Chapter 1: Statement and Significance of the Problem
- Introduction to the problem
- Significance to Women’s health
- Significance to Midwifery
Chapter 2: Review of Literature & Conceptual Framework
- Brief Restatement of the Problem
- Explanation of Search Results
- Study 1
- Study 11
- Study 111
- Study 1V
- Study V
- Conceptual Framework
- Conceptual Map
Chapter 3:- Quantitative Research Proposal
- Threats to internal and external validity
- Sampling Methods
- Ethical considerations
- Data collection Procedures
- Data analysis plan for each research question/hypothesis
- Strengths and Limitations
- Plan for disseminating findings
Meconium Aspiration syndrome (MAS) is defined as the presence of respiratory distress and hypoxemia in an infant, resulting in indications for admission to a Neonatal Intensive Care Unit (NICU) and a prolonged hospital stay. MAS can lead to morbidity and mortality among infants born through meconium-strained amniotic fluid (MSAF), which occurs in approximately 10-15% of all deliveries. Approaches to the prevention of MAS have changed over time, and MAS prevention remains one of the most common challenges for midwives and other healthcare providers. While recent studies have found no benefits to oropharyngeal and nasopharyngeal suctioning before the delivery of the infant’s shoulders or to postnatal suctioning in vigorous MSAF infants, it nonetheless still seems a reasonable practice for infants born in communities with limited resources (Lurdakok, 2011). The Normalization Process Model will be used as a guiding framework in this inquiry to help explore and review the outcomes of suctioning the upper airway of infants born through meconium-stained amniotic fluid before the shoulders are delivered and after the birth process, compared to no suctioning of infants.
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A Survey of Midwife Management of Infants Born through Meconium-Stained Amniotic Fluid
Chapter 1: Statement and Significance of the Problem
Introduction of the Problem
Midwifery management for the prevention of Meconium Aspiration Syndrome (MAS) in infants has changed markedly in the United States. In the past, all infants born through MSAF underwent oropharyngeal and nasopharyngeal suctioning before the delivery of the infant’s shoulders; postnatal suctioning was also used in vigorous infants in an effort to clear the airway and reduce the incidence and severity of MAS. However, current studies have shown that this management did not establish benefits in the prevention and reduction of incidences of MAS. In addition, as of 2005 the Neonatal Resuscitation Program (NRP) of the American Academy of Pediatrics has no longer recommended routinely suctioning the upper airway of all infants born through meconium before delivering the shoulders (Whitfield, Charsha, & Chiruvolu, 2009). There was some disagreement among NPR steering committee members during the development of this recommendation. Several members felt that this recommendation should not be interpreted to mean that intrapartum suctioning of infants born through MSAF is contraindicated. They believed that this form of management still seemed reasonable and could provide the benefit of clearing the oropharynx in case of a need for the visualization of the trachea in direct suctioning (Kattwinkel, 2008).
In clinical settings, adherence to the norms and recommendations of the NRP is not uniform. In addition, some studies still recommend intrapartum suctioning in case of MSAF where the infants are born in communities with limited resources (Lurdakok, 2011). Much contention has developed as to whether there is any benefit to vigorous infants from this intervention. in reducing the incidence of MAS. Also this research seeks to find out whether there is any benefit to depressed infants from suctioning the upper airway before the shoulders are delivered and given to the neonatal team. There are currently no studies either supporting or refuting this practice. Depressed infants are already required to undergo clearing of the upper airway prior to intubation for tracheal suctioning.
The passage of fetal meconium, resulting in MSAF, occurs in < 5% of preterm deliveries, 7-22% of term deliveries, and 23-52% of deliveries with a >42 weeks gestation (Xu, Wei, & Fraser, 2008). It occurs primarily in situations of advanced fetal maturity or fetal distress. MAS is associated with aspiration or diffusion of meconium into the fetal airway, which causes respiratory distress and hypoxemia during or just before the delivery. MSAF is commonly seen in approximately 10-15% of all deliveries, and at least 5% of affected infants develop true MAS (Fanaroff, 2008).
Significance to Women’s Health
Studies have shown where MAS does not affect women’s health directly, but it may cause psychosocial negative outcomes such as stress, anxiety, and a perceived loss of control in the provision for the infant’s health. MAS is a serious condition in infants; more than 4% of affected infants die, accounting for 2% of all perinatal deaths (Fanaroff, 2008). MAS can cause respiratory manifestations including respiratory distress, tachypnea, cyanosis, and air trapping, together with reduced pulmonary compliance (Fanaroff, 2008), which present indications for admission to the NICU and for a prolonged hospital stay.
