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NCT Number: NCT05673135

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

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.

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Key information

Age range

25 year–35 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Women Health Hospital - Assiut university

Asyut, 71111, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Anti-Hypertensive

Drug

For control of the blood pressure

Ultrasound

Radiation

For assessment of gestational age and fetal weight

Doppler ultrasound

Radiation

Umbilical artery Doppler assessment

Complete blood count

Diagnostic Test

For assessment of platelet count

Body mass index

Diagnostic Test

for assessment of maternal weight during pregnancy

Primary outcomes

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

    Time frame: 3 month

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 6, 2023
Registry last updated
Apr 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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