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临床试验/NCT03935607
NCT03935607已完成不适用

The Pseudo-Oligohydramnios/Hidden Pocket Study: The Added Contribution of Transvaginal Sonographic Evaluation of Amniotic Fluid Index

Rambam Health Care Campus1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2019年7月1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
350
试验地点
1
主要终点
Amniotic Fluid Fore-Pocket

研究概览

简要总结

The current study is based on the use of transvaginal sonography in the evaluation of oligohydramnios. Patients will be recruited after amniotic fluid index evaluation according to transabdominal sonography. After obtaining informed consent, transvaginal sonography will be used to evaluate and measure a possible amniotic fluid pocket that may precede the fetal presenting part.

详细描述

Background Normal amniotic fluid volume varies across gestation (Ounpraseuth 2017). Abnormal amniotic fluid volume has been associated with a variety of adverse pregnancy outcomes (Shrem 2016). In clinical practice, the amniotic fluid volume is a component of the biophysical profile which provides information on fetal well-being.

Transabdominal ultrasound is used to assess quantitatively the amniotic fluid volume, most commonly by either the Amniotic Fluid Index (AFI) or the Maximum Vertical Pocket (MVP) methods.

The value of the AFI method has been questioned in several studies, which have shown that an abnormal test, low or high, is neither highly accurate nor predictive of adverse outcome. Many pregnancies with normal AFI will be falsely characterized as abnormal, and a large number with truly abnormal AFI will be missed (Magann 1994, Chauhan 1997).

The MVP measurement may be preferred over the AFI method. A 2008 systematic review of randomized trials found that use of the AFI increased the rate of diagnosis of oligohydramnios (RR 2.3), induction of labor (RR 2.1), and cesarean delivery for fetal distress (RR 1.5) (Nabhan 2008).

Rationale and Hypothesis of the Study Recently, our group observed that when transvaginal ultrasound is being performed to non-laboring pregnant women at term for other obstetrical indications, there is a large amniotic fluid pocket above the internal cervical os and below the fetal presenting part. Due to the unique location of this pocket, we hypothesized that transvaginal ultrasound may provide better information than transabdominal ultrasound on amniotic fluid volume, particularly in cases when suspecting abnormal low amniotic fluid volume.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

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

  • Pregnant women at term beyond 37 weeks' gestation
  • Presented to our hospital for their routine care or prior to induction of labor
  • Singleton pregnancy
  • Planned for vaginal delivery
  • Non-laboring women with non-engaged fetal presenting part

排除标准

  • Pregnant women under 37 weeks' gestation
  • Planned cesarean deliveries
  • Laboring women with engaged fetal presenting part
  • Multiple gestation

结局指标

主要结局

Amniotic Fluid Fore-Pocket

时间窗: Up to 30 minutes from the beginning of patient evaluation.

Measurement of amniotic fluid pocket preceding fetal presenting part.

次要结局

  • 5 minute Apgar score(From the time of delivery up to 30 days postpartum)
  • 1 minute Apgar score(From the time of delivery up to 30 days postpartum)
  • pH level(From the time of delivery up to 30 days postpartum)
  • Neonatal intensive care unit admission(From the time of delivery up to 30 days postpartum)
  • Mode of delivery(From time of induction up to 48 hours postpartum)

研究者

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

ROY LAUTERBACH MD

Principal Investigator

Rambam Health Care Campus

研究点 (1)

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