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临床试验/NCT04911322
NCT04911322已完成不适用

Correlation Between Pulmonary Artery Doppler And Other Ultrasonographic Markers With Neonatal Outcome In Placenta Accreta Spectrum Patients

Cairo University1 个研究点 分布在 1 个国家目标入组 71 人开始时间: 2021年8月15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
71
试验地点
1
主要终点
Acceleration time to ejection time (At/Et) ratio of fetal pulmonary artery Doppler in neonates with good and poor outcome.

研究概览

简要总结

To correlate ultrasonographic markers of fetal lung maturity including Pulmonary artery Doppler indices in the late preterm and early term in placenta accreta spectrum patients with neonatal outcome.

详细描述

The increasing rates of cesarean section has led to several fold increase in the incidence of placenta accreta spectrum in the last three or four decades.

Placenta accreta spectrum (PAS) disorders is the term used to describe a variety of pregnancy complications resulting from abnormal placental implantation that is accompanied by deficiency of the uterine wall.

Placenta accreta spectrum includes placenta accreta, placenta increta, placenta percreta.

Placenta accreta spectrum is one of the devastating obstetric complications owing to massive hemorrhage encountered during manual removal of the placenta to preserve the uterus or even the need for peripartum hysterectomy, need for massive blood transfusion, maternal intensive care admission and maternal mortality.

Complications related to blood loss are lower in elective compared to emergency deliveries. This has led to the scheduling of surgical interventions with planned late preterm (35-36 weeks) or early term (37 weeks) delivery as a mechanism to avoid the need for emergency surgery. According to the RCOG guidelines, planned delivery at 35 0/7- 36 0/7 weeks of gestation provides the best chance between fetal maturity and the risk of unscheduled delivery while ACOG recommends 34 0/7- 35 6/7.

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 placenta accreta spectrum preoperatively according to (ACOG 2018), (Jauniaux et al., 2018 a), (Jauniaux et al., 2018 b)
  • Those who will undergo elective or emergency cesarean.
  • With gestational age: 34 0/7 - 38 6/7 weeks
  • Under the effect of general anesthesia

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
  • Diabetes with pregnancy either gestational or overt which is defined as any degree of glucose intolerance with an onset or first recognition during pregnancy
  • Pregnancy induced hypertension defined as either systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg. It is classified as one of four conditions: preexisting hypertension, gestational hypertension, preeclampsia, preexisting hypertension with superimposed preeclampsia
  • Premature rupture of membranes
  • BMI above 40 due to technical difficulties to obtain accurate measures
  • Narcotic usage during anesthesia before fetal delivery
  • 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)
  • Patients who have not completed the course of antenatal corticosteroids according to (RCOG 2010).
  • Intraoperative spontaneous separation of the placenta

结局指标

主要结局

Acceleration time to ejection time (At/Et) ratio of fetal pulmonary artery Doppler in neonates with good and poor outcome.

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 resistance index (RI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome(Baseline)
  • The systolic to diastolic ratio (S/D) of the fetal pulmonary artery Doppler in neonates with good and poor outcome(Baseline)
  • The peak systolic velocity (PSV) of the fetal pulmonary artery Doppler in neonates with good and poor outcome(Baseline)
  • Maternal morbidity in the form of organ injury will be recorded(baseline)
  • The need for peripartum hysterectomy will be recorded(Baseline)
  • The pulsatility index (PI) of the fetal pulmonary artery Doppler in neonates with good and poor outcome.(Baseline)
  • Optimal timing of delivery in PAS for best neonatal outcome(baseline)
  • Maternal mortality rate(Baseline)
  • The need for blood transfusion(baseline)
  • percent of women who will undergo cesarean hysterectomy versus conservative management(baseline)
  • Optimal timing of delivery in PAS for best maternal outcome(baseline)

研究者

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

Noran Amin

Nominated demonstrator of Obstetrics and Gynecology, Cairo University

Cairo University

研究点 (1)

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