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NCT01131260 · ClinicalTrials.gov registry record · NA

Fetal ST Segment and T Wave Analysis in Labor

A NA study of Pregnancy and Obstetric Labor, sponsored by The George Washington University Biostatistics Center.

Completed
Registry status
NA
Development phase
11,108
Enrollment target
13
Study locations

NCT01131260: Completed NA study of Pregnancy and Obstetric Labor, sponsored by The George Washington University Biostatistics Center.

NCT01131260 is a NA study of Pregnancy and Obstetric Labor that has completed, run by The George Washington University Biostatistics Center. The registered enrollment target is 11,108 participants, above the 815-participant average among 191 other Pregnancy trials with a reported enrollment target (1263% higher). The trial reports 13 study locations across 11 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01131260, a NA study of Pregnancy and Obstetric Labor, has completed, sponsored by The George Washington University Biostatistics Center.

COMPLETED
Registry status
NA
Development phase
11,108 participants
Enrollment target
13
Study locations

Study Summary

The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along with the existing electronic fetal monitor used to measure the baby's heart rate and the mother's contractions during birth. The specific purpose of this research study is to see if this new instrument (fetal STAN monitor) will have an impact on newborn health.

Primary Outcome

Composite primary outcome of intrapartum fetal death, neonatal death, Apgar score \<=3 at 5 minutes, neonatal seizure, umbilical artery blood pH \<= 7.05 with base deficit \>=12 mmol/L in extra-cellular fluid, intubation for ventilation at delivery, neonatal encelphalopathy

Interventions

  • DEVICE fetal STAN monitor

Study Locations (13)

Ohio

  • Case Western University - Cleveland
  • Ohio State University - Columbus

Texas

  • University of Texas - Galveston - Galveston
  • University of Texas - Houston - Houston

Alabama

  • University of Alabama - Birmingham - Birmingham

Illinois

  • Northwestern University - Chicago

Michigan

  • Wayne State University - Hutzel Hospital - Detroit

New York

  • Columbia University - New York

North Carolina

  • University of North Carolina - Chapel Hill - Chapel Hill

Oregon

  • Oregon Health & Science University - Portland

Trial Details

FieldValue
Enrollment Target 11,108 participants
Start Date 2010-11
Est. Completion 2014-08
Phase NA

What the finished NCT01131260 record still lists

NCT01131260 is an interventional study that assigns participants to a tested intervention. Its 11,108 participants enrollment target places it among the larger protocols in the corpus, above the 815-participant average among 191 other Pregnancy trials with a reported enrollment target (1263% higher).

The record links to 3 conditions, with Pregnancy appearing as the primary indexed condition, and to 1 intervention - of which fetal STAN monitor is the first listed.

NCT01131260 lists 13 locations in 11 states (Ohio, Texas, Alabama).

Frequently Asked Questions

What is clinical trial NCT01131260 about?

NCT01131260 is a clinical study titled "Fetal ST Segment and T Wave Analysis in Labor". The purpose of this research is to test a new instrument, called a fetal STAN monitor, that may be used during labor to monitor the electrical activity of the baby's heart. This new instrument is designed to help the doctor determine how well the baby is doing during labor. It will be used along wit...

What is the current status of trial NCT01131260?

This trial is currently completed. It is a NA study. The enrollment target is 11,108 participants. The study started on 2010-11. Estimated completion is 2014-08.

What conditions does trial NCT01131260 study?

This clinical trial studies the following conditions: Pregnancy, Obstetric Labor, Parturition.

What interventions are being tested in trial NCT01131260?

The interventions under investigation include: fetal STAN monitor (DEVICE).

Who is sponsoring clinical trial NCT01131260?

This trial is sponsored by The George Washington University Biostatistics Center, which has 24 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01131260 being conducted?

This trial has 13 study locations across Alabama, Illinois, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Pregnancy

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01131260's enrollment target sits among peer trials

11,108 3rd of 191 higher than 189 of 191 other Pregnancy trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Pregnancy trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01131260, the US trial registry maintained by the National Library of Medicine. NCT01131260 (large enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.