Ignite Creation Date:
2024-05-06 @ 10:15 AM
Last Modification Date:
2024-10-26 @ 12:27 PM
Study NCT ID:
NCT03200665
Status:
COMPLETED
Last Update Posted:
2020-01-21
First Post:
2017-06-24
Brief Title:
Sonographic Evaluation of Fetal Growth in the Third Trimester of Low-risk Pregnancy a Randomized Trial
Sponsor:
Hospital de Santa Maria Portugal
Organization:
Hospital de Santa Maria Portugal
Study Overview
Official Title:
Sonographic Evaluation of Fetal Growth in the Third Trimester of Low-risk Pregnancy a Randomized Trial
Status:
COMPLETED
Status Verified Date:
2020-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Sonographic fetal weight estimation at the last weeks of third trimester in low-risk pregnancies is an effective method for diagnosis of fetal growth restriction FGR permitting close surveillance and timely delivery The need for a systematic ultrasound evaluation at the last weeks of a low-risk pregnancy and the best time to perform it remains controversial The most commonly used clinical screening tool in this population is the serial measurement of symphysis-fundus distance which is a method of a variable and low sensitivity for detection of FGR
In Portugal in accordance with guidelines of Direcção Geral de Saúde from 2015 fetal growth restriction screening in low risk pregnancies is performed with an ultrasound for fetal weight estimation at 30th-33rd weeks Nonetheless recent data from randomized trials showed that FGR detection rate was superior at 36 vs 32 weeks gestation In cases of severe FGR detection rate was also superior at 36 vs 32 weeks gestation In a prior retrospective study our group analyzed 1429 term low risk pregnancies and the investigators concluded that small for gestational age term babies birthweight 10th centile had a statistically significant higher rate of operative deliveries for intrapartum fetal distress than appropriate for gestational age as well as a higher rate of admission to neonatal intensive care unit Moreover the investigators compared the same outcomes within small for gestational age neonates with antepartum detection at 30th-33rd weeks ultrasound vs undetected normal 30th-33rd weeks ultrasound Antepartum detection of small for gestational age neonates showed a statistically significant lower rate of operative deliveries for intrapartum fetal distress than undetected small for gestational age neonates The investigators will conduct a prospective randomized clinical trial with the aim to evaluate if a 35th-37th weeks after the standard of care ultrasound in low risk pregnancies is effective in improving the detection rate of FGR and in reducing cesarean deliveries for intrapartum fetal distress and admission to neonatal intensive care unit
In Portugal in accordance with guidelines of Direcção Geral de Saúde from 2015 fetal growth restriction screening in low risk pregnancies is performed with an ultrasound for fetal weight estimation at 30th-33rd weeks Nonetheless recent data from randomized trials showed that FGR detection rate was superior at 36 vs 32 weeks gestation In cases of severe FGR detection rate was also superior at 36 vs 32 weeks gestation In a prior retrospective study our group analyzed 1429 term low risk pregnancies and the investigators concluded that small for gestational age term babies birthweight 10th centile had a statistically significant higher rate of operative deliveries for intrapartum fetal distress than appropriate for gestational age as well as a higher rate of admission to neonatal intensive care unit Moreover the investigators compared the same outcomes within small for gestational age neonates with antepartum detection at 30th-33rd weeks ultrasound vs undetected normal 30th-33rd weeks ultrasound Antepartum detection of small for gestational age neonates showed a statistically significant lower rate of operative deliveries for intrapartum fetal distress than undetected small for gestational age neonates The investigators will conduct a prospective randomized clinical trial with the aim to evaluate if a 35th-37th weeks after the standard of care ultrasound in low risk pregnancies is effective in improving the detection rate of FGR and in reducing cesarean deliveries for intrapartum fetal distress and admission to neonatal intensive care unit
Detailed Description:
The population to include in this study corresponds to the low-risk pregnant women with surveillance at the Prenatal Consultation or referenced by the Primary Care units to the Department of Obstetrics Gynecology of Hospital de Santa Maria The screening method for detection of fetuses at risk of fetal growth restriction currently used in low-risk pregnancies is the measurement of the symphysis-uterine distal distance at all visits from 24 weeks and a third trimester ultrasound at 30-32 6 7 days weeks
The patients who agree to participate in the study after signing an informed consent will be randomized into 2 groups with and without an additional ultrasound evaluation at 35-356 6 7 days weeks The randomization will be done through computer software
Clinical data will be recorded such as maternal age ethnicity parity height weight socioeconomic status and smoking habits
