Heavy Metals' Influence on Early Pregnancy Through Oxidative Stress

June 27, 2019 updated by: Peking Union Medical College Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

40

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Peking, China, 100730
        • Recruiting
        • Peking Union Medical College Hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
oxident stress level
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Investigators

  • Study Chair: Xinyan U Liu, Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2019

Primary Completion (Anticipated)

December 30, 2019

Study Completion (Anticipated)

May 1, 2020

Study Registration Dates

First Submitted

June 27, 2019

First Submitted That Met QC Criteria

June 27, 2019

First Posted (Actual)

July 1, 2019

Study Record Updates

Last Update Posted (Actual)

July 1, 2019

Last Update Submitted That Met QC Criteria

June 27, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HML2019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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