Antenatal Testing in Obese Woman, is it Really Necessary?
试验速览
- 阶段
- 不适用
- 入组人数
- 100
- 主要终点
- Stillbirth
研究概览
简要总结
It is well established that obese women are at an increased risk of stillbirth compared to non obese women. This has led many physicians to begin antenatal testing in obese women in the third trimester through either nonstress tests or biophysical profiles. However, there is little evidence that antenatal testing improves fetal outcomes in obese women. The aim of this study is to determine if antenatal testing improves outcomes in obese women and to determine the optimal mode of testing (either nonstress tests or biophysical profiles).
详细描述
- Purpose: To determine if antenatal testing improves outcomes in obese pregnant women
- Rationale: It has been well established that obese pregnant women are at increase risk of stillbirth compared to matched non obese controls. This relative risk is increased not only with increasing gestational age in obese women but with increasing severity of obesity. The increased risk of stillbirth has led some obstetricians to begin antenatal testing in obese women; however, there is little evidence that antenatal fetal surveillance improves outcomes.
- Study/Project Population: Pregnant women before 32 weeks of gestation with an initial BMI >30kg/m2
- Research Design: Randomized Controlled Trial
- Study/Project Procedures: Patients will be randomized to one of three groups: daily kick counts only, nonstress test, amniotic fluid index, and daily kick counts, and biophysical profile and daily kick counts. These patients will be randomly assigned a group in a 1:1:1 ratio using a random number generator available online. Patients assigned to the daily kick counts only group will be called weekly to ensure they are doing daily kick counts. If they are noncompliant, they will be removed from the study and will undergo nonstress tests if they meet the initial BMI criteria as is the standard practice at our institution.
- Outcomes Measured: Stillbirth, induction of labor, mode of delivery, neonatal intensive care unit admission, AGPARs <7 at 5 minutes of life
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •less then 32 weeks gestation BMI > 30kg/m2 English speaking
排除标准
- •age < 18 age >45 medical comorbidity which requires antenatal testing other than obesity unwilling to consent Non-English speaking not pregnant Gestational age >32 weeks
研究组 & 干预措施
Nonstress test
Subjects will undergo weekly nonstress tests beginning at 32 weeks until delivery in addition to monitoring fetal kick counts.
A nonstress test is a test in which an external fetal monitor is placed on the mother to defect the fetal heart rate for 20 to 40 minutes. A test is considered reactive if there are more than 2 accelerations in fetal heart rate defined as an increase of at least 15 beats per minute lasting at least 15 seconds in a 20 minute period.
干预措施: External fetal monitor for Nonstress test (Device)
Biophysical profile
Subjects will undergo weekly biophysical profile testing beginning at 32 weeks until delivery in addition to monitoring fetal kick counts. A Biophysical profile is a test using real time ultrasonography to determine the presence of absence of certain components of fetal well being. There components include: an episode of fetal breathing lasting at least 30 seconds, 3 or more discrete body movements, 1 or more episodes of extension of a fetal extremity with return to flexion, and determination of amniotic fluid volume to detect a maximum vertical pocket of >2cm. The duration of this test is no more than 30 minutes.
干预措施: Ultrasonography for Biophysical profile (Device)
Kick counts only
Subjects will monitor fetal kick counts only.
结局指标
主要结局
Stillbirth
时间窗: until delivery, up to 41 weeks
demise of infant prior to delivery as verified by ultrasonography
Mode of delivery
时间窗: at delivery, up to 41 weeks
whether the subject undergoes a vaginal delivery, cesarean delivery, or operative delivery will be recorded
次要结局
- Apgar score of less than 7 at 5 minutes(at delivery, up to 41 weeks)
- Neonatal intensive care unit admission admission(at delivery, up to 41 weeks)
研究者
Laura Grese
MD
University of Tennessee