Placental AbruptionHEMOPLACENTANCT04168606
Study on Retroplacental Hematomas in Finistère
An observational study of Placental Abruption and Placenta Diseases, run by University Hospital, Brest at 1 site in France.
Trial summary
Cases with placental abruption will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018. First trimester PAPPA and bhCG levels will be recorded. PlGF levels will be measured in women with an available first trimester serum sample. 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
- Placental Abruption, Placenta Diseases
- How many people
- 134 participants
- Where
- 1 siteFrance
- Study dates
- 23 Sep 2019to 10 Apr 2020
- 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 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Pregnant women who had a placental abruption (clinically defined) with an available placental histological examination in one of 5 maternities of our county (Finistère, France) between January 2013 and December 2018. Women identified with placental abruption in the period of study will be sent an information letter explaining the study and its purpose. Women who express their opposition to participate to the study will be excluded.
Who may be able to join
- Pregnant women
- who had a placental abruption (clinically defined)
- with an available placental histological examination
- in one of 5 maternities of our county (Finistère, France)
- between January 2013 and December 2018.
Who cannot join
- Medical termination of pregnancy
- marginal abruption
- placenta previa
- cases without histological examination of the placenta
- histological cases without compatible clinical signs
- cases from an unselected maternity.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Descriptive Study on Retroplacental Hematomas in Finistère
Cases with placental abruption will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018. First trimester PAPPA and bhCG levels will be recorded. PlGF levels will be measured in women with an available first trimester serum sample. Histological findings in placentas, course of pregnancies, maternal and fetal characteristics will described and compared between cases with and without placental chronic inflammation.
Read the detailed description
Identification of cases:
Placental abruption cases will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018.
The women diagnosed with placental abruption will be first identified by interrogation of the Medical Registry Department (MRD) of Brest University Hospital and of five other maternities of our county between January 2013 and December 2018, using the keyword "placental abruption".
Simultaneously, placental abruption cases will be identified from the Pathology department files of Brest University Hospital using a computerized database (ADICAP system).
Cases of placental abruption included in the study will be clinically defined and will not be only diagnosed by histological examination. All cases will be reviewed by an experienced obstetrician in order to confirm the diagnosis.
Duplicates, medical termination of pregnancy, marginal abruption, placenta previa, cases without histological examination of the placenta, histological cases without compatible clinical signs and cases from an unselected maternity will be excluded.
Women identified with placental abruption in the period of study will be sent an information letter explaining the study and its purpose. Women who express their opposition to participate to the study will be excluded.
Clinical parameters:
The following data will be recorded from medical files on a computerized database: baseline maternal characteristics including preconceptional Body Mass Index (BMI), tobacco use, drug use (cocaine, cannabis, buprenorphine) medical history (chronic hypertension, chronic nephropathy, diabetes, cardiovascular disease, autoimmune disease, previous venous thromboembolism), blood and rhesus group, obstetrical history, especially past vasculoplacental disorder and past placental abruption, age at delivery. The following pregnancy characteristics will also be collected: method of conception, medication during pregnancy (in particular aspirin and low molecular-weight heparin (LMWH)), gestational diabetes, premature rupture of membrane, pre-eclampsia (according to the American College of Obstetricians and Gynecologists' definition published in 2013, term at pre-eclampsia diagnosis, term at delivery and method of delivery, postpartum complications including postpartum hemorrhage (defined by a blood loss > 500 ml, whatever the mode of delivery), disseminated intravascular coagulation (DIVC), thromboembolic event after delivery and before hospital discharge, intensive care admission and length of stay.
The following fetal characteristics will be recorded: presence and term at diagnosis of intrauterine growth restriction (IUGR), stillbirth, birthweight and sex of the newborn. IUGR will be defined according to the 2013 French College of Obstetricians and Gynecologists guidelines by an estimated fetal weight below the 10th percentile using locally-accepted curve (AUDIPOG) associated with signs of fetal growth pathological restriction.
Placental parameters:
Histopathological examination of the placentas had been performed by two senior perinatal pathologists at Brest University Hospital. Histological findings were recorded by interrogation of the pathology computerized database APIX V7.
Placentas were fixed in 4% buffered formalin. Standard sampling of three blocks in the central area was performed and slides were Hematoxylin, Eosin and Saffron (HES) stained.
Recorded macroscopic findings will correspond to the following items: placenta weight, fetoplacental weight ratio, placental abruption, abnormal placental set-up (only circumvallation), abnormal umbilical cord (villamentous implantation, thin umbilical cord with < 0,8 cm in diameter, presence of a knot), presence and number of placental infarcts, intervillous thrombi and thrombi in a vessel of the chorionic plate affecting ≥ one third of the placental surface.
Recorded microscopic lesions will correspond to the following items according to Amsterdam consensus: maternal vascular malperfusion lesions such as microscopic infarcts, decidual arteriopathy, abnormal villous maturation (hypermature villi or villous agglutination), presence of fetal vascular malperfusion signs such as obliterative fetal vasculopathy or avascular villi, chorangiosis and erythroblastosis, excessive fibrin deposition, chronic inflammation such as villitis or chronic intervillositis of unknown etiology, chronic chorioamniotitis or chronic deciduitis, acute inflammation such as acute villitis, acute chorioamniotitis or funiculitis.
Biological parameters:
First trimester Down syndrome screening results will be collected for each pregnancy.
First trimester pregnancy associated plasma protein-A (PAPP-A) and β-human chorionic gonadotrophin (βhCG) levels had been measured in international unit/liter and converted to multiples of the median (MoM) using the crown-rump length or biparietal diameter measurement when the blood sample was obtained as an estimate of gestational age.
Available blood samples collected at the end of first trimester of pregnancy (between 11 weeks of gestation (WG) and 13+6 WG) for Down syndrome screening stored at -20°C in Biochemistry department of Brest University Hospital will be used for Placental Growth Factor (PlGF) quantification. Measurements will be done with the automated B.R.A.H.M.S KRYPTOR compact PLUS system (B.R.A.H.M.S PlGF plus KRYPTOR: Thermo Fisher Scientific, Hennigsdorf, Berlin) according to the manufacturer's instructions described elsewhere. PlGF levels will be expressed in pg/ml.
Informed written consents were obtained from women whose blood samples had been collected at the end of first trimester.
- Conditions
- Placental Abruption, Placenta Diseases
- Keywords
- placental abruption
- Medical subject headings
- Abruptio Placentae, Placenta Diseases
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 |
|---|---|---|
| Cases with placental abruption | Cases of placental abruption included in our study will be clinically defined and will not be only diagnosed by histological examination. All cases will be reviewed by an experienced obstetrician in order to confirm the diagnosis. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Histological findings in placentas n°1
placenta weight
Measured: through study completion, an average of one year
Histological findings in placentas n°2
presence of an histologic placental abruption
Measured: through study completion, an average of one year
Histological findings in placentas n°3
presence of an abnormal placental set-up
Measured: through study completion, an average of one year
Histological findings in placentas n°4
presence of an abnormal umbilical cord
Measured: through study completion, an average of one year
Histological findings in placentas n°5
presence of thrombi in the chorionic plate or intervillous thrombi
Measured: through study completion, an average of one year
Histological findings in placentas n°6
presence of maternal vascular malperfusion lesions such as macroscopic or microscopic infarcts, decidual arteriopathy or abnormal villous maturation
Measured: through study completion, an average of one year
Histological findings in placentas n°7
presence of fetal vascular malperfusion signs such as obliterative fetal vasculopathy or avascular villi
Measured: through study completion, an average of one year
Histological findings in placentas n°8
presence of chorangiosis or erythroblastosis
Measured: through study completion, an average of one year
Histological findings in placentas n°9
presence of excessive fibrin deposition
Measured: through study completion, an average of one year
Histological findings in placentas n°10
presence of chronic inflammation such as villitis or chronic intervillositis of unknown etiology, chronic chorioamniotitis or chronic deciduitis
Measured: through study completion, an average of one year
Histological findings in placentas n°11
presence of acute inflammation such as acute chorioamniotitis or funiculitis
Measured: through study completion, an average of one year
Secondary outcomes (27)
Maternal first trimester biological markers n°1
PAPPA
Measured: through study completion, an average of one year
Maternal first trimester biological markers n°2
Beta HCG
Measured: through study completion, an average of one year
Maternal first trimester biological markers n°3
PlGF
Measured: through study completion, an average of one year
Course of the pregnancies n°1
single or twin pregnancy
Measured: through study completion, an average of one year
Course of the pregnancies n°2
use of aspirin or heparin during pregnancy
Measured: through study completion, an average of one year
