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

NCT ID: NCT05673135

Last Updated: 2024-04-24

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-04-01
• Study Completion Date: 2026-10-31

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Non-obese hypertensive pregnant women

Group Type: OTHER

Anti-Hypertensive

Intervention Type: DRUG

For control of the blood pressure

Ultrasound

Intervention Type: RADIATION

For assessment of gestational age and fetal weight

Doppler ultrasound

Intervention Type: RADIATION

Umbilical artery Doppler assessment

complete blood count

Intervention Type: DIAGNOSTIC_TEST

For assessment of platelet count

Body mass index

Intervention Type: DIAGNOSTIC_TEST

for assessment of maternal weight during pregnancy

Obese hypertensive pregnant women

Group Type: OTHER

Anti-Hypertensive

Intervention Type: DRUG

For control of the blood pressure

Ultrasound

Intervention Type: RADIATION

For assessment of gestational age and fetal weight

Doppler ultrasound

Intervention Type: RADIATION

Umbilical artery Doppler assessment

complete blood count

Intervention Type: DIAGNOSTIC_TEST

For assessment of platelet count

Body mass index

Intervention Type: DIAGNOSTIC_TEST

for assessment of maternal weight during pregnancy

Interventions

Anti-Hypertensive

For control of the blood pressure

Intervention Type: DRUG

Ultrasound

For assessment of gestational age and fetal weight

Intervention Type: RADIATION

Doppler ultrasound

Umbilical artery Doppler assessment

Intervention Type: RADIATION

complete blood count

For assessment of platelet count

Intervention Type: DIAGNOSTIC_TEST

Body mass index

for assessment of maternal weight during pregnancy

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. Women aged from 20-35 years.

2. Pregnant women from 28-30 weeks.

3. Pregnant women with a singleton pregnancy.

4. Women with chronic or gestational hypertension.

5. Women with normal baseline investigations (uncomplicated hypertension).

6. Obese women and non-obese women.

Exclusion Criteria

1. Women with preeclampsia/eclampsia.

2. Women need urgent termination of pregnancy.

3. Women with co-morbidities such as diabetes, renal diseases, cardiac ...etc.

4. Women with confirmed fetal malformation.

5. Women who will refuse to participate.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Khairy Ali

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Women Health Hospital - Assiut university

Asyut, , Egypt

Countries

Egypt

Other Identifiers

HT-pre

Identifier Type: -

Identifier Source: org_study_id