Twin Pregnancy, Antepartum Condition or ComplicationChiTwiMCNCT06414655
Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China
An observational study of Twin Pregnancy, Antepartum Condition or Complication and Twin to Twin Transfusion as Antepartum Condition, run by Peking University Third Hospital at 11 sites in China.
Trial summary
Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China (ChiTwiMC) is supported by National Key Research and Development Program of China - Reproductive Health and Women's and Children's Health Protection Project. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Twin Pregnancy, Antepartum Condition or Complication, Twin to Twin Transfusion as Antepartum Condition, Pre-Term
- How many people
- 2,000 participants
- Where
- 11 sitesChina
- Study dates
- 1 Mar 2024to 30 Nov 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: The ChiTwiMC is a prospective cohort that will enroll 2000 pregnant women aged 18-45 years and over from 9 large obstetrical centers of University-Affiliated Hospitals (Peking University Third Hospital; First Affiliated Hospital, Sun Yat-Sen University; Chongqing Medical University; Shengjing Hospital; Shanghai First Maternity and Infant Hospital; The First Affiliated Hospital of Anhui Medical University; International Peace Maternity and Child Health Hospital; The Second Hospital of Shandong University; Shandong Provincial Hospital). These hospitals located at 7 supercities (Beijing, Shanghai, Guangzhou, Shenyang, Jinan, Chongqing, and Hefei) of China. Pregnant women who are planning to receive prenatal healthcare and delivery in those hospitals are potential candidates for the study.
Who may be able to join
- Twin pregnancies
- Female aged between 18-45 years
- Gestational age is less than 14 weeks
- Planning to receive prenatal healthcare and delivery service at the study hospital
- Signing informed concent and willing to participate
Who cannot join
- Women with mental disorders or serious maternal illness that is not eligible to participate
- Inability to provide informed consent
- Pregnant women not registered in our hospital
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Tianchen Wu, PhD contact
11 sites in 1 country
China11 sites, 11 recruiting
- Recruiting
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Yuan Wei, PhD, MD, weiyuanbysy@163.com
Tianchen Wu, PhD, wtc17@pku.edu.cn
- Recruiting
Peking University
Beijing, Beijing Municipality, 10091
Xiaoli Wang, xlwang@bjmu.edu.cn
- Recruiting
Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Yubin Ding, dingyb@cqmu.edu.cn
- Recruiting
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510000
Yanmin Luo, luoyanm@mail.sysu.edu.cn
- Recruiting
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001
Zongzhi Yin, dr_yinzongzhi@qq.com
- Recruiting
Shandong Provincial Hospital
Jinan, Shandong, 250021
Jinlai Meng, adokemeng@163.com
- Recruiting
The Second Hospital of Shandong University
Jinan, Shandong, 250033
Fanzhen Hong, hongfz@sdu.edu.cn
- Recruiting
International Peace Maternity and Child Health Hospital
Shanghai, Shanghai Municipality, 200030
Yanlin Wang, wyanlin@163.com
- Recruiting
Shanghai First Maternity and Infant Hospital
Shanghai, Shanghai Municipality, 201204
Gang Zou, zougangshcn@sina.com
- Recruiting
Shengjing Hospital
Shenyang, Liaoning, 110000
Jun Wei, Weij@sj-hospital.org
- Recruiting
Nankai University
Tianjin, Tianjin Municipality, 300071
Ling Shuai, lshuai@nankai.edu.cn
About this study
Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China (ChiTwiMC) is supported by National Key Research and Development Program of China - Reproductive Health and Women's and Children's Health Protection Project. This project is funded by the Ministry of Science and Technology of China under grant number 2023YFC2705900. The ChiTwiMC cohort is led by Professor Wei Yuan from the Department of Gynecology and Obstetrics at Peking University Third Hospital.
