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Barbalace, Karen, Maryville, 2019
Evaluating a Process to Change the Culture from a Traditional Approach
of Labor Induction to an Evidence-based Approach.
A scholarly project Presented to
The Faculty of Maryville University
Catherine McAuley School of Nursing
In Fulfilment of the Requirements
For the Degree of Doctor of Nursing Practice
Karen Barbalace, BSN, RN
April 1, 2019
Committee Members
Carol Berger, DNP,APRN, FNP-C (Chair)
Karla Larson, PhD
David Campbell-O’Dell, DNP, ARNP, FNP-BC, FAANP
Rachel Sloan, RN, BSN (Community Member)
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Barbalace, Karen, Maryville, 2019
Acknowledgement
I dedicate and share this degree with my husband, Giuseppe Barbalace, who has supported me
throughout my education and believed in me the duration of the journey. I want to thank
Giuseppe and my children, Alyzabeth and Giuseppe, for their love, encouragement, and support.
I want to thank Dr. Carol Berger for her unwavering dedication throughout my writing process
and for sharing her wisdom and knowledge with me.
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Table of Contents
Abstract ………………………………………………………………………………… 5Chapter One ……………………………………………………………………….…… 6
Introduction ……………………………………………………………………… 6Purpose and Aims ………………………………………………………………. 7Background ……………………………………………………………………... 7Significance ……………………………………………………………………... 8
Nursing ………………………………………………………………….. 8 Healthcare ……………………………………………………………….. 9Advanced Practice ………………………………………………………. 9
Practice Support for Project …………………………………………………….. 10Benefit of Project to Practice …………………………………………………… 10Conclusion ……………………………………………………………………… 10
Chapter Two …………………………………………………………………………… 12 Literature Search History ……………………………………………………….. 12Integrated Review of Literature ………………………………………………… 12
Reduced Labor Time ……………………………………………………. 12Maternal Outcomes of Traditional Versus Foley Bulb Labor …………… 14Neonatal Outcomes of Traditional Versus Foley Bulb Labor …………... 17
Literature Critique ………………………………………………………………. 19Strengths ………………………………………………………………… 19Weaknesses ……………………………………………………………... 20Gaps in Evidence ………………………………………………………... 20Limitations …………………………………………………………….... 22
Concepts and Definitions ……………………………………………………….. 22Theoretical Framework …………………………………………………………. 23
Chapter Three ……………………………………………………………………..…… 25Methodology ……………………………………………………………………. 25
Design …………………………………………………………………… 26 Needs Assessment ………………………………………………………. 26Research Question ……………………………………………………… 27Data Collection Instrument …………………………………………….. 27Analysis Plan …………………………………………………………… 27 Budget ………………………………………………………………….. 28Protection of Human Subjects …………………………………………. 28 Resources ………………………………………………………………. 28Project Timeline …………………………………..……………………. 29
Chapter Four ………………………………………………………………………….. 30 Findings ………………………………………………………………………… 30
Data Collection Method ………………………………………………… 30Target Variables ………………………………………………………… 30Data Collection and Analysis …………………………………………… 31
Congruency Among Variables ………………………………………………….. 32Validity and Reliability …………………………………………………………. 33
Chapter Five …………………………………………………………………………… 34
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Barbalace, Karen, Maryville, 2019
Discussion ………………………………………………………………………. 34 Limitations ……………………………………………………………………… 34 Translation of Findings into Practice …………………………………………… 35 Summary ………………………………………………………………………... 35
References ……………………………………………………………………………… 37
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Barbalace, Karen, Maryville, 2019
Abstract
Evaluating a Process to Change the Culture from a Traditional Approach
of Labor Induction to an Evidence-based Approach.
Background: Approximately 25% of women in the United States undergo induction of labor, whether elective or medically indicated (Centers for Disease Control (CDC), 2014). As an increased number of women undergo this procedure it is imperative that evidence-based practices are implemented and utilized for the best patient outcomes. Underutilization of EBR not only affects patient outcomes, but also can have a major impact on healthcare costs (Melnyk, Gallagher-Ford, Long, & Fineout-Overholt, 2014). Research has shown that induction of labor with intracervical Foley bulb insertion in combination with a pharmacological agent significantly decreases the number of hours a woman is in labor, and improves maternal outcomes (Al-Ibraheemi, et al., 2018; Carbone, Tuuli, Fogertey, & Roeh 2013; Chen, Xue, Gaudet, Walker, & Wen, 2015; Garba et al., 2016; Graham, Nguyen, Sit, Morfin, & Garabedian, 2018; Levine et al., 2016; Schoen, 2017).
Purpose: To determine (1) Does personalized education on intracervical Foley bulb insertion along with pharmacological agents for labor induction increase the use of this method by physicians; (2) Does use of Foley bulb insertion along with pharmacological agents improve maternal outcomes?
Design: The study utilized a retrospective chart review using a quantitative exploratory method that did not engage participants. The following information was collected from medical records: (a) method of induction pharmacological agent only; (b) method of induction Foley bulb only; (c) method of induction combination Foley bulb with pharmacological agent; (d) length of labor time. A sequential inclusion and exclusion process will continue until the determined 60 EMRs is achieved.
Results: The findings of this project determined that no physicians (0/5 or 0%) used the Foley bulb before the intervention and five out of five physicians (5/5 or 100%) used it post-implementation. Twenty-three labor inductions were done with the Foley bulb and a pharmacological agent post-implementation, which resulted in this method being adopted 32% of the time. The study also showed the average time from start of induction of labor to delivery using Foley bulb with pharmacological agent to be 10.19 hours as compared to 13.94 labor time with pharmacological agent only.
Conclusions: Evidence based practices are the foundation of patient care to ensure the best patient outcomes. This capstone project shows a translation of evidence into practice along with statistically significant increase in physician adoption of Foley bulb usage with pharmacological agent for labor induction. It also showed a decrease in labor time by using this method.
Key Word: misoprostol, induction of labor, mechanical induction, Foley bulb, transcervical catheter, oxytocin, cervical ripening.
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Chapter One
Introduction
Approximately 25% of women in the United States undergo induction of labor, whether
elective or medically indicated (Centers for Disease Control (CDC), 2014). As an increased
number of women undergo this procedure it is imperative that evidence-based practices are
implemented and utilized for the best patient outcomes. Underutilization of EBR not only
affects patient outcomes, but also can have a major impact on healthcare costs (Melnyk,
Gallagher-Ford, Long, & Fineout-Overholt, 2014). Research has shown that induction of labor
with intracervical Foley bulb insertion in combination with a pharmacological agent significantly
decreases the number of hours a woman is in labor, and improves maternal outcomes (Al-
Ibraheemi, et al., 2018; Carbone, Tuuli, Fogertey, & Roeh 2013; Chen, Xue, Gaudet, Walker, &
Wen, 2015; Garba et al., 2016; Graham, Nguyen, Sit, Morfin, & Garabedian, 2018; Levine et al.,
2016; Schoen, 2017).
The process of introducing evidenced-based research in an environment where traditional
practices have been held can be a daunting experience. Process change can be difficult, and
implementation can be met with resistance even when change is necessary. Although process
change can be met with resistance, it is considered a core competency in medical care by the
Institute of Medicine (Weng et al., 2013). Often healthcare professionals are aware of evidence-
based practices but lack knowledge and skills to successfully implement these practices (Weng et
al., 2013). Successful implementation of evidence-based practice calls for policymakers and
practitioners to work together to provide patient care with the best possible outcomes
(Zimmerman, 2017). Studies show that while 71.5% of health care professionals have positive
attitudes towards evidence-based practice, only 59.8% support the implementation of evidence-
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based practice (Weng et al., 2013). Furthermore, Weng et al. (2013) found lack of time was the
most commonly reported reason by physicians for not implementing evidence-based practices
into their practice. Zimmerman (2017) found that a culture of support and collaboration is
necessary between clinicians, community needs, leadership, and available resources for
successful implementation of evidence-based practices.
Purpose and Aims
The purpose of this study is to evaluate the effectiveness of a personalized approach to
introduce evidence-based practices for methods of inducing labor, which includes the use of an
intracervical Foley bulb insertion along with pharmacological agents, to providers who have, up
to this point, been choosing a variety of methods that are outdated. The overall aim of this
project is to increase the utilization of the Foley bulb insertion along with pharmacological
agents in induction of labor and to decrease the number of hours in laboring women. Scholarly
literature on this subject is consistent with its findings and supports the combination use of a
Foley bulb and a pharmacological agent as the preferred method (Al-Ibraheemi, Brustman,
Bimson, Porat, & Rosenn, 2018; Carbone, Tuuli, Fogertey, & Roeh 2013; Chen, Xue, Gaudet,
Walker, & Wen, 2015; Garba et al., 2016; Levine et al., 2016; Schoen, Grant, Berghella,
Hoffman, & Sciscione, 2017).
Background
Scheduled induction of labor is quickly rising in popularity as opposed to allowing labor
to begin and progress naturally. Approximately 25% of women in the United States choose to
undergo induction of labor, whether elective or indicated, and various methods to promote
cervical ripening, disintegrating or dissolution of extracellular collagen, are utilized (Al-
Ibraheemi, et al., 2018; Centers for Disease Control (CDC), 2014). An unfavorable cervix with a
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Bishop score (a number ranging from 0–13 that is given to rate the condition of the cervix
(American College of Obsterticians and Gynecologists (ACOG), n.d.) less than six must undergo
ripening which is an integral part of the process (Al-Ibraheemi et al., 2018). Physicians must
choose the method of cervical ripening, either mechanical, pharmacological, or both, that is best
for a woman who presents with an unfavorable cervix (Bishop score less than six). Evidence-
based practice guidelines provide physicians with the most up to date practices for cervical
ripening for the best maternal and neonatal outcomes.
Physicians should consider safe and effective means of cervical ripening such as
intracervical Foley bulb insertion in combination with a pharmacological agent (Chen et al.,
2015). Foley bulb insertion in combination with a pharmacological agent has been proven to
significantly decrease the number of hours a woman is in labor (Al-Ibraheemi, et al., 2018;
Carbone et al., 2013; Chen et al., 2015; Garba et al., 2016; Levine et al., 2016; Schoen et al.,
2017). This evidence-based method has been proven to have little to no negative effect on
maternal or fetal outcomes such as cesarean section rate, postpartum hemorrhage,
chorioamnionitis, Apgar scores, and neonatal admission to the Neonatal Intensive Care Unit
(NICU) (Al-Ibraheemi et al., 2018; Carbone et al., 2013; Chen et al., 2015; Garba et al., 2016;
Levine et al., 2016; Schoen et al., 2017).
Significance
Nursing
The American Association of Nurses (ANA) (2015) reports understaffing due to pressure
to reduce labor costs often contributes to nurse-patient ratios that are not within patient safety
guidelines. Furthermore, often there is an imbalance of novice nurses to experienced nurses.
The World Health Organization (WHO) (n.d.) and Association of Women's Health, Obstetric and
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Neonatal Nurses (AWHONN) (2011) recommend that a woman should never be left unattended
while using oxytocin, misoprostol, or other prostaglandins. Often nurses are forced to practice
well outside the guidelines set forth by the ANA, WHO, and AWHONN, which can compromise
patient safety. As evidence in literature shows, the use of a Foley bulb in combination with
pharmacological agents can decrease time in labor by three to six hours and delivery within 24
hours from the start of the induction (Al-Ibraheemi, et al., 2018; Carbone et al., 2013; Chen et
al., 2015; Garba et al., 2016; Levine et al., 2016; Schoen et al., 2017). Reduced time in labor
with the implementation of a Foley bulb and pharmacological agent can help reduce unsafe
nurse-patient ratios.
Healthcare
Evidence-based practices have become the forefront of healthcare and help reduce the
cost associated with the demand for improvement in healthcare outcomes (Zimmerman, 2017).
Evidence-based practice improves quality, safety, and patient outcomes and reduces costs
(Zimmerman, 2017). Physician implementation of the combination of a Foley bulb and
pharmacological agents for induction of labor reduces healthcare costs by using evidence-based
practice for a positive impact on patient outcomes (Al-Ibraheemi et al., 2018; Carbone et al.,
2013; Chen et al., 2015; Garba et al., 2016; Levine et al., 2016; Schoen et al., 2017).
Furthermore, patient costs can be reduced because induction of labor with a Foley bulb and
pharmacological agent combination can reduce medication costs, as prostaglandins such as
misoprostol are relatively inexpensive (Roudsari et al., 2011).
