CardiotocographyNCT03279068
Electronic Fetal Monitoring With and Without Pattern Interpretation
An observational study of Cardiotocography, run by University of Illinois Chicago at 1 site in Ethiopia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cardiotocography
- What is being tested?
- Teaching and EFM Paper
- How many people
- 637 participants
- Where
- 1 siteEthiopia
- Study dates
- 6 Oct 2017to 29 Jun 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
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 years and older
- Women only
- Adult, Older adult
Study population: Women of childbearing age presenting for care at Ayder Referral Hospital in Mekelle, Ethiopia. Most patients are from the Tigray, Afar, or Amahara regions in Ethiopia.
Who may be able to join
- Women who have a singleton pregnancy.
- Women admitted for labor to Ayder Referral Hospital in Mekelle, Ethiopia.
- Pregnant women aged 18 years or older.
- Receiving EFM for intrapartum management.
- Patients assigned to receive EFM will be designated by the current protocol regarding "high risk" vs. "low risk" patients at Ayder Referral Hospital as per discretion of the supervising provider in Labor and Delivery.
Who cannot join
- Women who are carrying multiple gestation.
- Pregnant women under 18 years of age.
- Low risk women who are undergoing IA.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Electronic Fetal Monitoring With and Without Pattern Interpretation: A Prospective Cohort Study
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.
Read the detailed description
"Intrapartum electronic fetal monitoring (EFM) also known as cardiotocography (CTG) is used for most women who give birth in the United States," as per American College of Obstetrics and Gynecology (ACOG) Practice Bulletin 116 - Management of Intrapartum Fetal Heart Rate Tracings. This document regarding recommendations of intrapartum management functions on the assumption that electronic fetal monitoring is being recorded, either on paper or electronically, to allow for interpretation of the pattern of the fetal heart rate over time. In the US, the widespread availability of electronic medical record systems allows continuous visualization of fetal heart tracings. In hospitals that have not transitioned to electronic recording of fetal heart rate tracings, these tracings are continuously recorded on paper. The guidelines put forth by ACOG in Practice Bulletin 116 define how to interpret patterns of fetal heart rates, and furthermore, how to manage patients based on these interpretations by categorizing features of tracings that are concerning vs. reassuring.
The International Federation of Gynecology and Obstetrics (FIGO), of which ACOG is a member, produced several documents in 2015 to address Consensus Guidelines for Intrapartum Fetal Monitoring. The document addressing CTG for an international audience provides the same guidelines for interpretation of fetal heart tracing patterns as ACOG, and very similar recommendations for management based on slightly different categorization terminology. Both the ACOG Practice Bulletin and the FIGO Consensus Guideline addressing intrapartum fetal monitoring describe fetal heart rate patterns including baseline rate, variability, accelerations, and decelerations. Specifically, they address the various types of decelerations, some of which are benign, and others which are ominous for fetal well-being, as well as the importance of variability in assessing fetal well-being. For example, moderate baseline variability reflects the oxygenation of the central nervous system and reliably predicts the absence of ongoing hypoxic injury and metabolic acidemia at the time it is observed.
An alternative method for intrapartum fetal monitoring is via intermittent auscultation (IA). IA is a technique by which the fetal heart rate is appreciated by a stethoscope, fetoscope, or handheld Doppler to assess the fetal heart rate over established periods of time during different stages of labor, but does not produce a continuous numerical output of the fetal heart rate. As such, certain features of a fetal heart rate pattern cannot be evaluated by IA, including fetal heart rate variability or the different types of decelerations. According to the FIGO Guidelines on Intermittent Auscultation, "Based on expert opinion, IA should be recommended in all labors in settings where there is no access to CTG monitors or to the resources necessary for using them. When the resources for CTG monitoring are available, intermittent auscultation may be used for routine intrapartum monitoring in low-risk cases. However, approximately half of the panel members believe that continuous CTG should be the option during the second stage of labor, although there is no direct scientific evidence to support this." In settings where CTG is available, the conditions required to use IA are stringent and even preclude patients who don't deliver within 1 hour of pushing. Furthermore, management of abnormal findings on IA includes proceeding to CTG if it is available. These provisions to using IA convey the implication that it is preferred to have CTG available for use, if possible. It is important to note that electronic fetal monitoring without paper or the ability to interpret a pattern, is not the same as IA or electronic fetal monitoring as described above. Therefore, there is no set of guidelines to interpret and manage patients monitored with continuous monitoring without pattern interpretation.