Read the detailed description
The ChiTwiMC Cohort focusing on the serious complications of twin pregnancy, establish a multicenter large prospective mother-child cohort of twin pregnancy covering pregnancy→neonatal period→early childhood, and a multi-variety, multi-stage biobank for the study of adverse outcomes of twin pregnancy. The ChiTwiMC Cohort is planning to recruit 2000 pregnant women aged 18-45 years from 9 large obstetrical center of major University-affiliated Hospitals across China, between December 2023 and May 2026. All women will be enrolled prior to 14 wks of gestation, pregnancy was followed up at 22-28 wks, 30-38 wks of gestation, delivery, postpartum 42 days, 6 months, 12 months. Data including demographics, medical history, reproductive history, clinical diagnosis, treatment information, and pregnancy and birth outcomes will be collected via electronic data capture system. Track the outcome of severe maternal-fetal complications and early neonatal outcomes of twins, and collect biological samples, including peripheral venous blood, hair and cervicovaginal secretions from pregnant women, placenta tissue, amniotic fluid and unbilical cord blood at delivery, meconium and hair from newborns, buccal mucosa from infants and peripheral venous blood from the husband.
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication, Twin to Twin Transfusion as Antepartum Condition, Pre-Term, Pre-Eclampsia, Twin Monochorionic Diamniotic Placenta, Twin Dichorionic Diamniotic Placenta
- Medical subject headings
- Premature Birth, Pre-Eclampsia
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of preterm delivery
Preterm delivery is defined as delivery between 28 and 37 gestational weeks.
Measured: From inclusion to delivery
Rate of preeclampsia
Preeclampsia is defined as the condition occurring in pregnant women after 20 weeks of gestation, characterized by systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, accompanied by any of the following: a urinary protein quantification ≥0.3 g/24 h, or a urine protein/creatinine ratio ≥0.3, or random urine protein ≥ (+) (as a method of examination when protein quantification is not feasible). In the absence of proteinuria, the condition may still be diagnosed if there is involvement of any organ or system, including but not limited to critical organs such as the heart, lungs, liver, kidneys, or abnormalities in the hematological, digestive, or neurological systems, as well as complications affecting the placenta-fetus.
Measured: From inclusion to delivery
Rate of twin-to-twin transfusion syndrome (TTTS)
TTTS is diagnosed in monochorionic diamniotic twin pregnancies when there is a discordance in amniotic fluid volumes, with one fetus exhibiting polyhydramnios and the other oligohydramnios. Specifically, before 20 weeks of gestation, the condition is diagnosed if one fetus (the recipient) has a deepest vertical pocket (DVP) of amniotic fluid ≥8cm, while the other fetus (the donor) has a DVP ≤2cm; after 20 weeks of gestation, the diagnosis is made if one fetus (the recipient) has a DVP ≥10cm, while the other fetus (the donor) has a DVP ≤2cm.
Measured: From inclusion to delivery
Rate of selective fetal growth restriction (sFGR)
sFGR is diagnosed in monochorionic diamniotic twin pregnancies when one fetus has an estimated fetal weight below the 10th percentile for its gestational age, and there is a discrepancy of ≥25% in the estimated fetal weights between the two fetuses.
Measured: From inclusion to delivery
Rate of fetal brain injury
Fetal brain injury is an abnormality in the structural and functional integrity of the cerebrum, cerebellum, or brainstem during the gestational period, caused by various factors such as hypoxic-ischemic events, infections, hemorrhage, congenital malformations, and genetic metabolic disorders.
Measured: From inclusion to delivery
Rate of neonatal brain injury
Brain injury refers to damage to the central nervous system resulting from various risk factors during pregnancy, childbirth, and the neonatal period. Clinically, it manifests as central motor disorders, cognitive impairments, language disorders, visual and auditory impairments, as well as difficulties in social interaction and psychological and behavioral disorders. It needs pregnant history or birth history, (such as one of twin intrauterine fetal death, Intrauterine distress), manifestation, and ultrasound, CT, MRI, electroencephalogram to make a definite diagnosis.
Measured: From inclusion to delivery
Rate of early childhood developmental delay of the offspring
Early childhood developmental delay of the offspring refers to a significant lag or delay in achieving age-appropriate developmental milestones across one or more domains, including cognitive, language, motor, social-emotional, and adaptive skills, during the early years of life (typically from birth to 5 years of age) in comparison to established norms or peers. The assessment of early childhood developmental delay is conducted using standardized scales such as Ages Stages Questionnaires (Third Edition), Gesell Developmental Schedules, and Bayley Scales of Infant and Toddler Development. The actual measurement process will be depending on the routine pediatric settings and resources available at each participating institution.
