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

Официальное название

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

Обзор

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.

Вмешательства

• Препарат Anti-Hypertensive
  For control of the blood pressure
• Лучевая терапия Ultrasound
  For assessment of gestational age and fetal weight
• Лучевая терапия Doppler ultrasound
  Umbilical artery Doppler assessment
• Диагностический тест complete blood count
  For assessment of platelet count
• Диагностический тест Body mass index
  for assessment of maternal weight during pregnancy

Первичные конечные точки

• The rate of adverse maternal outcome related to hypertension in both groups [Срок оценки: 3 month]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Нерандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Women Health Hospital - Assiut university — Asyut

Идентификаторы

NCT: NCT05673135 · HT-pre

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

Открыть это исследование на ClinicalTrials.gov ↗