every 10 maternal deaths in Sub-Saharan Africa are associated with HDP, and most of these deaths are preventable with timely, implementation of evidence-based strategies, including postpartum blood pressure (BP) monitoring, treatment of elevated BP and comprehensive postpartum follow up as recommended by the American College of Obstetricians and Gynecologists (ACOG) and the World Health Organization (WHO). This study aims to contextualize, implement, and evaluate the feasibility, fidelity, and acceptability of: 1) postpartum remote blood pressure monitoring and 2) NTproBNP testing for postpartum risk stratification in women with HDP at the University of Abuja Teaching Hospital in the Federal Capital Territory of Nigeria
Detailed Description
Aims: To evaluate the feasibility, fidelity, and acceptability of home blood pressure monitoring in postpartum patients (n=90) with HDP. The investigators hypothesize that remote blood pressure monitoring will be feasible, implemented as intended, and acceptable among patients, physicians, and other health care workers to improve awareness and early diagnosis of elevated blood pressures (>140/90 mm Hg) in postpartum patients with HDP. To evaluate the association between N Terminal-proBNP (NT-proBNP) levels and short-term cardiovascular outcomes (i.e., all-cause cardiovascular hospital readmission, postpartum pre-eclampsia, hypertensive urgency/emergency, stroke, heart failure/pulmonary edema, seizure and mortality at 12-weeks postpartum) in patients with HDP.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertensive Disorder of Pregnancy

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
BP monitoring arm
Arm Type
Experimental
Arm Description
Participants will be adults >18 years of age admitted for delivery with a diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia) per the American College of Obstetricians and Gynecologists Criteria.
Arm Title
Control arm
Arm Type
Active Comparator
Arm Description
Control participants will be adults >18 years of age with an uncomplicated pregnancy and delivery, and without a diagnosis of HDP.
Intervention Type
Behavioral
Intervention Name(s)
Remote blood pressure monitoring
Intervention Description
Participants will receive a blood pressure monitor to check daily BPs for two weeks post partum
Intervention Type
Diagnostic Test
Intervention Name(s)
NT proBNP assessment
Intervention Description
Participants will have biomarker assessment at 0-2 days postpartum
Primary Outcome Measure Information:
Title
Rate of recruitment
Description
Number of participants recruited
Time Frame
Through study completion at 1 year
Secondary Outcome Measure Information:
Title
Fidelity
Description
10 daily home BP checks per participant during 2-week study period
Time Frame
2 weeks
Title
Retention
Description
Proportion (95% CI) of participants who remained with the home BP monitoring pilot study for the 14-day period
Time Frame
2 weeks
Other Pre-specified Outcome Measures:
Title
Exploratory Outcome
Description
Detection of elevated BP>140/90 mm Hg Detection of elevated BP>140/90 mm Hg
Time Frame
2 weeks
Title
Incidence of combined adverse cardiovascular events
Description
The incidence of a combined adverse cardiovascular endpoint (all-cause cardiovascular hospital readmission, postpartum pre-eclampsia, hypertensive urgency/emergency, stroke, heart failure/pulmonary edema, seizure and mortality) at 12-weeks postpartum.
Time Frame
12 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Adults >18 years of age Admitted for delivery Clinical diagnosis of HDP (i.e., chronic hypertension, gestational hypertension, preeclampsia, eclampsia, the HELLP syndrome, or chronic hypertension with superimposed preeclampsia) Control participants: Adults >18 years of age Admitted for delivery with an uncomplicated pregnancy and delivery Exclusion Criteria: Unable to provide consent Unable to check blood pressure at home
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Zainab Mahmoud, MD MSc
Phone
08090299333
Email
zmahmoud@wustl.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Dike Ojji, MBBS PhD
Phone
08060094456
Email
dike.ojji@uniabuja.edu.ng
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zainab Mahmoud, MD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark D Huffman, MD MPH
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Dike Ojji, MBBS PhD
Organizational Affiliation
University of Abuja Teaching Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Kathryn Lindley, MD
Organizational Affiliation
Vanderbilt University
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Abuja Teaching Hospital
City
Gwagwalada
State/Province
FCT
Country
Nigeria
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dike Ojji, MBBS PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD will be available within 1 year of study completion
IPD Sharing Time Frame
Data will be available within 1 year of study conclusion
IPD Sharing Access Criteria
Criteria and URL will be provided

Learn more about this trial

Feasibility and Acceptability of Risk Stratification in the Fourth Trimester to Reduce Maternal Morbidity and Mortality

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