Advanced Practice Nursing
Advanced Practice Nurse’s role in evidence-based practice is to ensure engagement at the
point of care (Moseley, 2012). Translation of evidence is the role of the Advanced Nurse
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Practitioner and, therefore, critical competencies such as clinical reasoning and leadership are
values that should be upheld (Sebastian et al., 2000). The leadership skills of the Advanced
Practice Nurse should effectively integrate evidence-based practices into organizational settings.
This process intervention for induction of labor supports the leadership skills of the Advanced
Practice Nurse.
Practice Support for Project
Discussions among colleagues in the Labor and Delivery practice setting have already
begun. This process was welcomed and supported by most healthcare providers, but some
resistance was anticipated. Staff nurses have expressed concern over implementing this process
as more work to their already busy workload. Concerns were addressed with all questions
answered.
Benefit of Project to Practice
This project will be beneficial to the Labor and Delivery practice setting due to the
reduced time to delivery. (Al-Ibraheemi, et al., 2018; Carbone et al., 2013; Chen et al., 2015;
Garba et al., 2016; Levine et al., 2016; Schoen et al., 2017). As mentioned earlier, nurses often
are forced to practice outside of the recommended guidelines. Implementing this process of
induction of labor can help nurses remain safely within the recommended guidelines.
Furthermore, practicing within recommended guidelines helps reduce nurse fatigue and turnover
rates.
Conclusion
Evaluating evidence-based practices and translating them into practice is imperative for
the best patient outcome. Implementation of new practices can be difficult and requires
collaboration among healthcare providers. Evidence-based practice has shown that an
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intracervical Foley bulb insertion in combination with a pharmacological agent is effective in
reducing a woman’s time in labor and physician implantation of this practice is beneficial to the
patient, facility, and healthcare workers. Patients will receive high-quality care with the best
patient outcomes, costs absorbed by the facility will be reduced, and nurse fatigue and turnover
will be reduced. Although it is the role of the Advanced Practice Nurse to translate and integrate
evidence-based practice into organizational settings, some resistance to change can be expected.
It is hoped that a process to change intervention can help alleviate resistance to implementation
of evidence-based practices.
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Chapter Two
Literature Search History
Search history for this literature review consisted of an online search through several
databases such as Cumulative Index of Nursing and Allied Health Literature (CINAHL) Plus
with Full Text-EBSCO Publishing, Cochran Database of Systematic Reviews, OVID
Technologies, Inc. (OVID), and Up-To-Date through the Maryville University online library.
Inclusion criteria for this literature review were articles that compared the use of a Foley bulb by
itself, the use of pharmacological agents, and the use of a combination of Foley bulb and
pharmacological agents for the induction of labor. Exclusion criteria consisted of articles that
did not use any mechanical induction methods for induction of labor. The key terms used were
misoprostol, induction of labor, mechanical induction, Foley bulb, transcervical catheter,
oxytocin, and cervical ripening were used to narrow the search. The search yielded 6,474
articles. The literature review was narrowed to articles published in English within the past ten
years. The results of the search produced nine articles that met inclusion criteria.
Integrated Review of Literature
Reduced Labor Time
Reduced time in labor may be beneficial to women undergoing induction of labor,
especially if life-threatening conditions such as preeclampsia, eclampsia, and hemolysis, elevated
liver enzymes, and low platelet count (HELLP) syndrome are present which can only be cured
with the delivery of the fetus (Bracken et al., 2014). Other indications for induction of labor
include rupture of membranes without labor, gestational hypertension, gestational diabetes,
intrauterine growth restriction (IUGR), oligohydramnios, post-dated pregnancy, chronic
hypertension, and diabetes (Bracken et al., 2014).
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Research indicated the combination of a Foley bulb and misoprostol could reduce a
woman’s time in labor. Al-Ibraheemi, Brustman, Bimson, Porat, & Rosenn (2018) compared
misoprostol alone to Foley bulb with misoprostol and found the time to delivery was
significantly shorter in the Foley bulb with misoprostol group. In a similar study Graham,
Nguyen, Sit, Morfin, & Garabedian (2018) had similar results in which a Foley bulb with
misoprostol was more favorable to achieve a shorter phase of active labor but found the
combination did not shorten induction-to-delivery time. Carbone, Tuuli, Fogertey, & Roehl
(2013) also concluded that the synergistic effect of the Foley bulb with misoprostol resulted in a
shorter induction-to-delivery time although it was not significant. Chen, Xue, Gaudet, Walker,
& Wen (2015) had similar results to Carbone et al. (2013) in that although Foley catheter in
combination with misoprostol yielded a shorter mean time to delivery than misoprostol alone, the
results were not significant. However, when low-quality trials were eliminated, it was
determined there was a significant reduction in time to deliver with the combination Foley bulb
and misoprostol (Chen et al., 2015).
Other methods of induction of labor have been compared using single agents. Noor,
Mehkat, Ali, & Parvee, (2015) compared misoprostol alone to Foley bulb alone and determined
that misoprostol alone was associated with significantly shortened induction-to-delivery time
than the Foley bulb. Roudsari et al. (2011) conducted a similar study and found the misoprostol
group also had a significantly shorter mean time to delivery. Roudsari et al. also found there was
no significance in time from induction to the active phase of labor in the misoprostol alone
group.
Further analysis of other pharmacological agents for induction of labor was considered
along with other variables. Schoen, Grant, Berghella, Hoffman, & Sciscione (2017) compared
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several factors such as parity and induction of labor methods that included comparing Foley bulb
induction with and without oxytocin. In both nulliparous and multiparous groups, it was
determined that time in labor yielded a shorter induction-to-delivery time in women who
received both Foley bulb concurrently with oxytocin.
Levine et al. (2016) further evaluated multiple induction of labor methods. These
methods included Foley bulb only, misoprostol only, Foley bulb with misoprostol, and Foley
bulb with oxytocin. Levine et al. concluded the combination groups yielded a faster mean time
to delivery then single method agents. Results in order from fastest time to delivery were Foley
bulb with misoprostol, Foley bulb with oxytocin, misoprostol alone, and Foley bulb alone
respectively. However, Garba et al. (2016) determined that misoprostol alone had a shorter
mean time to delivery than the combination of Foley bulb and oxytocin in both nulliparous and
multiparous women.
Maternal Outcomes of Traditional Versus Foley Bulb Labor
Maternal outcomes should be considered when choosing an induction of labor method
and, therefore, consideration for the best maternal outcome should be carefully examined. Al-
Ibraheemi et al. (2018) found there was no difference in cesarean section rates among either.
This finding was consistent with Graham et al. (2018). Furthermore, Carbone et al. (2103) did
not note a higher rate of cesarean section in either group of misoprostol or Foley bulb with
misoprostol. Noor et al. (2018) reported a higher rate of cesarean section among the Foley
catheter group compared to the misoprostol group although it was not significant. Rousari et al.
(2011) did, however, note a significantly higher vaginal delivery rate when comparing
misoprostol alone and Foley bulb alone. When comparing cesarean section rates between Foley
bulb with oxytocin and oxytocin alone, Schoen et al. (2017) noted there was no difference in
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mode of delivery between the two variables. Levine et al. (2016) can further corroborate the lack
of statistical significance in cesarean section rate among women who are induced with oxytocin
only, misoprostol only, Foley bulb combined with oxytocin, and Foley bulb combined with
misoprostol. Garba et al. (2016) reported no statistical difference in cesarean delivery rated
between induction of labor with Foley bulb combined with oxytocin and Foley bulb combined
with misoprostol. Chen et al. (2015) found cesarean delivery rates between induction of labor
methods was similar among women in both the Foley bulb combined with misoprostol and
misoprostol alone groups. Based on the studies mentioned above it can be determined there is not
a statistically significant difference in the rate of cesarean section with the use of a Foley bulb in
combination with a pharmacological agent for induction of labor.
Chorioamnionitis, an inflammation of the membranes and chorion of the placenta, is a
serious condition and is often bacterial (Tita & Andrews, 2010). Chen et al. (2015) found the
rate of chorioamnionitis was considered a significantly higher risk in the group induced with a
Foley catheter plus misoprostol versus the misoprostol alone group. Although the risk of
chorioamnionitis was higher in the combination group, there was no determination made as to
why the risk of chorioamnionitis was higher. Carbone et al. (2013) reported the risk of
chorioamnionitis was not significantly different among Foley bulb-misoprostol and misoprostol
alone groups. Al-Ibraheemi et al. (2018) and Graham et al. (2018) determined there was no
difference in chorioamnionitis rates among women induced with Foley bulb-misoprostol and
misoprostol alone. Schoen et al. (2017) determined there was no increased risk of
chorioamnonoitis between inductions of labor with Foley bulb in combination with oxytocin
compared to oxytocin alone. For the most part, research determined there was no statistical
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significance of increased rate of chorioamnionitis. However, this outcome should be interpreted
with caution and further studied.
Uterine tachysystole is a contributory factor to uterine rupture and fetal hypoxia. Chen et
al. (2015) noted a significant decrease in uterine tachysystole with fetal heart rate changes in the
group induced with a Foley bulb plus misoprostol. Chen et al. (2015) report this finding could
be beneficial to women with risk factors associated with an increased rate of fetal hypoxia such
as intrauterine growth restriction (IUGR), sickle cell anemia, or a chronic disease. Al-Ibraheemi
et al. (2018) noted no difference between the misoprostol alone and Foley bulb misoprostol
groups. Carbone et al. (2013) came to the same conclusion. However, Garba et al. (2016)
reported increased uterine tachysystole was present in the misoprostol-only group when no
uterine tachysystole was noted in the Foley catheter-oxytocin group. Schoen et al. (2017) also
noted no statistical significance associated with increased uterine tachysystole in either the Foley
bulb-oxytocin or oxytocin alone groups. Roudsari et al. (2011) found no correlation for
increased uterine tachysystole in relation to misoprostol or Foley bulb. Noor et al. (2015) also
determined there was no significant increased rate of uterine tachysystole with misoprostol or
Foley bulb induction of labor.
Additional maternal outcomes such as estimated blood loss (EBL) and uterine rupture
were measured. Al-Ibraheemi et al. (2018) determined there was no difference in EBL between
women receiving Foley bulb-misoprostol combination versus misoprostol alone. Graham et al.
(2018) had the same findings. Carbone et al. (2013) also had the same findings. Garba et al.
(2016) found increased EBL in the Foley bulb oxytocin group compared to the misoprostol alone
group, although this finding was not statistically significant. Schoen et al. (2017) found no
difference in EBL when comparing Foley bulb alone with Foley bulb with oxytocin.
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Furthermore, in the studies discussed above, there was no instance of uterine rupture among any
of the groups studied.
Neonatal Outcomes for Traditional versus Foley Bulb Delivery
Apgar scores, taken at one minute and five minutes of life, are used to evaluate the
newborn’s condition at birth and need for resuscitation (ACOG, 2017b). Al-Ibraheemi et al.
(2018) found no difference in Apgar scores when comparing Foley bulb and misoprostol and
misoprostol alone. Likewise, Carbone et al. (2013) found no adverse effects on Apgar scores
when comparing Foley bulb-misoprostol to misoprostol alone. When comparing four groups:
Foley bulb alone, misoprostol alone, Foley bulb-misoprostol, and Foley bulb oxytocin Levine et
al. (2016) found no difference in Apgar scores among the groups. Garba et al. (2016) found
slightly higher Apgar scores at one minute in the combination Foley bulb and oxytocin group,
but the five minute Apgar score was higher in the misoprostol alone group but neither was
significant. Schoen et al. (2017) also found no significant difference between NICU admissions
with induction of labor with Foley bulb-oxytocin versus the Foley bulb alone. Noor et al. (2015)
observed no difference in either group studied when comparing Foley bulb alone versus
misoprostol alone. In a similar study, Roudsari et al. (2011) also determined there was no
difference between the groups studied.
Meconium-stained amniotic fluid is a possible sign of fetal hypoxia, often caused by a
uterine event, which causes fetal gasping (Sori, Belete, & Wolde, 2106). It is also considered a
potential toxin if is aspirated by the fetus when taking its first breath after birth (Sori, Belete, &
Wolde, 2106). Al-Ibraheemi et al. (2018) found a higher rate of meconium-stained amniotic
fluid among the misoprostol alone group compared to the Foley bulb and misoprostol group.