Measured: Within 1 year after delivery
Children's height
Each child is measured twice. If the difference is less than 0.1 cm, the average of the two measurements is taken. If the difference is greater than 0.1 cm, the measurement is repeated.
Measured: Within 1 year after delivery
Children's weight
Each newborn is measured twice. If the difference is less than 0.01 kg, the average of the two measurements is taken. If the difference is greater than 0.01 kg, the measurement is repeated.
Measured: Within 1 year after delivery
Secondary outcomes (9)
Rate of sleep disorders
Women's physiological and psychological changes during pregnancy will affect sleep, and the occurrence of bad sleep during pregnancy is more common. It is generally assessed by a sleep questionnaire.
Measured: From inclusion to delivery
Rate of mental and phycological disorders
Maternal mental health is as important as physical health, and good maternal mental health helps to promote the physical and mental health of the baby, as well as their own physical condition and natural childbirth. The condition of pregnant women is generally assessed by psychiatric departments.
Measured: From inclusion to delivery
Rate of single intrauterine fetal demise
The death of one fetus for twin pregnancy，the occurrence in the second and third trimesters of pregnancy has substantial adverse effects on surviving infants.
Measured: From inclusion to delivery
Rate of gestational hypertension
Take two consecutive measurements on the same arm, the systolic blood pressure more than 140 mmHg and (or) the diastolic blood pressure more than 90 mmHg. High blood pressure may lead to severe complications such as preclampsia and clampsia.
Measured: From inclusion to delivery
Rate of gestational diabetes mellitus
Diagnosed with gestational diabetes through an oral glucose tolerance test (OGTT). The blood glucose threshold of fasting, 1 h and 2 h after taking oral glucose was 5.1, 10.0, 8.5 mmolL, respectively, and the blood glucose level reached or exceeded the above criteria at any time point was diagnosed as GDM. GDM is clearly associated with adverse pregnancy outcomes such as fetal macrosomia, cesarean section delivery, preterm birth, and preeclampsia
Measured: From inclusion to delivery
Number of maternal death
Deaths during pregnancy or less than 42 days after termination of pregnancy.
Measured: From inclusion to delivery
Rate of stillbirth
After 28 gestational weeks, the fetus dies before or during delivery
Measured: From inclusion to delivery
Birth weight
Each newborn is measured twice. If the difference is less than 0.01 kg, the average of the two measurements is taken. If the difference is greater than 0.01 kg, the measurement is repeated.
Measured: At delivery
Birth length
Each newborn is measured twice. If the difference is less than 0.1 cm, the average of the two measurements is taken. If the difference is greater than 0.1 cm, the measurement is repeated.
Measured: At delivery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 May 2024
- Study start1 Mar 2024
- Primary completion30 Nov 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Twin Pregnancy, Antepartum Condition or ComplicationStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Chongqing Medical University, Shengjing Hospital, Peking University, Nankai University, Shanghai First Maternity and Infant Hospital, The First Affiliated Hospital of Anhui Medical University, International Peace Maternity and Child Health Hospital, The Second Hospital of Shandong University, Shandong Provincial Hospital
- Responsible party
- Sponsor
- Investigators
- Yuan Wei, PhD, MD, Study chair, Obstetrics and Gynecology Department of Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06414655
- Sponsor's protocol ID
- ChiTwiMC
- Acronym
- ChiTwiMC
- Status last verified
- Jan 2024
- First submitted
- 17 Mar 2024
- Last updated
- 16 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We have decided that the program will be confidential and not open to other researchers
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China
- ClinicalTrials.gov ID
- NCT06414655
- Acronym / sponsor ID
- ChiTwiMC / ChiTwiMC
- Conditions
- Twin Pregnancy, Antepartum Condition or Complication, Twin to Twin Transfusion as Antepartum Condition, Pre-Term, Pre-Eclampsia, Twin Monochorionic Diamniotic Placenta, Twin Dichorionic Diamniotic Placenta
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Chongqing Medical University, Shengjing Hospital, Peking University, Nankai University, Shanghai First Maternity and Infant Hospital, The First Affiliated Hospital of Anhui Medical University, International Peace Maternity and Child Health Hospital, The Second Hospital of Shandong University, Shandong Provincial Hospital
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 30 Nov 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 16 May 2024 (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.
