Obstructive Sleep ApneaNCT02755831
Targeted CPAP Therapy for Obstructive Sleep Apnea in Pregnancy
A study testing CPAP and Pre-natal care in people with Obstructive Sleep Apnea, run by United States Naval Medical Center, San Diego at 1 site in United States.
Trial summary
Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Obstructive Sleep Apnea
- What is being tested?
- CPAP and Pre-natal care
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 193 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Feb 2017to 14 Oct 2019
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least one of the following risk factors for OSA: prepregnancy BMI ≥ 30kg/m2, chronic hypertension, pregestational diabetes, twin gestation, or a history of prior pregnancy affected by: preeclampsia, eclampsia or fetal growth restriction.
- Between 6 and 16 weeks gestation at time of enrollment.
Who cannot join
- Current diagnosis and treatment of OSA.
- Patient refusal to randomization.
- Permanent Pacemaker (interfere with WATCHPAT sleep study).
- Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
- Coronary artery disease or congestive heart failure or cardiomyopathy.
- Not delivering and completing their postpartum visit at Naval Medical Center San Diego (NMCSD).
- Inability to read or understand the consent.
- <18 years of age.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes
Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again between 8 to 12 weeks postpartum.
Read the detailed description
Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for obstructive sleep apnea (OSA; defined as an apnea hypopnea index [AHI] ≥5 events/hour) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late = between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation). At 8 to 12 months postpartum subjects in both groups will complete a sleep study.
- Conditions
- Obstructive Sleep Apnea
- Being tested
- CPAP, Pre-natal care
- Keywords
- OSA, pregnancy, adverse pregnancy outcomes, continuous positive airway pressure, preeclampsia, gestational diabetes
- Medical subject headings
- Sleep Apnea, Obstructive, Pre-Eclampsia, Diabetes, Gestational
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CPAPDevice
Continuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea
Pre-natal careOther
Standard Pre-Natal Care
| Study group | Role | What they receive |
|---|---|---|
| Sleep Study + CPAP group | Experimental | Pregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment Receives: Device: CPAP |
| Standard Prenatal Care group | Other | Pregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. Receives: Other: Pre-natal care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Pregnancy Outcomes
Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
Measured: time of delivery
Secondary outcomes (4)
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
Incidence of OSA severity in early pregnancy (6-16 weeks) in treatment group only. Data were not collected for Control group at this time point.
Measured: early pregnancy (6-16 weeks)
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
Incidence and severity of OSA in late pregnancy- treatment group only (27-33 weeks). Data were not collected for Control group at this time point
Measured: 27-33 weeks
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
Incidence and severity of OSA at 8 to 12 weeks postpartum in treatment and control group.
Measured: 8-12 weeks postpartum
Hospital Costs at Time of Delivery
Hospital costs at time of delivery in treatment and control group.
Measured: Hospital costs at time of delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2016 (estimated)
- Study start20 Feb 2017
- Primary completion14 Oct 2019
- Study completion14 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (38)Papers the sponsor has linked to this study.
- Other trials for Obstructive Sleep ApneaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 193 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Naval Medical Center, San Diego
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, CAPT Dennis Spence, NC, USN, PhD, CRNA, United States Naval Medical Center, San Diego
- Investigators
- Dennis L Spence, PhD, Study director, United States Naval Medical Center, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02755831
- Sponsor's protocol ID
- NMCSD.2016.0029
- Status last verified
- Nov 2019
- First submitted
- 11 Mar 2016
- Last updated
- 27 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Plan to submit manuscripts to appropriate journals and present data at appropriate conferences
Publications
Poyares D, Guilleminault C, Hachul H, Fujita L, Takaoka S, Tufik S, Sass N. Pre-eclampsia and nasal CPAP: part 2. Hypertension during pregnancy, chronic snoring, and early nasal CPAP intervention. Sleep Med. 2007 Dec;9(1):15-21. doi: 10.1016/j.sleep.2007.04.019. Epub 2007 Jul 20.
PubMed 17644475Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829.
PubMed 10770144Young T, Finn L, Peppard PE, Szklo-Coxe M, Austin D, Nieto FJ, Stubbs R, Hla KM. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008 Aug;31(8):1071-8.
PubMed 18714778Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.
