Routine third-trimester ultrasound in low-risk pregnancies and perinatal death: a systematic review and meta-analysis.
Leen Al-Hafez, Suneet P Chauhan, Melissa Riegel...
https://pubmed.ncbi.nlm.nih.gov/33345941Actively Recruiting
Led by University of Modena and Reggio Emilia · Updated on 2024-12-09
1566
Participants Needed
3
Research Sites
8 weeks
Total Duration
Researchers are evaluating how well symphysis fundal height (SFH) measurements alone compare to SFH combined with point of care ultrasound (POC-US) measuring fetal abdominal circumference (AC) for detecting small or large for gestational age infants among low-risk pregnant women after 35 weeks' gestation. The study aims to improve prenatal identification of abnormal fetal growth, which is linked to risks for mother and baby. This open-label, randomized trial is investigator-sponsored and focuses on low-risk pregnancies managed by midwives. Participants are randomly assigned to one of two groups: one group will have fetal growth monitored using SFH measurements alone, while the other will have SFH plus POC-US to measure fetal AC and assess amniotic fluid volume. Measurements occur at scheduled antenatal visits at 35-38, 40, 41, and beyond 41 weeks' gestation. If screening suggests abnormal growth or amniotic fluid levels, a formal obstetric ultrasound by a specialist will be performed. All women will have POC-US at 41 and 41+ weeks to check amniotic fluid, regardless of group. During the study, midwives will review medical histories, conduct physical measurements, and perform ultrasound assessments following the assigned method. Researchers will compare prenatal screening results to actual birth weights to identify small or large infants. They will also track the number of formal ultrasounds requested, cases of abnormal amniotic fluid, and maternal and neonatal outcomes. Participation lasts from enrollment at 35-38 weeks through delivery and initial postnatal assessment, about one year on average.
CONDITIONS
"Fetal gRowth AbnorMality dEtection Trial"
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Duration - From 35 to 41+ weeks' gestation
Participants undergo screening for fetal growth abnormalities using symphysis fundal height measurement alone or combined with point of care ultrasound measuring fetal abdominal circumference during routine antenatal visits.
Visits at enrollment (35-38 weeks), 40 weeks, 41 weeks, and 41+ weeks' gestation
Duration - Until delivery and birth outcomes are assessed
Participants are monitored through delivery to evaluate birthweight and outcomes related to fetal growth abnormalities detected prenatally.
Follow-up at delivery
Total: 3 locations
1
Azienda Ospedaliero Universitaria Policlinico di Modena
Modena, Modena, Italy, 41125
Actively Recruiting
2
Cesena Hospital
Cesena, Italy, 47521
Not Yet Recruiting
3
Foundation MBBM at San Gerardo Hospital, University of Milan-Bicocca School of Medicine and Surgery, Monza, Italy.
Monza, Italy, 20900
Not Yet Recruiting
G
Giuseppe Chiossi, MD
F
Fabio Facchinetti, MD
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Leen Al-Hafez, Suneet P Chauhan, Melissa Riegel...
https://pubmed.ncbi.nlm.nih.gov/33345941Committee on Practice Bulletins—Obstetrics and the American Institute of Ultrasound in Medicine
https://pubmed.ncbi.nlm.nih.gov/27875472American College of Obstetricians and Gynecologists' Committee on Practice Bulletins—Obstetrics and the Society forMaternal-FetalMedicin
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