Pre-eclampsiaIMPROvEDNCT01891240
IMproved PRegnancy Outcome by Early Detection
An observational study of Pre-eclampsia and Pregnancy, run by Louise Kenny at 6 sites in 4 countries.
Trial summary
The overall objective of the IMPROvED project is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for preeclampsia. This will involve a multicentre, phase IIa clinical predictive study to assess and refine novel and innovative prototype tests based on emerging… Read more about this study
- Who is it for?
- Ages 16 years and older, women only
- Conditions the study is for
- Pre-eclampsia, Pregnancy, Pregnancy, High-risk
- How many people
- 5,000 participants
- Where
- 6 sitesin 4 countries
- Study dates
- Nov 2013to Apr 2018
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: First time, low risk mothers attending antenatal care units. Women will be referred to IMPROvED through a number of routes including referral by their midwife, obstetrician or general practitioner and self-referral following exposure to the study through friends, posters, advertisements, website and news stories. Maternity caregivers in each centre will provide information about the study to eligible women in early pregnancy.
Who may be able to join
- Nulliparous.
- Singleton pregnancy, between 9+0 and 16+6 weeks' gestation.
- Signed informed consent.
Who cannot join
- Unsure of last menstrual period (LMP) and unwilling to have ultrasonography screening (USS) at ≤ 20 weeks.
- ≥ 3 miscarriages.
- ≥3 terminations of pregnancy.
- Known or suspected major fetal anomaly/abnormal karyotype.
- Essential hypertension treated pre-pregnancy.
- Moderate-severe hypertension at booking (BP >160/100 mmHg).
Show all 21Show fewer
- Diabetes mellitus.
- Renal disease.
- Systemic lupus erythematosus.
- Anti-phospholipid syndrome.
- Sickle cell disease.
- HIV positive.
- Hepatitis B or C positive.
- Major uterine anomaly.
- Cervical suture in situ.
- Knife cone biopsy.
- Long-term steroids.
- Treatment with low-dose aspirin.
- Treatment with heparin/LMW heparin.
- Lack of informed consent.
- After recruitment, if the woman is found to be outside the stated gestation limits for the IMPROvED 1st visit of 9 weeks 0 days to 13 weeks 6 days she will be retained in the study if she is willing to take part in the second and third visit and is otherwise eligible. There is one pre-specified criteria for discontinuation of a participant. If a woman is recruited into the IMPROvED study and later identified as having a pregnancy exclusion criterion, i.e., ≥ 3 miscarriages, ≥ 3 TOPS, or using low-dose aspirin at the time of recruitment, she shall be excluded. However, women diagnosed during the pregnancy but after recruitment with an exclusion criterion, e.g., diseases such as renal disease, anti-phospholipid syndrome, etc. shall be retained within the study. Women who are recruited but later discontinue from the study do not count towards recruitment targets for each centre. Accordingly, such dropouts must be replaced.
Trial locations and contacts
6 sites in 4 countries.
6 sites in 4 countries
United Kingdom3 sites, 1 recruiting
- Recruiting
Liverpool Women's Hospital, University of Liverpool
Liverpool, Merseyside
Zarko Alfirevic, +44 (0)151 795 9550, Zarko@liverpool.ac.uk
- Completed
Keele University School of Medicine, Shrewsbury and Telford Hospital NHS Trust
Shrewsbury, Shropshire
- Completed
Keele University School of Medicine, University Hospital of North Midlands
Stoke-on-Trent, Staffordshire
Ireland1 site, 1 recruiting
- Recruiting
Cork University Maternity Hospital, University College Cork
Wilton, Cork
Louise Kenny, +353 (0)21 420 5023, l.kenny@ucc.ie
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus Medical Center Rotterdam
Rotterdam
Hans Duvekot, j.j.duvekot@erasmusmc.nl
Sweden1 site, 1 recruiting
- Recruiting
Karolinska University Hospital Huddinge, Karolinska Institute
Stockholm
Karolina Kublickiene, +46 735 930988, karolina.kublickiene@ki.se
About this study
Official title: Personalized Medicine for Pregnant Women: Novel Metabolomic and Proteomic Biomarkers to Detect Pre-eclampsia and Improve Outcome.
