NCT01881685

Brief Summary

The objective of the study is to evaluate the association between certain markers in the blood of neonatal brain injury and specific Fetal Heart Rate monitoring findings using the device under study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2013

Typical duration for all trials

Geographic Reach
1 country

2 active sites

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

March 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 11, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 20, 2013

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

September 18, 2019

Status Verified

September 1, 2014

Enrollment Period

2.8 years

First QC Date

June 11, 2013

Last Update Submit

September 17, 2019

Conditions

Abnormality in Fetal Heart Rate or Rhythm

Outcome Measures

Primary Outcomes (1)

  • Quantitative FHR patterns predictive of adverse neonatal outcome

    1)quantitative analysis of fetal heart-rate (FHR) data recorded during labor using advanced mathematical techniques, including pattern-recognition analysis using EKG stickers applied to the maternal abdomen.

    During Labor

Secondary Outcomes (1)

  • Uterine contraction measurement

    During Labor

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Women in labor who are having their fetus' heart rate monitored continuously

You may qualify if:

  • Pregnant women in their third trimester and Women in labor (the progressive effacement and dilatation of the cervix) who are having their fetus' heart rate monitored continuously will form the eligible population for recruitment into our study
  • years old or older
  • Women with the diagnosis of fetal intrauterine growth restriction may be included.

You may not qualify if:

  • Speakers of languages other than English
  • Gestational age less than 24 weeks 0 days

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Summa Center for Women's Health Research

Akron, Ohio, 44304, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

1\) umbilical cord arterial and venous blood; 2)placenta for pathological evaluation.

Study Officials

  • Timothy Drake, MD

    Summa Center for Women's Health Research

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 11, 2013

First Posted

June 20, 2013

Study Start

March 1, 2013

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

September 18, 2019

Record last verified: 2014-09

Locations

US(2)