In many developing countries, hospitals have the ability to provide intrapartum electronic fetal monitoring. At Ayder Referral Hospital, a teaching hospital for Mekelle University, labor and delivery is equipped with electronic CTG monitors that display fetal heart rate in real time, and potentially have the ability to record on paper. Secondary to limited number of CTG monitors, EFM is reserved for use for patients who are considered "high risk," and IA is used to monitor patients who are "low risk." "High risk" patients are those who have maternal conditions or fetal conditions that prompt higher level of fetal monitoring, such as pre-eclampsia, history of prior cesarean delivery, or concerns regarding fetal well-being. However, at this hospital, as in many other hospitals in sub-Saharan Africa, paper strip supplies were depleted and have not been replenished. Thus, patients are currently monitored intrapartum with a live feedback of fetal heart rate, but with no ability to interpret fetal heart rate pattern. Management of patients in this setting is based on real-time fetal heart rates that are continuously observed, which is an intermediate entity of fetal monitoring for which there are no established recommendations for management. Neither the ACOG Bulletin nor the FIGO Consensus Guidelines address CTG/EFM without pattern interpretation.
In a setting such as Ayder Referral Hospital in Mekelle, making efforts to minimize the cesarean delivery rate while optimizing neonatal outcomes is paramount for many reasons. In Mekelle, personal and socioeconomic implications of a major surgery such as cesarean delivery are considered seriously, and refusal of cesarean delivery is higher in many developing countries in comparison to resource-rich countries. Furthermore, performance of a cesarean delivery in a patient population that has a high aversion to cesarean delivery puts these patients at risk of avoiding a subsequent delivery in a hospital to avoid a repeat cesarean section, which can have dire consequences. Preventing adverse fetal outcome is equally as important as preventing unnecessary cesarean section, as resources available for neonatal resuscitation are limited in comparison to developed countries.
While there is a lack of data regarding the use of EFM without pattern interpretation, the investigators' hypothesis is that the implementation of EFM with pattern interpretation will result in a decrease in cesarean delivery rates without altering neonatal outcomes. This hypothesis arises from anecdotal experience. Providers at Ayder Referral Hospital and the principal investigator's observation of the intrapartum management on Labor and Delivery noted that several of the cesarean deliveries that occurred may have been averted given the opportunity for intrauterine resuscitation.
This prospective cohort study comparing current standard of care at Ayder Referral Hospital (EFM without pattern interpretation for high risk obstetric patients) with EFM as per ACOG and FIGO recommendations (with pattern evaluation) may reveal a change in cesarean delivery rate and/or neonatal outcomes.
- Conditions
- Cardiotocography
- Being tested
- Teaching and EFM Paper
- Keywords
- electronic fetal monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Teaching and EFM PaperOther
Also called Teaching and 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Teaching and EFM Paper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cesarean delivery rate for non-reassuring fetal status
Measured: July 2018
Secondary outcomes (2)
Adverse neonatal outcomes
Neonatal demise before mother's discharge, admission to neonatal ICU, duration of neonatal ICU admission, APGAR <7 at 5 minutes
Measured: July 2018
Cesarean delivery rate
Measured: July 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start6 Oct 2017
- Primary completion29 Jun 2019
- Study completion29 Jun 2019
Why it stopped: Civil unrest in region/country of study
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for CardiotocographyStudies of the same condition, open and under way.
- More trials run by University of Illinois ChicagoThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 637 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Illinois Chicago
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abida Hasan, University of Illinois Chicago
- Investigators
- Abida Hasan, MD, Principal investigator, University of Illinois, Maternal Fetal Medicine Fellow
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279068
- Sponsor's protocol ID
- 2017-0723
- Status last verified
- Dec 2020
- First submitted
- 6 Sep 2017
- Last updated
- 19 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
American College of Obstetricians and Gynecologists. Practice bulletin no. 116: Management of intrapartum fetal heart rate tracings. Obstet Gynecol. 2010 Nov;116(5):1232-40. doi: 10.1097/AOG.0b013e3182004fa9.
PubMed 20966730Ayres-de-Campos D, Spong CY, Chandraharan E; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Cardiotocography. Int J Gynaecol Obstet. 2015 Oct;131(1):13-24. doi: 10.1016/j.ijgo.2015.06.020. No abstract available.
PubMed 26433401Lewis D, Downe S; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Intermittent auscultation. Int J Gynaecol Obstet. 2015 Oct;131(1):9-12. doi: 10.1016/j.ijgo.2015.06.019. No abstract available.
PubMed 26433400Malek J. Responding to refusal of recommended cesarean section: Promoting good parenting. Semin Perinatol. 2016 Jun;40(4):216-21. doi: 10.1053/j.semperi.2015.12.009. Epub 2016 Jan 21.