The overall objective of the IMPROvED project is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for preeclampsia.
This will involve a multicentre, phase IIa clinical predictive study to assess and refine novel and innovative prototype tests based on emerging metabolomic and proteomic technologies developed by SMEs (small to medium size enterprise) within the consortium. The study will i) recruit 5000 first-time pregnant women; ii) establish a high calibre biobank, augmented by accurate clinical metadata; iii) determine whether prototype predictive assays and algorithms translate to the clinical environment; iv) assess potential synergy of a combined metabolomic and proteomic approach and v) progress regulatory approval and development of the selected test into the clinical arena.
Read the detailed description
Sample size calculations have been considered extensively and given the complexity of the study; there is no single simple solution. For the purpose of sample size estimation in the overall study, we used a binary outcome and associated measures of sensitivity and likelihood ratio as determinants of the value of these tests. Although the predictive algorithms will produce a continuous risk score, the use of a categorical outcome fits with the final binary decision process (to treat or not to treat) based on the risk score. Based on the lowest estimated prevalence of pre-eclampsia of 3% and a test sensitivity of 93% and a test specificity of 97%, then to be 90% certain that the true specificity of the patient population is no less than 95%, a sample size of 4,800 participants is required. Thus, allowing for patient dropout, a study population of 5,000 women is needed.
- Keywords
- Diagnostic, Pre-eclampsia, Pregnancy outcome, Mass screening, Diagnostic Techniques and Procedures
- Medical subject headings
- Pre-Eclampsia, Pregnancy Complications, Disease
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 |
|---|---|---|
| First time, low risk mothers | The study population will consist of first time, low risk mothers attending for antenatal care in one of the participating clinical centres. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pre-eclampsia.
Preeclampsia is defined as gestational hypertension defined as systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg (Korotkoff V) on at least 2 occasions 4h apart after 20 weeks' gestation, but before the onset of labour or postpartum systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg on at least 2 occasions 4h apart with either proteinuria ≥300mg/24h or spot urine protein:creatinine ratio ≥30mg/mmol creatinine or urine dipstick protein ≥++.
Measured: 7 days after birth
Spontaneous pre-term birth
Spontaneous pre-term birth is defined as spontaneous preterm labour or preterm premature rupture of the membranes resulting in preterm birth at <37+0 weeks' gestation.
Measured: Up to 37+0 weeks´ gestation
Small for gestational age (SGA)
The birth weight is converted to a customized centile, adjusting for gestation, maternal weight, height, parity, ethnicity and infant sex. SGA is defined as <10th customised centile.
Measured: Within 24 hours after birth
Secondary outcomes (13)
Early onset pre-eclampsia
Pre-eclampsia resulting in delivery at <34+0 weeks' gestation.
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Multisystem complications of pre-eclampsia
Defined as one or more of the following:
- Acute renal insufficiency defined as new increase in serum creatinine to >100μmol/L antepartum or >130μmol/L postpartum.
- Liver disease defined as raised aspartate transaminase and/or alanine transaminase >45 IU/L and/or severe right upper quadrant or epigastric pain or liver rupture.
- Neurological problems defined as eclampsia, imminent eclampsia (severe headache with hyperreflexia and persistent visual disturbance) or cerebral haemorrhage.
- Haematological abnormalities including thrombocytopenia (platelets <100x109/L), disseminated intravascular coagulation or haemolysis, diagnosed by features on blood film (such as fragmented cells, helmet cells) and reduced haptoglobin.
Measured: Between 20 weeks´gestation and 6 weeks after birth
Pre-eclampsia with severe fetal or neonatal complications
Pre-eclampsia resulting in either delivery at < 32+0 weeks' gestation or major neonatal morbidity or stillbirth or neonatal death or post-neonatal death.
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Major neonatal morbidity in preterm infants
One or more of the following amongst babies delivered before 37 weeks' gestation:
Grade III or IV intraventricular haemorrhage; Chronic lung disease; Necrotizing enterocolitis; Retinopathy of prematurity stage 3 or 4; Sepsis (blood or CSF culture proven); Or cystic periventricular leukomalacia. These conditions will be defined using the Australian and New Zealand neonatal network definitions.
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Major neonatal morbidity in term infants
One or more of the following amongst babies delivered at or after 37 weeks' gestation:
Grade II or III hypoxic ischaemic encephalopathy; Ventilation >24 hours; Neonatal unit care admission >4 days; Apgars < 4 at 5 minutes; Cord arterial pH <7.0 and/or base excess >-15; Or neonatal seizures.
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Pre-eclampsia with severe maternal complications
The development of pre-eclampsia with one or more of the following:
Maternal death; Persistent severe hypertension (systolic blood pressure ≥170mmHg or diastolic blood pressure ≥110mmHg on more than one occasion antepartum or postpartum); Or multi-system complication (as defined in outcome above.
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Preeclampsia with either severe maternal complication or severe fetal or neonatal complications
Pregnancies affected by severe maternal or severe fetal or neonatal complications (as defined in Major neonatal morbidity in preterm infants or Major neonatal morbidity term infants).
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Early onset SGA
SGA resulting in delivery at <34+0 weeks' gestation.
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
SGA with severe fetal or neonatal complications
SGA and either delivery at <32+0 weeks' gestation or major neonatal morbidity (as defined in Major neonatal morbidity in preterm infants) or stillbirth or neonatal death or post-neonatal death.
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Early onset spontaneous preterm birth
Spontaneous pre-term birth resulting in delivery < 34+0 weeks' gestation.
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Spontaneous preterm birth with severe fetal or neonatal complications
Spontaneous preterm birth (PTB) resulting in either delivery at <32+0 weeks' or spontaneous PTB resulting in major neonatal morbidity (as defined in Major neonatal morbidity in preterm infants) or stillbirth or neonatal death or post-neonatal death.
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Spontaneous preterm birth with PPROM
Spontaneous PTB following preterm premature rupture of the membranes (PPROM).
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Spontaneous preterm birth without PPROM
Spontaneous PTB with intact membranes at the onset of labour.
Measured: Followed for the duration of hospital stay, an expected average of 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2013 (estimated)
- Study startNov 2013
- Primary completionOct 2017 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pre-eclampsiaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Louise Kenny
- Sponsor type
- University, hospital or other
- Collaborators
- Keele University, University of Liverpool, Karolinska University, Erasmus Medical Center, Copenhagen Trial Unit, Center for Clinical Intervention Research, MedSciNet AB, Stockholm, Sweden, MyCartis, Ghent, Belgium, Metabolomic Diagnostics Ltd, Cork, Ireland, Accelopment AG, University of Groningen, The Netherlands, INFANT centre, University College Cork, Republic of Ireland
- Responsible party
- Sponsor-investigator, Louise Kenny, University College Cork
- Investigators
- Louise Kenny, Professor, Principal investigator, INFANT Centre, University College Cork, IrelandPhilip N Baker, Professor, Principal investigator, Keele Univeristy School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01891240
- Sponsor's protocol ID
- Study Protocol v. 8.0 20122013
- Other IDs
- Project no: 305169
- Acronym
- IMPROvED
- Status last verified
- Nov 2016
- First submitted
- 20 May 2013
- Last updated
- 8 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
McCarthy EK, Schneck D, Basu S, Xenopoulos-Oddsson A, McCarthy FP, Murray DM, Georgieff MK, Kiely ME. Impact of Maternal Iron Deficiency in Early Pregnancy on Neonatal Iron Status and Neurodevelopment at Two Years of Age: a Prospective, Maternal-Infant Cohort Study. J Nutr. 2026 Jan;156(1):101240. doi: 10.1016/j.tjnut.2025.11.009. Epub 2025 Nov 12.
