Department of Obstetrics and Gynecology Modena Policlinico Hospital Vial Del Pozzo 71, 41125 Modena
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,566
- 试验地点
- 6
- 主要终点
- Number of prenatally identified fetuses that will be classified as small or large for gestational age as infants (SGA and LGA infants)
研究概览
简要总结
The present trial intends to assess the diagnostic accuracy of symphysis fundal height (SFH) as opposed to SFH combined with point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC) in identifying small and large for gestational age infants (SGA and LGA infants) among low-risk pregnant women cared for by midwives after 35 weeks' gestation.
Low risk pregnancies will be evaluated at 35-38, 40, 41, and 41+ weeks' gestation by midwives trained in SFH measurement and POC-US. Formal obstetric US performed by a perinatologist (i.e high risk obstetrician) will be performed in case SFH and/or POC-US suspect fetal growth or amniotic fluid abnormalities. Prenatal evaluations will be compared to actual birthweights.
详细描述
Birthweight below the 10th (small for gestational age or SGA) or above the 90th (large for gestational age or LGA) percentile for gestational age has been associated with adverse maternal, fetal and neonatal outcomes. As birthweight reflects intrauterine development, accurate identification of abnormal fetal growth would allow obstetric providers to prevent adverse outcomes and mitigate complications associated with abnormal development.
Symphysis fundal height (SFH) measured in centimeters after 24 weeks of gestation is recommended as the standard of care to screen for fetal growth abnormalities among low-risk pregnancies. This method is low-cost, and easy to perform, but there is a lack of evidence supporting its effectiveness due to its poor sensitivity. Ultrasonography, the technique utilized to identify fetal growth abnormalities, is a costly procedure which involves the use of advanced equipment and providers, to perform and review the ultrasound, as well as a full examination with multiple measurements and images. Despite a few encouraging reports, insufficient evidence supports routine 3rd trimester ultrasound in low- risk pregnancies to improve detection of abnormal fetal growth.
Sonographic measurement of the abdominal circumference (AC) in the fetus was shown to be the single most useful indicator of fetal growth. Measurement of AC does not require extensive training, long time to acquire, or expensive ultrasound machines. It can be easily performed in the office by midwives who are specifically trained in obtaining the measurement. Therefore, we intended to evaluate if the use of bedside point of care ultrasound (POC-US) by midwives to evaluate fetal AC during routine antenatal visits in low-risk pregnancies would increase the accuracy of SFH in identifying fetuses with birthweight < 10th or > 90th, when compared to SFH alone.
This is an open label, investigator sponsored, two arms randomized controlled trial. Patients who satisfy all inclusion criteria, have no exclusion criteria, and have signed the written informed consent will be randomly assigned to screening of fetal growth abnormalities during routine antenatal appointments held by midwives according to SFH or SFH + POC-US-AC.
Low risk pregnant women are interviewed by a midwife at 35-38 weeks' gestation, who also reviews their medical and obstetrical history, prenatal labs and the ultrasound reports to discriminate between high and low-risk pregnancies. Patients who satisfy all inclusion criteria and do not have any exclusion criteria will be randomly assigned to one of two different approaches to identify fetal growth abnormalities and predict abnormal birthweight, after signing the written informed consent.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Maternal age ≥ 18 years and ability to give informed consent.
- •Singleton gestation
- •Ultrasound examination that confirms or revises the EDD before 14 weeks of gestational age
- •Gestational age ≥ 35 weeks' gestation
- •Normal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT) when performed
- •Spontaneously conceived pregnancy (i.e the current pregnancy is not the result of in vitro fertilization)
排除标准
- •Fetal chromosomal or genetic abnormalities if invasive prenatal diagnosis is performed
- •Fetal malformations or soft markers identified on fetal anatomy survey
- •Episodes of uterine bleeding after 24 weeks gestation. Unobserved self-reported bleeding with confirmed intact pregnancy on ultrasound after the bleeding episode is not an exclusion criteria.
