Actively Recruiting

Phase Not Applicable
Age: 18Years - 45Years
FEMALE
Healthy Volunteers
ID05043753

Fetal Growth Abnormality Detection Trial Comparing Symphysis Fundal Height Alone Versus Symphysis Fundal Height with Point of Care Ultrasound Measuring Fetal Abdominal Circumference in Low-Risk Pregnant Women

Led by University of Modena and Reggio Emilia · Updated on 2024-12-09

1566

Participants Needed

3

Research Sites

8 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Brief Title

"Fetal gRowth AbnorMality dEtection Trial"

Who Can Participate

Age: 18Years - 45Years
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Maternal age 18 years or older with ability to give informed consent
  • Singleton pregnancy
  • Ultrasound confirming or revising estimated due date before 14 weeks gestation
  • Gestational age at least 35 weeks
  • Normal aneuploidy screening when performed
  • Pregnancy conceived spontaneously (not via in vitro fertilization)
Not Eligible

You will not qualify if you...

  • Fetal chromosomal or genetic abnormalities if invasive prenatal diagnosis performed
  • Fetal malformations or soft markers on fetal anatomy survey
  • Uterine bleeding episodes after 24 weeks gestation (except unobserved self-reported bleeding with confirmed intact pregnancy)
  • Uterine or placental abnormalities including uterine malformations and abnormal placentation
  • Current pregnancy cerclage
  • History of intrauterine fetal demise
  • History of fetal growth restriction or prior infant birth weight over 4 kg
  • Fetal isoimmunization or alloimmunization
  • Previous fetal demise
  • Cancer (including melanoma but excluding other skin cancers); dysplastic or pre-neoplastic cervical conditions allowed
  • Endocrine diseases including unstable thyroid disease, adrenal disease, pregestational or gestational diabetes
  • Renal disease with altered function
  • Epilepsy or seizure disorders
  • Collagen diseases such as lupus or scleroderma
  • Active liver disease or chronic liver disorders causing cholestasis
  • Hematological disorders excluding mild iron deficiency anemia; sickle cell disease excluded
  • Chronic pulmonary disease requiring regular medication or active tuberculosis
  • Heart disease except 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 treatment with aspirin, steroids, antihypertensives, immunosuppressants, or antineoplastics
  • Prior uterine surgeries entering the uterine cavity such as myomectomies
  • Prior resectoscopic myomectomies
  • Prior classical cesarean deliveries

AI-Screening

AI-Powered Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 screening and enrollment visit (in-person)

Diagnostic Evaluation

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

Long-term Monitoring

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

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

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Research Team

G

Giuseppe Chiossi, MD

F

Fabio Facchinetti, MD

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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Published Research Related To This Trial

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/33345941

ACOG Practice Bulletin No. 204: Fetal Growth Restriction.

American College of Obstetricians and Gynecologists' Committee on Practice Bulletins—Obstetrics and the Society forMaternal-FetalMedicin

https://pubmed.ncbi.nlm.nih.gov/30681542

Abdominal Circumference Alone versus Estimated Fetal Weight after 24 Weeks to Predict Small or Large for Gestational Age at Birth: A Meta-Analysis.

Nathan R Blue, José M Pérez Yordan, Bradley D Holbrook...

https://pubmed.ncbi.nlm.nih.gov/28672412

Diagnostic performance of third-trimester ultrasound for the prediction of late-onset fetal growth restriction: a systematic review and meta-analysis.

Javier Caradeux, Raigam J Martinez-Portilla, Anna Peguero...

https://pubmed.ncbi.nlm.nih.gov/30633918

Suspicion of intrauterine growth restriction: Use of abdominal circumference alone or estimated fetal weight below 10%.

Suneet P Chauhan, Jill Cole, Maureen Sanderson...

https://pubmed.ncbi.nlm.nih.gov/16966124