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

Hypertension in Pregnancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05673135
• Other study ID #: HT-pre
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 1, 2025
• Est. completion date: October 2026

Study information

• Verified date: April 2024
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 260
• Est. completion date: October 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Hypertension
• Hypertension in Pregnancy
• Hypertension, Pregnancy-Induced

Intervention

Drug:
• Anti-Hypertensive
For control of the blood pressure

Radiation:
• Ultrasound
For assessment of gestational age and fetal weight
• Doppler ultrasound
Umbilical artery Doppler assessment

Diagnostic Test:
• complete blood count
For assessment of platelet count
• Body mass index
for assessment of maternal weight during pregnancy

Locations

Country	Name	City	State
Egypt	Women Health Hospital - Assiut university	Assiut

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The rate of adverse maternal outcome related to hypertension in both groups		3 month