In addition, most mothers with an infant in the NICU are vulnerable because a relationship has not been established with their infant. Separation may interrupt the mother-infant attachment process, and can result in negative outcomes such as an inability to promote breastfeeding exclusively, initiating postpartum depression, and a predisposition towards delayed infant development.
Significance to Midwifery
Meconium aspiration is a major complication, which leads to highly variable morbidity and mortality in affected infants, resulting in midwife liability risk. According to the American College of Nurse-Midwives (ACNM) (2010), in order to reduce liability risk, midwives must provide an appropriate response and recognize conditions, situations, and outcomes that may be associated with professional liability claims. Midwifery strategies for liability risk reduction may include management of labor and birth in accordance with evidence based practice and/or institutional guidelines. It requires provision of immediate neonatal resuscitation, utilization of the appropriate level of neonatal care, and facilitation of the mother-infant attachment.
Furthermore, an improvement of the health and well-being of women and their infants is the goal of Health People 2020. The prevention and reduction of morbidity and mortality are included in objectives for maternal, infant, and child health topic area (Healthy People, 2012). The goal of this study is not only to reduce liability risk for midwives, but also promote prompt and appropriate care for MAS-affected infants. This is expected to minimize the effects of MAS and improve infant outcomes in order to achieve the goal of Healthy People 2020.
Chapter 2: Review of Literature & Conceptual Framework
Brief Restatement of the Problem
Midwifery management for prevention of MAS in infants has changed markedly in the United States. Current studies reveal that suctioning all infants born through MSAF before the delivery of the shoulders is not beneficial for reducing the incidence and severity of MAS. Furthermore, the Neonatal Resuscitation Program (NRP) of the American Academy of Pediatrics no longer recommends routine suctioning of the upper airway for all infants born through meconium before delivering the shoulders (Whitfield, Charsha, & Chiruvolu, 2009). However, this practice persists in many clinical settings. Therefore, adherence to the norms and recommendations of the NRP became inconsistent across the obstetric nursing environment. Some studies still recommend intrapartum suctioning in case of MSAF when infants are born in communities with limited resources (Lurdakok, 2011).
The methods used to identify and retrieve articles were browsing Philadelphia University Guttman Library along with Google Scholar. Keywords meconium, intrapartum suction, meconium aspiration syndrome, and midwife management meconium became the focus of this scrutiny. However, the number of available current articles (2007-2012) was very limited. Five articles were chosen for this inquiry, and some related articles were more than five years old.
Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicenter randomized controlled trial by Vain, Szyld, Prudent, Wiswell, Aguilar and Vivas (2004) was the first valuable research found.
Statement of Purpose
The purpose of this study was to assess the effectiveness of intrapartum oropharyngeal and nasopharyngeal suctioning compared with no suctioning in the prevention of meconium aspiration syndrome (MAS) and its complications.
A sample of eleven hospitals in Argentina and one in the United States participated in the randomized controlled trial. Participants were 1,263 patients with meconium-strained amniotic fluid (MSAF) of any consistency, gestational age of 37 weeks or longer, with cephalic pelvic presentation. They were enrolled under a ‘no informed consent’ protocol, which was approved by the institutional review boards of all participating institutions, as well as an independent ethics committee at the University of Buenos Aires. Infants were randomly allocated to either suctioning of the oropharynx and nasopharyns before delivery of the shoulders, or no suctioning. Computer-generated numbers were used to randomly assign groups. These were sealed in envelopes, which were opened immediately before attendance at deliveries complicated by meconium staining. In the suction group, intrapartum suctioning was undertaken with an appropriately sized suction catheter connected to negative pressure of 150 mmHg. Oropharyngeal suctioning was done first, followed my bilateral nasopharyngeal suctioning. No pharyngeal suctioning was undertaken after delivery unless airway obstruction was clinically apparent. Tracheal suction was done only in the case of non-vigorous infants (Vain, Szyld, Prudent, Wiswell, Aguilar and Vivas, 2004)
The primary outcome was incidence of MAS, which included respiratory distress, the need for supplemental oxygen to maintain oxygen saturation level at 92% or greater, oxygen requirements started during the first 2 hours of life and lasting for 12 hours or longer, and absence of congenital malformation of the airway, lung, or heart. A major secondary outcome was mortality, the incidence of severe MAS, air leaks, occurrence of other disorders causing respiratory distress, and duration of oxygen treatment, mechanical ventilation, and hospitals stay. The effect of intrapartum suctioning in the following high-risk subgroups include thick-consistency MSAF, abnormal fetal heart rate patterns during labor, cesarean delivery, and the need for resuscitation in the delivery room were specifically examined (Vain et.al, 2004).