Multicenter Prospective Cohort Study of Twin Maternal-Child Dyads in China (ChiTwiMC) is supported by National Key Research and Development Program of China - Reproductive Health and Women's and Children's Health Protection Project. This project is funded by the Ministry of Science and Technology of China under grant number 2023YFC2705900. The ChiTwiMC cohort is led by Professor Wei Yuan from the Department of Gynecology and Obstetrics at Peking University Third Hospital.
Detailed description
The ChiTwiMC Cohort focusing on the serious complications of twin pregnancy, establish a multicenter large prospective mother-child cohort of twin pregnancy covering pregnancy→neonatal period→early childhood, and a multi-variety, multi-stage biobank for the study of adverse outcomes of twin pregnancy. The ChiTwiMC Cohort is planning to recruit 2000 pregnant women aged 18-45 years from 9 large obstetrical center of major University-affiliated Hospitals across China, between December 2023 and May 2026. All women will be enrolled prior to 14 wks of gestation, pregnancy was followed up at 22-28 wks, 30-38 wks of gestation, delivery, postpartum 42 days, 6 months, 12 months. Data including demographics, medical history, reproductive history, clinical diagnosis, treatment information, and pregnancy and birth outcomes will be collected via electronic data capture system. Track the outcome of severe maternal-fetal complications and early neonatal outcomes of twins, and collect biological samples, including peripheral venous blood, hair and cervicovaginal secretions from pregnant women, placenta tissue, amniotic fluid and unbilical cord blood at delivery, meconium and hair from newborns, buccal mucosa from infants and peripheral venous blood from the husband.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- The ChiTwiMC is a prospective cohort that will enroll 2000 pregnant women aged 18-45 years and over from 9 large obstetrical centers of University-Affiliated Hospitals (Peking University Third Hospital; First Affiliated Hospital, Sun Yat-Sen University; Chongqing Medical University; Shengjing Hospital; Shanghai First Maternity and Infant Hospital; The First Affiliated Hospital of Anhui Medical University; International Peace Maternity and Child Health Hospital; The Second Hospital of Shandong University; Shandong Provincial Hospital). These hospitals located at 7 supercities (Beijing, Shanghai, Guangzhou, Shenyang, Jinan, Chongqing, and Hefei) of China. Pregnant women who are planning to receive prenatal healthcare and delivery in those hospitals are potential candidates for the study.
Key inclusion criteria (5 listed)
- Twin pregnancies
- Female aged between 18-45 years
- Gestational age is less than 14 weeks
- Planning to receive prenatal healthcare and delivery service at the study hospital
- Signing informed concent and willing to participate
Key exclusion criteria (3 listed)
- Women with mental disorders or serious maternal illness that is not eligible to participate
- Inability to provide informed consent
- Pregnant women not registered in our hospital
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
Rate of preterm delivery
Time frame: From inclusion to delivery
Preterm delivery is defined as delivery between 28 and 37 gestational weeks.
Rate of preeclampsia
Time frame: From inclusion to delivery
Preeclampsia is defined as the condition occurring in pregnant women after 20 weeks of gestation, characterized by systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg, accompanied by any of the following: a urinary protein quantification ≥0.3 g/24 h, or a urine protein/creatinine ratio ≥0.3, or random urine protein ≥ (+) (as a method of examination when protein quantification is not feasible). In the absence of proteinuria, the condition may still be diagnosed if there is involvement of any organ or system, including but not limited to critical organs such as the heart, lungs, liver, kidneys, or abnormalities in the hematological, digestive, or neurological systems, as well as complications affecting the placenta-fetus.
