Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes

NCT05901688 | Recruiting DMC

• 1 other identifier: 001
• Study Type: observational
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of our study is to investigate the association of umbilical cord abnormalities with adverse pregnancy outcomes. The umbilical cord parameters that will be investigated as part of this study include the umbilical cord coiling index (UCI), umbilical cord (UC) diameter, umbilical vein (UV) diameter, UV flow velocity and the presence of nuchal cord. The UCI, UC, UV diameter \& flow and presence of nuchal cord will be measured in routine unselected populations at 20-22 weeks and 35-37 weeks gestation during the study period. We will also measure the UC and UV diameter in a nested population of high-risk pregnancies attending our placental disorders clinic which have been deemed to be at risk of having adverse pregnancy outcomes. Primary objective: To investigate if prenatal assessment of UCI, UC, UV diameter \& flow and presence of nuchal cord measured routinely in unselected screened populations at 20-22 weeks and 35-37 weeks' can provide an independent prediction of pregnancies that develop adverse pregnancy outcomes. Secondary objectives: To assess the correlation of UC and UV diameter measured by ultrasound scan and fetal magnetic resonance imaging in prediction of pregnancy outcome. To examine the association of these umbilical cord measurements and observations in a nested cohort of pregnancies in the high-risk placental disorders clinic.

Conditions

Small for Gestational Age at Delivery; Hypoxic-Ischemic Encephalopathy; Stillbirth; Admission to Neonatal Unit

Outcome Measures

Primary Outcomes (5)

• Delivery of small for gestational age (SGA) neonate

  Birth weight below the 5th and 10th percentile

  2 years

• Emergency CS for fetal distress

  Caesarean section carried out for fetal heart rate abnormalities in labour

  2 years

• Hypoxic ischaemic encephalopathy

  Brain damage in neonates causes due to lack of oxygen and confirmed on ultrasound scan

  2 years

• Stillbirth

  Death of a fetuses between 24 weeks and before the birth of the baby

  2 years

• Composite hypoxic morbidity

  A composite outcome measures of any of the above outcome measures

  2 years

Secondary Outcomes (3)

• Preterm delivery < 37 weeks

  2 years

• Development of preeclampsia

  2 years

• Admission to neonatal intensive care unit

  2 years

Study Arms (2)

Unselected population

Routine unselected populations at 20-22 weeks and 35-37 weeks

Other: Umbilical cord measurements & observations

High risk population

High-risk pregnancies attending the placental disorders clinic which have been deemed to be at risk of having adverse pregnancy outcomes.

Other: Umbilical cord measurements & observations

Interventions

Umbilical cord measurements & observations OTHER

In the screening study of an unselected population at 20-22 weeks' and 35-37 weeks' gestation, women are offered an ultrasound scan as part of standard care and will be invited to take part in the study which will involve taking the following additional ultrasound measurements: 1. Umbilical cord coiling index (UCI) 2. Transverse diameter of umbilical cord (UC) 3. Transverse diameter of umbilical vein (UV) and artery (UA) 4. Umbilical vein (UV) Doppler flow characteristics 5. Presence of nuchal cord

High risk population; Unselected population

Eligibility Criteria

• Age: 16 Years+
• Gender Eligibility Details: Gender eligibility based on biological gender
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study will be carried out in two cohorts: the first is the cohort of unselected population of pregnancies attending for their routine pregnancy care and ultrasound appointments at 20-22 weeks and 35-37 weeks. A nested cohort study will also be carried out in a high-risk cohort of pregnancies referred to the placental disorders clinic for women who have risk factors for delivering a small for gestational age baby or those at risk of developing preeclampsia.

You may qualify if:

• Singleton pregnancies.
• Women booked at our unit prior to 20 weeks' gestation.

You may not qualify if:

• Multiple pregnancies.
• Age \< 16 years.
• Those unable to provide consent.
• Pregnancies with fetal abnormalities.

Sponsors & Collaborators

• Medway NHS Foundation Trust: lead

Study Sites (1)

Medway NHS Foundation Trust

Gillingham, Kent, ME7 5NY, United Kingdom

RECRUITING

Related Publications (25)

• Hegazy AA. Anatomy and embryology of umbilicus in newborns: a review and clinical correlations. Front Med. 2016 Sep;10(3):271-7. doi: 10.1007/s11684-016-0457-8. Epub 2016 Sep 7.

  PMID: 27473223 BACKGROUND

• Moshiri M, Zaidi SF, Robinson TJ, Bhargava P, Siebert JR, Dubinsky TJ, Katz DS. Comprehensive imaging review of abnormalities of the umbilical cord. Radiographics. 2014 Jan-Feb;34(1):179-96. doi: 10.1148/rg.341125127.

