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临床试验/NCT05793125
NCT05793125已完成不适用

Correlation Between Pulmonary Artery Doppler And Neonatal Outcome In Hypertensive Disorders Of Pregnancy

Cairo University1 个研究点 分布在 1 个国家目标入组 72 人开始时间: 2023年4月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
72
试验地点
1
主要终点
Acceleration time to ejection time ratio (At/Et) of fetal pulmonary artery Doppler in neonates needing respiratory support

研究概览

简要总结

To correlate fetal Pulmonary artery Doppler parameters with neonatal outcome in patients diagnosed with hypertensive disorders of pregnancy.

详细描述

Hypertensive disorders include gestational hypertension, preeclampsia, chronic hypertension, preeclampsia superimposed on chronic hypertension. They complicate up to 10% of pregnancies. As a group they are one member of the deadly triad, along with hemorrhage and infection, that contributes greatly to maternal morbidity.

Preeclampsia, either alone or superimposed on chronic hypertension, is the most dangerous. Most hypertension related deaths are preventable. Also, nonsevere preeclampsia may progress rapidly to severe disease causing headache or visual disturbance that precede eclampsia. They also cause epigastic or right upper quadrant pain and elevated hepatic transaminases that frequently accompany hepatocellular necrosis, ischemia and edema, thrombocytopenia that represents platelet activation and aggregation, microangiopathic hemolysis, renal involvement and placental abruption. On the long term, preeclampsia is also associated with adverse health problems including chronic hypertension, ischemic heart disease, atherosclerosis, cardiomyopathy, peripheral vascular disease, type 2 diabetes, dyslipidemia, obesity and metabolic syndrome.

Termination of pregnancy is the only known cure for preeclampsia. Moreover, expectant management of preterm severe preeclampsia leads to disastrous results as increase in perinatal mortality rate, placental abruption, eclampsia, renal failure, hypertensive encephalopathy, intracranial hemorrhage or even rupture in hepatic hematoma.

Early attempts have been made to predict fetal maturity on the basis antenatal ultrasonographic parameters including lung characteristics, bowel pattern, placental grading, the presence or absence of intraamniotic particles (vernix caseosa) and the epiphyseal ossification centers appearance and enlargement.

More recently, fetal pulmonary artery Doppler has been used to predict neonatal respiratory rate (RDS). It was found that an elevated acceleration-to-ejection time ratio was significantly associated with neonatal RDS. However such indices cannot be generalized in all cases, especially those with hypertensive disorders of pregnancy who have abnormal trophoblastic invasion of uterine vessels affecting fetoplacental circulation resistance.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

年龄范围
18 Years 至 42 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Age: 18-42 years old
  • Patients who will be diagnosed with hypertensive disorders of pregnancy preoperatively according to (ACOG 2020)
  • Those who will undergo elective or emergency termination of pregnancy whether by vaginal or cesarean delivery .
  • Primi or multigravida
  • With gestational age: 28 0/7 - 37 6/7 weeks

排除标准

  • Multifetal pregnancy
  • Intrauterine fetal death
  • Intrauterine growth restriction (IUGR) which is defined as a rate of fetal growth that is less than normal for the growth potential of that specific infant
  • Placental abruption whether diagnosed before or during delivery.
  • Absent or reversed umbilical artery end diastolic flow.
  • Diabetes with pregnancy either gestational or overt which is defined as any degree of glucose intolerance with an onset or first recognition during pregnancy
  • Premature or prelabor rupture of membranes
  • BMI above 40 due to technical difficulties to obtain accurate measures
  • Major congenital fetal anomalies whether diagnosed before or after delivery
  • Maternal fever more than 37.4 degree
  • Emergent cases presenting with fetal distress (bradycardia will be defined as fetal heart rate < 110 beat per minute)
  • Patient receiving general anesthesia if termination was by cesarean delivery
  • Patients receiving narcotics 4 hours before delivery
  • Patients with unreliable dates or no crown rump length at first trimester.

结局指标

主要结局

Acceleration time to ejection time ratio (At/Et) of fetal pulmonary artery Doppler in neonates needing respiratory support

时间窗: Baseline

(At/Et) ratio will be measured in the fetal main pulmonary artery Doppler and will be correlated with the neonatal outcome

次要结局

  • The pulsatility index (PI) of fetal pulmonary artery Doppler in neonates needing respiratory support(Baseline)
  • The systolic to diastolic ratio (S/D) of fetal pulmonary artery Doppler in neonates needing respiratory support(baseline)
  • The resistance index (RI) of fetal pulmonary artery Doppler in neonates needing respiratory support(baseline)
  • The peak systolic velocity (PSV) of fetal pulmonary artery Doppler in neonates needing respiratory support(baseline)

研究者

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

Noran Amin

assistant lecturer of Obstetrics and Gynecology

Cairo University

研究点 (1)

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