Clinical trial

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

Name
HT-pre
Description
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.
Trial arms
Trial start
2025-04-01
Estimated PCD
2026-04-01
Trial end
2026-10-01
Status
Not yet recruiting
Treatment
Anti-Hypertensive
For control of the blood pressure
Arms:
Non-obese hypertensive pregnant women, Obese hypertensive pregnant women
Ultrasound
For assessment of gestational age and fetal weight
Arms:
Non-obese hypertensive pregnant women, Obese hypertensive pregnant women
Doppler ultrasound
Umbilical artery Doppler assessment
Arms:
Non-obese hypertensive pregnant women, Obese hypertensive pregnant women
complete blood count
For assessment of platelet count
Arms:
Non-obese hypertensive pregnant women, Obese hypertensive pregnant women
Body mass index
for assessment of maternal weight during pregnancy
Arms:
Non-obese hypertensive pregnant women, Obese hypertensive pregnant women
Size
260
Primary endpoint
The rate of adverse maternal outcome related to hypertension in both groups
3 month
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.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 260, 'type': 'ESTIMATED'}}
Updated at
2024-04-24

1 organization

1 product

1 indication

Organization
Assiut University