"Fetal GRowth AbnorMality DEtection Trial"

NCT05043753 | Recruiting

• 1 other identifier: University of Modena
• Study Type: interventional
• Target: 1,566
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Small for Gestational Age Infant; Large for Gestational Age Infant; Oligohydramnios; Polyhydramnios

Outcome Measures

Primary Outcomes (1)

• Number of prenatally identified fetuses that will be classified as small or large for gestational age as infants (SGA and LGA infants)

  Birthweight percentile will be classified according to the INeS neonatal charts (Bertino 2010) to identify SGA (birthweight \< 10th percentile) , LGA (birthweight \> 90th percentile) and AGA (appropriate for gestational age, whose birthweight ranges between the 10th and the 90th percentile) infants.

  From enrollment through study completion, an average of 1 year. Prenatal evaluation of fetal growth and amniotic fluid volume will be performed at 35-38, 40,41, and 41+ weeks' gestation. Infants' weights will be evaluated at birth

Secondary Outcomes (5)

• Number of formal obstetric ultrasound (US) requested due to abnormal fetal growth or amniotic fluid suspected prenatally

  From enrollment through study completion, an average of 1 year. Formal obstetric ultrasound will be requested in case of suspicion of abnormal fetal growth or amniotic fluid on screening with symphysis fundal height associated or not to POC ultrasound

• Number of cases of oligohydramnios and polyhydramnios identified on formal obstetric US after being suspected on prenatal evaluation

  From enrollment through study completion, an average of 1 year. Formal obstetric ultrasound will be requested in case of suspicion of abnormal fetal growth or amniotic fluid on screening with symphysis fundal height associated or not to POC ultrasound

• Number of deliveries indicated by amniotic fluid or fetal growth abnormalities detected on formal obstetric US

  At the time of delivery, from enrollment through study completion, an average of 1 year

• Number of adverse neonatal outcome cases

  At the time of delivery, from enrollment through study completion, an average of 1 year

• Number of adverse maternal outcome cases

  At the time of delivery, from enrollment through study completion, an average of 1 year

Study Arms (2)

Control group: Symphysis fundal height measurement

NO INTERVENTION

Screening for fetal growth abnormalities is performed by certified nurse midwives (CNMs) using symphysis fundal height (SFH)

intervention group: Symphysis fundal height measurement and point of care ultrasound.

EXPERIMENTAL

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)

Other: Point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC)

Interventions

Point of care ultrasound to measure the fetal abdominal circumference (POC-US-AC) OTHER

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).

Also known as: Bedside ultrasound

intervention group: Symphysis fundal height measurement and point of care ultrasound.

Eligibility Criteria

• Age: 18 Years - 45 Years
• Gender Eligibility Details: The study enrolls low risk pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Modena and Reggio Emilia: lead

Study Sites (3)

Azienda Ospedaliero Universitaria Policlinico di Modena

Modena, Modena, 41125, Italy

RECRUITING

Cesena Hospital

Cesena, 47521, Italy

NOT YET RECRUITING

Foundation MBBM at San Gerardo Hospital, University of Milan-Bicocca School of Medicine and Surgery, Monza, Italy.

Monza, 20900, Italy

NOT YET RECRUITING

Related Publications (24)

• Al-Hafez L, Chauhan SP, Riegel M, Balogun OA, Hammad IA, Berghella V. Routine third-trimester ultrasound in low-risk pregnancies and perinatal death: a systematic review and meta-analysis. Am J Obstet Gynecol MFM. 2020 Nov;2(4):100242. doi: 10.1016/j.ajogmf.2020.100242. Epub 2020 Oct 3.

  PMID: 33345941 BACKGROUND

• Committee on Practice Bulletins-Obstetrics and the American Institute of Ultrasound in Medicine. Practice Bulletin No. 175: Ultrasound in Pregnancy. Obstet Gynecol. 2016 Dec;128(6):e241-e256. doi: 10.1097/AOG.0000000000001815. No abstract available.

  PMID: 27875472 BACKGROUND

• Macrosomia: ACOG Practice Bulletin, Number 216. Obstet Gynecol. 2020 Jan;135(1):e18-e35. doi: 10.1097/AOG.0000000000003606.

  PMID: 31856124 BACKGROUND

• American College of Obstetricians and Gynecologists' Committee on Practice Bulletins-Obstetrics and the Society forMaternal-FetalMedicin. ACOG Practice Bulletin No. 204: Fetal Growth Restriction. Obstet Gynecol. 2019 Feb;133(2):e97-e109. doi: 10.1097/AOG.0000000000003070.