PubMed 41238120McCarthy EK, Schneck D, Basu S, Xenopoulos-Oddsson A, McCarthy FP, Kiely ME, Georgieff MK. Longitudinal evaluation of iron status during pregnancy: a prospective cohort study in a high-resource setting. Am J Clin Nutr. 2024 Nov;120(5):1259-1268. doi: 10.1016/j.ajcnut.2024.08.010. Epub 2024 Sep 26.
PubMed 39510727Navaratnam K, Alfirevic Z, Baker PN, Gluud C, Gruttner B, Kublickiene K, Zeeman G, Kenny LC. A multi-centre phase IIa clinical study of predictive testing for preeclampsia: improved pregnancy outcomes via early detection (IMPROvED). BMC Pregnancy Childbirth. 2013 Dec 7;13:226. doi: 10.1186/1471-2393-13-226.
PubMed 24314209
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Personalized Medicine for Pregnant Women: Novel Metabolomic and Proteomic Biomarkers to Detect Pre-eclampsia and Improve Outcome.
- ClinicalTrials.gov ID
- NCT01891240
- Acronym / sponsor ID
- IMPROvED / Study Protocol v. 8.0 20122013
- Keywords
- Diagnostic, Pre-eclampsia, Pregnancy outcome, Mass screening, Diagnostic Techniques and Procedures
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Louise KennyUniversity, hospital or other
- Collaborators
- Keele University, University of Liverpool, Karolinska University, Erasmus Medical Center, Copenhagen Trial Unit, Center for Clinical Intervention Research, MedSciNet AB, Stockholm, Sweden, MyCartis, Ghent, Belgium, Metabolomic Diagnostics Ltd, Cork, Ireland, Accelopment AG, University of Groningen, The Netherlands, INFANT centre, University College Cork, Republic of Ireland
- Study start
- Nov 2013
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 3 Jul 2013 (estimated)
- 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 overall objective of the IMPROvED project is to develop a sensitive, specific, high-throughput and economically viable early pregnancy screening test for preeclampsia.
This will involve a multicentre, phase IIa clinical predictive study to assess and refine novel and innovative prototype tests based on emerging metabolomic and proteomic technologies developed by SMEs (small to medium size enterprise) within the consortium. The study will i) recruit 5000 first-time pregnant women; ii) establish a high calibre biobank, augmented by accurate clinical metadata; iii) determine whether prototype predictive assays and algorithms translate to the clinical environment; iv) assess potential synergy of a combined metabolomic and proteomic approach and v) progress regulatory approval and development of the selected test into the clinical arena.
Detailed description
Sample size calculations have been considered extensively and given the complexity of the study; there is no single simple solution. For the purpose of sample size estimation in the overall study, we used a binary outcome and associated measures of sensitivity and likelihood ratio as determinants of the value of these tests. Although the predictive algorithms will produce a continuous risk score, the use of a categorical outcome fits with the final binary decision process (to treat or not to treat) based on the risk score. Based on the lowest estimated prevalence of pre-eclampsia of 3% and a test sensitivity of 93% and a test specificity of 97%, then to be 90% certain that the true specificity of the patient population is no less than 95%, a sample size of 4,800 participants is required. Thus, allowing for patient dropout, a study population of 5,000 women is needed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| First time, low risk mothers | – | –The study population will consist of first time, low risk mothers attending for antenatal care in one of the participating clinical centres. |
Who may qualify
- Ages
- 16 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- First time, low risk mothers attending antenatal care units. Women will be referred to IMPROvED through a number of routes including referral by their midwife, obstetrician or general practitioner and self-referral following exposure to the study through friends, posters, advertisements, website and news stories. Maternity caregivers in each centre will provide information about the study to eligible women in early pregnancy.
Key inclusion criteria (3 listed)
- Nulliparous.
- Singleton pregnancy, between 9+0 and 16+6 weeks' gestation.
- Signed informed consent.
Key exclusion criteria (21 listed)
- Unsure of last menstrual period (LMP) and unwilling to have ultrasonography screening (USS) at ≤ 20 weeks.
- ≥ 3 miscarriages.
- ≥3 terminations of pregnancy.
