Actively Recruiting
"Fetal gRowth AbnorMality dEtection Trial"
Led by University of Modena and Reggio Emilia · Updated on 2024-12-09
1566
Participants Needed
3
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
"Fetal gRowth AbnorMality dEtection Trial"
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Maternal age 18 years or older and able to give informed consent
- Singleton pregnancy
- Ultrasound confirming or revising due date before 14 weeks gestation
- Gestational age 35 weeks or more
- Normal aneuploidy screening when performed
- Pregnancy conceived naturally, not via in vitro fertilization
You will not qualify if you...
- Fetal chromosomal or genetic abnormalities if invasive prenatal diagnosis performed
- Fetal malformations or soft markers on anatomy survey
- Uterine bleeding episodes after 24 weeks gestation (except unobserved self-reported bleeding with confirmed intact pregnancy)
- Uterine or placental abnormalities including malformations, abnormal placentation, or fibroids
- Cerclage during current pregnancy
- History of intrauterine fetal death
- History of fetal growth restriction or birth weight over 4 kg in prior pregnancy
- Fetal isoimmunization or alloimmunization
- Previous fetal death
- Cancer excluding some skin cancers
- Endocrine diseases including unstable thyroid, adrenal disease, or diabetes
- Kidney disease with altered function
- Epilepsy or seizure disorders
- Collagen diseases like lupus or scleroderma
- Active liver disease or cholestasis diagnosed before enrollment
- Hematological disorders excluding mild iron deficiency anemia
- Chronic pulmonary diseases requiring regular medication or active tuberculosis
- Heart disease except mild mitral valve prolapse without medication
- Chronic or gestational hypertension or preeclampsia diagnosed before enrollment
- Infectious diseases including HIV, CMV, toxoplasmosis, parvovirus B19, HBV, HCV
- Chronic use of medications such as aspirin, steroids, antihypertensives, immunosuppressants, chemotherapy
- Prior uterine surgeries involving the uterine cavity
- Prior resectoscopic myomectomies
- Prior classical cesarean deliveries
AI-Screening
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Trial Site Locations
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
Research Team
G
Giuseppe Chiossi, MD
CONTACT
F
Fabio Facchinetti, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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