Small for Gestational Age at DeliveryULOOPNCT05901688
Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
An observational study of Small for Gestational Age at Delivery and Hypoxic-Ischemic Encephalopathy, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 16 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy, Stillbirth
- What is being tested?
- Umbilical cord measurements & observations
- How many people
- 5,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Oct 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- Women only
- Healthy volunteers accepted
- Child, Adult, Older adult
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.
Who may be able to join
- Singleton pregnancies.
- Women booked at our unit prior to 20 weeks' gestation.
Who cannot join
- Multiple pregnancies.
- Age < 16 years.
- Those unable to provide consent.
- Pregnancies with fetal abnormalities.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Medway NHS Foundation Trust
Gillingham, Kent, ME7 5NY
Ranjit Akolekar, MD, ranjit.akolekar@nhs.net
Tara Giacchino, MD, tara.giacchino@nhs.net
About this study
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:
Read more
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.
Read the detailed description
The umbilical diameter is less than 2 cm, grows to a length of 50-60 cm by 28 weeks gestation and contains around 40 helical turns, which are twisted to the left rather than right because of the arrangement of helical muscle fibers in the vessels of the umbilical cord. These twists in the umbilical cord add to the strength of the cord by providing protection and resistance against compression of umbilical vessels. The overall final length of the UC and the number of coils is thought to be determined by the tensile forces due to fetal movements, rate of growth of UA and UV, fetal hemodynamics, distribution of the muscle fibers in the UA and amniotic fluid volume.
One of the common causes of fetal and neonatal adverse outcomes such as stillbirths or hypoxic ischaemic encephalopathy (HIE) is fetal hypoxia. The optimally oxygenated blood is transferred from the maternal blood to the fetus, crossing the placenta and the UC to reach fetal circulation. There are several studies which demonstrate that fetal hypoxia due to placental causes, whether chronic or acute, can lead to reduced transfer of oxygen and nutrition to the fetus. There is evidence from clinical and histological studies that impaired trophoblastic proliferation causes impaired placentation and leads to reduced oxygen transfer to the fetus resulting in preeclampsia (PE), fetal growth restriction (FGR) or stillbirth. However, there is limited and uncertain evidence regarding the contribution of UC abnormalities in the prediction of pregnancies with fetal hypoxia that result in hypoxic adverse outcomes such as HIE and stillbirth. There is need for further research to investigate the causes related to UC as not all hypoxic adverse outcomes have a placental etiology and a significant proportion of pregnancies with FGR, stillbirth and HIE have no ultrasound or histological evidence of impaired placentation, suggesting that there may be other factors in addition to the placenta that lead to such hypoxic morbidity.
There are studies published in literature demonstrating an association between UC abnormalities and adverse pregnancy outcomes such as FGR, PE, stillbirth or adverse outcomes such as caesarean section (CS) for fetal distress; but many of these are postnatal studies based on morphological and histological examination rather than prospective cohort studies carried out in the antenatal period. The few studies that investigate UC abnormalities in prenatal period are retrospective case-control studies with a relatively small sample size. This makes the findings less generalizable and overall difficult to effectively assess the precise contribution of UC abnormalities detected on ultrasound in the prenatal period that can potentially improve management and prevent such adverse outcomes.
This is a prospective observational cohort study carried out at a single center. This study will be conducted in compliance with the study protocol, the Declaration of Helsinki (1996), the principles of Good Clinical Practice (GCP) and applicable regulatory requirements. The study will be reviewed and approved by the Research Ethics Committees (REC) and competent authorities.
At our centre, all women booked for their maternity care are offered 3 routine ultrasound scans in their pregnancy: 11-13 weeks', 20-22 weeks' and at 35-37 weeks' gestation. Pregnancies that are deemed to be at high risk for delivery of a small for gestational age neonate are referred to a specialist placental disorders clinic for closer antenatal monitoring and fetal surveillance. At these visits, we ensure that there is a complete record of their personal, medical and obstetric history and perform an ultrasound scan to assess fetal growth, amniotic fluid and Doppler studies. This prospective study has two parts: first, a prospective observational cohort study in an unselected population and a nested cohort study in a high-risk population. Those agreeing to take part will be offered a patient information sheet and requested to sign a consent form, confirming their willingness to participate.
