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HMLandSA: the Association Between Blood's and Urinary Heavy Metal Level in Pregnant Women and the Spontaneous Abortion

Sponsor
Peking Union Medical College Hospital (Other)
Overall Status
Unknown status
CT.gov ID
NCT03332706
Collaborator
(none)
200
Enrollment
1
Location
13.7
Anticipated Duration (Months)
14.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of the study was to define the possible association between heavy iron level and the consequence of pregnancy especially spontaneous abortion and missed abortion. The study population will comprised the first-trimester pregnant women in the PUMCH (Peking Union Medicine College Hospital) during 2017 October to 2018 November. We categorised the patients into two groups, the study group where the patients suffered from spontaneous abortion or missed abortion, and the control group where the patients carry the normal live fetal for at least 8 weeks and ask for artificial abortion. All the cases included in the study were examined with respect to 6 kinds of heavy iron level in venous blood and urine, then correlation analysis was applied to define heavy iron level between two groups.

Condition or Disease Intervention/Treatment Phase
  • Other: observation

Study Design

Study Type:
Observational
Anticipated Enrollment :
200 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Department of Gynecology and Obstetrics From Peking Union Medical College Hospital
Actual Study Start Date :
Oct 10, 2017
Anticipated Primary Completion Date :
Nov 1, 2018
Anticipated Study Completion Date :
Nov 30, 2018

Arms and Interventions

Arm Intervention/Treatment
SG

Study Group is the group where the patients during observation suffer from spontaneous abortion or missed abortion,

Other: observation
after the subjects are included into the groups,they are asked to do a questionaire.Then,we just observe the outcomes of pregnancy
CG

Control Group is where the patients carry the normal live fetal for at least 8 weeks

Other: observation
after the subjects are included into the groups,they are asked to do a questionaire.Then,we just observe the outcomes of pregnancy

Outcome Measures

Primary Outcome Measures

  1. blood's and urinary heavy metal level [12months]

    6 kinds of heavy metal:Pb,As,Hg,Gd,Cr,Se

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • early trimester pregnant women
Exclusion Criteria:

Contacts and Locations

Locations

Site City State Country Postal Code
1 Peking Union Medical College Hospital Pekin Pekin China 100730

Sponsors and Collaborators

  • Peking Union Medical College Hospital

Investigators

  • Study Director: Liu xinyan, Peking Union Medical College Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Peking Union Medical College Hospital
ClinicalTrials.gov Identifier:
NCT03332706
Other Study ID Numbers:
  • HML2017
First Posted:
Nov 6, 2017
Last Update Posted:
Nov 6, 2017
Last Verified:
Oct 1, 2017
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Abortion, Spontaneous
Heavy Metal Poisoning

Study Results

No Results Posted as of Nov 6, 2017