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NCT02950896 · ClinicalTrials.gov registry record

Intraoperative Fetal Heart Rate (FHR) Monitoring: a Feasibility Study

A clinical trial, sponsored by Washington University School of Medicine.

Terminated
Registry status
4
Enrollment target

NCT02950896: Clinical Trial study, sponsored by Washington University School of Medicine.

NCT02950896 is a clinical trial that was terminated before completion, run by Washington University School of Medicine. The registered enrollment target is 4 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02950896 was terminated before completion, sponsored by Washington University School of Medicine.

TERMINATED
Registry status
4 participants
Enrollment target

Study Summary

Fetal heart rate \[FHR\] monitoring is used widely to assess the well-being of the baby in the delivery period. If it is determined that an urgent cesarean delivery is required because of fetal distress, FHR is discontinued once the mother is in the operating room in order to allow for surgical site preparation. From this point, there is no real-time monitoring that permits assessment of the well-being of the infant. The investigators are evaluating the feasibility of intraoperative FHR monitoring using fetal ECG placed on the mother's upper abdominal wall and the standard acoustic device routinely used. The investigators will compare these to the traditional well-being tests: umbilical arterial blood gas and Apgar score. The first 15 subjects will be recruited from pregnant women who have scheduled induction of labor. The subsequent 40 subjects will be recruited from pregnant women who have scheduled cesarean sections.

Primary Outcome

This measure will be compared to the acoustic monitoring of FHR across the same 10 minutes.

Interventions

  • OTHER observational fetal heart rate monitoring

Trial Details

FieldValue
Enrollment Target 4 participants
Start Date 2016-10
Est. Completion 2017-10-29

Why NCT02950896 stopped before completion

NCT02950896 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 4 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which observational fetal heart rate monitoring is the first listed.

NCT02950896 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02950896 about?

NCT02950896 is a clinical study titled "Intraoperative Fetal Heart Rate (FHR) Monitoring: a Feasibility Study". Fetal heart rate \[FHR\] monitoring is used widely to assess the well-being of the baby in the delivery period. If it is determined that an urgent cesarean delivery is required because of fetal distress, FHR is discontinued once the mother is in the operating room in order to allow for surgical site...

What is the current status of trial NCT02950896?

This trial is currently terminated. The enrollment target is 4 participants. The study started on 2016-10. Estimated completion is 2017-10-29.

What interventions are being tested in trial NCT02950896?

The interventions under investigation include: observational fetal heart rate monitoring (OTHER).

Who is sponsoring clinical trial NCT02950896?

This trial is sponsored by Washington University School of Medicine, which has 1,502 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02950896, the US trial registry maintained by the National Library of Medicine. NCT02950896 (small enrollment · none site footprint · terminated) retrieved and formatted by PlainTrial, see methodology.