Rate of twin-to-twin transfusion syndrome (TTTS)
Time frame: From inclusion to delivery
TTTS is diagnosed in monochorionic diamniotic twin pregnancies when there is a discordance in amniotic fluid volumes, with one fetus exhibiting polyhydramnios and the other oligohydramnios. Specifically, before 20 weeks of gestation, the condition is diagnosed if one fetus (the recipient) has a deepest vertical pocket (DVP) of amniotic fluid ≥8cm, while the other fetus (the donor) has a DVP ≤2cm; after 20 weeks of gestation, the diagnosis is made if one fetus (the recipient) has a DVP ≥10cm, while the other fetus (the donor) has a DVP ≤2cm.
Rate of selective fetal growth restriction (sFGR)
Time frame: From inclusion to delivery
sFGR is diagnosed in monochorionic diamniotic twin pregnancies when one fetus has an estimated fetal weight below the 10th percentile for its gestational age, and there is a discrepancy of ≥25% in the estimated fetal weights between the two fetuses.
Rate of fetal brain injury
Time frame: From inclusion to delivery
Fetal brain injury is an abnormality in the structural and functional integrity of the cerebrum, cerebellum, or brainstem during the gestational period, caused by various factors such as hypoxic-ischemic events, infections, hemorrhage, congenital malformations, and genetic metabolic disorders.
Rate of neonatal brain injury
Time frame: From inclusion to delivery
Brain injury refers to damage to the central nervous system resulting from various risk factors during pregnancy, childbirth, and the neonatal period. Clinically, it manifests as central motor disorders, cognitive impairments, language disorders, visual and auditory impairments, as well as difficulties in social interaction and psychological and behavioral disorders. It needs pregnant history or birth history, (such as one of twin intrauterine fetal death, Intrauterine distress), manifestation, and ultrasound, CT, MRI, electroencephalogram to make a definite diagnosis.
Rate of early childhood developmental delay of the offspring
Time frame: Within 1 year after delivery
Early childhood developmental delay of the offspring refers to a significant lag or delay in achieving age-appropriate developmental milestones across one or more domains, including cognitive, language, motor, social-emotional, and adaptive skills, during the early years of life (typically from birth to 5 years of age) in comparison to established norms or peers. The assessment of early childhood developmental delay is conducted using standardized scales such as Ages Stages Questionnaires (Third Edition), Gesell Developmental Schedules, and Bayley Scales of Infant and Toddler Development. The actual measurement process will be depending on the routine pediatric settings and resources available at each participating institution.
Children's height
Time frame: Within 1 year after delivery
Each child is measured twice. If the difference is less than 0.1 cm, the average of the two measurements is taken. If the difference is greater than 0.1 cm, the measurement is repeated.
Children's weight
Time frame: Within 1 year after delivery
Each newborn is measured twice. If the difference is less than 0.01 kg, the average of the two measurements is taken. If the difference is greater than 0.01 kg, the measurement is repeated.
9 secondary outcomes
Rate of sleep disorders
Time frame: From inclusion to delivery
Rate of mental and phycological disorders
Time frame: From inclusion to delivery
Rate of single intrauterine fetal demise
Time frame: From inclusion to delivery
Rate of gestational hypertension
Time frame: From inclusion to delivery
Rate of gestational diabetes mellitus
Time frame: From inclusion to delivery
Number of maternal death
Time frame: From inclusion to delivery
Rate of stillbirth
Time frame: From inclusion to delivery
Birth weight
Time frame: At delivery
Birth length
Time frame: At delivery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Individual participant dataSharing planned: No. We have decided that the program will be confidential and not open to other researchers
Related trials for Twin Pregnancy, Antepartum Condition or Complication
RecruitingObservational study
Role of Doppler Echoflowmetry to Define Risk Factors for the Development of Complications in Twin Pregnancies
Twin Pregnancy, Antepartum Condition or Complication
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.
Tianchen Wu, PhD contact
Yuan Wei, PhD, MD study chair
Obstetrics and Gynecology Department of Peking University Third Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Twin Pregnancy, Antepartum Condition or Complication and Twin to Twin Transfusion as Antepartum Condition, run by Peking University Third Hospital at 11 sites in China.
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 3 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: looking for participants now, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yuan Wei, PhD, MD (01082267852, weiyuanbysy@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of preterm delivery (time frame: From inclusion to delivery). The study lists 9 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 16 May 2024.