Infant, Small for Gestational AgeKBTH-HBWSNCT03062228
KBTH-GIRHL Healthy Birth Weight Study: A Cross-Section
An observational study of Infant, Small for Gestational Age and Infant, Low Birth Weight, run by IWK Health Centre at 1 site in Ghana.
Trial summary
This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help pregnant women to avoid sleeping on their back during sleep in the third trimester. Read more about this study
- Who is it for?
- Ages 18 to 35 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Infant, Small for Gestational Age, Infant, Low Birth Weight, Pregnancy
- How many people
- 162 participants
- Where
- 1 siteGhana
- Study dates
- 28 Apr 2016to 1 Mar 2017
- Phase
- Observational
- 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 to 35 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The participants (subjects) will be healthy, Ghanaian women who have recently delivered a live birth at KBTH. The inclusion/exclusion criteria criteria will be similar to the Ghana PrenaBelt Trial with one difference (* below) and one additional inclusion criterion (** below).
Who may be able to join
- Low-risk singleton pregnancy
- *Delivered a live birth >28 weeks gestation at KBTH within the past 48 hours.
- Residing in the Greater Accra Metropolitan Area or area served by the KBTH.
- Fluent in either English, Twi, or Ga
- **Has not received education/ information about back sleep position in pregnancy as a potential risk factor for stillbirth and low birth weight.
Who cannot join
- BMI ≥ 35 at booking (first antenatal appointment for current pregnancy)
- Pregnancy complicated by obstetric complications (hypertension [pre-eclampsia, gestational hypertension, chronic hypertension], diabetes [gestational or not], or intra-uterine growth restriction [<10th %ile for growth])
- Sleep complicated by medical conditions (known to get <4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side [e.g., arthritic shoulder])
- Multiple pregnancy
- Known fetal abnormality
- Maternal age >35
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life Healthy Birth Weight Study: A Cross-Section
This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help pregnant women to avoid sleeping on their back during sleep in the third trimester. This study will seek to establish the typical birth weight of babies born to a cohort of healthy pregnant Ghanian women who are similar in characteristics to the women in the Ghana PrenaBelt Trial but who have not been educated to avoid back sleep during pregnancy nor have received a device to prevent back sleep.
Read the detailed description
Recently, three studies have suggested that maternal back sleep may be a risk factor for stillbirth (SB) and low birth weight (LBW). This is significant given that the majority of third-trimester pregnant women spend up to 25% of their sleep time on their back. The Ghana PrenaBelt Trial (GPT), completed by our team at the Korle Bu Teaching Hospital (KBTH) from September 2015 - May 2016, was the first interventional trial investigating this possible relationship between maternal back sleep and LBW. However, a limitation of the GPT was that due to its sham-control design, all participants in the trial (treatment group and sham-control group) were educated during the consent process about back-sleep in late pregnancy as a possible risk factor for SB and LBW. At interim analysis of the GPT (February 2016), no difference in birth weight was found between the two groups. Also around this time, the study team had anecdotal reports from sham-group participants who indicated that they trained themselves to sleep exclusively on their left side. Further, there is evidence in the literature that when instructed to sleep on their left, third-trimester pregnant women can increase the percentage of left-sided sleep to approximately 60% of the night on average and maintain this across multiple nights.
Given this, it was questioned if the back-sleep education during the consent process could be having an effect on the sleep behaviour of the GPT participants independently of their treatment allocation; therefore, the KBTH-GIRHL Healthy Birth Weight Study was designed in March 2016 to investigate this question further. The aim of this study is to establish a reference birth weight of babies born to a cohort of women comparable to the cohort in the GPT but who have not received back-sleep education, did not participate in the GPT, and whose babies were born in a similar time period and weighed on the same newborn scales - in essence, a control group for the GPT.
This cross-sectional study will be accomplished via recruiting a control group from a pool of women having recently delivered at KBTH, reviewing their hospital records, and having them complete a short survey about their demographics, obstetric history, and sleep behaviors.