Sample size analysis revealed that at least 2,286 patients (1,143 per group) needed to be enrolled to fulfill statistical equivalence between the suction and no suction group. Data was analyzed on an intention-to-treat basis. Normal distributions and the Mann-Whitney-U-test were used to analyze variance. Statistical analysis was undertaken with SAS 8.02 software. An independent data safety and monitoring committee undertook interim analyses at two time points, on enrollment of 400 and 1,000 babies, respectively (Vain et.al, 2004).
The incidence of MAS was similar in both groups, as was the need for mechanical ventilation, and the number of the infants who died. The mean duration of oxygen treatment, mechanical ventilation, or hospital care did not differ significantly between the two treatment groups. There were no significant differences in the frequency of other respiratory disorders, pneumothoraces, 1-min or 5-min Apgar scores, or the need for positive-pressure ventilation in the delivery room. Intrapartum suctioning made no difference to the occurrence of either MAS, MAS needing mechanical ventilation, or mortality (Vain et.al, 2004).
Strengths and Limitations
The strength of this study is its sample size and randomized controlled trial technique. Randomized controlled trials (RCTs) were used, which require a large sample size; obtaining statistically significant differences between the two samples would be easy if large differences were expected. In addition, the characteristics of patients in this study were as likely to be similar with meconium-strained amniotic fluid (MSAF) of any consistency, gestational age of 37 weeks or longer and cephalic presentation, which helped reduce the risk of a serious imbalance in known and unknown factors.
Polit and Beck (2011) stated that an experimental design (RCTs) offers greater corroboration than any other approach. The major limitations found in this study were insufficient time for a randomization method due to factors such as delayed notification of MSAF, refusal by the obstetrician to allow his or her patient to participate, and other reasons due mostly to technical difficulties. According to Polit and Beck (2011), a problem with RCTs conducted in the clinical setting is that clinical staffers, rather than researchers, often administer an intervention (Polit & Beck, 2011). The researchers found that routine intrapartum oropharyngeal and nasopharyngeal suctioning of term-gestation infants born through MSAF does not prevent or decrease the incidence of MAS (Vain et.al, 2004). The information from this study will help determine the midwifery management of infants born through meconium-stained amniotic fluid.
Oronasopharyngeal Suction Versus No Suction in Normal and Term Infants Delivered by Elective Cesarean Section: A Prospective Randomized Controlled Trial by Gungor, Kurt, Teksoz, Goktolga, Ceyhan and Baser ( 2006)was the second study reviewed.
Statement of Purpose
The purpose of this study was to compare the effects of oronasopharyngeal suction (ONPS) to those of no suction in normal, term infants delivered by cesarean section.
This was a randomized controlled trial of 140 patients who were admitted to the hospital for cesarean section with a written informed consent prior the operation. Newborns were randomized to either the ONPS group or the no suction group using computer-generated random numbers. Group selection was determined by assignments from sealed envelopes opened in the operation room following onset of general anesthesia. ONPS was performed immediately after birth and before the first breath to prevent aspiration of oronasal secretions in the suction group within less than 15 seconds (Gungor, Kurt, Teksoz, Goktolga, Ceyhan & Baser, 2006).