PubMed 19743755Memtsoudis SG, Sun X, Chiu YL, Nurok M, Stundner O, Pastores SM, Mazumdar M. Utilization of critical care services among patients undergoing total hip and knee arthroplasty: epidemiology and risk factors. Anesthesiology. 2012 Jul;117(1):107-16. doi: 10.1097/ALN.0b013e31825afd36.
PubMed 22634871Luque-Fernandez MA, Bain PA, Gelaye B, Redline S, Williams MA. Sleep-disordered breathing and gestational diabetes mellitus: a meta-analysis of 9,795 participants enrolled in epidemiological observational studies. Diabetes Care. 2013 Oct;36(10):3353-60. doi: 10.2337/dc13-0778.
PubMed 24065843Ding XX, Wu YL, Xu SJ, Zhang SF, Jia XM, Zhu RP, Hao JH, Tao FB. A systematic review and quantitative assessment of sleep-disordered breathing during pregnancy and perinatal outcomes. Sleep Breath. 2014 Dec;18(4):703-13. doi: 10.1007/s11325-014-0946-4. Epub 2014 Feb 12.
PubMed 24519711Pamidi S, Pinto LM, Marc I, Benedetti A, Schwartzman K, Kimoff RJ. Maternal sleep-disordered breathing and adverse pregnancy outcomes: a systematic review and metaanalysis. Am J Obstet Gynecol. 2014 Jan;210(1):52.e1-52.e14. doi: 10.1016/j.ajog.2013.07.033. Epub 2013 Aug 2.
PubMed 23911687Louis J, Auckley D, Miladinovic B, Shepherd A, Mencin P, Kumar D, Mercer B, Redline S. Perinatal outcomes associated with obstructive sleep apnea in obese pregnant women. Obstet Gynecol. 2012 Nov;120(5):1085-92. doi: 10.1097/AOG.0b013e31826eb9d8.
PubMed 23090526American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):268-86. doi: 10.1097/ALN.0000000000000053. No abstract available.
PubMed 24346178Ankichetty SP, Angle P, Joselyn AS, Chinnappa V, Halpern S. Anesthetic considerations of parturients with obesity and obstructive sleep apnea. J Anaesthesiol Clin Pharmacol. 2012 Oct;28(4):436-43. doi: 10.4103/0970-9185.101895.
PubMed 23225920Reutrakul S, Zaidi N, Wroblewski K, Kay HH, Ismail M, Ehrmann DA, Van Cauter E. Interactions between pregnancy, obstructive sleep apnea, and gestational diabetes mellitus. J Clin Endocrinol Metab. 2013 Oct;98(10):4195-202. doi: 10.1210/jc.2013-2348. Epub 2013 Aug 21.
PubMed 23966237Epstein LJ, Kristo D, Strollo PJ Jr, Friedman N, Malhotra A, Patil SP, Ramar K, Rogers R, Schwab RJ, Weaver EM, Weinstein MD; Adult Obstructive Sleep Apnea Task Force of the American Academy of Sleep Medicine. Clinical guideline for the evaluation, management and long-term care of obstructive sleep apnea in adults. J Clin Sleep Med. 2009 Jun 15;5(3):263-76.
PubMed 19960649Louis JM, Mogos MF, Salemi JL, Redline S, Salihu HM. Obstructive sleep apnea and severe maternal-infant morbidity/mortality in the United States, 1998-2009. Sleep. 2014 May 1;37(5):843-9. doi: 10.5665/sleep.3644.
PubMed 24790262Facco FL, Ouyang DW, Zee PC, Grobman WA. Sleep disordered breathing in a high-risk cohort prevalence and severity across pregnancy. Am J Perinatol. 2014 Nov;31(10):899-904. doi: 10.1055/s-0033-1363768. Epub 2014 Feb 10.
PubMed 24515622
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial for a Sleep Study and Targeted CPAP Therapy for Obstructive Sleep Apnea to Reduce the Incidence Adverse Pregnancy Related Outcomes
- ClinicalTrials.gov ID
- NCT02755831
- Acronym / sponsor ID
- NMCSD.2016.0029
- Conditions
- Obstructive Sleep Apnea
- Keywords
- OSA, pregnancy, adverse pregnancy outcomes, continuous positive airway pressure, preeclampsia, gestational diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 193 participants (actual)
- Lead sponsor
- United States Naval Medical Center, San DiegoUS federal agency
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 14 Oct 2019 (actual)
- Study completion
- 14 Oct 2019 (actual)
- First posted
- 29 Apr 2016 (estimated)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Prospective, randomized controlled trial. Pregnant women in early pregnancy will be randomized to either the Sleep Study + CPAP (Continuous Positive Airway Pressure Therapy) group or to a Standard Prenatal Care group. Subjects in the Sleep Study + CPAP group will complete a sleep study (WatchPAT-200, Itamar Medical, Inc.) and have CPAP initiated if the Apnea Hypopnea Index (AHI) ≥5 as indicated, in early and late pregnancy, whereas the other group will receive standard prenatal care. All subjects will complete a sleep study again between 8 to 12 weeks postpartum.
Detailed description
Objective/Hypothesis: The purpose of this study is to determine if parturients identified as high risk for obstructive sleep apnea (OSA; defined as an apnea hypopnea index [AHI] ≥5 events/hour) who are randomized to receive an unattended sleep study during early and late pregnancy (early = between 6 and 16 weeks; late = between 27 and 33 weeks) plus initiation of CPAP therapy if the AHI ≥5 events/hour and standard prenatal care have a decreased incidence of adverse pregnancy outcomes (defined as a composite variable which includes gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm birth, low birth weight, or stillbirth) at the time of delivery when compared to a group who receives standard prenatal care only (no sleep study and CPAP initiation). At 8 to 12 months postpartum subjects in both groups will complete a sleep study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sleep Study + CPAP group | Experimental | Device: CPAPPregnant women in early pregnancy may be randomized to this arm and be assigned Sleep study + CPAP treatment |
| Standard Prenatal Care group | Other | Other: Pre-natal carePregnant women in early pregnancy may be randomized to this arm and will receive standard prenatal care without CPAP treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- At least one of the following risk factors for OSA: prepregnancy BMI ≥ 30kg/m2, chronic hypertension, pregestational diabetes, twin gestation, or a history of prior pregnancy affected by: preeclampsia, eclampsia or fetal growth restriction.
- Between 6 and 16 weeks gestation at time of enrollment.
Key exclusion criteria (8 listed)
- Current diagnosis and treatment of OSA.
- Patient refusal to randomization.
- Permanent Pacemaker (interfere with WATCHPAT sleep study).
- Currently taking alpha blockers or nitrates (interfere with WATCHPAT sleep study).
- Coronary artery disease or congestive heart failure or cardiomyopathy.
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 |
|---|---|---|
| CPAPContinuous Positive Airway Pressure (CPAP) Therapy for Obstructive Sleep Apnea | Device | Sleep Study + CPAP group |
| Pre-natal careStandard Pre-Natal Care | Other | Standard Prenatal Care group |
Primary outcome
Number of Participants With Adverse Pregnancy Outcomes
Time frame: time of delivery
Number of participants with adverse pregnancy outcomes (composite outcome includes: gestational hypertension, preeclampsia, eclampsia, gestational diabetes, preterm delivery, low birth weight, or stillbirth)
4 secondary outcomes
Incidence of Obstructive Sleep Apnea (OSA) in Early Pregnancy - Treatment Group Only (6-16 Weeks)
Time frame: early pregnancy (6-16 weeks)
Incidence of OSA in Late Pregnancy- Treatment Group Only (27-33 Weeks)
Time frame: 27-33 weeks
Incidence of OSA at 8 to 12 Weeks Postpartum in Treatment and Control Group
Time frame: 8-12 weeks postpartum
Hospital Costs at Time of Delivery
Time frame: Hospital costs at time of delivery
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 17644475Poyares D, Guilleminault C, Hachul H, Fujita L, Takaoka S, Tufik S, Sass N. Pre-eclampsia and nasal CPAP: part 2. Hypertension during pregnancy, chronic snoring, and early nasal CPAP intervention. Sleep Med. 2007 Dec;9(1):15-21. doi: 10.1016/j.sleep.2007.04.019. Epub 2007 Jul 20.
- Background: PubMed 10770144Nieto FJ, Young TB, Lind BK, Shahar E, Samet JM, Redline S, D'Agostino RB, Newman AB, Lebowitz MD, Pickering TG. Association of sleep-disordered breathing, sleep apnea, and hypertension in a large community-based study. Sleep Heart Health Study. JAMA. 2000 Apr 12;283(14):1829-36. doi: 10.1001/jama.283.14.1829.
