What is this study trying to find out about fetal growth abnormalities?

This study is evaluating how well measuring symphysis fundal height alone compares to combining it with point of care ultrasound to detect babies that are smaller or larger than expected for their gestational age. The goal is to improve prenatal identification of growth problems in low-risk pregnancies. The University of Modena and Reggio Emilia is sponsoring this research.

Who may be eligible for this fetal growth abnormality clinical trial?

Women aged 18 to 45 years with a single, naturally conceived pregnancy at 35 weeks or more may be eligible. Participants must have normal aneuploidy screening when performed and no significant uterine or placental abnormalities. This trial is open to female participants only. Please review eligibility criteria for more details.

Is there any cost to participate in this fetal growth abnormality clinical trial?

Study-related care, including the study procedures and all trial visits, is provided at no cost. However, personal travel expenses may vary and are not guaranteed to be covered by the study.

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

Research Sites

8 weeks

Total Duration

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

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)

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

Research Team

Giuseppe Chiossi, MD

Fabio Facchinetti, MD

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here