Course of the pregnancies n°3
occurrence of pre-eclampsia
Measured: through study completion, an average of one year
Course of the pregnancies n°4
occurrence of IUGR
Measured: through study completion, an average of one year
Course of the pregnancies n°5
occurrence of stillbirth
Measured: through study completion, an average of one year
Course of the pregnancies n°6
occurrence of premature rupture of membrane
Measured: through study completion, an average of one year
Course of the pregnancies n°7
occurrence of gestational diabetes
Measured: through study completion, an average of one year
Course of the pregnancies n°8
term at delivery
Measured: through study completion, an average of one year
Course of the pregnancies n°9
mode of delivery
Measured: through study completion, an average of one year
Course of the pregnancies n°10
occurrence of disseminated intravascular coagulation
Measured: through study completion, an average of one year
Course of the pregnancies n°11
occurrence of postpartum haemorrhage
Measured: through study completion, an average of one year
maternal characteristics n°1
parity
Measured: through study completion, an average of one year
maternal characteristics n°2
previous vasculoplacental disorder
Measured: through study completion, an average of one year
maternal characteristics n°3
BMI before pregnancy
Measured: through study completion, an average of one year
maternal characteristics n°4
age at delivery
Measured: through study completion, an average of one year
maternal characteristics n°5
Tobacco use and drug use
Measured: through study completion, an average of one year
maternal characteristics n°6
chronic hypertension or chronic nephropathy
Measured: through study completion, an average of one year
maternal characteristics n°7
diabetes
Measured: through study completion, an average of one year
maternal characteristics n°8
APL syndrome or SLE
Measured: through study completion, an average of one year
maternal characteristics n°9
previous VTE event
Measured: through study completion, an average of one year
maternal characteristics n°10
blood group
Measured: through study completion, an average of one year
maternal characteristics n°11
mode of conception
Measured: through study completion, an average of one year
fetal characteristics n°1
newborn weight
Measured: through study completion, an average of one year
fetal characteristics n°2
sex
Measured: through study completion, an average of one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2019
- Study start23 Sep 2019
- Primary completion23 Sep 2019
- Study completion10 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Placental AbruptionStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe sponsor's other registered studies.
- 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 only
- Time perspective
- Retrospective
- Enrolment
- 134 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04168606
- Sponsor's protocol ID
- 29BRC19.0193
- Acronym
- HEMOPLACENTA
- Status last verified
- Sep 2020
- First submitted
- 4 Nov 2019
- Last updated
- 11 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Descriptive Study on Retroplacental Hematomas in Finistère
- ClinicalTrials.gov ID
- NCT04168606
- Acronym / sponsor ID
- HEMOPLACENTA / 29BRC19.0193
- Conditions
- Placental Abruption, Placenta Diseases
- Keywords
- placental abruption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 134 participants (actual)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 23 Sep 2019 (actual)
- Primary completion
- 23 Sep 2019 (actual)
- Study completion
- 10 Apr 2020 (actual)
- First posted
- 19 Nov 2019 (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.
Cases with placental abruption will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018. First trimester PAPPA and bhCG levels will be recorded. PlGF levels will be measured in women with an available first trimester serum sample. Histological findings in placentas, course of pregnancies, maternal and fetal characteristics will described and compared between cases with and without placental chronic inflammation.
Detailed description
Identification of cases:
Placental abruption cases will be identified by interrogation of two databases of Brest University Hospital between January 2013 and December 2018.
The women diagnosed with placental abruption will be first identified by interrogation of the Medical Registry Department (MRD) of Brest University Hospital and of five other maternities of our county between January 2013 and December 2018, using the keyword "placental abruption".
Simultaneously, placental abruption cases will be identified from the Pathology department files of Brest University Hospital using a computerized database (ADICAP system).
Cases of placental abruption included in the study will be clinically defined and will not be only diagnosed by histological examination. All cases will be reviewed by an experienced obstetrician in order to confirm the diagnosis.
Duplicates, medical termination of pregnancy, marginal abruption, placenta previa, cases without histological examination of the placenta, histological cases without compatible clinical signs and cases from an unselected maternity will be excluded.
