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Clinical Trials/NCT05673135
NCT05673135
Not yet recruiting
Not Applicable

The Differences in Adverse Maternal and Fetal Outcomes Related to Hypertension in Obese Versus Non-obese Pregnant Women

Assiut University1 site in 1 country260 target enrollmentApril 1, 2025

Overview

Phase
Not Applicable
Intervention
Anti-Hypertensive
Conditions
Hypertension in Pregnancy
Sponsor
Assiut University
Enrollment
260
Locations
1
Primary Endpoint
The rate of adverse maternal outcome related to hypertension in both groups
Status
Not yet recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2025
End Date
October 2026
Last Updated
2 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Khairy Ali

Assistant Professor

Assiut University

Eligibility Criteria

Inclusion Criteria

  • 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.

Exclusion Criteria

  • 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.

Arms & Interventions

Obese hypertensive pregnant women

Intervention: Anti-Hypertensive

Non-obese hypertensive pregnant women

Intervention: Anti-Hypertensive

Non-obese hypertensive pregnant women

Intervention: Ultrasound

Non-obese hypertensive pregnant women

Intervention: Doppler ultrasound

Non-obese hypertensive pregnant women

Intervention: complete blood count

Non-obese hypertensive pregnant women

Intervention: Body mass index

Obese hypertensive pregnant women

Intervention: Ultrasound

Obese hypertensive pregnant women

Intervention: Doppler ultrasound

Obese hypertensive pregnant women

Intervention: complete blood count

Obese hypertensive pregnant women

Intervention: Body mass index

Outcomes

Primary Outcomes

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

Time Frame: 3 month

Study Sites (1)

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