The Outcomes of Hypertension in Obese Versus Non-obese Pregnant Women
Primary Purpose
Hypertension in Pregnancy
Status
Not yet recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Anti-Hypertensive
Ultrasound
Doppler ultrasound
complete blood count
Body mass index
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension in Pregnancy
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.
Sites / Locations
- Women Health Hospital - Assiut university
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Non-obese hypertensive pregnant women
Obese hypertensive pregnant women
Arm Description
Outcomes
Primary Outcome Measures
The rate of adverse maternal outcome related to hypertension in both groups
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05673135
Brief Title
The Outcomes of Hypertension in Obese Versus Non-obese Pregnant Women
Official Title
The Differences in Adverse Maternal and Fetal Outcomes Related to Hypertension in Obese Versus Non-obese Pregnant Women
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
April 2023 (Anticipated)
Primary Completion Date
April 2025 (Anticipated)
Study Completion Date
October 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension in Pregnancy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
260 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Non-obese hypertensive pregnant women
Arm Type
Other
Arm Title
Obese hypertensive pregnant women
Arm Type
Other
Intervention Type
Drug
Intervention Name(s)
Anti-Hypertensive
Intervention Description
For control of the blood pressure
Intervention Type
Radiation
Intervention Name(s)
Ultrasound
Intervention Description
For assessment of gestational age and fetal weight
Intervention Type
Radiation
Intervention Name(s)
Doppler ultrasound
Intervention Description
Umbilical artery Doppler assessment
Intervention Type
Diagnostic Test
Intervention Name(s)
complete blood count
Intervention Description
For assessment of platelet count
Intervention Type
Diagnostic Test
Intervention Name(s)
Body mass index
Intervention Description
for assessment of maternal weight during pregnancy
Primary Outcome Measure Information:
Title
The rate of adverse maternal outcome related to hypertension in both groups
Time Frame
3 month
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Women Health Hospital - Assiut university
City
Assiut
ZIP/Postal Code
71111
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
The Outcomes of Hypertension in Obese Versus Non-obese Pregnant Women
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