NCT03332706

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.

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
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 10, 2017

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

November 2, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 6, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2018

Completed
29 days until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2018

Completed
Last Updated

November 6, 2017

Status Verified

October 1, 2017

Enrollment Period

1.1 years

First QC Date

November 2, 2017

Last Update Submit

November 2, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • blood's and urinary heavy metal level

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

    12months

Study Arms (2)

SG

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

Other: observation

CG

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

Other: observation

Interventions

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

CGSG

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

the first-trimester pregnant women in the PUMCH (Peking Union Medicine College Hospital) during 2017 October to 2018 November.

You may qualify if:

  • \- early trimester pregnant women

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Peking Union Medical College Hospital

Beijing, Pekin, 100730, China

RECRUITING

MeSH Terms

Conditions

Heavy Metal PoisoningAbortion, Spontaneous

Interventions

Observation

Condition Hierarchy (Ancestors)

PoisoningChemically-Induced DisordersPregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital Diseases

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Liu xinyan

    Peking Union Medical College Hospital

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2017

First Posted

November 6, 2017

Study Start

October 10, 2017

Primary Completion

November 1, 2018

Study Completion

November 30, 2018

Last Updated

November 6, 2017

Record last verified: 2017-10

Locations