- Background: PubMed 18714778Young T, Finn L, Peppard PE, Szklo-Coxe M, Austin D, Nieto FJ, Stubbs R, Hla KM. Sleep disordered breathing and mortality: eighteen-year follow-up of the Wisconsin sleep cohort. Sleep. 2008 Aug;31(8):1071-8.
- Background: PubMed 19743755Young T, Palta M, Dempsey J, Peppard PE, Nieto FJ, Hla KM. Burden of sleep apnea: rationale, design, and major findings of the Wisconsin Sleep Cohort study. WMJ. 2009 Aug;108(5):246-9.
- Background: PubMed 22634871Memtsoudis SG, Sun X, Chiu YL, Nurok M, Stundner O, Pastores SM, Mazumdar M. Utilization of critical care services among patients undergoing total hip and knee arthroplasty: epidemiology and risk factors. Anesthesiology. 2012 Jul;117(1):107-16. doi: 10.1097/ALN.0b013e31825afd36.
- Background: PubMed 24065843Luque-Fernandez MA, Bain PA, Gelaye B, Redline S, Williams MA. Sleep-disordered breathing and gestational diabetes mellitus: a meta-analysis of 9,795 participants enrolled in epidemiological observational studies. Diabetes Care. 2013 Oct;36(10):3353-60. doi: 10.2337/dc13-0778.
- Background: PubMed 24519711Ding XX, Wu YL, Xu SJ, Zhang SF, Jia XM, Zhu RP, Hao JH, Tao FB. A systematic review and quantitative assessment of sleep-disordered breathing during pregnancy and perinatal outcomes. Sleep Breath. 2014 Dec;18(4):703-13. doi: 10.1007/s11325-014-0946-4. Epub 2014 Feb 12.
- Background: PubMed 23911687Pamidi S, Pinto LM, Marc I, Benedetti A, Schwartzman K, Kimoff RJ. Maternal sleep-disordered breathing and adverse pregnancy outcomes: a systematic review and metaanalysis. Am J Obstet Gynecol. 2014 Jan;210(1):52.e1-52.e14. doi: 10.1016/j.ajog.2013.07.033. Epub 2013 Aug 2.
- Background: PubMed 23090526Louis J, Auckley D, Miladinovic B, Shepherd A, Mencin P, Kumar D, Mercer B, Redline S. Perinatal outcomes associated with obstructive sleep apnea in obese pregnant women. Obstet Gynecol. 2012 Nov;120(5):1085-92. doi: 10.1097/AOG.0b013e31826eb9d8.
- Background: PubMed 24346178American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Practice guidelines for the perioperative management of patients with obstructive sleep apnea: an updated report by the American Society of Anesthesiologists Task Force on Perioperative Management of patients with obstructive sleep apnea. Anesthesiology. 2014 Feb;120(2):268-86. doi: 10.1097/ALN.0000000000000053. No abstract available.
- Background: PubMed 23225920Ankichetty SP, Angle P, Joselyn AS, Chinnappa V, Halpern S. Anesthetic considerations of parturients with obesity and obstructive sleep apnea. J Anaesthesiol Clin Pharmacol. 2012 Oct;28(4):436-43. doi: 10.4103/0970-9185.101895.
- Background: PubMed 23966237Reutrakul S, Zaidi N, Wroblewski K, Kay HH, Ismail M, Ehrmann DA, Van Cauter E. Interactions between pregnancy, obstructive sleep apnea, and gestational diabetes mellitus. J Clin Endocrinol Metab. 2013 Oct;98(10):4195-202. doi: 10.1210/jc.2013-2348. Epub 2013 Aug 21.
- Individual participant dataSharing planned: Yes. Plan to submit manuscripts to appropriate journals and present data at appropriate conferences
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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.
Dennis L Spence, PhD study director
United States Naval Medical Center, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CPAP and Pre-natal care in people with Obstructive Sleep Apnea, run by United States Naval Medical Center, San Diego at 1 site in United States.
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 8 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 27 Nov 2019. 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 States. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Pregnancy Outcomes (time frame: time of delivery). 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 NCT02755831, which also lists 38 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 27 Nov 2019.