In the study group ultrasound evaluation at 35-356 6 7 days weeks the ultrasound evaluation will include biometric parameters of the fetus cephalic perimeter biparietal diameter abdominal circumference and femur length Based on these measurements the computer system Astraia provides the estimated fetal weight and respective percentile according to the Hadlock formula Amniotic fluid will also be measured maximum column Functional evaluation will include Doppler of the umbilical artery middle cerebral artery and Uterine arteries The respective index of pulsatility and cerebroplacental ratio will be registered All Doppler evaluations will be performed in the absence of somatic and respiratory fetal movements under transitory maternal apnea with the lowest insonation angle possible and at least 3 successive complexes will be evaluated for each measurement
Obstetric and neonatal outcomes will be registered after delivery by revising medical records such as gestational age at delivery prepartum hemoglobin type of labor spontaneous or induced and respective indication type of delivery eutocic instrumental antepartum or intrapartum cesarean section indication of instrumental or cesarean delivery cardiotocographic register characteristics repeated severe variable decelerations late decelerations absence of variability evidence of meconial fluid neonatal morbidity hypoglycemia hypothermia transient tachypnea hyperbilirubinemia requiring phototherapy meconium aspiration syndrome admission to neonatal intensive care unit metabolic acidosis intraventricular hemorrhage necrotizing enterocolitis sepsis seizures and asphyxia and mortality
Sample size calculation
According to a retrospective analysis performed in the target population of this study the rate of intrapartum fetal hypoxia requiring obstetric intervention in pregnant women with fetal growth restriction is 28 Aiming to reduce this adverse perinatal outcome by 10 it is estimated that the investigators will need to include a total sample of 2700 pregnant women 1350 in each group with 80 power and α level of 005
Performing third-trimester ultrasound at 30-32 weeks the rate of antenatal detection of fetal growth restriction is 205 in low risk pregnancies Aiming to increase the detection rate by at least 7 the investigators will require a total sample of 1200 pregnant women 600 in each group with 80 power and α level of 005 Thus an interim analysis is expected to be performed when 1200 cases are recruited to the study to compare the detection rate of fetal growth restriction between the two groups
The patients who agree to participate in the study after signing an informed consent will be randomized into 2 groups with and without an additional ultrasound evaluation at 35-356 6 7 days weeks The randomization will be done through computer software
Clinical data will be recorded such as maternal age ethnicity parity height weight socioeconomic status and smoking habits
In the study group ultrasound evaluation at 35-356 6 7 days weeks the ultrasound evaluation will include biometric parameters of the fetus cephalic perimeter biparietal diameter abdominal circumference and femur length Based on these measurements the computer system Astraia provides the estimated fetal weight and respective percentile according to the Hadlock formula Amniotic fluid will also be measured maximum column Functional evaluation will include Doppler of the umbilical artery middle cerebral artery and Uterine arteries The respective index of pulsatility and cerebroplacental ratio will be registered All Doppler evaluations will be performed in the absence of somatic and respiratory fetal movements under transitory maternal apnea with the lowest insonation angle possible and at least 3 successive complexes will be evaluated for each measurement
Obstetric and neonatal outcomes will be registered after delivery by revising medical records such as gestational age at delivery prepartum hemoglobin type of labor spontaneous or induced and respective indication type of delivery eutocic instrumental antepartum or intrapartum cesarean section indication of instrumental or cesarean delivery cardiotocographic register characteristics repeated severe variable decelerations late decelerations absence of variability evidence of meconial fluid neonatal morbidity hypoglycemia hypothermia transient tachypnea hyperbilirubinemia requiring phototherapy meconium aspiration syndrome admission to neonatal intensive care unit metabolic acidosis intraventricular hemorrhage necrotizing enterocolitis sepsis seizures and asphyxia and mortality
Sample size calculation
According to a retrospective analysis performed in the target population of this study the rate of intrapartum fetal hypoxia requiring obstetric intervention in pregnant women with fetal growth restriction is 28 Aiming to reduce this adverse perinatal outcome by 10 it is estimated that the investigators will need to include a total sample of 2700 pregnant women 1350 in each group with 80 power and α level of 005
Performing third-trimester ultrasound at 30-32 weeks the rate of antenatal detection of fetal growth restriction is 205 in low risk pregnancies Aiming to increase the detection rate by at least 7 the investigators will require a total sample of 1200 pregnant women 600 in each group with 80 power and α level of 005 Thus an interim analysis is expected to be performed when 1200 cases are recruited to the study to compare the detection rate of fetal growth restriction between the two groups
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None