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NCT04003064 Clinical Trial

Heavy Metals' Influence on Early Pregnancy Through Oxidative Stress

Oxidative Stress Clinical Trial

Official title:
Heavy Metals' Influence on Early Pregnancy Through Oxidative Stress

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04003064
Other study ID # HML2019
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date May 20, 2019
Est. completion date May 1, 2020

Study information
Verified date May 2019
Source Peking Union Medical College Hospital
Contact Xinyan U Liu
Phone 01069156699
Email cristinaO@163.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical 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. 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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date May 1, 2020
Est. primary completion date December 30, 2019
Accepts healthy volunteers No
Gender Female
Age group N/A and older
Eligibility Inclusion Criteria:

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.

Study Design

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• Blood
3ml blood

Locations
Country Name City State
China Peking Union Medical College Hospital Peking

Sponsors (1)
Lead Sponsor Collaborator
Peking Union Medical College Hospital

Country where clinical trial is conducted

China, 

Outcome
Type Measure Description Time frame Safety issue
Primary oxident stress level 1 year
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