- •Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelpus uterus), abnormal placentation (placenta previa, accreta, percreta), uterine fibroids.
- •Cerclage in the current pregnancy
- •History of intrauterine fetal demise
- •History of fetal growth restriction or birth weight > 4Kg in a previous pregnancy
- •Fetal isoimmunization or alloimmunization
- •Fetal demise in previous pregnancies
- •Cancer (including melanoma but excluding other skin cancers). Dysplastic or pre-neoplatic conditions such as cervical intraepithelial neoplasia are admissible.
- •Endocrine disease including thyroid disease (recently diagnosed or whose medication dose is not stable), adrenal disease, diabetes mellitus (pregestational and gestational).
- •Renal disease with altered renal function (creatinine > 0.9, proteinuria > 300 mg/24 hour)
- •Epilepsy or other seizure disorder
- •Any collagen disease (lupus erythematosus, scleroderma, etc.)
- •Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes). Liver disorders accounting for cholestasis (including cholestasis of pregnancy) if diagnosed prior to enrollment.
- •Hematological disorder including alloimmune and isoimmune thrombocytopenia but excluding mild iron deficiency anemia (Hb > 9 gm/dl). Patients with sickle cell disease are excluded.
- •Chronic pulmonary disease including asthma requiring regular use of medication and active TB. An asthma inhaler used on an as needed basis for a cold or an asthma attack is not considered regular use.
- •Heart disease except mitral value prolapse not requiring medication
- •Cardiovascular disorders: chronic hypertension, gestational hypertension or preeclampsia diagnosed prior to enrollment
- •Infectious diseases: HIV, CMV, toxoplasmosis, parvovirus B19, HBV, HCV
- •Chronic treatments with medications such as aspirin, steroids, anti-hypertensive agents, immunosuppressants, antineoplastic drugs.
- •Prior laparoscopic or open uterine surgeries where the uterine cavity was entered (such as myomectomies)
- •Resectoscopic myomectomies (prior resectoscopic polypectomies are not contraindications)
- •Prior classical cesarean deliveries.
结局指标
主要结局
Number of prenatally identified fetuses that will be classified as small or large for gestational age as infants (SGA and LGA infants)
时间窗: From enrollment through study completion, an average of 1 year. Prenatal evaluation of fetal growth and amniotic fluid volume will be performed at 35-38, 40,41, and 41+ weeks' gestation. Infants' weights will be evaluated at birth
Birthweight percentile will be classified according to the INeS neonatal charts (Bertino 2010) to identify SGA (birthweight \< 10th percentile) , LGA (birthweight \> 90th percentile) and AGA (appropriate for gestational age, whose birthweight ranges between the 10th and the 90th percentile) infants.
次要结局
- Number of adverse maternal outcome cases(At the time of delivery, from enrollment through study completion, an average of 1 year)
- Number of deliveries indicated by amniotic fluid or fetal growth abnormalities detected on formal obstetric US(At the time of delivery, from enrollment through study completion, an average of 1 year)
- Number of formal obstetric ultrasound (US) requested due to abnormal fetal growth or amniotic fluid suspected prenatally(From enrollment through study completion, an average of 1 year. Formal obstetric ultrasound will be requested in case of suspicion of abnormal fetal growth or amniotic fluid on screening with symphysis fundal height associated or not to POC ultrasound)
- Number of cases of oligohydramnios and polyhydramnios identified on formal obstetric US after being suspected on prenatal evaluation(From enrollment through study completion, an average of 1 year. Formal obstetric ultrasound will be requested in case of suspicion of abnormal fetal growth or amniotic fluid on screening with symphysis fundal height associated or not to POC ultrasound)
- Number of adverse neonatal outcome cases(At the time of delivery, from enrollment through study completion, an average of 1 year)
研究者
Giuseppe Chiossi
Attending Physician, Department of Obstetrics and Gynecology
University of Modena and Reggio Emilia