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临床试验/NCT06346327
NCT06346327已完成不适用

Clinical Significance Of Intermittently Absent End-Diastolic Flow Of The Fetal Umbilical Artery On Perinatal And Neonatal Outcomes Zeynep Kayaoğlu Yıldırım, Gynecologist and Obstetrician, Perinatologist, İstanbul Başakşehir Çam ve Sakura City Hospital, Drkayaoglu@Hotmail.Com, Alperen İnce, MD, Obstetrics and Gynecology Medical Student, Başakşehir Çam ve Sakura City Hospital,Gökhan Bayanmelek, Gynecologist and Obstetrician, Perinatologist, İstanbul Başakşehir Çam ve Sakura City Hospital,Gökhan Bolluk, Gynecologist and Obstetrician, Perinatologist, Başakşehir Çam ve Sakura City Hospital

Başakşehir Çam & Sakura City Hospital1 个研究点 分布在 1 个国家目标入组 137 人开始时间: 2020年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
137
试验地点
1
主要终点
pregnancy complications (Number of Pregnancies complicated with IUMF, ablatio placenta, fetal distress, Intrauterine growth restriction and amniotic fluid abnormalities).

研究概览

简要总结

Objective: This study aimed to estimate the risk of adverse perinatal outcomes among pregnant patients with intermittently absent (iAEDF) and persistently absent end-diastolic umbilical artery flow (pAEDF). The fetal risks associated with persistently absent end-diastolic flow have been described. However, the risks associated with intermittent absent end-diastolic flow are not well-known.

Study design: We performed a retrospective cohort study of patients diagnosed with the iAEDF or pAEDF at our institution from 2020 to 2023. Fetuses were classified under two categories: iAEDF group and pAEDF group.Neonatal outcomes, demographic information, pregnancy outcomes and pregnancy complications were compared between patients with iAEDF and those with pAEDF.

详细描述

Doppler velocity measurement of the umbilical artery (UA) serves as a crucial clinical tool for monitoring feto-placental hemodynamics and assessing fetal well-being in high-risk pregnancies. This technique has demonstrated notable advantages in monitoring potentially risky fetuses, particularly in pregnancies complicated by placental disorders, such as fetal growth restriction (FGR). Since UA Doppler (UAD) results can deteriorate over the course of pregnancy, regular assessments are recommended. However, the frequency of these assessments, management protocols, and delivery timing recommendations vary among major national obstetric societies.

The UA blood velocity waveform is typically characterized by the pulsatility index (PI) and qualitative information concerning the potential absence or reversal of end-diastolic flow (EDF). Absent end-diastolic flow (AEDF) signifies increased resistance to flow in the placental vascular bed and is associated with elevated risks of intrauterine death and adverse perinatal outcomes. AEDF in the UA can be either persistent (pAEDF), occurring in most or all fetal cardiac cycles, or intermittent (iAEDF), manifesting in only some of the cardiac cycles. However, standardized definitions for these terms lack and the clinical implications of the iAEDF versus the pAEDF remain unclear.

A previous study indicated that, compared to fetuses with pAEDF, those with iAEDF are diagnosed with UAD abnormalities later in pregnancy and are delivered at a later gestational age (GA) with higher birth weights. Consequently, it is plausible that some fetuses with an iAEDF may remain in utero for an extended duration without facing an immediate risk of death. Identifying this specific subgroup might allow the avoidance of some neonatal risks associated with extremely preterm birth.

In this study, we aimed to assess the risk of adverse perinatal outcomes among pregnant patients with intermittently absent and persistently absent end-diastolic umbilical artery flow. This investigation seeks to contribute to a better understanding of the fetal risks associated with different patterns of absent end-diastolic flow, thereby informing clinical management and decision-making for high-risk pregnancies.

We performed a retrospective cohort study of patients with non-anomalous, singleton pregnancies diagnosed with intermittent absence of end-diastolic umbilical artery Doppler flow or persistent absence of end-diastolic flow at our institution from 2020 to 2023. The study was approved by the Başakşehir Çam ve Sakura City Hospital Clinical Research Ethics Committee (ethics no.2023-561, date 08/11/2023) and was conducted in accordance with the latest version of the Declaration of Helsinki (2019/92). Fetuses were classified into two categories: intermittent absent end-diastolic flow and persistent absent end-diastolic flow.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Pregnancies with absent umbilical artery end-diastolic velocity

排除标准

  • Multiple pregnancies
  • Pregnancies with unknown outcomes

结局指标

主要结局

pregnancy complications (Number of Pregnancies complicated with IUMF, ablatio placenta, fetal distress, Intrauterine growth restriction and amniotic fluid abnormalities).

时间窗: time from diagnosis to birth

Pregnancy complications were compared between patients with iAEDF and those with pAEDF.

latency from the time of absent endiastolic flow diagnosis to delivery

时间窗: time from diagnosis to birth

time (time in days) elapsed from diagnosis to birth was compared between patients with iAEDF and those with pAEDF.

neonatal outcomes

时间窗: first 24 hours after birth

The primary outcome was a composite of neonatal outcomes, including birth weight (weight in grams), Z-score for standardized birth weight (weight in grams), Apgar score in the first minute, Apgar score in the fifth minute, Apgar score in the fifth minute lower than seven, admission to the ICU, and the need for intubation.These outcomes were compared between patients with intermittantly absent end-diastolic flow and those with persistantly absent end-diastolic flow.

次要结局

未报告次要终点

研究者

发起方
Başakşehir Çam & Sakura City Hospital
申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Zeynep Kayaoğlu Yıldırım

Gynecologist and Obstetrician, Perinatology fellow

Başakşehir Çam & Sakura City Hospital

研究点 (1)

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