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 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.

Study Overview

• Status: Terminated
• Conditions: Labor, Obstetric; Fetal Monitoring
• Intervention / Treatment: Other: observational fetal heart rate monitoring

Detailed Description

Fetal heart rate (FHR) monitoring has become the most widely used assessment of fetal well-being in the peripartum period and the only routinely used method that provides continuous fetal monitoring. Despite a false positive rate for the detection of intrapartum asphyxia leading to cerebral palsy of over 99% [1-3] FHR monitoring continues to be the mainstay of peripartum fetal surveillance. FHR monitoring is routinely available in the operating room, where it is typically reassessed in cases of urgent cesarean delivery for fetal distress since it may direct immediate anesthetic and peripartum management. However, despite the ubiquitous use of FHR monitoring in labor and the typical use of FHR monitoring on arrival to the OR, FHR monitoring is universally stopped once anesthesia has been performed in order to allow abdominal skin preparation and for surgery to proceed. From the moment of anesthesia induction until fetal delivery, no real-time data is available that allows assessment of fetal well-being. A few isolated studies and case reports in the 1970s-1980s examined intraoperative FHR monitoring using scalp-clip electrodes during Cesarean deliveries [4-7]. None of these studies assessed external FHR monitors or current anesthesia techniques. To the investigators' knowledge no studies since that time have examined FHR monitoring during Cesarean deliveries using external monitoring or spinal anesthesia

• Study Type: Observational
• Enrollment (Actual): 4

Contacts and Locations

Study Locations

• United States
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University St Louis School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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

Exclusion Criteria:

1. Urgent or emergent cesarean sections
2. Cesarean sections performed under general anesthesia

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
intraoperative FHR monitoring; Intraoperative fetal heart rate (FHR) monitoring	Other: observational fetal heart rate monitoring; Patients will have fetal heart rate monitoring

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Washington University School of Medicine
• Investigators: Principal Investigator: Heather McKenzie, MD, Washington University School of Medicine

Study record dates

Study Major Dates

• Study Start: October 1, 2016
• Primary Completion (Actual): October 29, 2017
• Study Completion (Actual): October 29, 2017

Study Registration Dates

• First Submitted: October 28, 2016
• First Submitted That Met QC Criteria: October 28, 2016
• First Posted (Estimate): November 1, 2016

Study Record Updates

• Last Update Posted (Actual): May 10, 2019
• Last Update Submitted That Met QC Criteria: February 8, 2019
• Last Verified: February 1, 2019

More Information

Terms related to this study

• Other Study ID Numbers: 201606134

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO