Cardiotocography Clinical Trial
Official title:
Electronic Fetal Monitoring With and Without Pattern Interpretation: A Prospective Cohort Study
NCT number | NCT03279068 |
Other study ID # | 2017-0723 |
Secondary ID | |
Status | Terminated |
Phase | |
First received | |
Last updated | |
Start date | October 6, 2017 |
Est. completion date | June 29, 2019 |
Verified date | December 2020 |
Source | University of Illinois at Chicago |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Terminated |
Enrollment | 637 |
Est. completion date | June 29, 2019 |
Est. primary completion date | June 29, 2019 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: - 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. Exclusion Criteria: - Women who are carrying multiple gestation. - Pregnant women under 18 years of age. - Low risk women who are undergoing IA. |
Country | Name | City | State |
---|---|---|---|
Ethiopia | Ayder Referral Hospital, Mekelle University | Mekelle | Tigray |
Lead Sponsor | Collaborator |
---|---|
University of Illinois at Chicago |
Ethiopia,
Ajah 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. — View Citation
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. — View Citation
Ayres-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. — View Citation
Ayres-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. — View Citation
Ayres-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. — View Citation
Boyle 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. — View Citation
Lewis 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. — View Citation
Malek 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. Review. — View Citation
Ohel 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. Erratum in: J Matern Fetal Neonatal Med. 2009 Aug;22(8):717. Iris, Ohel [corrected to Ohel, Iris]; Amalia, Levy [corrected to Levy, Amalia]; Moshe, Mazor [corrected to Mazor, Moshe]; Arnon, Wiznitzer [corrected to Wiznitzer, Arnon]; Eyal, Sheiner [corrected to Sheiner, Eyal]. — View Citation
Ugwu 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. — View Citation
Visser 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. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Cesarean delivery rate for non-reassuring fetal status | July 2018 | ||
Secondary | Adverse neonatal outcomes | Neonatal demise before mother's discharge, admission to neonatal ICU, duration of neonatal ICU admission, APGAR <7 at 5 minutes | July 2018 | |
Secondary | Cesarean delivery rate | July 2018 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT06135961 -
Intrapartum Non-invasive Electrophysiological Monitoring
|
N/A | |
Recruiting |
NCT04632017 -
Computerized Cardiotocography Monitoring of Fetuses With pPROM
|
||
Recruiting |
NCT05904314 -
Evaluation of the Effectiveness of Teaching Method With Simulation in Electronic Fetal Monitoring Management
|
N/A | |
Not yet recruiting |
NCT04186975 -
Computerized Antepartum Monitoring Using Non-invasive Fetal Ecg for High Risk Pregnancy
|
||
Not yet recruiting |
NCT06366711 -
Remote Telemedicine Fetal Monitoring Feasibility Study
|
N/A |