  PMID: 24428290 BACKGROUND

• Mitchell KE, Weiss ML, Mitchell BM, Martin P, Davis D, Morales L, Helwig B, Beerenstrauch M, Abou-Easa K, Hildreth T, Troyer D, Medicetty S. Matrix cells from Wharton's jelly form neurons and glia. Stem Cells. 2003;21(1):50-60. doi: 10.1634/stemcells.21-1-50.

  PMID: 12529551 BACKGROUND

• Pacora P, Romero R, Jaiman S, Erez O, Bhatti G, Panaitescu B, Benshalom-Tirosh N, Jung EJ, Hsu CD, Hassan SS, Yeo L, Kadar N. Mechanisms of death in structurally normal stillbirths. J Perinat Med. 2019 Feb 25;47(2):222-240. doi: 10.1515/jpm-2018-0216.

  PMID: 30231013 BACKGROUND

• Man J, Hutchinson JC, Heazell AE, Ashworth M, Jeffrey I, Sebire NJ. Stillbirth and intrauterine fetal death: role of routine histopathological placental findings to determine cause of death. Ultrasound Obstet Gynecol. 2016 Nov;48(5):579-584. doi: 10.1002/uog.16019. Epub 2016 Oct 25.

  PMID: 27781319 BACKGROUND

• Ashoor G, Syngelaki A, Papastefanou I, Nicolaides KH, Akolekar R. Development and validation of model for prediction of placental dysfunction-related stillbirth from maternal factors, fetal weight and uterine artery Doppler at mid-gestation. Ultrasound Obstet Gynecol. 2022 Jan;59(1):61-68. doi: 10.1002/uog.24795.

  PMID: 34643306 BACKGROUND

• Hammad IA, Blue NR, Allshouse AA, Silver RM, Gibbins KJ, Page JM, Goldenberg RL, Reddy UM, Saade GR, Dudley DJ, Thorsten VR, Conway DL, Pinar H, Pysher TJ; NICHD Stillbirth Collaborative Research Network Group. Umbilical Cord Abnormalities and Stillbirth. Obstet Gynecol. 2020 Mar;135(3):644-652. doi: 10.1097/AOG.0000000000003676.

  PMID: 32028503 BACKGROUND

• Akolekar R, Tokunaka M, Ortega N, Syngelaki A, Nicolaides KH. Prediction of stillbirth from maternal factors, fetal biometry and uterine artery Doppler at 19-24 weeks. Ultrasound Obstet Gynecol. 2016 Nov;48(5):624-630. doi: 10.1002/uog.17295.

  PMID: 27854387 BACKGROUND

• Tantbirojn P, Saleemuddin A, Sirois K, Crum CP, Boyd TK, Tworoger S, Parast MM. Gross abnormalities of the umbilical cord: related placental histology and clinical significance. Placenta. 2009 Dec;30(12):1083-8. doi: 10.1016/j.placenta.2009.09.005. Epub 2009 Oct 22.

  PMID: 19853300 BACKGROUND

• Jessop FA, Lees CC, Pathak S, Hook CE, Sebire NJ. Umbilical cord coiling: clinical outcomes in an unselected population and systematic review. Virchows Arch. 2014 Jan;464(1):105-12. doi: 10.1007/s00428-013-1513-2. Epub 2013 Nov 21.

  PMID: 24259031 BACKGROUND

• Damasceno EB, de Lima PP. Wharton's jelly absence: a possible cause of stillbirth. Autops Case Rep. 2013 Dec 31;3(4):43-47. doi: 10.4322/acr.2013.038. eCollection 2013 Oct-Dec.

  PMID: 28584806 BACKGROUND

• de Laat MW, Franx A, van Alderen ED, Nikkels PG, Visser GH. The umbilical coiling index, a review of the literature. J Matern Fetal Neonatal Med. 2005 Feb;17(2):93-100. doi: 10.1080/14767050400028899.

  PMID: 16076615 BACKGROUND

• de Laat MW, van Alderen ED, Franx A, Visser GH, Bots ML, Nikkels PG. The umbilical coiling index in complicated pregnancy. Eur J Obstet Gynecol Reprod Biol. 2007 Jan;130(1):66-72. doi: 10.1016/j.ejogrb.2006.01.018. Epub 2006 Mar 2.

  PMID: 16513244 BACKGROUND

• Strong TH Jr, Jarles DL, Vega JS, Feldman DB. The umbilical coiling index. Am J Obstet Gynecol. 1994 Jan;170(1 Pt 1):29-32.

  PMID: 8296839 BACKGROUND

• De Laat MW, Franx A, Nikkels PG, Visser GH. Prenatal ultrasonographic prediction of the umbilical coiling index at birth and adverse pregnancy outcome. Ultrasound Obstet Gynecol. 2006 Oct;28(5):704-9. doi: 10.1002/uog.2786.