The results of this study, together with the results of the GPT, will enable us to determine whether or not education about back-sleep in pregnancy affects pregnancy outcomes, specifically birth weight.
- Conditions
- Infant, Small for Gestational Age, Infant, Low Birth Weight, Pregnancy, Sleep, Infant, Very Low Birth Weight, Fetal Growth Retardation
- Keywords
- stillbirth, sleep, low birth weight, pregnancy, supine, small for gestational age
- Medical subject headings
- Fetal Growth Retardation, Stillbirth, Deception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Controls | Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Birth Weight of Baby
At delivery, birth weight will be measured and recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Measured: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Customized Birth Weight Centile
Individual customized birth weight centile calculated using the Gestation Network (Perinatal Institute; Birmingham, UK) Bulk Centile Calculator (BCC), which calculates customized birthweight centiles using the principles of the Gestation Related Optimal Weight (GROW) method.
The main non-pathological factors affecting birth weight are gestational age, maternal height, maternal weight at booking, parity, and ethnic group. The sex of fetus/neonate, when known, should also be adjusted for. These six variables need to be adjusted for to calculate the true growth potential, which can be represented as individually customized fetal growth curves and birth weight percentiles using the principles of the GROW. This method for calculating growth potential has been validated in a number of international studies.
Measured: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Secondary outcomes (6)
Gestational Age at Delivery
Gestational age at delivery (weeks) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Measured: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Small for Gestational Age
Small for Gestational Age is defined as a birthweight centile ≤10th centile per the Gestation-Related Optimal Weight (GROW) standard.
Measured: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Low Birth Weight
Low birth weight is defined has birth weight ≤ 2500 grams.
Measured: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Sex of Newborn
Sex of participant's newborn.
Measured: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Preterm Delivery
Preterm delivery is defined as gestational age at birth <37 weeks.
Measured: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Mode of Delivery
Mode of delivery (spontaneous vaginal, Cesarean section, instrumented) will be recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Measured: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2017
- Study start28 Apr 2016
- Primary completion22 Feb 2017
- Study completion1 Mar 2017
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 (10)Papers the sponsor has linked to this study.
- Other trials for Infant, Small for Gestational AgeStudies 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
- Cross-sectional
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- IWK Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Korle Bu Teaching Hospital, University of Michigan, Innovative Canadians for Change, Dalhousie University, Global Innovations for Reproductive Health and Life, University of Ghana Medical School
- Responsible party
- Principal investigator, Allan Kember, IWK Health Centre
- Investigators
- Maxfield Okere, B.Sc., Principal investigator, Korle Bu Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03062228
- Sponsor's protocol ID
- KBTH-IRB/00020/2016
- Acronym
- KBTH-HBWS
- Status last verified
- Mar 2020
- First submitted
- 19 Feb 2017
- Last updated
- 31 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Owusu JT, Anderson FJ, Coleman J, Oppong S, Seffah JD, Aikins A, O'Brien LM. Association of maternal sleep practices with pre-eclampsia, low birth weight, and stillbirth among Ghanaian women. Int J Gynaecol Obstet. 2013 Jun;121(3):261-5. doi: 10.1016/j.ijgo.2013.01.013. Epub 2013 Mar 15.
PubMed 23507553Stacey T, Thompson JM, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan LM. Association between maternal sleep practices and risk of late stillbirth: a case-control study. BMJ. 2011 Jun 14;342:d3403. doi: 10.1136/bmj.d3403.
PubMed 21673002Gordon A, Raynes-Greenow C, Bond D, Morris J, Rawlinson W, Jeffery H. Sleep position, fetal growth restriction, and late-pregnancy stillbirth: the Sydney stillbirth study. Obstet Gynecol. 2015 Feb;125(2):347-355. doi: 10.1097/AOG.0000000000000627.
