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

NCT02950896 | Terminated Results

• 1 other identifier: 201606134
• Study Type: observational
• Target: 4
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Fetal Monitoring; Labor, Obstetric

Outcome Measures

Primary Outcomes (1)

• ECG of Fetal Heart Rate

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

  10 minutes of evaluable ECG reading

Study Arms (1)

intraoperative FHR monitoring

Intraoperative fetal heart rate (FHR) monitoring

Other: observational fetal heart rate monitoring

Interventions

observational fetal heart rate monitoring OTHER

Patients will have fetal heart rate monitoring

intraoperative FHR monitoring

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Pregnant women with scheduled induction of labor and pregnant women with schedule cesarean delivery.

You may qualify if:

• First 15 patients only- Elective induction of labor, not yet in active labor.
• Subsequent 40 patients - Scheduled cesarean sections performed under spinal anesthesia
• Patients ages 18-45

You may not qualify if:

• Urgent or emergent cesarean sections
• Cesarean sections performed under general anesthesia

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University St Louis School of Medicine

St Louis, Missouri, 63110, United States

Location

Results Point of Contact

• Title: Heather McKenzie
• Organization: Washington University School of Medicine

heather.mckenzie@wustl.edu

3142862628

Study Officials

• Heather McKenzie, MD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 28, 2016
• First Posted: November 1, 2016
• Study Start: October 1, 2016
• Primary Completion: October 29, 2017
• Study Completion: October 29, 2017
• Last Updated: May 10, 2019
• Results First Posted: May 10, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)