Negative pressure was used, not to exceed 30 centimeters of water. In the no suction group, the only intervention was to wipe away any visible matter. Umbilical artery blood was collected immediately at birth. Oxygen saturation (SaO2) and heart rate were monitored with a reusable neonatal saturation sensor, which was attached to the middle finger of the right hand of the newborn. SaO2 and heart rate measurements were documented minute-by-minute until a SaO2 level of ≥ 92% was reached. The primary outcome of the study was time to reach ≥ 92% SaO2. Major secondary outcome variables were Apgar scores, heart rate, and time to reach ≥ 86% SaO2. In addition, any type of intervention that might have been relevant to suctioning or no suctioning procedures, such as oxygen requirement, re-evaluation for respiratory distress, and neonatal intensive care unit admission, was monitored until the discharge of the newborns (Gungor , et.al, 2006)
Levene’s test was used to test the homogeneity of variance for the continuous variables. Categorical variables were analyzed with chi-square and Fisher’s exact tests, where appropriate. Continuous variables were analyzed with an independent samples t-test and a Mann- Whitney-U-test, where appropriate. Analysis of variance in repeated measures was performed to evaluate differences in SaO2 levels in minutes between the two groups. Survival analysis was used to estimate and interpret survivor function based on the time to reach SaO2 of 86% and 92%, to compare survivor function between the two groups, and to assess the relationship or explanatory variables to survival time. The Kaplan-Meier estimator was used to evaluate minutes to reach SaO2 of 86% and 92%. The log-rank test was used to perform an overall comparison of the Kaplan-Meier curves between the two groups. Statistical analysis was performed with SSPS 10.0 software (SSPS, Chicago, IL, USA). Data were expressed as mean 8 standard deviation, median, frequency, or proportions, where appropriate (Gungor, et.al, 2006).
The mean SaO2 values through the second and sixth min of life were significantly higher in the no suction group. The maximum times to reach SaO2 of ≥ 92% and ≥ 86% saturation were shorter in the no suction group than in the ONPS group. The mean heart rates were consistently and significantly lower in the no suction group during the first six min except the second min after delivery. All newborns without suction had an Apgar score of 10 at the fifth min, while only 24 of 70 newborns in the ONPS group demonstrated the same score (Gungor et.al, 2006).
Strengths and Limitations
The strength of this study lays in its moderate sample size and randomized controlled trial properties. Randomized controlled trials (RCTs) were used, which requires a large sample size; obtaining statistically significant differences between the two samples would be easy if large differences were expected. In addition, the two groups were similar in regard to maternal and fetal characteristics, which helped reduce the risk of a serious imbalance in known and unknown factors. Polit and Beck (2011) stated that their experimental design (RCTs) offers greater corroboration than any other approach. The major limitations found in this study were that it was only conducted in healthy, term infants and that it left unclear whether some of those 140 newborns had evidence of meconium-stained fluid during delivery (Gungor et.al, 2006).
Researchers stated that even the current study detected a negative effect of ONPS on levels of SaO2, but these findings did not lead to clinically adverse outcomes. The authors suggested that clinicians should review their suction policies because there is no statistical or physiological basis for ONPS as a systematic procedure in healthy, term infants delivered by cesarean section(Gungor, Kurt, Teksoz, Goktolga, Ceyhan, Baser, 2006). The information provides important data for this inquiry by showing that even though current studies do not recommend intrapartum suctioning of infants born through meconium-strained amniotic fluid, this management did not lead to adverse clinical outcomes and can still be acceptable in some cases of MSAF (Gungor et.al, 2006).
Delivery Room Management of the Apparently Vigorous Meconium-stained Neonate: Results of the Multicenter International Collaborative Trial by Wiswell, Gannon, Jacob, Goldsmith, Szyld, Weiss, Schutzman, Cleary, Filipov, Kurlat, Caballero, Abassi, Sprague, Oltorf, & Padula( 2000) was the third study retrieved.
Statement of Purpose
The purpose of this study was to assess whether intubation and suctioning of the apparently vigorous meconium-stained neonate would reduce the incidence of MAS and to determine the frequency of complications from delivery room intubation and suctioning of such infants.
This was a randomized controlled trial. 12 centers selected were included both university-affiliated hospitals and predominantly clinical centers that enrolled participants between July 1995 and September 1997. There was a no informed consent protocol, which involved several invited ethicists and neonatologists in the review process. The inclusion criteria included presenting of meconium in the amniotic fluid, having gestational age equal to or greater than 37 weeks, and infants appearing vigorous in the delivery room immediately after birth (Wiswell, Gannon, Jacob, Goldsmith, Szyld, Weiss, Schutzman, Cleary, Filipov, Kurlat, Caballero, Abassi, Sprague, Oltorf, & Padula, 2000).
