Ignite Creation Date:
2024-05-06 @ 4:39 PM
Last Modification Date:
2024-10-26 @ 2:13 PM
Study NCT ID:
NCT05043753
Status:
UNKNOWN
Last Update Posted:
2021-09-14
First Post:
2021-09-02
Brief Title:
Fetal gRowth AbnorMality dEtection Trial
Sponsor:
University of Modena and Reggio Emilia
Organization:
University of Modena and Reggio Emilia
Study Overview
Official Title:
Department of Obstetrics and Gynecology Modena Policlinico Hospital Vial Del Pozzo 71 41125 Modena
Status:
UNKNOWN
Status Verified Date:
2021-09
Last Known Status:
NOT_YET_RECRUITING
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:
FRAME
Brief Summary:
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 ie high risk obstetrician will be performed in case SFH andor POC-US suspect fetal growth or amniotic fluid abnormalities Prenatal evaluations will be compared to actual birthweights
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 ie high risk obstetrician will be performed in case SFH andor POC-US suspect fetal growth or amniotic fluid abnormalities Prenatal evaluations will be compared to actual birthweights
Detailed Description:
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
Screening test in the control group Symphysis fundal height measurement Fundal height is measured by trained midwives at each scheduled antenatal appointment from the pubis symphysis to the top of the uterine fundus using a paper measuring tape in centimeters Size greater than dates is suspected if the measurement is above the 90th gestational age specific percentile according to the Intergrowth 21 SFH references Papageorghiu 2016 Similarly size less than dates is recorded if the measurement is below the 10th percentile for age according to the Intergrowth 21 SFH references Papageorghiu 2016 Formal obstetric ultrasound is requested if the SFH is 90th percentile if it is 10th or if it drops 50 growth centiles in two subsequent evaluations
Screening test in the intervention group Symphysis fundal height measurement point of care ultrasound After assessing SFH at each clinical encounter the midwife will perform a POC-US to measure the fetal AC and evaluate the quantity of amniotic fluid A positive screen for fetal growth restriction indicative of a potential SGA infant consists in a measured AC less than the 10th percentile for gestational age according to the standards defined by Nicolini et al in 1986 on an Italian population instead a positive screen for macrosomia suggestive of a potential LGA infant is an AC greater than the 90th percentile for gestational age according to the references set by Nicolini et al in 1996 Formal obstetric ultrasound is requested if the AC is 90th percentile if it is 10th or if it drops 50 growth centiles in two subsequent evaluations Amniotic fluid volume will be evaluated determining the deepest vertical pocket DVP
A formal US is requested in case uterine size is measured as than the 10th or than the 90th percentile for gestational age according to Intergrowth 21 when POC - US reveals AC 10th percentile AC 90th percentile according to Nicolini et al in case DVP 2 x 1 cm or DVP 8 x 1 cm or also if SFH or AC drop 50 percentiles comparing two subsequent evaluations Patients randomized to SFH POC-US will have a formal US if either technique suspects abnormal fetal growth
Formal US requested due to an abnormal screening test will be distinguished from scans ordered due to other indications such as hypertensive disorders of pregnancy or cholestasis of pregnancy diagnosed after enrollment Hadlock s references will be used to estimate fetal weight and therefore to define FGR ie estimated fetal weight or AC 10th percentile as well as macrosomia ie estimated fetal weight or AC 90th percentile
Prenatal evaluation of fetal growth will be compared to the birthweight percentile according to the INeS neonatal charts Bertino 2010 to identify SGA LGA and AGA appropriate for gestational age infants
After the initial evaluation low risk pregnancies are scheduled for antenatal appointments with a midwife at 40 41 and 41 weeks gestation All patients will have a POC-US by a midwife at 41 and 41 weeks gestation to screen for amniotic fluid abnormalities associated with protracted pregnancy independently of the randomization arm A midwife will perform SFH or SFH POCT-US according to randomization at enrolment 35-38 weeks gestation and at 40 weeks As sonographic assessment of fetal growth should not be performed more frequently than every 2 weeks due to the error associated with measurements POC-US will only evaluate amniotic fluid volume at 41 and 413 weeks gestation unless the patient has missed a previous appointment even among women randomized to SFH POC-US