Chen et al. (2015) determined there was no difference in the occurrence of meconium-stained
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amniotic fluid between the Foley bulb and misoprostol and misoprostol alone groups. Garba et
al. (2016) found there was no meconium-stained amniotic fluid in the Foley bulb and oxytocin
combination group, however, when compared to the misoprostol alone group there was not a
significant difference. Schoen et al. (2017) determined there was no increase in meconium-
stained amniotic fluid between induction of labor with a Foley bulb-oxytocin combination and
induction of labor with Foley bulb alone. Noor et al. (2015) examined Foley bulb alone versus
misoprostol alone and found no significant difference between the two groups. Roudsari et al.
(2011) further determined there was no difference in the occurrence of meconium-stained
amniotic fluid when comparing Foley bulb alone versus misoprostol alone for induction of labor.
Neonatal Intensive Care Unit (NICU) can have profound effects on both the newborn and
the family as a whole. Al-Ibraheemi et al. (2018) found no difference in NICU admissions when
comparing the Foley bulb and misoprostol group to the misoprostol alone group. Chen et al.
(2015) also determined there was no difference in NICU admissions between the Foley bulb and
misoprostol and misoprostol alone groups. In a similar study, Graham (2018) further concluded
there was no difference in NICU admissions among the Foley bulb-misoprostol and misoprostol
alone groups. Carbone et al. (2013) also observed no difference in NICU admissions between
the Foley bulb-misoprostol and misoprostol alone groups. Levine et al. (2016) reported there
were no increased NICU admissions among the Foley bulb alone, misoprostol alone, Foley bulb-
misoprostol, and Foley bulb oxytocin groups. Whereas Garba et al. (2016) noted NICU
admissions in both groups and a slightly higher occurrence in the misoprostol alone group
although it was not significant in comparison to the Foley bulb-oxytocin combination group.
Schoen et al. (2017) compared Foley bulb-oxytocin combination and induction of labor with
Foley bulb alone and found no increased NICU admissions in either group. Noor et al. (2015)
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determined there was no difference in the occurrence NICU admissions when comparing Foley
bulb alone versus misoprostol alone.
Additional neonatal outcomes that were considered such as neonatal blood transfusions,
hypoxic ischemia, necrotizing enterocolitis, neonatal sepsis, severe respiratory distress
syndrome, and head cooling showed no statistically significant differences among studies listed
above (Chen et al., 2015; Levine et al., 2016). These factors provide evidence that the methods
of induction of labor discussed above do not contribute to poor neonatal outcomes.
Literature Critique
Strengths
The research studies included in this research presented an analysis of various methods of
induction of labor. There is a strong quality of evidence that supports the use of a Foley bulb in
combination with a pharmacological agent. In addition, strengths that are present across multiple
studies are the evaluation of maternal and neonatal outcomes (Al-Ibraheemi, et al., 2018;
Carbone et al., 2013; Chen et al., 2015; Garba et al., 2016; Graham et al., 2018; Levine et al.,
2016; Noor et al., 2015; Roudsari et al., 2011; Schoen et al., 2017). The studies used in this
research included a wide variety of variables such as race, socioeconomic factors, age,
gestational age, parity, and Bishop score that support the use of a Foley bulb in combination with
a pharmacological agent (Al-Ibraheemi, et al., 2018; Carbone et al., 2013; Chen et al., 2015;
Garba et al., 2016; Graham et al., 2018; Levine et al., 2016; Noor et al., 2015; Roudsari et al.,
2011; Schoen et al., 2017). Furthermore, randomized control trials may lend a hand in
strengthening the evidence (Al-Ibraheemi, et al., 2018; Carbone et al., 2013).
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Although there was a small sample size used in some of the studies overall, the quality of
evidence remains strong for the use of a Foley bulb in combination with a pharmacological agent
for reduced time in labor. The use of a meta-analysis contributed to the strength of this research.
Weaknesses
All interventions in the research studies were evaluated with some weaknesses noted. A
variation in fluid volume in Foley bulbs was inconsistent among the studies, as well as the
catheter size (Al-Ibraheemi, et al., 2018; Carbone et al., 2013; Chen et al., 2015; Garba et al.,
2016; Graham et al., 2018; Levine et al., 2016; Noor et al., 2015; Roudsari et al., 2011; Schoen et
al., 2017). Dose, route (oral versus vaginal versus rectal), and time between administrations of
misoprostol were contributed as a weakness (Al-Ibraheemi, et al., 2018; Carbone et al., 2013;
Chen et al., 2015; Garba et al., 2016; Graham et al., 2018; Levine et al., 2016; Noor et al., 2015;
Roudsari et al., 2011). Furthermore, the studies although blinded to the researchers, were not
blinded to the physicians (Al-Ibraheemi, et al., 2018; Carbone et al., 2013; Chen et al., 2015;
Garba et al., 2016; Graham et al., 2018; Levine et al., 2016; Noor et al., 2015; Roudsari et al.,
2011; Schoen et al., 2017).
Gaps in Evidence
The literature review focused on the effects of a Foley bulb on the induction of labor,
however, gaps in evidence existed. There were four major gaps found in the evidence related to
induction of labor. The first major gap identified was administration of misoprostol was
incongruent among the studies, which could skew the results (Al-Ibraheemi, et al., 2018;
Carbone et al., 2013; Chen et al., 2015; Garba et al., 2016; Graham et al., 2018; Levine et al.,
2016; Noor et al., 2015; Roudsari et al., 2011). Delaying administration of misoprostol may
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lengthen the time in labor. Although the delays in misoprostol administration were medically
indicated due to uterine tachysystole, it should still be considered a gap in evidence.
The second major gap was incongruent oxytocin increase intervals can lengthen the time
in labor. AWHONN (2011) standards for oxytocin administration state oxytocin should be
increased by two milliunits every 30 minutes until there is an average of three contractions every
10 minutes. If these standards were not followed or oxytocin administration was stopped due to
uterine tachysystole the research results could be skewed. All studies were dependent on nurse
or physician administration of misoprostol and oxytocin, as well as Foley bulb placement. (Al-
Ibraheemi, et al., 2018; Carbone et al., 2013; Chen et al., 2015; Garba et al., 2016; Graham et al.,
2018; Levine et al., 2016; Noor et al., 2015; Roudsari et al., 2011; Schoen et al., 2017).