PubMed 25568999Platts J, Mitchell EA, Stacey T, Martin BL, Roberts D, McCowan L, Heazell AE. The Midland and North of England Stillbirth Study (MiNESS). BMC Pregnancy Childbirth. 2014 May 21;14:171. doi: 10.1186/1471-2393-14-171.
PubMed 24885461Warland J, Mitchell EA. A triple risk model for unexplained late stillbirth. BMC Pregnancy Childbirth. 2014 Apr 14;14:142. doi: 10.1186/1471-2393-14-142.
PubMed 24731396O'Brien LM, Warland J. Typical sleep positions in pregnant women. Early Hum Dev. 2014 Jun;90(6):315-7. doi: 10.1016/j.earlhumdev.2014.03.001. Epub 2014 Mar 21.
PubMed 24661447Stone PR, Burgess W, McIntyre JP, Gunn AJ, Lear CA, Bennet L, Mitchell EA, Thompson JM; Maternal Sleep In Pregnancy Research Group, The University of Auckland. Effect of maternal position on fetal behavioural state and heart rate variability in healthy late gestation pregnancy. J Physiol. 2017 Feb 15;595(4):1213-1221. doi: 10.1113/JP273201. Epub 2016 Dec 11.
PubMed 27871127Warland J, Dorrian J. Accuracy of self-reported sleep position in late pregnancy. PLoS One. 2014 Dec 23;9(12):e115760. doi: 10.1371/journal.pone.0115760. eCollection 2014.
PubMed 25535960Gardosi J, Chang A, Kalyan B, Sahota D, Symonds EM. Customised antenatal growth charts. Lancet. 1992 Feb 1;339(8788):283-7. doi: 10.1016/0140-6736(92)91342-6.
PubMed 1346292Gardosi J, Mongelli M, Wilcox M, Chang A. An adjustable fetal weight standard. Ultrasound Obstet Gynecol. 1995 Sep;6(3):168-74. doi: 10.1046/j.1469-0705.1995.06030168.x.
PubMed 8521065
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Korle Bu Teaching Hospital - Global Innovations for Reproductive Health & Life Healthy Birth Weight Study: A Cross-Section
- ClinicalTrials.gov ID
- NCT03062228
- Acronym / sponsor ID
- KBTH-HBWS / KBTH-IRB/00020/2016
- Conditions
- Infant, Small for Gestational Age, Infant, Low Birth Weight, Pregnancy, Sleep, Infant, Very Low Birth Weight, Fetal Growth Retardation
- Keywords
- stillbirth, sleep, low birth weight, pregnancy, supine, small for gestational age
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- IWK Health CentreUniversity, hospital or other
- Collaborators
- Korle Bu Teaching Hospital, University of Michigan, Innovative Canadians for Change, Dalhousie University, Global Innovations for Reproductive Health and Life, University of Ghana Medical School
- Study start
- 28 Apr 2016 (actual)
- Primary completion
- 22 Feb 2017 (actual)
- Study completion
- 1 Mar 2017 (actual)
- First posted
- 23 Feb 2017 (actual)
- Results
- Posted 31 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study was designed and conducted in an effort to establish a comparison group for the Ghana PrenaBelt Trial (NTC02379728). The Ghana PrenaBelt Trial examined the effect, on birth weight, of a belt-like device to help pregnant women to avoid sleeping on their back during sleep in the third trimester. This study will seek to establish the typical birth weight of babies born to a cohort of healthy pregnant Ghanian women who are similar in characteristics to the women in the Ghana PrenaBelt Trial but who have not been educated to avoid back sleep during pregnancy nor have received a device to prevent back sleep.
