The Outcomes of Hypertension in Obese Versus Non-obese Pregnant Women

NCT05673135 | Not Yet Recruiting

• 1 other identifier: HT-pre
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 1

Brief Summary

Hypertensive disorders of pregnancy, include pre-existing and gestational hypertension, preeclampsia, and eclampsia, it complicates up to 10% of pregnancies and represents a significant cause of maternal and perinatal morbidity and mortality. Following the "National High Blood Pressure Education Program Working Group on High Blood Pressure in Pregnancy" recommendation is currently a systolic blood pressure (SBP) ⩾ of 140 mmHg and diastolic blood pressure (DBP) ⩾ of 90 mmHg. The diagnosis generally requires two separate measurements. Accepted across international guidelines are the following four categories: Chronic/pre-existing hypertension (Hypertension discovered preconception or prior to 20 weeks gestation), Gestational hypertension (Hypertension that appears de novo after 20 weeks gestation and normalizes after pregnancy), Preeclampsia-eclampsia (De novo hypertension after 20 weeks' gestation accompanied by proteinuria, other features of maternal organ dysfunction or uteroplacental dysfunction), Chronic/pre-existing hypertension with superimposed preeclampsia-eclampsia. Over the past 2 decades, extensive epidemiologic studies have clearly established that obesity is a major risk for gestational hypertension and preeclampsia. The risk of preeclampsia typically doubles with each 5-7 kg/m2 increase in pre-pregnancy. The mechanisms have only been partially explored; increased cytokine-mediated inflammation and oxidative stress, increased shear stress, dyslipidemia, and increased sympathetic activity1 have all been proposed as possible pathways. Few studies have examined the relationship between pre-pregnancy BMI, gestational weight gain (GWG), and the risk of preeclampsia. So, our study aims to evaluate the adverse maternal and fetal outcomes related to hypertension in obese and non-obese pregnant women.

Conditions

Hypertension in Pregnancy

Outcome Measures

Primary Outcomes (1)

• The rate of adverse maternal outcome related to hypertension in both groups

  3 month

Study Arms (2)

Non-obese hypertensive pregnant women

OTHER

Drug: Anti-Hypertensive; Radiation: Ultrasound; Radiation: Doppler ultrasound; Diagnostic Test: complete blood count; Diagnostic Test: Body mass index

Obese hypertensive pregnant women

OTHER

Drug: Anti-Hypertensive; Radiation: Ultrasound; Radiation: Doppler ultrasound; Diagnostic Test: complete blood count; Diagnostic Test: Body mass index

Interventions

Anti-Hypertensive DRUG

For control of the blood pressure

Non-obese hypertensive pregnant women; Obese hypertensive pregnant women

Ultrasound RADIATION

For assessment of gestational age and fetal weight

Non-obese hypertensive pregnant women; Obese hypertensive pregnant women

Doppler ultrasound RADIATION

Umbilical artery Doppler assessment

Non-obese hypertensive pregnant women; Obese hypertensive pregnant women

complete blood count DIAGNOSTIC_TEST

For assessment of platelet count

Non-obese hypertensive pregnant women; Obese hypertensive pregnant women

Body mass index DIAGNOSTIC_TEST

for assessment of maternal weight during pregnancy

Non-obese hypertensive pregnant women; Obese hypertensive pregnant women

Eligibility Criteria

• Age: 25 Years - 35 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Women aged from 20-35 years.
• Pregnant women from 28-30 weeks.
• Pregnant women with a singleton pregnancy.
• Women with chronic or gestational hypertension.
• Women with normal baseline investigations (uncomplicated hypertension).
• Obese women and non-obese women.

You may not qualify if:

• Women with preeclampsia/eclampsia.
• Women need urgent termination of pregnancy.
• Women with co-morbidities such as diabetes, renal diseases, cardiac ...etc.
• Women with confirmed fetal malformation.
• Women who will refuse to participate.

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Location

MeSH Terms

Conditions

Hypertension, Pregnancy-Induced

Interventions

Antihypertensive Agents; High-Energy Shock Waves; Blood Cell Count; Body Mass Index

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Hypertension; Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Cardiovascular Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Body Weights and Measures; Body Constitution; Physical Examination; Anthropometry; Physiological Phenomena; Biometry; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 1, 2023
• First Posted: January 6, 2023
• Study Start: April 1, 2025
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: April 24, 2024

Record last verified: 2024-04

Locations

EG (1)