The third major gap was inconsistency in both Foley bulb size and fluid volume. These
factors were physician dependent and may have skewed results. (Al-Ibraheemi, et al., 2018;
Carbone et al., 2013; Chen et al., 2015; Garba et al., 2016; Graham et al., 2018; Noor et al.,
2015; Roudsari et al., 2011; Schoen et al., 2017). This gap can easily be closed with regulations
of Foley bulb size and fluid volume.
The fourth gap is a lack of studies that examine all methods of induction of labor
discussed (Al-Ibraheemi, et al., 2018; Carbone et al., 2013; Chen et al., 2015; Garba et al., 2016;
Graham et al., 2018; Levine et al., 2016; Noor et al., 2015; Roudsari et al., 2011; Schoen et al.,
2017). Closing this gap with additional studies would provide an excellent analysis of the best
method for induction of labor. Further regimented studies on misoprostol placement and
oxytocin administration along with a standard sized Foley bulb and amount of normal saline used
need to be evaluated.
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Limitations
Levine et al., (2016) noted limitations that included healthcare workers and patients that
were not blinded due to required examinations related to methods of induction. Studies that
include identical protocols for Foley bulb size and fluid volume should be considered in order to
validate results from the studies discussed above (Schoen et al., 2017). Further limitations were
the use of participants who were considered postdated, or 41 weeks gestational age (Garba et al.,
2016). Further studies should be done that include other medical indications for induction of
labor such as pregnancy-induced hypertension and diabetes mellitus and elective inductions.
Larger studies should also be done to further evaluate adverse maternal and neonatal outcomes
(Al-Ibraheemi, et al., 2018; Carbone et al., 2013; Chen et al., 2015; Garba et al., 2016; Graham et
al., 2018; Levine et al., 2016; Noor et al., 2015; Roudsari et al., 2011; Schoen et al., 2017).
Concepts and Definitions
Induction of labor: Initiation of uterine contractions by medical and/or surgical means for the
purpose of delivery before the spontaneous onset of labor (i.e., before labor has begun) (CDC,
2014).
Bishop score: score to rate the readiness of the cervix for labor ranging from 0–13. A Bishop
score of less than six indicates the cervix may not be ready for labor (American College of
Obstetricians and Gynecologists (ACOG), 2017a).
Active labor: accelerated cervical dilation typically beginning at six centimeters (ACOG, 2014a).
Latent labor: from the onset of labor to the active phase (ACOG, 2014a).
Oxytocin : a hormone that causes contractions of the uterus (ACOG, 2017a).
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Barbalace, Karen, Maryville, 2019
Chorioamnionitis: acute inflammation of the membranes and chorion of the placenta, typically
due to a bacterial infection (Tita & Andrews, 2010).
Uterine tachysystole: more than five contractions in 10 minutes averaged over 30 minutes, can
occur spontaneously or because of uterotonic agents (i.e., oxytocin or prostaglandins) and can be
associated with fetal heart rate changes (ACOG, 2014b).
Post-term : 42 weeks or greater gestation age (ACOG, 2013).
Nulliparous: a woman with a parity of zero (ACOG, 2014a).
Parity: The number of pregnancies reaching 20 weeks and 0 days of gestation or beyond,
regardless of the number of fetuses or outcomes (ACOG, 2014a).
Vertex or cephalic presentation: A fetal presentation where the head is presenting first in the
pelvic inlet (ACOG, 2014a).
HELLP syndome (hemolysis, which is the breaking down of red blood cells, elevated liver
enzymes, low platelet count) - a life-threatening pregnancy complication usually considered to
be a variant of preeclampsia. Both conditions usually occur during the later stages of pregnancy,
or sometimes after childbirth (Preeclampsia Foundation, 2015).
Theoretical Framework
Change is needed to grow from a current state to a desired state that keeps up with ever-
changing evidence-based healthcare practices. Kurt Lewin’s change theory model is an
approach to change and is based on a three-step process: Unfreeze-Change-Freeze (Nursing
Theory, n.d.). Unfreezing is the driving force or need for change. This stage involves a general
idea and planning to begin. Research and fact-finding are instrumental and may result in
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modifications to the changes necessary, as well as to overcome individual resistance and group
conformity (Nursing Theory, n.d.). After determining a current change in practice must be
made, a method for implementing the change must be determined (Lewin, 1997). This method
must help move in the direction of the change. The next step in Lewin’s change theory involves
the actual change in practice. This step includes the actual change in thoughts, feelings, or
behaviors or all three. In other words, executing the plan. This step includes constant
reevaluation to determine any strengths or weaknesses associated with the change that was put
into place (Lewin, 1997). Last is the freeze step, which involves maintaining the change to avoid
returning to old habits (Nursing Theory, n.d.).
Lewin (1997) tested his hypothesis to determine the effect of the individual against group
settings. This was an attempt to determine if teams would keep their relationship after the
workshop ended, giving rise to the greater chance of continued enthusiasm and group
productivity to bring about change. Lewin (1996) found that continued support after the freeze
phase helped instill the changes that were made.
Lewin’s change theory model provided the framework needed to implement the process
to change the culture from a traditional approach of labor induction to an evidence-based
approach.
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Chapter Three
Methodology
A quantitative, exploratory design was utilized to determine the effectiveness of this
program. This study consisted of three phases, based on Lewin’s model; (1) Unfreeze; (2)
Change; and (3) Refreeze. During the Unfreezing period the author of this project observed that
providers at a hospital located in the Midwest region of the United States were using traditional
methods for cervical ripening as opposed to an evidence-based approach indicating a need for
change. After discussion with the Labor and Delivery director and support was obtained, an
educational presentation was developed. During the Change period the author of this project
implemented this educational presentation with each physician individually, supporting a
personalized touch. The author of this project kept tract of whenever a physician utilized this
method to be available to answer any questions and continue to reinforce the use of this method.
During the Refreezing period of this project the author continues to monitor the utilization of this
method and discuss its success with collaborating providers. Continued support for both
physicians and healthcare staff members will help solidify this change in practice. Without this
stage, old habits may reemerge.
