Department of Obstetrics and Gynecology Modena Policlinico Hospital Vial Del Pozzo 71, 41125 Modena

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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 (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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: t
View:

• Maternal age ≥ 18 years and ability to give informed consent.

• Singleton gestation

• Ultrasound examination that confirms or revises the EDD before 14 weeks of gestational age

• Gestational age ≥ 35 weeks' gestation

• Normal aneuploidy screening (1st trimester screening, 2nd trimester screening, integrated screening, NIPT) when performed

• Spontaneously conceived pregnancy (i.e the current pregnancy is not the result of in vitro fertilization)

Locations
Other Locations
Italy
Cesena Hospital
NOT_YET_RECRUITING
Cesena
Azienda Ospedaliero Universitaria Policlinico di Modena
RECRUITING
Modena
Foundation MBBM at San Gerardo Hospital, University of Milan-Bicocca School of Medicine and Surgery, Monza, Italy.
NOT_YET_RECRUITING
Monza
Contact Information
Primary
Giuseppe Chiossi, MD
ossidi74seppie@yahoo.it
+39 059 4225607
Backup
Fabio Facchinetti, MD
fabio.facchinetti@unimore.it
+39 059 4225607
Time Frame
Start Date: 2024-01-20
Estimated Completion Date: 2025-12-21
Participants
Target number of participants: 1566
Treatments
No_intervention: Control group: Symphysis fundal height measurement
Screening for fetal growth abnormalities is performed by certified nurse midwives (CNMs) using symphysis fundal height (SFH)
Experimental: intervention group: Symphysis fundal height measurement and point of care ultrasound.
Screening for fetal growth abnormalities is performed by certified nurse midwives (CNM) using symphysis fundal height (SFH) and point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC)
Related Therapeutic Areas
Sponsors
Leads: University of Modena and Reggio Emilia

This content was sourced from clinicaltrials.gov