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

Study Overview
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Brief Summary
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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.

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

Conditions
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Hypertension in Pregnancy

Intervention / Treatment
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* Drug: Anti-Hypertensive
* Radiation: Ultrasound
* Radiation: Doppler ultrasound
* Diagnostic Test: complete blood count
* Diagnostic Test: Body mass index


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Non-obese hypertensive pregnant women<br> | Drug: Anti-Hypertensive<br>* For control of the blood pressure<br>Radiation: Ultrasound<br>* For assessment of gestational age and fetal weight<br>Radiation: Doppler ultrasound<br>* Umbilical artery Doppler assessment<br>Diagnostic Test: complete blood count<br>* For assessment of platelet count<br>Diagnostic Test: Body mass index<br>* for assessment of maternal weight during pregnancy<br>|
| Other: Obese hypertensive pregnant women<br> | Drug: Anti-Hypertensive<br>* For control of the blood pressure<br>Radiation: Ultrasound<br>* For assessment of gestational age and fetal weight<br>Radiation: Doppler ultrasound<br>* Umbilical artery Doppler assessment<br>Diagnostic Test: complete blood count<br>* For assessment of platelet count<br>Diagnostic Test: Body mass index<br>* for assessment of maternal weight during pregnancy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of adverse maternal outcome related to hypertension in both groups |  | 3 month |