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

Fetal Monitoring Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02950896
• Other study ID #: 201606134
• Status: Terminated
• Start date: October 2016
• Est. completion date: October 29, 2017

Study information

• Verified date: February 2019
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 4
• Est. completion date: October 29, 2017
• Est. primary completion date: October 29, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Related Conditions & MeSH terms

• Fetal Monitoring
• Labor, Obstetric

Intervention

Other:
• observational fetal heart rate monitoring
Patients will have fetal heart rate monitoring

Locations

Country	Name	City	State
United States	Washington University St Louis School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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