Fetal MonitoringNCT02950896
Intraoperative Fetal Heart Rate (FHR) Monitoring: a Feasibility Study
An observational study of Fetal Monitoring and Labor, Obstetric, run by Washington University School of Medicine at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Fetal Monitoring, Labor, Obstetric
- What is being tested?
- observational fetal heart rate monitoring
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 29 Oct 2017
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women with scheduled induction of labor and pregnant women with schedule cesarean delivery.
Who may be able to join
- 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
Who cannot join
- Urgent or emergent cesarean sections
- Cesarean sections performed under general anesthesia
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University St Louis School of Medicine
St Louis, Missouri, 63110
About this 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.
Read the 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
- Conditions
- Fetal Monitoring, Labor, Obstetric
- Being tested
- observational fetal heart rate monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational fetal heart rate monitoringOther
Patients will have fetal heart rate monitoring
| Study group | Role | What they receive |
|---|---|---|
| intraoperative FHR monitoring | Intraoperative fetal heart rate (FHR) monitoring Receives: Other: observational fetal heart rate monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECG of Fetal Heart Rate
This measure will be compared to the acoustic monitoring of FHR across the same 10 minutes.
Measured: 10 minutes of evaluable ECG reading
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2016 (estimated)
- Study startOct 2016
- Primary completion29 Oct 2017
- Study completion29 Oct 2017
Why it stopped: Appropriate devices for fetal heart rate monitoring were not available.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Fetal MonitoringStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Heather McKenzie, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02950896
- Sponsor's protocol ID
- 201606134
- Status last verified
- Feb 2019
- First submitted
- 28 Oct 2016
- Last updated
- 10 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Fetal Heart Rate (FHR) Monitoring: a Feasibility Study
- ClinicalTrials.gov ID
- NCT02950896
- Acronym / sponsor ID
- 201606134
- Conditions
- Fetal Monitoring, Labor, Obstetric
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Appropriate devices for fetal heart rate monitoring were not available.
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- 29 Oct 2017 (actual)
- Study completion
- 29 Oct 2017 (actual)
- First posted
- 1 Nov 2016 (estimated)
- Results
- Posted 10 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| intraoperative FHR monitoring | – | Other: observational fetal heart rate monitoringIntraoperative fetal heart rate (FHR) monitoring |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women with scheduled induction of labor and pregnant women with schedule cesarean delivery.
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Urgent or emergent cesarean sections
- Cesarean sections performed under general anesthesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational fetal heart rate monitoringPatients will have fetal heart rate monitoring | Other | intraoperative FHR monitoring |
Primary outcome
ECG of Fetal Heart Rate
Time frame: 10 minutes of evaluable ECG reading
This measure will be compared to the acoustic monitoring of FHR across the same 10 minutes.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Fetal Monitoring
Not yet recruiting
Wearable Ultrasound Patch in Parturients
Pregnancy - Labor Monitoring, Labor and Childbirth
Not yet recruiting
Safety and Feasibility of the INGA Sensor System for Fetal and Uterine Monitoring During Cervical Ripening
Induced Labor, Cervical Ripening
Not yet recruitingObservational study
Gemini Flash 3.6 Versus Human Observers for FIGO-Based Interpretation of Intrapartum Cardiotocography
Fetal Hypoxia, Fetal Distress
Recruiting
Study of Fetal Health Outcomes: Working With a Missouri E-telehealth Platform (The SHOW-ME Study)
Pregnancy
Recruiting
Implementation Models for Blood Pressure Monitoring in Pregnancy and Postpartum: Connected MOM Plus
Maternal Health Care, Hypertensive Disorder of Pregnancy
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Heather McKenzie, MD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fetal Monitoring and Labor, Obstetric, run by Washington University School of Medicine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 10 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ECG of Fetal Heart Rate (time frame: 10 minutes of evaluable ECG reading). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.