NCT05378516

Brief Summary

This investigation is on placental pathological changes and inflammatory factors associated with obstetric antiphospholipid syndrome.

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 Jan 2022

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

January 1, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

May 12, 2022

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 12, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 18, 2022

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

May 18, 2022

Status Verified

January 1, 2022

Enrollment Period

4 months

First QC Date

May 12, 2022

Last Update Submit

May 12, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • expression of ACC1 in placenta in pregnancy with/without antiphospholipid syndrome

    in two years

Study Arms (1)

obstetric antiphospholipid syndrome

obstetric antiphospholipid syndrome 20 cases and normal pregnant women 20 cases

Other: no intervention

Interventions

no intervention

obstetric antiphospholipid syndrome

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

pregnant women with antiphospholipid syndrome (diagnosed by experts with clinical evidence) and healthy pregnant women without antiphospholipid syndrome as a control group

You may qualify if:

  • pregnant women with antiphospholipid syndrome (diagnosed by experts with clinical evidence) and healthy pregnant women without antiphospholipid syndrome as a control group
  • consent to join this study and finish the informed consents

You may not qualify if:

  • pregnant women with other autoimmune diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PekingUPH

Beijing, China

RECRUITING

Study Officials

  • Jingjing Yang, doctor

    Peking University People's Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Jingjing Yang, deputy chief physician, doctor

CONTACT

Xinyang Ma, resident, bachelor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Deputy chief physician

Study Record Dates

First Submitted

May 12, 2022

First Posted

May 18, 2022

Study Start

January 1, 2022

Primary Completion

May 12, 2022

Study Completion

December 31, 2023

Last Updated

May 18, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations