Clinical trial NCT02950896: Intraoperative Fetal Heart Rate (FHR) Monitoring: a Feasibility Study
Official title: Intraoperative Fetal Heart Rate (FHR) Monitoring: a Feasibility Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Fetal Monitoring
Labor, Obstetric
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
First posted: 2016-11-01
Enrollment: 4
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women with scheduled induction of labor and pregnant women with schedule cesarean delivery.

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.

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

Eligibility criteria: 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

Primary outcomes:
measure: ECG of Fetal Heart Rate
timeFrame: 10 minutes of evaluable ECG reading
Secondary outcomes:
Other outcomes:
Locations:
city: Saint Louis
country: United States
facility: Washington University St Louis School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Heather McKenzie, MD
role: PRINCIPAL_INVESTIGATOR
References: