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Clinical Trials/NCT06100484
NCT06100484CompletedNot Applicable

Potential Impact of Blood Pressure Variability on Right Ventricular Remodeling in Pregnant Women With Pre-eclampsia or Gestational Hypertension

Aswan University1 site in 1 country60 target enrollmentStarted: October 6, 2023Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
60
Locations
1
Primary Endpoint
Number of participants that experienced right ventricular remodeling

Study Overview

Brief Summary

The goal of this observational study is to learn about the potential effect of blood pressure variability changes on right ventricular strain in pregnant women with gestational hypertension or pre-eclampsia

Detailed Description

Hypertensive disorders of pregnancy include chronic hypertension, gestational hypertension, pre-eclampsia and chronic hypertension with superimposed pre-eclampsia. Pre-eclampsia, and all hypertensive disorders affect about 5-10% of pregnancies.

The term Blood Pressure Variability is an entity that characterizes the continuous and dynamic fluctuations that occur in blood pressure levels throughout a lifetime.

It encompasses a wide range of blood pressure variations; occurring over seconds or minutes (very short- term BPV), along 24 hours (short- term BPV, usually assessed by ambulatory BP monitoring), and between days (mid- term or day- to- day BPV, assessed with home BP monitoring), Long-term BPV has also been described, including seasonal BP variations and changes between clinic visits over months or years (visit- to- visit BPV).

Studies showed that visit-to-visit BP variability was associated with gestational hypertension and preeclampsia , as well as with risk of adverse birth outcomes in pregnant women without proteinuria or chronic hypertension.

Preeclampsia is a pregnancy-specific disorder that complicates 2-8% of pregnancies worldwide.

Study Design

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 50 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Patients with ages equal to or more than 18 years old.
  • women with gestational hypertension ( systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg after 20 weeks of gestation without proteinuria ).
  • Women with pre-eclampsia (systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg after 20 weeks of gestation with proteinuria < 300mg /24 h).

Exclusion Criteria

  • Pregnancy less than 20 weeks gestation.
  • Patients with congenital heart diseases.
  • Patients with moderate to severe valvular heart diseases.
  • Patients with cardiomyopathy whatever its cause.
  • Patients with underlying right ventricular dysfunction.
  • Poor image quality.

Outcomes

Primary Outcomes

Number of participants that experienced right ventricular remodeling

Time Frame: From Baseline at time of examination till 3 months post-partum

Assessment of right ventricular strain via 2D Echocardiography and Speckle tracking

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Mahmoud Elsayed Abdellatif

Cardiology resident

Aswan University

Study Sites (1)

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