The purpose of the study is to evaluate the most accurate approach to identify prenatally those pregnancies that will result in SGA or LGA infants Prenatal evaluation consists in a universal screening test for fetal growth abnormalities either SFH or SFH POC US followed by a confirmatory test formal obstetric US performed only when the initial screening test is positive Fetal growth or amniotic fluid abnormalities are diagnosed in utero if confirmed by a formal obstetric ultrasound and not when only suspected by a screening test in fact the study seeks to evaluate what is the most accurate combination of screening and confirmatory tests and not the effectiveness of the screening test alone
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
Screening test in the control group Symphysis fundal height measurement Fundal height is measured by trained midwives at each scheduled antenatal appointment from the pubis symphysis to the top of the uterine fundus using a paper measuring tape in centimeters Size greater than dates is suspected if the measurement is above the 90th gestational age specific percentile according to the Intergrowth 21 SFH references Papageorghiu 2016 Similarly size less than dates is recorded if the measurement is below the 10th percentile for age according to the Intergrowth 21 SFH references Papageorghiu 2016 Formal obstetric ultrasound is requested if the SFH is 90th percentile if it is 10th or if it drops 50 growth centiles in two subsequent evaluations
Screening test in the intervention group Symphysis fundal height measurement point of care ultrasound After assessing SFH at each clinical encounter the midwife will perform a POC-US to measure the fetal AC and evaluate the quantity of amniotic fluid A positive screen for fetal growth restriction indicative of a potential SGA infant consists in a measured AC less than the 10th percentile for gestational age according to the standards defined by Nicolini et al in 1986 on an Italian population instead a positive screen for macrosomia suggestive of a potential LGA infant is an AC greater than the 90th percentile for gestational age according to the references set by Nicolini et al in 1996 Formal obstetric ultrasound is requested if the AC is 90th percentile if it is 10th or if it drops 50 growth centiles in two subsequent evaluations Amniotic fluid volume will be evaluated determining the deepest vertical pocket DVP
A formal US is requested in case uterine size is measured as than the 10th or than the 90th percentile for gestational age according to Intergrowth 21 when POC - US reveals AC 10th percentile AC 90th percentile according to Nicolini et al in case DVP 2 x 1 cm or DVP 8 x 1 cm or also if SFH or AC drop 50 percentiles comparing two subsequent evaluations Patients randomized to SFH POC-US will have a formal US if either technique suspects abnormal fetal growth
Formal US requested due to an abnormal screening test will be distinguished from scans ordered due to other indications such as hypertensive disorders of pregnancy or cholestasis of pregnancy diagnosed after enrollment Hadlock s references will be used to estimate fetal weight and therefore to define FGR ie estimated fetal weight or AC 10th percentile as well as macrosomia ie estimated fetal weight or AC 90th percentile
Prenatal evaluation of fetal growth will be compared to the birthweight percentile according to the INeS neonatal charts Bertino 2010 to identify SGA LGA and AGA appropriate for gestational age infants
After the initial evaluation low risk pregnancies are scheduled for antenatal appointments with a midwife at 40 41 and 41 weeks gestation All patients will have a POC-US by a midwife at 41 and 41 weeks gestation to screen for amniotic fluid abnormalities associated with protracted pregnancy independently of the randomization arm A midwife will perform SFH or SFH POCT-US according to randomization at enrolment 35-38 weeks gestation and at 40 weeks As sonographic assessment of fetal growth should not be performed more frequently than every 2 weeks due to the error associated with measurements POC-US will only evaluate amniotic fluid volume at 41 and 413 weeks gestation unless the patient has missed a previous appointment even among women randomized to SFH POC-US
The purpose of the study is to evaluate the most accurate approach to identify prenatally those pregnancies that will result in SGA or LGA infants Prenatal evaluation consists in a universal screening test for fetal growth abnormalities either SFH or SFH POC US followed by a confirmatory test formal obstetric US performed only when the initial screening test is positive Fetal growth or amniotic fluid abnormalities are diagnosed in utero if confirmed by a formal obstetric ultrasound and not when only suspected by a screening test in fact the study seeks to evaluate what is the most accurate combination of screening and confirmatory tests and not the effectiveness of the screening test alone
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