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New treatment option for Small for Gestational Age Infant
Official title "Fetal gRowth AbnorMality dEtection Trial"
ClinicalTrials.gov ID: NCT05043753
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 45, women only. Healthy volunteers may be eligible.
You may be able to join if
- 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
You likely can't join if
- Fetal chromosomal or genetic abnormalities if invasive prenatal diagnosis is performed
- Fetal malformations or soft markers identified on fetal anatomy survey
- Episodes of uterine bleeding after 24 weeks gestation. Unobserved self-reported bleeding with confirmed intact pregnancy on ultrasound after the...
- Uterine/placental abnormalities including uterine malformations (i.e bicornuate uterus, didelpus uterus), abnormal placentation (placenta previa...
- Cerclage in the current pregnancy
- History of intrauterine fetal demise
See the full eligibility criteria
- 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)
- Fetal chromosomal or genetic abnormalities if invasive prenatal diagnosis is performed
- Fetal malformations or soft markers identified on fetal anatomy survey
- Episodes of uterine bleeding after 24 weeks gestation. Unobserved self-reported bleeding with confirmed intact pregnancy on ultrasound after the bleeding episode is not an exclusion criteria.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Modena, Modena, Italy
- Cesena, Italy
- Monza, Italy
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 45 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Modena, Modena, Italy; Cesena, Italy; Monza, Italy. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.