Detailed description
Recently, three studies have suggested that maternal back sleep may be a risk factor for stillbirth (SB) and low birth weight (LBW). This is significant given that the majority of third-trimester pregnant women spend up to 25% of their sleep time on their back. The Ghana PrenaBelt Trial (GPT), completed by our team at the Korle Bu Teaching Hospital (KBTH) from September 2015 - May 2016, was the first interventional trial investigating this possible relationship between maternal back sleep and LBW. However, a limitation of the GPT was that due to its sham-control design, all participants in the trial (treatment group and sham-control group) were educated during the consent process about back-sleep in late pregnancy as a possible risk factor for SB and LBW. At interim analysis of the GPT (February 2016), no difference in birth weight was found between the two groups. Also around this time, the study team had anecdotal reports from sham-group participants who indicated that they trained themselves to sleep exclusively on their left side. Further, there is evidence in the literature that when instructed to sleep on their left, third-trimester pregnant women can increase the percentage of left-sided sleep to approximately 60% of the night on average and maintain this across multiple nights.
Given this, it was questioned if the back-sleep education during the consent process could be having an effect on the sleep behaviour of the GPT participants independently of their treatment allocation; therefore, the KBTH-GIRHL Healthy Birth Weight Study was designed in March 2016 to investigate this question further. The aim of this study is to establish a reference birth weight of babies born to a cohort of women comparable to the cohort in the GPT but who have not received back-sleep education, did not participate in the GPT, and whose babies were born in a similar time period and weighed on the same newborn scales - in essence, a control group for the GPT.
This cross-sectional study will be accomplished via recruiting a control group from a pool of women having recently delivered at KBTH, reviewing their hospital records, and having them complete a short survey about their demographics, obstetric history, and sleep behaviors.
The results of this study, together with the results of the GPT, will enable us to determine whether or not education about back-sleep in pregnancy affects pregnancy outcomes, specifically birth weight.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Controls | – | –Healthy, Ghanaian women who have recently delivered a live birth at the Korle Bu Teaching Hospital. No interventions will be administered. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The participants (subjects) will be healthy, Ghanaian women who have recently delivered a live birth at KBTH. The inclusion/exclusion criteria criteria will be similar to the Ghana PrenaBelt Trial with one difference (* below) and one additional inclusion criterion (** below).
Key inclusion criteria (5 listed)
- Low-risk singleton pregnancy
- *Delivered a live birth >28 weeks gestation at KBTH within the past 48 hours.
- Residing in the Greater Accra Metropolitan Area or area served by the KBTH.
- Fluent in either English, Twi, or Ga
- **Has not received education/ information about back sleep position in pregnancy as a potential risk factor for stillbirth and low birth weight.
Key exclusion criteria (6 listed)
- BMI ≥ 35 at booking (first antenatal appointment for current pregnancy)
- Pregnancy complicated by obstetric complications (hypertension [pre-eclampsia, gestational hypertension, chronic hypertension], diabetes [gestational or not], or intra-uterine growth restriction [<10th %ile for growth])
- Sleep complicated by medical conditions (known to get <4 hours of sleep per night due to insomnia, or musculoskeletal disorder that prevents sleeping on a certain side [e.g., arthritic shoulder])
- Multiple pregnancy
- Known fetal abnormality
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
Birth Weight of Baby
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
At delivery, birth weight will be measured and recorded in the participant's health record as a part of routine obstetric care at the Korle Bu Teaching Hospital.
Customized Birth Weight Centile
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Individual customized birth weight centile calculated using the Gestation Network (Perinatal Institute; Birmingham, UK) Bulk Centile Calculator (BCC), which calculates customized birthweight centiles using the principles of the Gestation Related Optimal Weight (GROW) method. The main non-pathological factors affecting birth weight are gestational age, maternal height, maternal weight at booking, parity, and ethnic group. The sex of fetus/neonate, when known, should also be adjusted for. These six variables need to be adjusted for to calculate the true growth potential, which can be represented as individually customized fetal growth curves and birth weight percentiles using the principles of the GROW. This method for calculating growth potential has been validated in a number of international studies.
