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

Not Applicable

Not yet recruiting

• Conditions: Hypertension in Pregnancy
• Interventions: Drug: Anti-Hypertensive; Radiation: Ultrasound; Radiation: Doppler ultrasound; Diagnostic Test: complete blood count; Diagnostic Test: Body mass index

• Registration Number: NCT05673135
• Lead Sponsor: Assiut University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2023-01-01
• Study First Submitted QC: 2023-01-04
• Study First Posted: 2023-01-06
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-23
• Last Update Posted: 2024-04-24
• Study Start: 2025-04-01
• Primary Completion: 2026-04
• Study Completion: 2026-10

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: Female
• Target Recruitment: 260

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Obese hypertensive pregnant women	Ultrasound	-
Obese hypertensive pregnant women	Doppler ultrasound	-
Non-obese hypertensive pregnant women	Anti-Hypertensive	-
Obese hypertensive pregnant women	Anti-Hypertensive	-
Obese hypertensive pregnant women	complete blood count	-
Non-obese hypertensive pregnant women	Ultrasound	-
Non-obese hypertensive pregnant women	Doppler ultrasound	-
Non-obese hypertensive pregnant women	complete blood count	-
Obese hypertensive pregnant women	Body mass index	-
Non-obese hypertensive pregnant women	Body mass index	-

Primary Outcome Measures

Name	Time	Method
The rate of adverse maternal outcome related to hypertension in both groups	3 month

Trial Locations

Locations (1)

Women Health Hospital - Assiut university; 🇪🇬 Assiut, Egypt