Spontaneous AbortionNCT04003064
Heavy Metals' Influence on Early Pregnancy Through Oxidative Stress
An observational study of Spontaneous Abortion and Oxidative Stress, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Patients with diagnosis of spontaneous abortion are enrolled in the cohort, in the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken for heavy metal level examnation. Part of the villi tissue was sent for genetic testing, and the results were traced. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Spontaneous Abortion, Oxidative Stress
- What is being tested?
- Blood
- How many people
- 40 participants
- Where
- 1 siteChina
- Study dates
- 20 May 2019to 1 May 2020
- How long will I take part?
- 6 Months
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Exclusion Criteria: not long-term residents in Peking; Inconvenient for following up; Long-term of drug use; Cesarean section scar pregnancy and other high-risk pregnancy; Diagnosis of pregnancy beyond 12 weeks.
Who may be able to join
- 1) the length of fetal bud is equal to or greater than 7 mm and there is no cardiac activity; 2) the maximum zh diameter of the pregnancy sac is equal to or greater than 25mm, and there is no fetal heart beat; 3) an embryo with no heartbeat at 2 weeks or more after ultrasound examination showing a pregnancy sac without yolk sac; 4) embryos without heartbeat for 11 days or longer after ultrasonography showed the yolk sac as a type pregnancy sac.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking Union Medical College Hospital
Beijing, 100730
Xinyan Liu, 01069156699 ext. 01069156699, cristinaO@163.com
Ou Jie, 01069156699 ext. 01069156699, cristinaO@163.com
About this study
Patients with diagnosis of spontaneous abortion are enrolled in the cohort, in the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken for heavy metal level examnation. Part of the villi tissue was sent for genetic testing, and the results were traced. In addition, about 10g of villi tissue was frozen for testing. Patients with normal genetic results of villi tissue will have villus samples go through oxidative stress level detection.
Read the detailed description
From May 1, 2019, patients with diagnosis of spontaneous abortion are enrolled in the cohort, exclusion criteria were: not long-term residents in Peking; Inconvenient for following up; Long-term of drug use; Cesarean section scar pregnancy and other high-risk pregnancy; Diagnosis of pregnancy beyond 12 weeks.
In the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken on the day of admission for curettage and suction, and the levels of heavy metals were tested. Part of the villi tissue was sent for genetic testing, and the results were traced. In addition, about 10g of villi tissue was frozen for testing. Patients with normal genetic results of villi tissue will have villus samples go through oxidative stress level detection.
- Conditions
- Spontaneous Abortion, Oxidative Stress
- Being tested
- Blood
- Medical subject headings
- Abortion, Spontaneous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BloodDiagnostic test
3ml blood
What is being measured
The primary outcome is the main question the study is designed to answer.
oxident stress level
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2019
- Study start20 May 2019
- Primary completion30 Dec 2019 (estimated)
- Study completion1 May 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spontaneous AbortionStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College 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
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
- Target duration
- 6 Months
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinyan U Liu, Study chair, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04003064
- Sponsor's protocol ID
- HML2019
- Status last verified
- May 2019
- First submitted
- 27 Jun 2019
- Last updated
- 1 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Heavy Metals' Influence on Early Pregnancy Through Oxidative Stress
- ClinicalTrials.gov ID
- NCT04003064
- Acronym / sponsor ID
- HML2019
- Conditions
- Spontaneous Abortion, Oxidative Stress
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- 20 May 2019 (actual)
- Primary completion
- 30 Dec 2019 (estimated)
- Study completion
- 1 May 2020 (estimated)
- First posted
- 1 Jul 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.
Patients with diagnosis of spontaneous abortion are enrolled in the cohort, in the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken for heavy metal level examnation. Part of the villi tissue was sent for genetic testing, and the results were traced. In addition, about 10g of villi tissue was frozen for testing. Patients with normal genetic results of villi tissue will have villus samples go through oxidative stress level detection.
Detailed description
From May 1, 2019, patients with diagnosis of spontaneous abortion are enrolled in the cohort, exclusion criteria were: not long-term residents in Peking; Inconvenient for following up; Long-term of drug use; Cesarean section scar pregnancy and other high-risk pregnancy; Diagnosis of pregnancy beyond 12 weeks.
In the cohort of patients who met the criteria, 3ml of whole blood intravenous and 5ml of urine were taken on the day of admission for curettage and suction, and the levels of heavy metals were tested. Part of the villi tissue was sent for genetic testing, and the results were traced. In addition, about 10g of villi tissue was frozen for testing. Patients with normal genetic results of villi tissue will have villus samples go through oxidative stress level detection.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 6 Months
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Exclusion Criteria: not long-term residents in Peking; Inconvenient for following up; Long-term of drug use; Cesarean section scar pregnancy and other high-risk pregnancy; Diagnosis of pregnancy beyond 12 weeks.
Key inclusion criteria (1 listed)
- 1) the length of fetal bud is equal to or greater than 7 mm and there is no cardiac activity; 2) the maximum zh diameter of the pregnancy sac is equal to or greater than 25mm, and there is no fetal heart beat; 3) an embryo with no heartbeat at 2 weeks or more after ultrasound examination showing a pregnancy sac without yolk sac; 4) embryos without heartbeat for 11 days or longer after ultrasonography showed the yolk sac as a type pregnancy sac.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood3ml blood | Diagnostic test | – |
Primary outcome
oxident stress level
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2019.
- 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.
Xinyan U Liu study chair
Peking Union Medical College 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 Spontaneous Abortion and Oxidative Stress, run by Peking Union Medical College Hospital at 1 site 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 1 inclusion and 0 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 1 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xinyan U Liu (01069156699 ext. 01069156699, cristinaO@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
oxident stress level (time frame: 1 year). 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 1 Jul 2019.