Prospective cohort study: 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:
- Umbilical cord coiling index (UCI)
- Transverse diameter of umbilical cord (UC)
- Transverse diameter of umbilical vein (UV) and artery (UA)
- Umbilical vein (UV) Doppler flow characteristics
- Presence of nuchal cord
Nested cohort study: In the nested cohort study of the high-risk pregnancies, women are offered measurement of fetal biometry and Doppler assessments including UA Doppler as part of the standard care. Women will be invited to take part in the study which will involve taking the following additional ultrasound measurements:
- Umbilical cord coiling index (UCI)
- Transverse diameter of umbilical cord (UC)
- Transverse diameter of umbilical vein (UV) and artery (UA)
- Umbilical vein (UV) Doppler flow characteristics
The additional measurements of UC, UV and nuchal cord will only add 2-3 minutes of examination time and will not affect the care of women attending for their routine assessments as well as in the high-risk placental disorders clinic. These measurements taken as part of the study will not be available for clinical management and will be analysed after the completion of the study period.
- Conditions
- Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy, Stillbirth, Admission to Neonatal Unit
- Being tested
- Umbilical cord measurements & observations
- Medical subject headings
- Hypoxia-Ischemia, Brain, Stillbirth
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Umbilical cord measurements & observationsOther
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:
- Umbilical cord coiling index (UCI)
- Transverse diameter of umbilical cord (UC)
- Transverse diameter of umbilical vein (UV) and artery (UA)
- Umbilical vein (UV) Doppler flow characteristics
- Presence of nuchal cord
| Study group | Role | What they receive |
|---|---|---|
| Unselected population | Routine unselected populations at 20-22 weeks and 35-37 weeks Receives: 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. Receives: Other: Umbilical cord measurements & observations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delivery of small for gestational age (SGA) neonate
Birth weight below the 5th and 10th percentile
Measured: 2 years
Emergency CS for fetal distress
Caesarean section carried out for fetal heart rate abnormalities in labour
Measured: 2 years
Hypoxic ischaemic encephalopathy
Brain damage in neonates causes due to lack of oxygen and confirmed on ultrasound scan
Measured: 2 years
Stillbirth
Death of a fetuses between 24 weeks and before the birth of the baby
Measured: 2 years
Composite hypoxic morbidity
A composite outcome measures of any of the above outcome measures
Measured: 2 years
Secondary outcomes (3)
Preterm delivery < 37 weeks
Spontaneous and iatrogenic preterm delivery
Measured: 2 years
Development of preeclampsia
High blood pressure developing in pregnancy based on ISSHP criteria
Measured: 2 years
Admission to neonatal intensive care unit
Admission to intensive or high-dependency care
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2023
- Study start3 Oct 2023
- Primary completion3 Jul 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (25)Papers the sponsor has linked to this study.
- Other trials for Small for Gestational Age at DeliveryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Medway NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Professor Ranjit Akolekar, Medway NHS Foundation Trust
- Investigators
- Ranjit Akolekar, MD MRCOG PhD, Principal investigator, Medway NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05901688
- Sponsor's protocol ID
- 001
- Acronym
- ULOOP
- Status last verified
- Mar 2024
- First submitted
- 5 Jun 2023
- Last updated
- 12 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 27473223Moshiri 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.
PubMed 24428290Mitchell 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.
PubMed 12529551Pacora 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.
PubMed 30231013Man 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.
PubMed 27781319Ashoor 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.
PubMed 34643306Hammad 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.
PubMed 32028503Akolekar 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.
PubMed 27854387Tantbirojn 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.
PubMed 19853300Jessop 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.
PubMed 24259031Damasceno 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.
PubMed 28584806de 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.
PubMed 16076615de 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.
PubMed 16513244Strong TH Jr, Jarles DL, Vega JS, Feldman DB. The umbilical coiling index. Am J Obstet Gynecol. 1994 Jan;170(1 Pt 1):29-32.
PubMed 8296839De 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.
PubMed 16952204
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Umbilical Cord Abnormalities in the Prediction of Adverse Pregnancy Outcomes
- ClinicalTrials.gov ID
- NCT05901688
- Acronym / sponsor ID
- ULOOP / 001
- Conditions
- Small for Gestational Age at Delivery, Hypoxic-Ischemic Encephalopathy, Stillbirth, Admission to Neonatal Unit
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Medway NHS Foundation TrustUniversity, hospital or other
- Study start
- 3 Oct 2023 (actual)
- Primary completion
- 3 Jul 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 13 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The umbilical diameter is less than 2 cm, grows to a length of 50-60 cm by 28 weeks gestation and contains around 40 helical turns, which are twisted to the left rather than right because of the arrangement of helical muscle fibers in the vessels of the umbilical cord. These twists in the umbilical cord add to the strength of the cord by providing protection and resistance against compression of umbilical vessels. The overall final length of the UC and the number of coils is thought to be determined by the tensile forces due to fetal movements, rate of growth of UA and UV, fetal hemodynamics, distribution of the muscle fibers in the UA and amniotic fluid volume.
One of the common causes of fetal and neonatal adverse outcomes such as stillbirths or hypoxic ischaemic encephalopathy (HIE) is fetal hypoxia. The optimally oxygenated blood is transferred from the maternal blood to the fetus, crossing the placenta and the UC to reach fetal circulation. There are several studies which demonstrate that fetal hypoxia due to placental causes, whether chronic or acute, can lead to reduced transfer of oxygen and nutrition to the fetus. There is evidence from clinical and histological studies that impaired trophoblastic proliferation causes impaired placentation and leads to reduced oxygen transfer to the fetus resulting in preeclampsia (PE), fetal growth restriction (FGR) or stillbirth. However, there is limited and uncertain evidence regarding the contribution of UC abnormalities in the prediction of pregnancies with fetal hypoxia that result in hypoxic adverse outcomes such as HIE and stillbirth. There is need for further research to investigate the causes related to UC as not all hypoxic adverse outcomes have a placental etiology and a significant proportion of pregnancies with FGR, stillbirth and HIE have no ultrasound or histological evidence of impaired placentation, suggesting that there may be other factors in addition to the placenta that lead to such hypoxic morbidity.
There are studies published in literature demonstrating an association between UC abnormalities and adverse pregnancy outcomes such as FGR, PE, stillbirth or adverse outcomes such as caesarean section (CS) for fetal distress; but many of these are postnatal studies based on morphological and histological examination rather than prospective cohort studies carried out in the antenatal period. The few studies that investigate UC abnormalities in prenatal period are retrospective case-control studies with a relatively small sample size. This makes the findings less generalizable and overall difficult to effectively assess the precise contribution of UC abnormalities detected on ultrasound in the prenatal period that can potentially improve management and prevent such adverse outcomes.
This is a prospective observational cohort study carried out at a single center. This study will be conducted in compliance with the study protocol, the Declaration of Helsinki (1996), the principles of Good Clinical Practice (GCP) and applicable regulatory requirements. The study will be reviewed and approved by the Research Ethics Committees (REC) and competent authorities.
