NCT04003064

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 20, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

June 27, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 1, 2019

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2019

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2020

Completed
Last Updated

July 1, 2019

Status Verified

May 1, 2019

Enrollment Period

7 months

First QC Date

June 27, 2019

Last Update Submit

June 27, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • oxident stress level

    1 year

Interventions

BloodDIAGNOSTIC_TEST

3ml blood

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • \) 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

blood and urine

MeSH Terms

Conditions

Abortion, Spontaneous

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Xinyan U Liu

    Peking Union Medical College Hospital

    STUDY CHAIR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 27, 2019

First Posted

July 1, 2019

Study Start

May 20, 2019

Primary Completion

December 30, 2019

Study Completion

May 1, 2020

Last Updated

July 1, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations