Clinical Utility of Uterine, Fetal Cerebral Doppler and Oligohydramnios to Predict Abnormal Heart Rate Tracings in Pregnancies at or Beyond 41 Weeks
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 227
- 试验地点
- 1
- 主要终点
- Category III fetal heart rate tracings
研究概览
简要总结
Objective: To estimate the value of uterine, fetal cerebral Doppler and oligohydramnios to predict abnormal fetal heart rate tracings in pregnancies at or beyond 41 weeks
详细描述
This will be a nested case-control study that was conducted at University Hospital Dr. Jose E. Gonzalez after the approval of Institutional ethical committee. Women with low risk late term or postterm pregnancy (at least 41 weeks) with confirm gestational age who will be referred to our Maternal-fetal unit and admitted 1 to 2 days prior to induction of labour according institutional protocol will be recruited and constitute the cohort.
Cases will be patients with abnormal intrapartum cardiotocogram (category III fetal heart rate tracing). For each case, four controls will be matched. The primary outcome will be to obtain odds ratios for the Doppler parameters (middle cerebral artery pulsatility index, mean uterine artery pulsatility index and Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio) and amniotic fluid index that would be associated with intrapartum category III fetal heart rate tracing.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Singleton pregnancy
- •Gestational age of at least 287 days (41 weeks)
- •Low risk pregnancy (defined as the absence of maternal or fetal complications other than postterm pregnancy)
排除标准
- •Twin or multiple gestation
- •Uncertain gestational age
- •Non vertex presentation
- •Estimated fetal weight below the 10th percentile for gestational age (Hadlock´s formula)
- •Fetal macrosomia (estimated fetal weight ≥ 4 Kilos) diagnosed by clinical measurement (Johnson´s technique) or ultrasound measurement (Hadlock´s formula).
- •Fetal abnormalities found on routine anomaly scan.
- •Maternal medical disorder (preeclampsia, chronic hypertension, diabetes, lupus, hyperthyroidism)
- •Prelabour rupture of membranes
- •Antepartum hemorrhage
- •Any fetopelvic disproportion that could create dystocia during labor.
结局指标
主要结局
Category III fetal heart rate tracings
时间窗: 24 hours
Absent baseline fetal heart rate variability and any of the following: recurrent late decelerations, recurrent variable decelerations, bradycardia, sinusoidal pattern
次要结局
- Middle cerebral artery pulsatility index to mean uterine artery pulsatility index ratio(24 hours before delivery)
- Middle cerebral artery pulsatility index(24 hours before delivery)
- Oligohydramnios(24 hours before delivery)
- Mean uterine artery pulsatility index(24 hours before delivery)
研究者
Flavio Hernández Castro
Principal investigator Flavio Hernández Castro MD PhD
Hospital Universitario Dr. Jose E. Gonzalez