- Known or suspected major fetal anomaly/abnormal karyotype.
- Essential hypertension treated pre-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
Pre-eclampsia.
Time frame: 7 days after birth
Preeclampsia is defined as gestational hypertension defined as systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg (Korotkoff V) on at least 2 occasions 4h apart after 20 weeks' gestation, but before the onset of labour or postpartum systolic BP ≥140mmHg and/or diastolic BP ≥90mmHg on at least 2 occasions 4h apart with either proteinuria ≥300mg/24h or spot urine protein:creatinine ratio ≥30mg/mmol creatinine or urine dipstick protein ≥++.
Spontaneous pre-term birth
Time frame: Up to 37+0 weeks´ gestation
Spontaneous pre-term birth is defined as spontaneous preterm labour or preterm premature rupture of the membranes resulting in preterm birth at <37+0 weeks' gestation.
Small for gestational age (SGA)
Time frame: Within 24 hours after birth
The birth weight is converted to a customized centile, adjusting for gestation, maternal weight, height, parity, ethnicity and infant sex. SGA is defined as <10th customised centile.
13 secondary outcomes
Early onset pre-eclampsia
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Multisystem complications of pre-eclampsia
Time frame: Between 20 weeks´gestation and 6 weeks after birth
Pre-eclampsia with severe fetal or neonatal complications
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Major neonatal morbidity in preterm infants
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Major neonatal morbidity in term infants
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Pre-eclampsia with severe maternal complications
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Preeclampsia with either severe maternal complication or severe fetal or neonatal complications
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Early onset SGA
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
SGA with severe fetal or neonatal complications
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Early onset spontaneous preterm birth
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Spontaneous preterm birth with severe fetal or neonatal complications
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Spontaneous preterm birth with PPROM
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Spontaneous preterm birth without PPROM
Time frame: Followed for the duration of hospital stay, an expected average of 6 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2016.
- Derived from this study: PubMed 41238120McCarthy EK, Schneck D, Basu S, Xenopoulos-Oddsson A, McCarthy FP, Murray DM, Georgieff MK, Kiely ME. Impact of Maternal Iron Deficiency in Early Pregnancy on Neonatal Iron Status and Neurodevelopment at Two Years of Age: a Prospective, Maternal-Infant Cohort Study. J Nutr. 2026 Jan;156(1):101240. doi: 10.1016/j.tjnut.2025.11.009. Epub 2025 Nov 12.
- Derived from this study: PubMed 39510727McCarthy EK, Schneck D, Basu S, Xenopoulos-Oddsson A, McCarthy FP, Kiely ME, Georgieff MK. Longitudinal evaluation of iron status during pregnancy: a prospective cohort study in a high-resource setting. Am J Clin Nutr. 2024 Nov;120(5):1259-1268. doi: 10.1016/j.ajcnut.2024.08.010. Epub 2024 Sep 26.
- Derived from this study: PubMed 24314209Navaratnam K, Alfirevic Z, Baker PN, Gluud C, Gruttner B, Kublickiene K, Zeeman G, Kenny LC. A multi-centre phase IIa clinical study of predictive testing for preeclampsia: improved pregnancy outcomes via early detection (IMPROvED). BMC Pregnancy Childbirth. 2013 Dec 7;13:226. doi: 10.1186/1471-2393-13-226.
- Official website of IMPROvEDLink provided by the sponsor.
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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.
Cork University Maternity Hospital, University College Cork
Wilton, Ireland
Karolinska University Hospital Huddinge, Karolinska Institute
Stockholm, Sweden
Louise Kenny, Professor principal investigator
INFANT Centre, University College Cork, Ireland
Philip N Baker, Professor principal investigator
Keele Univeristy School of Medicine
6 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pre-eclampsia and Pregnancy, run by Louise Kenny at 6 sites in 4 countries.
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 3 inclusion and 21 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 8 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United Kingdom, Ireland, Netherlands, Sweden. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-eclampsia. (time frame: 7 days after birth). The study lists 3 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 NCT01891240, which also lists 3 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 8 Nov 2016.