  PMID: 30681542 BACKGROUND

• Bertino E, Spada E, Occhi L, Coscia A, Giuliani F, Gagliardi L, Gilli G, Bona G, Fabris C, De Curtis M, Milani S. Neonatal anthropometric charts: the Italian neonatal study compared with other European studies. J Pediatr Gastroenterol Nutr. 2010 Sep;51(3):353-61. doi: 10.1097/MPG.0b013e3181da213e.

  PMID: 20601901 BACKGROUND

• Blue NR, Yordan JMP, Holbrook BD, Nirgudkar PA, Mozurkewich EL. Abdominal Circumference Alone versus Estimated Fetal Weight after 24 Weeks to Predict Small or Large for Gestational Age at Birth: A Meta-Analysis. Am J Perinatol. 2017 Sep;34(11):1115-1124. doi: 10.1055/s-0037-1604059. Epub 2017 Jul 3. No abstract available.

  PMID: 28672412 BACKGROUND

• Bricker L, Medley N, Pratt JJ. Routine ultrasound in late pregnancy (after 24 weeks' gestation). Cochrane Database Syst Rev. 2015 Jun 29;2015(6):CD001451. doi: 10.1002/14651858.CD001451.pub4.

  PMID: 26121659 BACKGROUND

• Caradeux J, Martinez-Portilla RJ, Peguero A, Sotiriadis A, Figueras F. Diagnostic performance of third-trimester ultrasound for the prediction of late-onset fetal growth restriction: a systematic review and meta-analysis. Am J Obstet Gynecol. 2019 May;220(5):449-459.e19. doi: 10.1016/j.ajog.2018.09.043. Epub 2019 Jan 8.

  PMID: 30633918 BACKGROUND

• Chauhan SP, Cole J, Sanderson M, Magann EF, Scardo JA. Suspicion of intrauterine growth restriction: Use of abdominal circumference alone or estimated fetal weight below 10%. J Matern Fetal Neonatal Med. 2006 Sep;19(9):557-62. doi: 10.1080/14767050600798267.

  PMID: 16966124 BACKGROUND

• Doyle LW. Long-term neurologic outcome for the very preterm growth-restricted fetus. Pediatrics. 2011 Apr;127(4):e1048-9. doi: 10.1542/peds.2011-0262. Epub 2011 Mar 7. No abstract available.

  PMID: 21382952 BACKGROUND

• Society for Maternal-Fetal Medicine (SMFM). Electronic address: pubs@smfm.org; Martins JG, Biggio JR, Abuhamad A. Society for Maternal-Fetal Medicine Consult Series #52: Diagnosis and management of fetal growth restriction: (Replaces Clinical Guideline Number 3, April 2012). Am J Obstet Gynecol. 2020 Oct;223(4):B2-B17. doi: 10.1016/j.ajog.2020.05.010. Epub 2020 May 12.

  PMID: 32407785 BACKGROUND

• Goto E. Symphysis-fundal height to identify large-for-gestational-age and macrosomia: a meta-analysis. J Obstet Gynaecol. 2020 Oct;40(7):929-935. doi: 10.1080/01443615.2019.1673713. Epub 2019 Dec 8.

  PMID: 31814480 BACKGROUND

• Henrichs J, Verfaille V, Jellema P, Viester L, Pajkrt E, Wilschut J, van der Horst HE, Franx A, de Jonge A; IRIS study group. Effectiveness of routine third trimester ultrasonography to reduce adverse perinatal outcomes in low risk pregnancy (the IRIS study): nationwide, pragmatic, multicentre, stepped wedge cluster randomised trial. BMJ. 2019 Oct 15;367:l5517. doi: 10.1136/bmj.l5517.

  PMID: 31615781 BACKGROUND

• Lees CC, Stampalija T, Baschat A, da Silva Costa F, Ferrazzi E, Figueras F, Hecher K, Kingdom J, Poon LC, Salomon LJ, Unterscheider J. ISUOG Practice Guidelines: diagnosis and management of small-for-gestational-age fetus and fetal growth restriction. Ultrasound Obstet Gynecol. 2020 Aug;56(2):298-312. doi: 10.1002/uog.22134. No abstract available.

  PMID: 32738107 BACKGROUND

• Lindhard A, Nielsen PV, Mouritsen LA, Zachariassen A, Sorensen HU, Roseno H. The implications of introducing the symphyseal-fundal height-measurement. A prospective randomized controlled trial. Br J Obstet Gynaecol. 1990 Aug;97(8):675-80. doi: 10.1111/j.1471-0528.1990.tb16237.x.

