"Fetal GRowth AbnorMality DEtection Trial"
Department of Obstetrics and Gynecology Modena Policlinico Hospital Vial Del Pozzo 71, 41125 Modena
University of Modena and Reggio Emilia
1,566 participants
Jan 20, 2024
INTERVENTIONAL
Conditions
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
Inclusion Criteria6
- 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)
Exclusion Criteria23
- Fetal chromosomal or genetic abnormalities if invasive prenatal diagnosis is performed
- Fetal malformations or soft markers identified on fetal anatomy survey
- Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelpus uterus), abnormal placentation (placenta previa, accreta, percreta), uterine fibroids.
- Cerclage in the current pregnancy
- History of intrauterine fetal demise
- History of fetal growth restriction or birth weight \> 4Kg in a previous pregnancy
- Fetal isoimmunization or alloimmunization
- Fetal demise in previous pregnancies
- Cancer (including melanoma but excluding other skin cancers). Dysplastic or pre-neoplatic conditions such as cervical intraepithelial neoplasia are admissible.
- Endocrine disease including thyroid disease (recently diagnosed or whose medication dose is not stable), adrenal disease, diabetes mellitus (pregestational and gestational).
- Renal disease with altered renal function (creatinine \> 0.9, proteinuria \> 300 mg/24 hour)
- Epilepsy or other seizure disorder
- Any collagen disease (lupus erythematosus, scleroderma, etc.)
- Active liver disease (acute hepatitis, chronic active hepatitis, persistently abnormal liver enzymes). Liver disorders accounting for cholestasis (including cholestasis of pregnancy) if diagnosed prior to enrollment.
- Hematological disorder including alloimmune and isoimmune thrombocytopenia but excluding mild iron deficiency anemia (Hb \> 9 gm/dl). Patients with sickle cell disease are excluded.
- Chronic pulmonary disease including asthma requiring regular use of medication and active TB. An asthma inhaler used on an as needed basis for a cold or an asthma attack is not considered regular use.
- Heart disease except mitral value prolapse not requiring medication
- Cardiovascular disorders: chronic hypertension, gestational hypertension or preeclampsia diagnosed prior to enrollment
- Infectious diseases: HIV, CMV, toxoplasmosis, parvovirus B19, HBV, HCV
- Chronic treatments with medications such as aspirin, steroids, anti-hypertensive agents, immunosuppressants, antineoplastic drugs.
- Prior laparoscopic or open uterine surgeries where the uterine cavity was entered (such as myomectomies)
- Resectoscopic myomectomies (prior resectoscopic polypectomies are not contraindications)
- Prior classical cesarean deliveries.
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Midwives perform a POC-US to measure the fetal abdominal circumference (AC) and evaluate the quantity of amniotic fluid. In order to identify the appropriate sonographic plane the following markers need to be identified on POC-US * Fluid filled fetal stomach on the left. * Umbilical vein * Umbilical portion of left portal vein within liver, as it meets the "pars transversa" (horizontal portion of left portal vein) seen as a right sided " L " or " C " shape. * Fetal spine seen in cross section Amniotic fluid volume will be evaluated determining the deepest vertical pocket (DVP). Measurement is performed by assessing a pocket of maximal depth of amniotic fluid free of umbilical cord and fetal parts. The transducer is held perpendicularly to the patient's abdomen. The absence of a pocket measuring at least 2 cm in depth and 1 cm in width is indicative of oligohydramnios, while detection of a pocket measuring 8 cm or larger is suggestive of polyhydramnios (ACOG bulletin 175, 2016).
Locations(3)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05043753