PubMed 26803168Ohel I, Levy A, Mazor M, Wiznitzer A, Sheiner E. Refusal of treatment in obstetrics - A maternal-fetal conflict. J Matern Fetal Neonatal Med. 2009 Jul;22(7):612-5. doi: 10.1080/14767050802668698.
PubMed 19479647Ugwu NU, de Kok B. Socio-cultural factors, gender roles and religious ideologies contributing to Caesarian-section refusal in Nigeria. Reprod Health. 2015 Aug 12;12:70. doi: 10.1186/s12978-015-0050-7.
PubMed 26265149Ajah LO, Ibekwe PC, Onu FA, Onwe OE, Ezeonu TC, Omeje I. Evaluation of Clinical Diagnosis of Fetal Distress and Perinatal Outcome in a Low Resource Nigerian Setting. J Clin Diagn Res. 2016 Apr;10(4):QC08-11. doi: 10.7860/JCDR/2016/17274.7687. Epub 2016 Apr 1.
PubMed 27190897Ayres-de-Campos D, Arulkumaran S; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Physiology of fetal oxygenation and the main goals of intrapartum fetal monitoring. Int J Gynaecol Obstet. 2015 Oct;131(1):5-8. doi: 10.1016/j.ijgo.2015.06.018. No abstract available.
PubMed 26433399Boyle A, Reddy UM, Landy HJ, Huang CC, Driggers RW, Laughon SK. Primary cesarean delivery in the United States. Obstet Gynecol. 2013 Jul;122(1):33-40. doi: 10.1097/AOG.0b013e3182952242.
PubMed 23743454Ayres-de-Campos D, Arulkumaran S; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Introduction. Int J Gynaecol Obstet. 2015 Oct;131(1):3-4. doi: 10.1016/j.ijgo.2015.06.017. No abstract available.
PubMed 26433398Visser GH, Ayres-de-Campos D; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Adjunctive technologies. Int J Gynaecol Obstet. 2015 Oct;131(1):25-9. doi: 10.1016/j.ijgo.2015.06.021. No abstract available.
PubMed 26433402
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Electronic Fetal Monitoring With and Without Pattern Interpretation: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT03279068
- Acronym / sponsor ID
- 2017-0723
- Conditions
- Cardiotocography
- Keywords
- electronic fetal monitoring
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Civil unrest in region/country of study
- Enrolment
- 637 participants (actual)
- Lead sponsor
- University of Illinois ChicagoUniversity, hospital or other
- Study start
- 6 Oct 2017 (actual)
- Primary completion
- 29 Jun 2019 (actual)
- Study completion
- 29 Jun 2019 (actual)
- First posted
- 12 Sep 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
"Intrapartum electronic fetal monitoring (EFM) also known as cardiotocography (CTG) is used for most women who give birth in the United States," as per American College of Obstetrics and Gynecology (ACOG) Practice Bulletin 116 - Management of Intrapartum Fetal Heart Rate Tracings. This document regarding recommendations of intrapartum management functions on the assumption that electronic fetal monitoring is being recorded, either on paper or electronically, to allow for interpretation of the pattern of the fetal heart rate over time. In the US, the widespread availability of electronic medical record systems allows continuous visualization of fetal heart tracings. In hospitals that have not transitioned to electronic recording of fetal heart rate tracings, these tracings are continuously recorded on paper. The guidelines put forth by ACOG in Practice Bulletin 116 define how to interpret patterns of fetal heart rates, and furthermore, how to manage patients based on these interpretations by categorizing features of tracings that are concerning vs. reassuring.
The International Federation of Gynecology and Obstetrics (FIGO), of which ACOG is a member, produced several documents in 2015 to address Consensus Guidelines for Intrapartum Fetal Monitoring. The document addressing CTG for an international audience provides the same guidelines for interpretation of fetal heart tracing patterns as ACOG, and very similar recommendations for management based on slightly different categorization terminology. Both the ACOG Practice Bulletin and the FIGO Consensus Guideline addressing intrapartum fetal monitoring describe fetal heart rate patterns including baseline rate, variability, accelerations, and decelerations. Specifically, they address the various types of decelerations, some of which are benign, and others which are ominous for fetal well-being, as well as the importance of variability in assessing fetal well-being. For example, moderate baseline variability reflects the oxygenation of the central nervous system and reliably predicts the absence of ongoing hypoxic injury and metabolic acidemia at the time it is observed.
An alternative method for intrapartum fetal monitoring is via intermittent auscultation (IA). IA is a technique by which the fetal heart rate is appreciated by a stethoscope, fetoscope, or handheld Doppler to assess the fetal heart rate over established periods of time during different stages of labor, but does not produce a continuous numerical output of the fetal heart rate. As such, certain features of a fetal heart rate pattern cannot be evaluated by IA, including fetal heart rate variability or the different types of decelerations. According to the FIGO Guidelines on Intermittent Auscultation, "Based on expert opinion, IA should be recommended in all labors in settings where there is no access to CTG monitors or to the resources necessary for using them. When the resources for CTG monitoring are available, intermittent auscultation may be used for routine intrapartum monitoring in low-risk cases. However, approximately half of the panel members believe that continuous CTG should be the option during the second stage of labor, although there is no direct scientific evidence to support this." In settings where CTG is available, the conditions required to use IA are stringent and even preclude patients who don't deliver within 1 hour of pushing. Furthermore, management of abnormal findings on IA includes proceeding to CTG if it is available. These provisions to using IA convey the implication that it is preferred to have CTG available for use, if possible. It is important to note that electronic fetal monitoring without paper or the ability to interpret a pattern, is not the same as IA or electronic fetal monitoring as described above. Therefore, there is no set of guidelines to interpret and manage patients monitored with continuous monitoring without pattern interpretation.
In many developing countries, hospitals have the ability to provide intrapartum electronic fetal monitoring. At Ayder Referral Hospital, a teaching hospital for Mekelle University, labor and delivery is equipped with electronic CTG monitors that display fetal heart rate in real time, and potentially have the ability to record on paper. Secondary to limited number of CTG monitors, EFM is reserved for use for patients who are considered "high risk," and IA is used to monitor patients who are "low risk." "High risk" patients are those who have maternal conditions or fetal conditions that prompt higher level of fetal monitoring, such as pre-eclampsia, history of prior cesarean delivery, or concerns regarding fetal well-being. However, at this hospital, as in many other hospitals in sub-Saharan Africa, paper strip supplies were depleted and have not been replenished. Thus, patients are currently monitored intrapartum with a live feedback of fetal heart rate, but with no ability to interpret fetal heart rate pattern. Management of patients in this setting is based on real-time fetal heart rates that are continuously observed, which is an intermediate entity of fetal monitoring for which there are no established recommendations for management. Neither the ACOG Bulletin nor the FIGO Consensus Guidelines address CTG/EFM without pattern interpretation.
In a setting such as Ayder Referral Hospital in Mekelle, making efforts to minimize the cesarean delivery rate while optimizing neonatal outcomes is paramount for many reasons. In Mekelle, personal and socioeconomic implications of a major surgery such as cesarean delivery are considered seriously, and refusal of cesarean delivery is higher in many developing countries in comparison to resource-rich countries. Furthermore, performance of a cesarean delivery in a patient population that has a high aversion to cesarean delivery puts these patients at risk of avoiding a subsequent delivery in a hospital to avoid a repeat cesarean section, which can have dire consequences. Preventing adverse fetal outcome is equally as important as preventing unnecessary cesarean section, as resources available for neonatal resuscitation are limited in comparison to developed countries.
While there is a lack of data regarding the use of EFM without pattern interpretation, the investigators' hypothesis is that the implementation of EFM with pattern interpretation will result in a decrease in cesarean delivery rates without altering neonatal outcomes. This hypothesis arises from anecdotal experience. Providers at Ayder Referral Hospital and the principal investigator's observation of the intrapartum management on Labor and Delivery noted that several of the cesarean deliveries that occurred may have been averted given the opportunity for intrauterine resuscitation.
This prospective cohort study comparing current standard of care at Ayder Referral Hospital (EFM without pattern interpretation for high risk obstetric patients) with EFM as per ACOG and FIGO recommendations (with pattern evaluation) may reveal a change in cesarean delivery rate and/or neonatal outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | – | Other: Teaching and EFM PaperAll 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Age groups
- Adult, Older adult
- Study population
- Women of childbearing age presenting for care at Ayder Referral Hospital in Mekelle, Ethiopia. Most patients are from the Tigray, Afar, or Amahara regions in Ethiopia.
Key inclusion criteria (5 listed)
- Women who have a singleton pregnancy.
- Women admitted for labor to Ayder Referral Hospital in Mekelle, Ethiopia.
- Pregnant women aged 18 years or older.
- Receiving EFM for intrapartum management.
- Patients assigned to receive EFM will be designated by the current protocol regarding "high risk" vs. "low risk" patients at Ayder Referral Hospital as per discretion of the supervising provider in Labor and Delivery.
