Blood Pressure Variability Effect on Right Ventricular Strain in Women With Hypertensive Disorders With Pregnancy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-10-06

Study Completion Date

2024-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Vascular Biomarkers Predictive of the Progression From Hypertensive Disorders in Pregnancy to Preeclampsia in Pregnant Women

NCT04520048

Hypertension Disorders in Pregnancy Gestational Hypertension Pre-Eclampsia

RECRUITING NA

Fetal Cardiac Function

NCT06381258

Fetal Growth Retardation

COMPLETED

Comparison Between Uterine Artery Doppler and Placental Vascular Indices in Prediction of Preeclampsia

NCT03838887

Pre-Eclampsia

UNKNOWN

NT-proBNP Levels in the Prediction of Intrapartum and Postpartum Events in Adult Congenital Heart Disease Patients

NCT04231591

Congenital Heart Disease Pregnancy Complications

COMPLETED

Minimally-invasive Assessment of Cardiac Output in Severe Preeclampsia

NCT00465114

Preeclampsia

WITHDRAWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Traditionally the condition is diagnosed in the case of de novo development of hypertension (\> 140/90 mmHg) and proteinuria during the second half of pregnancy (\>20 weeks of gestation).

Preeclampsia (PE) is a life-threatening condition in pregnancy and a major cause of maternal and neonatal morbidity and mortality.

It affects 2-8% of pregnancies that develop serious complications such as eclampsia, hemolysis, elevated liver enzyme levels,thrombocytopenia, and pulmonary edema. These end organ damages usually disappear 12 weeks after delivery.

Gestational hypertension refers to hypertension with onset in the latter part of pregnancy (\>20 weeks' gestation) without any other features of preeclampsia, and followed by normalization of the blood pressure postpartum, however, be a harbinger of chronic hypertension later in life as compared with patients who do not have such a history.

There is an association between RV longitudinal strain and functional capacity in hypertensive patients. as well as the strong relationship between RV longitudinal strain and cardiovascular mortality and morbidity in a wide range of cardiovascular conditions.

Over the past few decades, there has been a lot of research done on left ventricular remodeling in hypertensive diseases of pregnancy, especially in gestational hypertension and preeclampsia.However, anatomical, functional, and mechanical changes to the right ventricle are still largely unclear. The limited data are also contradictory because some authors reported significant functional changes in the form of increased RV diameter, elevated pulmonary pressure, and decreased RV longitudinal strain. while other studies showed no difference in RV structure and function between normotensive controls and pregnant women with hypertensive disorders.

In the current study, we are going to assess the impact of gestational hypertension and preeclampsia on RV remodeling. If remodeling occurs, we are going to assess RV recovery post partum.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hypertension, Pregnancy Induced Preeclampsia

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healthy group

Pregnant women above 20 weeks of pregnancy with no hypertensive disorders with pregnancy

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Two-dimensional RV strain imaging will be performed by using three consecutive cardiac cycles of 2D images in the apical four-chamber view to assess RV-GLS

Diseased group

Pregnant women above 20 weeks of pregnancy with gestational hypertension or pre-eclampsia

Echocardiography

Intervention Type DIAGNOSTIC_TEST

Two-dimensional RV strain imaging will be performed by using three consecutive cardiac cycles of 2D images in the apical four-chamber view to assess RV-GLS

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Echocardiography

Two-dimensional RV strain imaging will be performed by using three consecutive cardiac cycles of 2D images in the apical four-chamber view to assess RV-GLS

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes