Preterm LaborPreterm laborNCT05632003
Uterocervical Angle in Prediction of Preterm Labor
An observational study of Preterm Labor, run by Ain Shams Maternity Hospital at 1 site in Egypt.
Trial summary
Preterm delivery occurs in about 5-18% of pregnancies before 37 weeks' gestation all over the world.It is associated with a high prevalence of neurological deficits, developmental disabilities and is a leading cause of infant and neonatal mortality. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women only
- Conditions the study is for
- Preterm Labor
- How many people
- 77 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2022to 31 Dec 2022
- 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 18 to 35 years
- Women only
- Adult
Study population: Pregnant women attending the obstetrics outpatient clinic at AinShams university maternity hospital
Who may be able to join
- Singleton pregnancy
- History of spontaneous preterm birth
- Recruitment at 16 to 24 weeks of pregnancy
- Normal growth pattern evaluated by estimated fetal weight or abdominal circumference
Who cannot join
- Medical disorders which can lead to uteroplacental insufficiency
- Congenital uterine anomalies, as it may change the uterocervical angle.
- Congenital fetal malformations detected on midtrimesteric anomaly scan
- Pregnancy on IVF/ICSI
- Smoking during pregnancy
- History of cervical trauma
Show all 10Show fewer
- Preterm prelabor rupture of the membranes
- Polyhydramnios
- Cervical cerclage
- Antepartum hemorrhage
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Uterocervical Angle Versus Cervical Length in The Prediction Of Spontaneous Preterm Birth In Women With History Of Spontaneous Preterm Birth A Prospective Observational Study
Preterm delivery occurs in about 5-18% of pregnancies before 37 weeks' gestation all over the world.It is associated with a high prevalence of neurological deficits, developmental disabilities and is a leading cause of infant and neonatal mortality.
Many of the methods used for predicting preterm birth has not been proven efficacy and is not currently recommended for use.The length of the cervix has been one of the most useful methods in predicting the risk of premature delivery. Detection rates may be improved if combined with other parameters such as the uterocervical angle as a new predictor of spontaneous preterm birth.
In this study we will compare between using the uterocervical angle and cervical length in the prediction of preterm labour.
Read the detailed description
Preterm birth, defined as birth before 37 weeks of gestation, affects 5 to 18% of pregnancies. It is the leading cause of neonatal death and the second cause of childhood death below the age of 5 years. Preterm delivery (birth before 37 weeks' gestation) is further delineated into very early preterm (before 32 weeks), early preterm (32 0/7 to 33 6/7 weeks), and late preterm (34 0/7 to 36 6/7 weeks). It is logical to divide PTD into different subcategories: live-borns vs. intrauterine fetal deaths, singleton pregnancies vs. multiple pregnancies and spontaneous PTD vs. iatrogenic PTD. About 80% of all the preterm infants are live born singletons. The majority of these deliveries are spontaneous, due to onset of contractions or to spontaneously ruptured membranes. Conversely, iatrogenic preterm deliveries are due to the physician's decision to induce labor for maternal or fetal medical reasons. However, since the terminology varies, it is crucial to use clear definitions in all circumstances where the different phenotypical terms are used.
Preterm delivery is the consequence of four main mechanisms: activation of the maternal-fetal placental interaction with the hypothalamic-pituitary-adrenal axis, inflammation in the amniochorionic-decidual tissue, decidual hemorrhage and pathological distention of the myometrium. Although in most cases preterm births occur idiopathically, fetal, uterine, and placental factors as well as maternal chronic diseases, can affect preterm birth. It is estimated that of all cases of PTB, only 8.7% and 1.7- 2.3% of women, respectively, have the risk factors of prior PTB or significant cervical shortening in the midtrimester and would benefit from prophylactic therapy. A number of risk factors for preterm birth are known, but this does not mean that recognizing one of them in a pregnant woman before the 37th week means that a preterm birth will certainly begin. Knowledge of the risk factors allows for more intensive observation of the pregnant woman and gives obstetricians insight into what should be avoide . There are many maternal or fetal characteristics that have been associated with preterm birth, including maternal demographic characteristics, nutritional status, pregnancy history, present pregnancy characteristics, psychological characteristics, adverse behaviours, infection, uterine contractions and cervical length, and biological and genetic markers. Proposed techniques for detecting at-risk pregnancies include risk factor-based scoring systems, home uterine activity monitoring, maternal serum chemistries, salivary estriol, cervicovaginal chemistries, and amniotic fluid analytes. These modalities are characterized by either inadequate screening efficiencies, invasiveness, expense, or lack of commercial availability. Moreover, their use does not demonstrate reduced spontaneous preterm birth rates. Cervical length (CL) measured by transvaginal sonography (TVS) has been shown to be an effective predictor of spontaneous preterm birth (PTB). This finding has been confirmed in singleton and multiple gestations, in women with or without risk factors for preterm birth, and in asymptomatic women as well as women with preterm labor (PTL) or preterm prelabor rupture of the membranes (PPROM). The anterioruterocervical angle (aUCA) is a novel transvaginal ultrasonographic marker that showed evidence of being useful as a screening tool for spontaneous PTB. It can be used as an alternative to cervical length (CL) as screening method for sPTB. It involves measurement of the angle between the anterior lower uterine segment (LUS) and cervix. A wide, or obtuse, anterior uterocervical angle (aUCA) lends a more direct, linear outlet of uterine contents onto the cervix. A narrower, or acute, UCA supports an anatomical geometry that would exert less direct force on the internal os, which may be protective from cervical deformation. A wide aUCA ≥95ᶿ and ≥105ᶿ detected during the 2nd trimester was associated with an increased risk for sPTB<37 and <34 weeks, respectively. However, the studies that provided this evidence were retrospective and their results were heterogeneous. Our objective is to evaluate whether the anterior UCA can predict risk of sPTB in a general population of singletons and to evaluate its performance for predicting sPTB relative to CL.
- Conditions
- Preterm Labor
- Medical subject headings
- Obstetric Labor, Premature
What is being measured
The primary outcome is the main question the study is designed to answer.
Early preterm birth
birth between 32 0/7 and 33 6/7 weeks of gestation
Measured: from 16 0/7 to 36 6/7 weeks of gestation
Secondary outcomes (1)
Late preterm birth
birth between 34 0/7 and 36 6/7 weeks of gestation
Measured: from 16 0/7 to 36 6/7 weeks of gestation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2022
- Study start1 Jan 2022
- Primary completion31 Dec 2022
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Preterm LaborStudies 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
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams Maternity Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mohammed Elmaraghy, Ain Shams Maternity Hospital
- Investigators
- Mohammed S Elsokkary, MD, Study director, Ainshams university maternity hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632003
- Sponsor's protocol ID
- 7
- Acronym
- Preterm labor
- Status last verified
- Jan 2023
- First submitted
- 20 Nov 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Berghella V, Palacio M, Ness A, Alfirevic Z, Nicolaides KH, Saccone G. Cervical length screening for prevention of preterm birth in singleton pregnancy with threatened preterm labor: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Mar;49(3):322-329. doi: 10.1002/uog.17388. Epub 2017 Feb 8.
PubMed 27997053DeFranco EA, Lewis DF, Odibo AO. Improving the screening accuracy for preterm labor: is the combination of fetal fibronectin and cervical length in symptomatic patients a useful predictor of preterm birth? A systematic review. Am J Obstet Gynecol. 2013 Mar;208(3):233.e1-6. doi: 10.1016/j.ajog.2012.12.015. Epub 2012 Dec 12.
PubMed 23246314Di Renzo GC, Cabero Roura L, Facchinetti F, Helmer H, Hubinont C, Jacobsson B, Jorgensen JS, Lamont RF, Mikhailov A, Papantoniou N, Radzinsky V, Shennan A, Ville Y, Wielgos M, Visser GHA. Preterm Labor and Birth Management: Recommendations from the European Association of Perinatal Medicine. J Matern Fetal Neonatal Med. 2017 Sep;30(17):2011-2030. doi: 10.1080/14767058.2017.1323860. No abstract available.
PubMed 28482713Dziadosz M, Bennett TA, Dolin C, West Honart A, Pham A, Lee SS, Pivo S, Roman AS. Uterocervical angle: a novel ultrasound screening tool to predict spontaneous preterm birth. Am J Obstet Gynecol. 2016 Sep;215(3):376.e1-7. doi: 10.1016/j.ajog.2016.03.033. Epub 2016 Mar 24.
PubMed 27018466Farras Llobet A, Higueras T, Calero IZ, Regincos Marti L, Maiz N, Goya MM, Carreras E. Prospective evaluation of the uterocervical angle as a predictor of spontaneous preterm birth. Acta Obstet Gynecol Scand. 2020 Nov;99(11):1511-1518. doi: 10.1111/aogs.13879. Epub 2020 Jun 3.
PubMed 32311754Halimi Asl AA, Safari S, Parvareshi Hamrah M. Epidemiology and Related Risk Factors of Preterm Labor as an obstetrics emergency. Emerg (Tehran). 2017;5(1):e3. Epub 2017 Jan 8.
PubMed 28286810Kagan KO, Sonek J. How to measure cervical length. Ultrasound Obstet Gynecol. 2015 Mar;45(3):358-62. doi: 10.1002/uog.14742. Epub 2015 Jan 29. No abstract available.
PubMed 25632014Khamees RE, Khattab BM, Elshahat AM, Taha OT, Aboelroose AA. Uterocervical angle versus cervical length in the prediction of spontaneous preterm birth in singleton pregnancy. Int J Gynaecol Obstet. 2022 Feb;156(2):304-308. doi: 10.1002/ijgo.13629. Epub 2021 Feb 23.
PubMed 33507541Pawelec M, Palczynski B, Krzemieniewska J, Karmowski M, Korys J, Latkowski K, Karmowski A. Initiation of preterm labor. Adv Clin Exp Med. 2013 Mar-Apr;22(2):283-8.
PubMed 23709385Romero R, Dey SK, Fisher SJ. Preterm labor: one syndrome, many causes. Science. 2014 Aug 15;345(6198):760-5. doi: 10.1126/science.1251816. Epub 2014 Aug 14.
PubMed 25124429Rundell K, Panchal B. Preterm Labor: Prevention and Management. Am Fam Physician. 2017 Mar 15;95(6):366-372.
PubMed 28318214Sen C. Preterm labor and preterm birth. J Perinat Med. 2017 Nov 27;45(8):911-913. doi: 10.1515/jpm-2017-0298. No abstract available.
PubMed 29055176Wax JR, Cartin A, Pinette MG. Biophysical and Biochemical Screening for the Risk of Preterm Labor: An Update. Clin Lab Med. 2016 Jun;36(2):369-83. doi: 10.1016/j.cll.2016.01.019. Epub 2016 Mar 25.
PubMed 27235918Elmaraghy AM, Shaaban SMA, Elsokkary MS, Elshazly ISMA. Uterocervical angle versus cervical length in the prediction of spontaneous preterm birth in women with history of spontaneous preterm birth: a prospective observational study. BMC Pregnancy Childbirth. 2023 Sep 13;23(1):658. doi: 10.1186/s12884-023-05977-9.
PubMed 37704977
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Uterocervical Angle Versus Cervical Length in The Prediction Of Spontaneous Preterm Birth In Women With History Of Spontaneous Preterm Birth A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT05632003
- Acronym / sponsor ID
- Preterm labor / 7
- Conditions
- Preterm Labor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- Ain Shams Maternity HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Dec 2022 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 30 Nov 2022 (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.
Preterm delivery occurs in about 5-18% of pregnancies before 37 weeks' gestation all over the world.It is associated with a high prevalence of neurological deficits, developmental disabilities and is a leading cause of infant and neonatal mortality.
Many of the methods used for predicting preterm birth has not been proven efficacy and is not currently recommended for use.The length of the cervix has been one of the most useful methods in predicting the risk of premature delivery. Detection rates may be improved if combined with other parameters such as the uterocervical angle as a new predictor of spontaneous preterm birth.
In this study we will compare between using the uterocervical angle and cervical length in the prediction of preterm labour.
Detailed description
Preterm birth, defined as birth before 37 weeks of gestation, affects 5 to 18% of pregnancies. It is the leading cause of neonatal death and the second cause of childhood death below the age of 5 years. Preterm delivery (birth before 37 weeks' gestation) is further delineated into very early preterm (before 32 weeks), early preterm (32 0/7 to 33 6/7 weeks), and late preterm (34 0/7 to 36 6/7 weeks). It is logical to divide PTD into different subcategories: live-borns vs. intrauterine fetal deaths, singleton pregnancies vs. multiple pregnancies and spontaneous PTD vs. iatrogenic PTD. About 80% of all the preterm infants are live born singletons. The majority of these deliveries are spontaneous, due to onset of contractions or to spontaneously ruptured membranes. Conversely, iatrogenic preterm deliveries are due to the physician's decision to induce labor for maternal or fetal medical reasons. However, since the terminology varies, it is crucial to use clear definitions in all circumstances where the different phenotypical terms are used.
Preterm delivery is the consequence of four main mechanisms: activation of the maternal-fetal placental interaction with the hypothalamic-pituitary-adrenal axis, inflammation in the amniochorionic-decidual tissue, decidual hemorrhage and pathological distention of the myometrium. Although in most cases preterm births occur idiopathically, fetal, uterine, and placental factors as well as maternal chronic diseases, can affect preterm birth. It is estimated that of all cases of PTB, only 8.7% and 1.7- 2.3% of women, respectively, have the risk factors of prior PTB or significant cervical shortening in the midtrimester and would benefit from prophylactic therapy. A number of risk factors for preterm birth are known, but this does not mean that recognizing one of them in a pregnant woman before the 37th week means that a preterm birth will certainly begin. Knowledge of the risk factors allows for more intensive observation of the pregnant woman and gives obstetricians insight into what should be avoide . There are many maternal or fetal characteristics that have been associated with preterm birth, including maternal demographic characteristics, nutritional status, pregnancy history, present pregnancy characteristics, psychological characteristics, adverse behaviours, infection, uterine contractions and cervical length, and biological and genetic markers. Proposed techniques for detecting at-risk pregnancies include risk factor-based scoring systems, home uterine activity monitoring, maternal serum chemistries, salivary estriol, cervicovaginal chemistries, and amniotic fluid analytes. These modalities are characterized by either inadequate screening efficiencies, invasiveness, expense, or lack of commercial availability. Moreover, their use does not demonstrate reduced spontaneous preterm birth rates. Cervical length (CL) measured by transvaginal sonography (TVS) has been shown to be an effective predictor of spontaneous preterm birth (PTB). This finding has been confirmed in singleton and multiple gestations, in women with or without risk factors for preterm birth, and in asymptomatic women as well as women with preterm labor (PTL) or preterm prelabor rupture of the membranes (PPROM). The anterioruterocervical angle (aUCA) is a novel transvaginal ultrasonographic marker that showed evidence of being useful as a screening tool for spontaneous PTB. It can be used as an alternative to cervical length (CL) as screening method for sPTB. It involves measurement of the angle between the anterior lower uterine segment (LUS) and cervix. A wide, or obtuse, anterior uterocervical angle (aUCA) lends a more direct, linear outlet of uterine contents onto the cervix. A narrower, or acute, UCA supports an anatomical geometry that would exert less direct force on the internal os, which may be protective from cervical deformation. A wide aUCA ≥95ᶿ and ≥105ᶿ detected during the 2nd trimester was associated with an increased risk for sPTB<37 and <34 weeks, respectively. However, the studies that provided this evidence were retrospective and their results were heterogeneous. Our objective is to evaluate whether the anterior UCA can predict risk of sPTB in a general population of singletons and to evaluate its performance for predicting sPTB relative to CL.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Age groups
- Adult
- Study population
- Pregnant women attending the obstetrics outpatient clinic at AinShams university maternity hospital
Key inclusion criteria (4 listed)
- Singleton pregnancy
- History of spontaneous preterm birth
- Recruitment at 16 to 24 weeks of pregnancy
- Normal growth pattern evaluated by estimated fetal weight or abdominal circumference
Key exclusion criteria (10 listed)
- Medical disorders which can lead to uteroplacental insufficiency
- Congenital uterine anomalies, as it may change the uterocervical angle.
- Congenital fetal malformations detected on midtrimesteric anomaly scan
- Pregnancy on IVF/ICSI
- Smoking during pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Early preterm birth
Time frame: from 16 0/7 to 36 6/7 weeks of gestation
birth between 32 0/7 and 33 6/7 weeks of gestation
1 secondary outcome
Late preterm birth
Time frame: from 16 0/7 to 36 6/7 weeks of gestation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
- Background: PubMed 27997053Berghella V, Palacio M, Ness A, Alfirevic Z, Nicolaides KH, Saccone G. Cervical length screening for prevention of preterm birth in singleton pregnancy with threatened preterm labor: systematic review and meta-analysis of randomized controlled trials using individual patient-level data. Ultrasound Obstet Gynecol. 2017 Mar;49(3):322-329. doi: 10.1002/uog.17388. Epub 2017 Feb 8.
- Background: PubMed 23246314DeFranco EA, Lewis DF, Odibo AO. Improving the screening accuracy for preterm labor: is the combination of fetal fibronectin and cervical length in symptomatic patients a useful predictor of preterm birth? A systematic review. Am J Obstet Gynecol. 2013 Mar;208(3):233.e1-6. doi: 10.1016/j.ajog.2012.12.015. Epub 2012 Dec 12.
- Background: PubMed 28482713Di Renzo GC, Cabero Roura L, Facchinetti F, Helmer H, Hubinont C, Jacobsson B, Jorgensen JS, Lamont RF, Mikhailov A, Papantoniou N, Radzinsky V, Shennan A, Ville Y, Wielgos M, Visser GHA. Preterm Labor and Birth Management: Recommendations from the European Association of Perinatal Medicine. J Matern Fetal Neonatal Med. 2017 Sep;30(17):2011-2030. doi: 10.1080/14767058.2017.1323860. No abstract available.
- Background: PubMed 27018466Dziadosz M, Bennett TA, Dolin C, West Honart A, Pham A, Lee SS, Pivo S, Roman AS. Uterocervical angle: a novel ultrasound screening tool to predict spontaneous preterm birth. Am J Obstet Gynecol. 2016 Sep;215(3):376.e1-7. doi: 10.1016/j.ajog.2016.03.033. Epub 2016 Mar 24.
- Background: PubMed 32311754Farras Llobet A, Higueras T, Calero IZ, Regincos Marti L, Maiz N, Goya MM, Carreras E. Prospective evaluation of the uterocervical angle as a predictor of spontaneous preterm birth. Acta Obstet Gynecol Scand. 2020 Nov;99(11):1511-1518. doi: 10.1111/aogs.13879. Epub 2020 Jun 3.
- Background: PubMed 28286810Halimi Asl AA, Safari S, Parvareshi Hamrah M. Epidemiology and Related Risk Factors of Preterm Labor as an obstetrics emergency. Emerg (Tehran). 2017;5(1):e3. Epub 2017 Jan 8.
- Background: PubMed 25632014Kagan KO, Sonek J. How to measure cervical length. Ultrasound Obstet Gynecol. 2015 Mar;45(3):358-62. doi: 10.1002/uog.14742. Epub 2015 Jan 29. No abstract available.
- Background: PubMed 33507541Khamees RE, Khattab BM, Elshahat AM, Taha OT, Aboelroose AA. Uterocervical angle versus cervical length in the prediction of spontaneous preterm birth in singleton pregnancy. Int J Gynaecol Obstet. 2022 Feb;156(2):304-308. doi: 10.1002/ijgo.13629. Epub 2021 Feb 23.
- Background: PubMed 23709385Pawelec M, Palczynski B, Krzemieniewska J, Karmowski M, Korys J, Latkowski K, Karmowski A. Initiation of preterm labor. Adv Clin Exp Med. 2013 Mar-Apr;22(2):283-8.
- Background: PubMed 25124429Romero R, Dey SK, Fisher SJ. Preterm labor: one syndrome, many causes. Science. 2014 Aug 15;345(6198):760-5. doi: 10.1126/science.1251816. Epub 2014 Aug 14.
- Background: PubMed 28318214Rundell K, Panchal B. Preterm Labor: Prevention and Management. Am Fam Physician. 2017 Mar 15;95(6):366-372.
- Background: PubMed 29055176Sen C. Preterm labor and preterm birth. J Perinat Med. 2017 Nov 27;45(8):911-913. doi: 10.1515/jpm-2017-0298. No abstract available.
- Individual participant dataSharing planned: No
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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.
Mohammed S Elsokkary, MD study director
Ainshams university maternity hospital
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 Preterm Labor, run by Ain Shams Maternity Hospital at 1 site in Egypt.
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 4 inclusion and 10 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: finished, as of the sponsor's last update on 31 Jan 2023. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early preterm birth (time frame: from 16 0/7 to 36 6/7 weeks of gestation). 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 NCT05632003, which also lists 14 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 31 Jan 2023.