  PMID: 2205286 BACKGROUND

• Lindqvist PG, Molin J. Does antenatal identification of small-for-gestational age fetuses significantly improve their outcome? Ultrasound Obstet Gynecol. 2005 Mar;25(3):258-64. doi: 10.1002/uog.1806.

  PMID: 15717289 BACKGROUND

• Nicolini U, Todros T, Ferrazzi E, Zorzoli A, Groli C, Zucca S, Tinti A, Dodero D, Destro F, Ceccarello P, et al. [Transverse fetal growth curves. A multicenter study]. Minerva Ginecol. 1986 Nov;38(11):873-87. No abstract available. Italian.

  PMID: 3808422 BACKGROUND

• Moraitis AA, Shreeve N, Sovio U, Brocklehurst P, Heazell AEP, Thornton JG, Robson SC, Papageorghiou A, Smith GC. Universal third-trimester ultrasonic screening using fetal macrosomia in the prediction of adverse perinatal outcome: A systematic review and meta-analysis of diagnostic test accuracy. PLoS Med. 2020 Oct 13;17(10):e1003190. doi: 10.1371/journal.pmed.1003190. eCollection 2020 Oct.

  PMID: 33048935 BACKGROUND

• Papageorghiou AT, Ohuma EO, Gravett MG, Hirst J, da Silveira MF, Lambert A, Carvalho M, Jaffer YA, Altman DG, Noble JA, Bertino E, Purwar M, Pang R, Cheikh Ismail L, Victora C, Bhutta ZA, Kennedy SH, Villar J; International Fetal and Newborn Growth Consortium for the 21st Century (INTERGROWTH-21st). International standards for symphysis-fundal height based on serial measurements from the Fetal Growth Longitudinal Study of the INTERGROWTH-21st Project: prospective cohort study in eight countries. BMJ. 2016 Nov 7;355:i5662. doi: 10.1136/bmj.i5662.

  PMID: 27821614 BACKGROUND

• Pay AS, Wiik J, Backe B, Jacobsson B, Strandell A, Klovning A. Symphysis-fundus height measurement to predict small-for-gestational-age status at birth: a systematic review. BMC Pregnancy Childbirth. 2015 Feb 10;15:22. doi: 10.1186/s12884-015-0461-z.

  PMID: 25884884 BACKGROUND

• Robert Peter J, Ho JJ, Valliapan J, Sivasangari S. Symphysial fundal height (SFH) measurement in pregnancy for detecting abnormal fetal growth. Cochrane Database Syst Rev. 2015 Sep 8;2015(9):CD008136. doi: 10.1002/14651858.CD008136.pub3.

  PMID: 26346107 BACKGROUND

• Sovio U, White IR, Dacey A, Pasupathy D, Smith GCS. Screening for fetal growth restriction with universal third trimester ultrasonography in nulliparous women in the Pregnancy Outcome Prediction (POP) study: a prospective cohort study. Lancet. 2015 Nov 21;386(10008):2089-2097. doi: 10.1016/S0140-6736(15)00131-2. Epub 2015 Sep 7.

  PMID: 26360240 BACKGROUND

• Sparks TN, Cheng YW, McLaughlin B, Esakoff TF, Caughey AB. Fundal height: a useful screening tool for fetal growth? J Matern Fetal Neonatal Med. 2011 May;24(5):708-12. doi: 10.3109/14767058.2010.516285. Epub 2010 Sep 17.

  PMID: 20849205 BACKGROUND

• von Beckerath AK, Kollmann M, Rotky-Fast C, Karpf E, Lang U, Klaritsch P. Perinatal complications and long-term neurodevelopmental outcome of infants with intrauterine growth restriction. Am J Obstet Gynecol. 2013 Feb;208(2):130.e1-6. doi: 10.1016/j.ajog.2012.11.014. Epub 2012 Nov 15.

  PMID: 23159694 BACKGROUND

Related Links

• NICE. Antenatal care for uncomplicated pregnancies. 2008.

MeSH Terms

Conditions

Oligohydramnios; Polyhydramnios

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases

Study Officials

• Giuseppe Chiossi, MD

  University of Modena and Reggio Emilia, Modena Policlinico Hospital, Department of Obstetrics and Gynecology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Giuseppe Chiossi, MD

CONTACT

+39 059 4225607; ossidi74seppie@yahoo.it

Fabio Facchinetti, MD

CONTACT

+39 059 4225607; fabio.facchinetti@unimore.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician, Department of Obstetrics and Gynecology

Model Details: To compare 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

Study Record Dates

• First Submitted: September 2, 2021
• First Posted: September 14, 2021
• Study Start: January 20, 2024
• Primary Completion: October 20, 2025
• Study Completion: December 21, 2025
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)