At our centre, all women booked for their maternity care are offered 3 routine ultrasound scans in their pregnancy: 11-13 weeks', 20-22 weeks' and at 35-37 weeks' gestation. Pregnancies that are deemed to be at high risk for delivery of a small for gestational age neonate are referred to a specialist placental disorders clinic for closer antenatal monitoring and fetal surveillance. At these visits, we ensure that there is a complete record of their personal, medical and obstetric history and perform an ultrasound scan to assess fetal growth, amniotic fluid and Doppler studies. This prospective study has two parts: first, a prospective observational cohort study in an unselected population and a nested cohort study in a high-risk population. Those agreeing to take part will be offered a patient information sheet and requested to sign a consent form, confirming their willingness to participate.
Prospective cohort study: 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:
- Umbilical cord coiling index (UCI)
- Transverse diameter of umbilical cord (UC)
- Transverse diameter of umbilical vein (UV) and artery (UA)
- Umbilical vein (UV) Doppler flow characteristics
- Presence of nuchal cord
Nested cohort study: In the nested cohort study of the high-risk pregnancies, women are offered measurement of fetal biometry and Doppler assessments including UA Doppler as part of the standard care. Women will be invited to take part in the study which will involve taking the following additional ultrasound measurements:
- Umbilical cord coiling index (UCI)
- Transverse diameter of umbilical cord (UC)
- Transverse diameter of umbilical vein (UV) and artery (UA)
- Umbilical vein (UV) Doppler flow characteristics
The additional measurements of UC, UV and nuchal cord will only add 2-3 minutes of examination time and will not affect the care of women attending for their routine assessments as well as in the high-risk placental disorders clinic. These measurements taken as part of the study will not be available for clinical management and will be analysed after the completion of the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unselected population | – | Other: Umbilical cord measurements & observationsRoutine unselected populations at 20-22 weeks and 35-37 weeks |
| High risk population | – | Other: Umbilical cord measurements & observationsHigh-risk pregnancies attending the placental disorders clinic which have been deemed to be at risk of having adverse pregnancy outcomes. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Singleton pregnancies.
- Women booked at our unit prior to 20 weeks' gestation.
Key exclusion criteria (4 listed)
- Multiple pregnancies.
- Age < 16 years.
- Those unable to provide consent.
- Pregnancies with fetal abnormalities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Umbilical cord measurements & observationsIn 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 | Other | High risk population, Unselected population |
Primary outcome
Delivery of small for gestational age (SGA) neonate
Time frame: 2 years
Birth weight below the 5th and 10th percentile
Emergency CS for fetal distress
Time frame: 2 years
Caesarean section carried out for fetal heart rate abnormalities in labour
Hypoxic ischaemic encephalopathy
Time frame: 2 years
Brain damage in neonates causes due to lack of oxygen and confirmed on ultrasound scan
Stillbirth
Time frame: 2 years
Death of a fetuses between 24 weeks and before the birth of the baby
Composite hypoxic morbidity
Time frame: 2 years
A composite outcome measures of any of the above outcome measures
3 secondary outcomes
Preterm delivery < 37 weeks
Time frame: 2 years
Development of preeclampsia
Time frame: 2 years
Admission to neonatal intensive care unit
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2024.
- Background: PubMed 27473223Hegazy 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.
- Background: PubMed 24428290Moshiri 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.
- Background: PubMed 12529551Mitchell 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.
- Background: PubMed 30231013Pacora 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.
- Background: PubMed 27781319Man 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.
- Background: PubMed 34643306Ashoor 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.
- Background: PubMed 32028503Hammad 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.
- Background: PubMed 27854387Akolekar 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.
- Background: PubMed 19853300Tantbirojn 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.
- Background: PubMed 24259031Jessop 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.
- Background: PubMed 28584806Damasceno 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.
- Background: PubMed 16076615de 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ranjit Akolekar, MD MRCOG PhD principal investigator
Medway NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Small for Gestational Age at Delivery and Hypoxic-Ischemic Encephalopathy, run by Medway NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ranjit Akolekar, MD MRCOG PhD (+44 7944052009, ranjit.akolekar@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delivery of small for gestational age (SGA) neonate (time frame: 2 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05901688, which also lists 25 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2024.