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临床试验/NCT05673135
NCT05673135尚未招募不适用

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

Assiut University1 个研究点 分布在 1 个国家目标入组 260 人开始时间: 2025年4月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
尚未招募
入组人数
260
试验地点
1
主要终点
The rate of adverse maternal outcome related to hypertension in both groups

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
25 Years 至 35 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

研究组 & 干预措施

Obese hypertensive pregnant women

Other

干预措施: Anti-Hypertensive (Drug)

Non-obese hypertensive pregnant women

Other

干预措施: Anti-Hypertensive (Drug)

Non-obese hypertensive pregnant women

Other

干预措施: Ultrasound (Radiation)

Non-obese hypertensive pregnant women

Other

干预措施: Doppler ultrasound (Radiation)

Non-obese hypertensive pregnant women

Other

干预措施: complete blood count (Diagnostic Test)

Non-obese hypertensive pregnant women

Other

干预措施: Body mass index (Diagnostic Test)

Obese hypertensive pregnant women

Other

干预措施: Ultrasound (Radiation)

Obese hypertensive pregnant women

Other

干预措施: Doppler ultrasound (Radiation)

Obese hypertensive pregnant women

Other

干预措施: complete blood count (Diagnostic Test)

Obese hypertensive pregnant women

Other

干预措施: Body mass index (Diagnostic Test)

结局指标

主要结局

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

时间窗: 3 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mohammed Khairy Ali

Assistant Professor

Assiut University

研究点 (1)

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