6 secondary outcomes
Gestational Age at Delivery
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Small for Gestational Age
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Low Birth Weight
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Sex of Newborn
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Preterm Delivery
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Mode of Delivery
Time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 23507553Owusu JT, Anderson FJ, Coleman J, Oppong S, Seffah JD, Aikins A, O'Brien LM. Association of maternal sleep practices with pre-eclampsia, low birth weight, and stillbirth among Ghanaian women. Int J Gynaecol Obstet. 2013 Jun;121(3):261-5. doi: 10.1016/j.ijgo.2013.01.013. Epub 2013 Mar 15.
- Background: PubMed 21673002Stacey T, Thompson JM, Mitchell EA, Ekeroma AJ, Zuccollo JM, McCowan LM. Association between maternal sleep practices and risk of late stillbirth: a case-control study. BMJ. 2011 Jun 14;342:d3403. doi: 10.1136/bmj.d3403.
- Background: PubMed 25568999Gordon A, Raynes-Greenow C, Bond D, Morris J, Rawlinson W, Jeffery H. Sleep position, fetal growth restriction, and late-pregnancy stillbirth: the Sydney stillbirth study. Obstet Gynecol. 2015 Feb;125(2):347-355. doi: 10.1097/AOG.0000000000000627.
- Background: PubMed 24885461Platts J, Mitchell EA, Stacey T, Martin BL, Roberts D, McCowan L, Heazell AE. The Midland and North of England Stillbirth Study (MiNESS). BMC Pregnancy Childbirth. 2014 May 21;14:171. doi: 10.1186/1471-2393-14-171.
- Background: PubMed 24731396Warland J, Mitchell EA. A triple risk model for unexplained late stillbirth. BMC Pregnancy Childbirth. 2014 Apr 14;14:142. doi: 10.1186/1471-2393-14-142.
- Background: PubMed 24661447O'Brien LM, Warland J. Typical sleep positions in pregnant women. Early Hum Dev. 2014 Jun;90(6):315-7. doi: 10.1016/j.earlhumdev.2014.03.001. Epub 2014 Mar 21.
- Background: PubMed 27871127Stone PR, Burgess W, McIntyre JP, Gunn AJ, Lear CA, Bennet L, Mitchell EA, Thompson JM; Maternal Sleep In Pregnancy Research Group, The University of Auckland. Effect of maternal position on fetal behavioural state and heart rate variability in healthy late gestation pregnancy. J Physiol. 2017 Feb 15;595(4):1213-1221. doi: 10.1113/JP273201. Epub 2016 Dec 11.
- Background: PubMed 25535960Warland J, Dorrian J. Accuracy of self-reported sleep position in late pregnancy. PLoS One. 2014 Dec 23;9(12):e115760. doi: 10.1371/journal.pone.0115760. eCollection 2014.
- Background: PubMed 1346292Gardosi J, Chang A, Kalyan B, Sahota D, Symonds EM. Customised antenatal growth charts. Lancet. 1992 Feb 1;339(8788):283-7. doi: 10.1016/0140-6736(92)91342-6.
- Background: PubMed 8521065Gardosi J, Mongelli M, Wilcox M, Chang A. An adjustable fetal weight standard. Ultrasound Obstet Gynecol. 1995 Sep;6(3):168-74. doi: 10.1046/j.1469-0705.1995.06030168.x.
- 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.
Maxfield Okere, B.Sc. principal investigator
Korle Bu Teaching 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 Infant, Small for Gestational Age and Infant, Low Birth Weight, run by IWK Health Centre at 1 site in Ghana.
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 5 inclusion and 6 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 Mar 2020. 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 Ghana. 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 31 Mar 2020). 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?
Birth Weight of Baby (time frame: Within 48 hours of delivery of baby (on average, 38 - 40 weeks gestation)). The study lists 2 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 NCT03062228, which also lists 10 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 Mar 2020.