After a 16 week period a retrospective chart review was conducted to determine if the
following questions were answered (1) Does personalized education on intracervical Foley bulb
insertion along with pharmacological agents for labor induction increase the use of this method
by physicians; (2) Does use of Foley bulb insertion along with pharmacological agents improve
maternal outcomes
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Design
This intervention was conducted at a Labor and Delivery department in the Midwest
Region of the United States. After obtaining administrative approval, the project began on July
23,2018. All five of the physicians who deliver at this facility participated in a one on one
educational presentation. The author of this project presented information in regard to current
evidence-based practice for the induction of labor and the various methods that are used,
concluding with the evidence to support the recommendations for Foley bulb insertion in
combination with pharmacological agents as the most recommended approach. The author
monitored for the use of this method and then discussed the results with each physician and
answered any questions they may have had. This information was shared with the other
physicians and staff creating a snow-ball effect. Encouragement to continue using this method
was reinforced by the author of this project.
Needs Assessment
Prior to this intervention, no consistent process was in place to address induction of labor
choices, the method was completely up to the attending physician. The following strategies were
implemented to improve the use of EBR to include the use of intracervical Foley bulb insertion
along with pharmacological agents: (1) an educational intervention was presented to individual
physicians for induction of labor with Foley bulb insertion in combination with a
pharmacological agent, (2) to reinforce success physicians were encouraged to try this method by
the author who then followed up with physicians to answer any questions and continue to
reinforce the use of this method. This pilot project will determine the effectiveness of the
program designed to increase the use of Foley bulb insertion in combination with a
pharmacological agent by physicians for the induction of labor to improve maternal outcomes.
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Research Question
Does personalized education on intracervical Foley bulb insertion in combination with
pharmacological agents for labor induction, increase the use of this method by physicians and
does use of Foley bulb insertion in combination with pharmacological agents decrease labor
time?
Data Collection Instruments
Sixty electronic medical records (EMRs) were reviewed for this project. This number
yielded a power of 0.80. The data extracted from the EMRs were from an adult population. The
age of the female patients were 18 years or older. The data extracted from the EMRs were from
patients who had labor induced at the hospital from July 23, 2018 - November 10, 2018.
Inclusion criteria for the participants’ EMR to be included in data collection were: (a) 18 years or
older; (b) induction of labor at the hospital between July 23, 2018 - November 10, 2018.
Exclusion criteria consisted of the following (a) less than 18 years of age; (b) induction of labor
at the hospital before July 23, 2018 and after November 10, 2018. A sequential inclusion and
exclusion process were continued until the determined 60 EMRs was achieved.
Analysis Plan
It was determined that prior to the implementation of this project no physician had used
Foley bulb insertion with or without pharmacological agent. Evidence based research was not
being followed. A retrospective chart review was done sixteen weeks following the
implementation of this project. A Fisher’s Exact test was used to assess physician usage of the
Foley bulb in combination with a pharmacological agent for induction of labor. To determine
the difference of time in labor with pharmacological agents alone compared to a Foley bulb in
combination with pharmacological agents a Z-score analysis was done.
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Budget
This research study was done on a minimal budget. Costs included a ream of paper to
print presentations, and printed spreadsheets, ten presentation folders, black and color printer ink,
and tax. The researcher utilized the computer at her place of employment for data collection.
Protection of Human Subjects
The hospital location will be described as being located in the Midwest region of the United
States without any specifics about the exact location of the clinic. As this is a retrospective chart
review, there is no foreseeable risk to the subjects beyond the potential risk of breach of
confidentiality. The medical records used will be given a number and all potential identifiers
will be removed. The data collected will be stored on a password-protected computer in the
researcher’s office. Access to the password and office is strictly limited to the author. Data will
be destroyed when the project is completed.
Resources
Having the approval and support from the Labor and Delivery unit was an invaluable
resource. Resistance to change especially when things have never been done this way can be
very difficult. Evidence-based practice was presented to each physician individually. During
each presentation physicians asked questions that were answered according to research that had
been done for the presentation. Each physician was provided with a folder containing the
presentation as well as the American College of Obstetricians and Gynecologists (AGOG)
standards for placement of intracervical Foley bulb for induction of labor and a few key articles
used for research.
The Unit Director was approached, and the appropriate documentation resources were
requested and added to the electronic medical record (EMR) in order to easily track the use of
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Barbalace, Karen, Maryville, 2019
Foley bulbs for induction of labor. The Unit Director contacted the Information Technology (IT)
Department and requested the documentation be added to the EMR. This step took about one
week to complete and provided the ability to easily track Foley bulb usage providing it had been
adequately charted.
Nurses on the Labor and Delivery Unit were provided with education on how to properly
document the use of a Foley bulb for induction of labor. All questions were answered at the time
of the presentation and throughout the project.
Project Timeline
Approval to begin implementation of this project was obtained from the Labor and Delivery
unit director August 1, 2018. Approval from Maryville University IRB was obtained January 5,
2019 and approval from the hospital IRB was obtained on December 21, 2018. Data collection
began on Jan 15, 2019 and was completed on Jan 20, 2019. Finalization of the writing of this
paper was concluded on April 4, 2019. To complete the entire project, a strict timeline was
followed.
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Barbalace, Karen, Maryville, 2019
Chapter Four
Findings
Data Collection Method
The data was collected at a Labor and Delivery unit in the Midwest Region of the United
States. Implementation of this program began on July 23, 2018. After a 16-week implementation
period a retrospective chart review was conducted. The intended sixty electronic medical records
(EMRs) were accessed by the researcher. The instrument utilized for data collection was
completed by the researcher after an extensive literature review. As data was gathered it was
coded by the primary investigator and entered into an Excel spreadsheet for analysis.
Target variables
Basic variables such as age, method of induction of labor, and the length of labor was
collected from EMRs as well as each physician’s usage of the combination of Foley bulb and
pharmacological agents was evaluated. The rationale for collecting this type of data was that a
minimal criterion was needed to determine the outcome of this project. All patients were female
and were 18 years or older. The following data was collected from medical records (a) method of
induction pharmacological agent only; (b) method of induction Foley bulb only; (c) method of
induction combination Foley bulb with pharmacological agent; and d) length of labor time. A
sequential inclusion and exclusion process continued until the determined 60 medical records
were obtained. Collection of these variables enabled this researcher to be able to answer the
following questions (1) Does personalized education on intracervical Foley bulb insertion along
with pharmacological agents for labor induction increase the use of this method by physicians,
and (2) Does use of Foley bulb insertion along with pharmacological agents for labor induction
decrease labor time.