Key exclusion criteria (3 listed)
- Women who are carrying multiple gestation.
- Pregnant women under 18 years of age.
- Low risk women who are undergoing IA.
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 |
|---|---|---|
| Teaching and EFM PaperAlso: Teaching and PaperData 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 | With Pattern Interpretation |
Primary outcome
Cesarean delivery rate for non-reassuring fetal status
Time frame: July 2018
2 secondary outcomes
Adverse neonatal outcomes
Time frame: July 2018
Cesarean delivery rate
Time frame: July 2018
Results and safety
The study was stopped early (reason given: Civil unrest in region/country of study). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2020.
- Background: PubMed 20966730American College of Obstetricians and Gynecologists. Practice bulletin no. 116: Management of intrapartum fetal heart rate tracings. Obstet Gynecol. 2010 Nov;116(5):1232-40. doi: 10.1097/AOG.0b013e3182004fa9.
- Background: PubMed 26433401Ayres-de-Campos D, Spong CY, Chandraharan E; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Cardiotocography. Int J Gynaecol Obstet. 2015 Oct;131(1):13-24. doi: 10.1016/j.ijgo.2015.06.020. No abstract available.
- Background: PubMed 26433400Lewis D, Downe S; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Intermittent auscultation. Int J Gynaecol Obstet. 2015 Oct;131(1):9-12. doi: 10.1016/j.ijgo.2015.06.019. No abstract available.
- Background: PubMed 26803168Malek J. Responding to refusal of recommended cesarean section: Promoting good parenting. Semin Perinatol. 2016 Jun;40(4):216-21. doi: 10.1053/j.semperi.2015.12.009. Epub 2016 Jan 21.
- Background: PubMed 19479647Ohel I, Levy A, Mazor M, Wiznitzer A, Sheiner E. Refusal of treatment in obstetrics - A maternal-fetal conflict. J Matern Fetal Neonatal Med. 2009 Jul;22(7):612-5. doi: 10.1080/14767050802668698.
- Background: PubMed 26265149Ugwu NU, de Kok B. Socio-cultural factors, gender roles and religious ideologies contributing to Caesarian-section refusal in Nigeria. Reprod Health. 2015 Aug 12;12:70. doi: 10.1186/s12978-015-0050-7.
- Background: PubMed 27190897Ajah LO, Ibekwe PC, Onu FA, Onwe OE, Ezeonu TC, Omeje I. Evaluation of Clinical Diagnosis of Fetal Distress and Perinatal Outcome in a Low Resource Nigerian Setting. J Clin Diagn Res. 2016 Apr;10(4):QC08-11. doi: 10.7860/JCDR/2016/17274.7687. Epub 2016 Apr 1.
- Background: PubMed 26433399Ayres-de-Campos D, Arulkumaran S; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Physiology of fetal oxygenation and the main goals of intrapartum fetal monitoring. Int J Gynaecol Obstet. 2015 Oct;131(1):5-8. doi: 10.1016/j.ijgo.2015.06.018. No abstract available.
- Background: PubMed 23743454Boyle A, Reddy UM, Landy HJ, Huang CC, Driggers RW, Laughon SK. Primary cesarean delivery in the United States. Obstet Gynecol. 2013 Jul;122(1):33-40. doi: 10.1097/AOG.0b013e3182952242.
- Background: PubMed 26433398Ayres-de-Campos D, Arulkumaran S; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Introduction. Int J Gynaecol Obstet. 2015 Oct;131(1):3-4. doi: 10.1016/j.ijgo.2015.06.017. No abstract available.
- Background: PubMed 26433402Visser GH, Ayres-de-Campos D; FIGO Intrapartum Fetal Monitoring Expert Consensus Panel. FIGO consensus guidelines on intrapartum fetal monitoring: Adjunctive technologies. Int J Gynaecol Obstet. 2015 Oct;131(1):25-9. doi: 10.1016/j.ijgo.2015.06.021. No abstract available.
- Individual participant dataSharing planned: No
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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.
Abida Hasan, MD principal investigator
University of Illinois, Maternal Fetal Medicine Fellow
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 Cardiotocography, run by University of Illinois Chicago at 1 site in Ethiopia.
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 5 inclusion and 3 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 19 Dec 2020. 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 Ethiopia. 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?
The study was stopped early (reason given: Civil unrest in region/country of study). Results are not available in the source record.
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?
Cesarean delivery rate for non-reassuring fetal status (time frame: July 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03279068, which also lists 11 linked publications.
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 19 Dec 2020.