The Pseudo-Oligohydramnios/Hidden Pocket Study: The Added Contribution of Transvaginal Sonographic Evaluation of Amniotic Fluid Index
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
- 否
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
ROY LAUTERBACH MD
Principal Investigator
Rambam Health Care Campus