Electronic Fetal Monitoring With and Without Pattern Interpretation
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|ClinicalTrials.gov Identifier: NCT03279068|
Recruitment Status : Recruiting
First Posted : September 12, 2017
Last Update Posted : October 29, 2018
Cesarean section is one of the most common surgeries performed with the intention of optimizing maternal and fetal/neonatal outcomes. One of the major indications for cesarean delivery is "non-reassuring fetal status" (NRFS). Electronic fetal monitoring is used to evaluate and manage women while they are in labor. A fetal heart rate tracing is recorded on paper or electronically and produces a pattern to allow physicians to visually identify fetuses that are at risk for hypoxia and/or acidemia. This practice allows for prompt intervention via intrauterine resuscitation and expedited delivery if deemed necessary. National and international guidelines published by the International Federation of Gynecology and Obstetrics and American College of Obstetrics and Gynecology describe how fetal heart rate patterns obtained with electronic fetal monitoring should be interpreted and managed. In order to interpret fetal heart rate patterns, the ability to visualize a pattern is necessary. This is made possible either by using paper on which the fetal heart rate is recorded or electronic screens with recording systems. In hospitals where continuous fetal heart rate monitoring is available, but paper resources are depleted and electronic screens are not available, an image of the fetal heart rate pattern cannot be produced nor interpreted. Thus, electronic fetal monitoring is used as an incomplete tool has become standard of care for laboring patients.
Historical Western data revealed that implementation of continuous fetal monitoring with pattern interpretation increased rates of cesarean delivery in comparison to intermittent auscultation. However, it is not clear if the inability to interpret a pattern (because of a lack of paper or electronic recording) results in increased or decreased cesarean rates in comparison to pattern interpretation. It is possible that the implementation of pattern interpretation could decrease cesarean delivery rates allowing increased or earlier opportunity for fetal resuscitation for patients with tracing abnormalities which may avert cesarean delivery. The investigators' aim is to assess cesarean delivery rates using electronic fetal monitoring with versus without pattern interpretation in a hospital in a low-middle income country where resources are lacking.
If a decrease in cesarean delivery rate is observed and/or neonatal outcomes are improved, this study may serve as an impetus to encourage electronic fetal monitoring paper-producing companies to subsidize or donate supplies to hospitals in developing countries. Ensuring that fetal status is in fact non-reassuring by fetal heart rate pattern interpretation prior to proceeding with cesarean delivery may decrease the cesarean delivery rate while not compromising fetal outcomes.
|Condition or disease||Intervention/treatment|
|Cardiotocography||Other: Teaching and EFM Paper|
|Study Type :||Observational|
|Estimated Enrollment :||3600 participants|
|Official Title:||Electronic Fetal Monitoring With and Without Pattern Interpretation: A Prospective Cohort Study|
|Actual Study Start Date :||October 6, 2017|
|Estimated Primary Completion Date :||July 2019|
|Estimated Study Completion Date :||July 2019|
Without Pattern Interpretation
All women who are admitted for labor at Ayder Referral Hospital in Mekelle, Ethiopia will be asked to participate and a physician will obtain consent. If an indication arises and they are designated to receive EFM per previously established standard practice at Ayder Hospital, then their patient information will be collected. Patients who require EFM will be asked to provide basic health and demographic information, along with collection of information on labor and delivery course, post-partum outcome, and neonatal outcomes. The investigators estimate enrollment of up to 1800 patients which will result in at least 300 patients who will require EFM.
With Pattern Interpretation
All women who are admitted for labor at Ayder Referral Hospital in Mekelle, Ethiopia will be asked to participate and a physician will obtain consent. If an indication arises and they are designated to receive EFM per previously established standard practice at Ayder Hospital, then their patient information will be collected.
Their labor will be managed as in Phase 1 except that EFM will be interpreted and managed as per ACOG/FIGO guidelines using paper on which fetal heart tracings will be recorded. All other aspects of their care will proceed as per standard at Ayder Referral Hospital.
Patients who require EFM will be asked to provide basic health and demographic information, along with collection of information on labor and delivery course, post-partum outcome, and neonatal outcomes. The investigators estimate enrollment of up to 1800 patients which will result in at least 300 patients who will require EFM.
Other: Teaching and EFM Paper
Data will be collected for patients receiving EFM without pattern interpretation as the first phase of the study, as this is the current practice at Ayder Hospital. Then, the second phase will involve a week of teaching sessions regarding interpretation and management of EFM as per ACOG and FIGO guidelines. For the third phase of this study, paper will be provided for the use of EFM with pattern interpretation for all patients receiving EFM.
Other Name: Teaching and Paper
- Cesarean delivery rate for non-reassuring fetal status [ Time Frame: July 2018 ]
- Adverse neonatal outcomes [ Time Frame: July 2018 ]Neonatal demise before mother's discharge, admission to neonatal ICU, duration of neonatal ICU admission, APGAR <7 at 5 minutes
- Cesarean delivery rate [ Time Frame: July 2018 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03279068
|Contact: Abida Hasan, MDfirstname.lastname@example.org|
|Contact: Micaela Della Torre, MD/MSemail@example.com|
|Ayder Referral Hospital, Mekelle University||Recruiting|
|Mekelle, Tigray, Ethiopia|
|Contact: Yibrah B Zelelew, MD +251-93-965-3545 firstname.lastname@example.org|
|Principal Investigator:||Abida Hasan, MD||University of Illinois, Maternal Fetal Medicine Fellow|