  PMID: 16952204 BACKGROUND

• El Behery MM, Nouh AA, Alanwar AM, Diab AE. Effect of umbilical vein blood flow on perinatal outcome of fetuses with lean and/or hypo-coiled umbilical cord. Arch Gynecol Obstet. 2011 Jan;283(1):53-8. doi: 10.1007/s00404-009-1272-0. Epub 2009 Nov 7.

  PMID: 19898858 BACKGROUND

• Degani S, Leibovich Z, Shapiro I, Gonen R, Ohel G. Early second-trimester low umbilical coiling index predicts small-for-gestational-age fetuses. J Ultrasound Med. 2001 Nov;20(11):1183-8. doi: 10.7863/jum.2001.20.11.1183.

  PMID: 11758023 BACKGROUND

• Jo YS, Jang DK, Lee G. The sonographic umbilical cord coiling in late second trimester of gestation and perinatal outcomes. Int J Med Sci. 2011;8(7):594-8. doi: 10.7150/ijms.8.594. Epub 2011 Oct 7.

  PMID: 22022212 BACKGROUND

• Sharma B, Bhardwaj N, Gupta S, Gupta PK, Verma A, Malviya K. Association of umbilical coiling index by colour Doppler ultrasonography at 18-22 weeks of gestation and perinatal outcome. J Obstet Gynaecol India. 2012 Dec;62(6):650-4. doi: 10.1007/s13224-012-0230-0. Epub 2012 Aug 17.

  PMID: 24293842 BACKGROUND

• Mittal A, Nanda S, Sen J. Antenatal umbilical coiling index as a predictor of perinatal outcome. Arch Gynecol Obstet. 2015 Apr;291(4):763-8. doi: 10.1007/s00404-014-3456-5. Epub 2014 Sep 11.

  PMID: 25209352 BACKGROUND

• Kosus A, Kosus N, Turhan NO. Is there any relation between umbilical artery and vein diameter and estimated fetal weight in healthy pregnant women? J Med Ultrason (2001). 2012 Oct;39(4):227-34. doi: 10.1007/s10396-012-0360-0. Epub 2012 May 9.

  PMID: 27279109 BACKGROUND

• Tutus S, Asal N, Uysal G, Sahin H. Is there a relationship between high birth weight and umbilical vein diameter? J Matern Fetal Neonatal Med. 2021 Nov;34(21):3609-3613. doi: 10.1080/14767058.2020.1814247. Epub 2020 Oct 20.

  PMID: 33081536 BACKGROUND

• Di Naro E, Raio L, Ghezzi F, Franchi M, Romano F, Addario VD. Longitudinal umbilical vein blood flow changes in normal and growth-retarded fetuses. Acta Obstet Gynecol Scand. 2002 Jun;81(6):527-33.

  PMID: 12047306 BACKGROUND

• Clapp JF 3rd, Stepanchak W, Hashimoto K, Ehrenberg H, Lopez B. The natural history of antenatal nuchal cords. Am J Obstet Gynecol. 2003 Aug;189(2):488-93. doi: 10.1067/s0002-9378(03)00371-5.

  PMID: 14520223 BACKGROUND

• Hayes DJL, Warland J, Parast MM, Bendon RW, Hasegawa J, Banks J, Clapham L, Heazell AEP. Umbilical cord characteristics and their association with adverse pregnancy outcomes: A systematic review and meta-analysis. PLoS One. 2020 Sep 24;15(9):e0239630. doi: 10.1371/journal.pone.0239630. eCollection 2020.

  PMID: 32970750 BACKGROUND

MeSH Terms

Conditions

Hypoxia-Ischemia, Brain; Stillbirth

Interventions

Watchful Waiting

Condition Hierarchy (Ancestors)

Brain Ischemia; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Hypoxia, Brain; Vascular Diseases; Cardiovascular Diseases; Hypoxia; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Fetal Death; Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Death; Pathologic Processes

Intervention Hierarchy (Ancestors)

Outcome Assessment, Health Care; Outcome and Process Assessment, Health Care; Quality of Health Care; Health Services Administration

Study Officials

• Ranjit Akolekar, MD MRCOG PhD

  Medway NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ranjit Akolekar, MD MRCOG PhD

CONTACT

+44 7944052009; ranjit.akolekar@nhs.net

Tara Giacchino, MD MRCOG MCh

CONTACT

+44 7799453795; tara.giacchino@nhs.net

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant in Fetal Medicine & Obstetrics

Study Record Dates

• First Submitted: June 5, 2023
• First Posted: June 13, 2023
• Study Start: October 3, 2023
• Primary Completion: July 3, 2025
• Study Completion: December 31, 2025
• Last Updated: March 12, 2024

Record last verified: 2024-03

Locations

GB (1)