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Data Collection and Analysis
To answer the question ‘Does personalized education on intracervical Foley bulb
insertion in combination with pharmacological agents for labor induction increase the use of this
method by physicians?’ a Fisher's Exact Test was run on the data of no physicians (0/5 or 0%)
using the bulb before the intervention and five physicians (5/5 or 100%) using it afterwards as
seen in Figure 1. The results were X2 = (1) 10, p = .001, indicating there was a significant
statistical difference following the intervention. Before the intervention no physicians had used a
Foley bulb either alone or with a pharmacological agent. Once the intervention took place
physicians used a combination of a Foley bulb and a pharmacological agent for 23 labor
inductions (32%) compared to the traditional method 37 labor inductions (68%) with a
pharmacological agent alone. Although the inductions of labor using both Foley bulb and
pharmacological agent is still lower than pharmacological agent alone the method is growing in
popularity.
Figure 1
Before After 0123456
Physicain use Of Fo-ley with Pharmaco-
logical agent
Physicain use Of Foley with Pharmaco-logical agent
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Barbalace, Karen, Maryville, 2019
To answer the second question ‘Does use of Foley bulb insertion in combination with
pharmacological agents decrease labor time?’
The study showed the average time from start of induction of labor to deliver was 10.19
hours when Foley bulb with pharmacological agent was used, as opposed to 13.94 labor time
when only pharmacological agent was used as shown in Figure 2. A Z-score analysis was
conducted, the outcomes reveal a p value = 0.00016. A small p-value (≤ 0.05) indicates strong
evidence that the use of the Foley bulb in combination with pharmacological agents has shown to
significantly decreased time in labor.
Hours 0
2
4
6
8
10
12
14
16
Time in Labor
Foley bulb with pharmacological agent
Phamacological agent alone
Figure 2
Congruency Among Variables
Data collection is congruent with the measurements associated with the data collection
model, as there are no additional outliers to be contended with. Of the 60 post-intervention
EMRs reviewed, twenty-three women were induced with the Foley bulb in combination with
pharmacological agents, which has shown to significantly decreased time in labor. All five
physicians used a combination of a Foley bulb and a pharmacological agent after the
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Barbalace, Karen, Maryville, 2019
intervention, indicating strong congruence among the data collection instrument and the data
collected.
Validity and Reliability
Validity is the credibility of research findings (Polit & Beck, 2017). A retrospective chart
review was used for this scholarly project to determine if the combination of a Foley bulb and a
pharmacological agent was being used as a method of labor induction and decreased the amount
of time in labor from the start of the induction to delivery. Throughout the process of my
scholarly project several steps were taken to ensure validity and reliability of the project. The
success of this project relied greatly on the nurses appropriately charting Foley bulb usage. To
ensure success of proper charting this education was provided in alignment with the presentation
phase with the physicians. Reminders were placed at every computer at the nurse’s station to
further ensure the reliability and validity of this project. The Unit Director was approached, and
the appropriate documentation resources were requested and added to the electronic medical
record (EMR) in order to easily track the use of Foley bulbs for induction of labor.
The presentation for the physicians, the request for added documentation to the EMR,
and the education provided to the unit nurses were carefully thought out steps to ensure the
validity and reliability of this project. Simple data was collected with an inclusion and exclusion
criteria. The data extracted was only as good as the information that was put into the chart by the
physicians and nurses, which both were encouraged to consistently chart the use of Foley bulbs
in combination of pharmacological agents. Without these steps this scholarly project may have
been difficult to track and rendered invalid.
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Barbalace, Karen, Maryville, 2019
Chapter Five
Discussion
This pilot study demonstrates that the process change intervention was effective in
increasing the usage of a Foley bulb in combination with pharmacological agents for induction of
labor, which was a primary aim of the project. One hundred percent of the physicians who were
formally presented with EBP have verbalized his or her satisfaction and implemented the usage
of a Foley bulb in combination with pharmacological agents for induction of labor. Physicians
have verbalized their satisfaction in this project and indicate they will continue to use this
method of induction of labor in the future. Prior to this project 0% of women had induction of
labor utilizing Foley bulb insertion along with pharmacological agent, after the implementation
of this project 32% of the time this method is being utilized.
A secondary aim of this pilot study was to determine if the use of a Foley bulb in
combination with pharmacological agents for induction of labor decreased time in labor from the
start of the induction to delivery of the infant. This was accomplished by demonstrating the
statistically significant decreased time in labor by almost 3 hours less, with the usage of a Foley
bulb in combination with pharmacological agents for induction of labor. This finding is
consistent with the current research for utilization of this method.
Limitations
Although the findings are statistically significant, it is important to note that they are
limited in generalizability due to the small sample size. Moreover, future studies would benefit
from a longer period of data collection. A larger group of physicians and a larger sample size of
EMRs would lend greater credibility to the results.
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Barbalace, Karen, Maryville, 2019
Another limitation is possible sampling bias that could have been introduced. The project
took place at the researcher’s place of employment. Therefore, the increase in the use of a Foley
bulb in combination with pharmacological agents for induction of labor may not have been as
successful without the researcher’s presence on the unit. Upon further review it is also noted by
the researcher that this type of sampling has some inherent bias when compared to random
sampling methods, as it may not be fully representative of all inductions of labor (Polit & Beck,
2017).
Translation of Findings into Practice
I believe that part of the success of this program may have been the personalized
approach that was taken with each physician. Initially when this researcher suggested this
method, it was met with resistance as the physicians had never done things this way and they
were comfortable in their ways of doing things. This was also a hospital where things had been
done this way for years and introduction of change was not very welcome. However, by taking
the time to explain the process one on one a bond was formed. This researcher presented the
evidence in a friendly and informative way that was personalized to each physician on their time.
After one or two physicians tried this method and success was seen this started a snowball effect
encouraging others to try the method. I believe more research needs to be done to show the
effects of process change interventions so that implementing new evidence based research into
practice becomes more readily acceptable.
Summary
Using the most up to date evidence-based practices for induction of labor is ideal for the
best maternal and fetal outcomes. DNP nurses are trained to synthesize existing research that can
be used to inform others and to formulate improvements in outcomes. It is hoped that this small
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quality improvement study will be used as a stepping stone for physicians to make the changes
needed in their own practice.
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Barbalace, Karen, Maryville, 2019
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