NCT02482246

Brief Summary

Healthy parturients presenting for scheduled cesarean delivery will have blood drawn and measured for microparticles at baseline, immediately after delivery, and at several time points thereafter.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
completed

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, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
25 days until next milestone

First Posted

Study publicly available on registry

June 26, 2015

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2015

Enrollment Period

11 months

First QC Date

March 11, 2015

Last Update Submit

December 1, 2015

Conditions

Pregnancy

Outcome Measures

Primary Outcomes (1)

  • Change in Microparticle number and type

    Assay of withdrawn blood

    Baseline, delivery, and 1-hr, 4-hr and 24-36-hr post delivery

Eligibility Criteria

Age18 Years - 60 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pregnant women

You may qualify if:

  • All patients with a singleton pregnancy with gestational age greater than or equal to 36 weeks who present for scheduled cesarean delivery will be eligible for participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Chicago

Chicago, Illinois, 60637, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

Study Design

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

Study Record Dates

First Submitted

March 11, 2015

First Posted

June 26, 2015

Study Start

January 1, 2014

Primary Completion

December 1, 2014

Study Completion

June 1, 2015

Last Updated

December 2, 2015

Record last verified: 2015-12

Locations

US(1)