Women identified with placental abruption in the period of study will be sent an information letter explaining the study and its purpose. Women who express their opposition to participate to the study will be excluded.
Clinical parameters:
The following data will be recorded from medical files on a computerized database: baseline maternal characteristics including preconceptional Body Mass Index (BMI), tobacco use, drug use (cocaine, cannabis, buprenorphine) medical history (chronic hypertension, chronic nephropathy, diabetes, cardiovascular disease, autoimmune disease, previous venous thromboembolism), blood and rhesus group, obstetrical history, especially past vasculoplacental disorder and past placental abruption, age at delivery. The following pregnancy characteristics will also be collected: method of conception, medication during pregnancy (in particular aspirin and low molecular-weight heparin (LMWH)), gestational diabetes, premature rupture of membrane, pre-eclampsia (according to the American College of Obstetricians and Gynecologists' definition published in 2013, term at pre-eclampsia diagnosis, term at delivery and method of delivery, postpartum complications including postpartum hemorrhage (defined by a blood loss > 500 ml, whatever the mode of delivery), disseminated intravascular coagulation (DIVC), thromboembolic event after delivery and before hospital discharge, intensive care admission and length of stay.
The following fetal characteristics will be recorded: presence and term at diagnosis of intrauterine growth restriction (IUGR), stillbirth, birthweight and sex of the newborn. IUGR will be defined according to the 2013 French College of Obstetricians and Gynecologists guidelines by an estimated fetal weight below the 10th percentile using locally-accepted curve (AUDIPOG) associated with signs of fetal growth pathological restriction.
Placental parameters:
Histopathological examination of the placentas had been performed by two senior perinatal pathologists at Brest University Hospital. Histological findings were recorded by interrogation of the pathology computerized database APIX V7.
Placentas were fixed in 4% buffered formalin. Standard sampling of three blocks in the central area was performed and slides were Hematoxylin, Eosin and Saffron (HES) stained.
Recorded macroscopic findings will correspond to the following items: placenta weight, fetoplacental weight ratio, placental abruption, abnormal placental set-up (only circumvallation), abnormal umbilical cord (villamentous implantation, thin umbilical cord with < 0,8 cm in diameter, presence of a knot), presence and number of placental infarcts, intervillous thrombi and thrombi in a vessel of the chorionic plate affecting ≥ one third of the placental surface.
Recorded microscopic lesions will correspond to the following items according to Amsterdam consensus: maternal vascular malperfusion lesions such as microscopic infarcts, decidual arteriopathy, abnormal villous maturation (hypermature villi or villous agglutination), presence of fetal vascular malperfusion signs such as obliterative fetal vasculopathy or avascular villi, chorangiosis and erythroblastosis, excessive fibrin deposition, chronic inflammation such as villitis or chronic intervillositis of unknown etiology, chronic chorioamniotitis or chronic deciduitis, acute inflammation such as acute villitis, acute chorioamniotitis or funiculitis.
Biological parameters:
First trimester Down syndrome screening results will be collected for each pregnancy.
First trimester pregnancy associated plasma protein-A (PAPP-A) and β-human chorionic gonadotrophin (βhCG) levels had been measured in international unit/liter and converted to multiples of the median (MoM) using the crown-rump length or biparietal diameter measurement when the blood sample was obtained as an estimate of gestational age.
Available blood samples collected at the end of first trimester of pregnancy (between 11 weeks of gestation (WG) and 13+6 WG) for Down syndrome screening stored at -20°C in Biochemistry department of Brest University Hospital will be used for Placental Growth Factor (PlGF) quantification. Measurements will be done with the automated B.R.A.H.M.S KRYPTOR compact PLUS system (B.R.A.H.M.S PlGF plus KRYPTOR: Thermo Fisher Scientific, Hennigsdorf, Berlin) according to the manufacturer's instructions described elsewhere. PlGF levels will be expressed in pg/ml.
Informed written consents were obtained from women whose blood samples had been collected at the end of first trimester.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cases with placental abruption | – | –Cases of placental abruption included in our study will be clinically defined and will not be only diagnosed by histological examination. All cases will be reviewed by an experienced obstetrician in order to confirm the diagnosis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Pregnant women who had a placental abruption (clinically defined) with an available placental histological examination in one of 5 maternities of our county (Finistère, France) between January 2013 and December 2018. Women identified with placental abruption in the period of study will be sent an information letter explaining the study and its purpose. Women who express their opposition to participate to the study will be excluded.
Key inclusion criteria (5 listed)
- Pregnant women
- who had a placental abruption (clinically defined)
- with an available placental histological examination
- in one of 5 maternities of our county (Finistère, France)
- between January 2013 and December 2018.
Key exclusion criteria (6 listed)
- Medical termination of pregnancy
- marginal abruption
- placenta previa
- cases without histological examination of the placenta
- histological cases without compatible clinical signs
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
Histological findings in placentas n°1
Time frame: through study completion, an average of one year
placenta weight
Histological findings in placentas n°2
Time frame: through study completion, an average of one year
presence of an histologic placental abruption
Histological findings in placentas n°3
Time frame: through study completion, an average of one year
presence of an abnormal placental set-up
Histological findings in placentas n°4
Time frame: through study completion, an average of one year
presence of an abnormal umbilical cord
Histological findings in placentas n°5
Time frame: through study completion, an average of one year
presence of thrombi in the chorionic plate or intervillous thrombi
Histological findings in placentas n°6
Time frame: through study completion, an average of one year
presence of maternal vascular malperfusion lesions such as macroscopic or microscopic infarcts, decidual arteriopathy or abnormal villous maturation
Histological findings in placentas n°7
Time frame: through study completion, an average of one year
presence of fetal vascular malperfusion signs such as obliterative fetal vasculopathy or avascular villi
Histological findings in placentas n°8
Time frame: through study completion, an average of one year
presence of chorangiosis or erythroblastosis
Histological findings in placentas n°9
Time frame: through study completion, an average of one year
presence of excessive fibrin deposition
Histological findings in placentas n°10
Time frame: through study completion, an average of one year
presence of chronic inflammation such as villitis or chronic intervillositis of unknown etiology, chronic chorioamniotitis or chronic deciduitis
Histological findings in placentas n°11
Time frame: through study completion, an average of one year
presence of acute inflammation such as acute chorioamniotitis or funiculitis
27 secondary outcomes
Maternal first trimester biological markers n°1
Time frame: through study completion, an average of one year
Maternal first trimester biological markers n°2
Time frame: through study completion, an average of one year
Maternal first trimester biological markers n°3
Time frame: through study completion, an average of one year
Course of the pregnancies n°1
Time frame: through study completion, an average of one year
Course of the pregnancies n°2
Time frame: through study completion, an average of one year
Course of the pregnancies n°3
Time frame: through study completion, an average of one year
Course of the pregnancies n°4
Time frame: through study completion, an average of one year
Course of the pregnancies n°5
Time frame: through study completion, an average of one year
Course of the pregnancies n°6
Time frame: through study completion, an average of one year
Course of the pregnancies n°7
Time frame: through study completion, an average of one year
Course of the pregnancies n°8
Time frame: through study completion, an average of one year
Course of the pregnancies n°9
Time frame: through study completion, an average of one year
Course of the pregnancies n°10
Time frame: through study completion, an average of one year
Course of the pregnancies n°11
Time frame: through study completion, an average of one year
maternal characteristics n°1
Time frame: through study completion, an average of one year
maternal characteristics n°2
Time frame: through study completion, an average of one year
maternal characteristics n°3
Time frame: through study completion, an average of one year
maternal characteristics n°4
Time frame: through study completion, an average of one year
maternal characteristics n°5
Time frame: through study completion, an average of one year
maternal characteristics n°6
Time frame: through study completion, an average of one year
maternal characteristics n°7
Time frame: through study completion, an average of one year
maternal characteristics n°8
Time frame: through study completion, an average of one year
maternal characteristics n°9
Time frame: through study completion, an average of one year
maternal characteristics n°10
Time frame: through study completion, an average of one year
maternal characteristics n°11
Time frame: through study completion, an average of one year
fetal characteristics n°1
Time frame: through study completion, an average of one year
fetal characteristics n°2
Time frame: through study completion, an average of one year
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 11 Sep 2020.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Placental Abruption and Placenta Diseases, run by University Hospital, Brest at 1 site in France.
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 11 Sep 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 France. 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?
Histological findings in placentas n°1 (time frame: through study completion, an average of one year). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 11 Sep 2020.