Furthermore, the obstetrical policy at all sites was to suction the oropharynx of each meconium-stained neonate with either a catheter or a bulb syringe before delivery of the infant’s shoulders or trunk. Infants were randomized to intubation and intratracheal suctioning (INT) or to expectant management (EXP) by using computer-generated random numbers. Group selection was sealed in an opaque envelope and was opened immediately before the deliveries complicated by meconium staining. In the INT group, infants were intubated immediately after birth. A standard meconium suction device, the neotech aspirator, was connected to the proximal end of the endotracheal tube, attached to a wall suction, and set at 80 to 120 mmHg negative pressure. Suction was applied continuously for one to five seconds and as the endotracheal tube was withdrawn. The procedure was repeated until no additional meconium-stained fluid could be retrieved. In the EXP group, infants had routine vaginal delivery care (Wiswell et.al, 2000).
Sample size analysis revealed that at least 2,058 patients (1,029 per group) needed to be enrolled to fulfill statistical equivalence between INT and EXP groups. Researchers used univariate analyses, including two-group t-test, Wilcoxon rank- sum test, two-tailed Fisher’s exact test, and Mantel-Haenszel chi-square test, to compare the groups. Stepwise logistic regressions, which were conducted using SAS 6.08 software, were used to evaluate the effect of various factors in the occurrence of MAS or other respiratory disorders independent of the potentially confounding effects of other variables (Wiswell et.al, 2000).
There were no significant differences between both groups in the occurrence of MAS (INT = 3.2%; EXP = 2.7%) or in the development of other respiratory disorders (INT = 3.8%; EXP = 4.5%). There were 1,098 neonates successfully intubated, and 42 neonates had a total of 51 complications from the procedure, which were mild and transient in nature. The incidence of MAS in infants who did not have oropharyngeal suctioning was 8.5% compared to 2.7% of infants who had such suctioning. Among infants who had orophasyngeal suctioning, there were no differences in the occurrence of respiratory illnesses between those suctioned with a catheter and those suctioned with a bulb syringe (Wiswell et.al, 2000).
Strengths and Limitations
The strength of this study lays in the sample size and randomized controlled trials (RCTs) nature of the study. This required a large sample size; obtaining statistically significant differences between the two samples would be easy if large differences were expected. In addition, the characteristics of patients in this study were similar, with no differences between groups in maternal age, maternal gravidity or parity, amount of prenatal care, presence of oligohydramnios, consistency of MSAF, use of amnioinfusion therapy, application of electronic fetal heart rate (FHR) monitoring during labor, occurrence of abnormal FHR monitoring, use of oropharyngeal suctioning, or method of delivery. The major limitations found in this study were that the researcher did not clearly present the process of routine delivery care. This may lead to a difference in the management of the EXP group (Wiswell et.al, 2000).
Researchers discovered that there were no significant differences between the intubation and intratracheal suctioning group or in the routine delivery care group in MAS occurrence. However, the researchers found that incidence of MAS in infants who did not have oropharyngeal suctioning was greater than infants who had such suctioning (Wiswell, Gannon, Jacob, Goldsmith, Szyld, Weiss, Schutzman, Cleary, Filipov, Kurlat, Caballero, Abassi, Sprague, Oltorf, & Padula, 2000). This information is useful and supports this inquiry in establishing the midwifery management of infants born through meconium-strained amniotic fluid (Wiswell et.al, 2000).
Delivery Room Management of Infants Born Through Thin Meconium Stained Liquor by Suresh and Sarkar (1994) was the fourth study reviewed.
Statement of Purpose
The purpose of this study was to evaluate the importance of thin meconium stained liquor (MSL) in the causation of MAS and the efficacy of intrapartum plus endotracheal suction at birth in the prevention of MAS due to thin meconium.
There were 3,472 participants from August 1, 1992 to July 30, 1993, prospectively enrolled in this randomized controlled trail. The routine perinatal data, consistency of meconium (thick or thin), color of meconium, presence of meconium staining of the cord/skin/nails/vernix, cord blood pH, occurrence of respiratory distress, and neurological signs were recorded. The protocol management of such deliveries with meconium stained liquor consisted of intrapartum suctioning of the oropharynx and nose by the obstetrician on the delivery of the baby’s head, splinting of the chest by the nurse receiving the baby, immediate endotracheal intubation on the resuscitation table with a 3.0 or 3.5 millimeters endotracheal (ET) tube, sucking out meconium while withdrawing the ET tube, using mechanical suction, and release of chest splinting. The heart rate and color of the infant were monitored during endotracheal suctioning (Suresh & Sarkar, 1994).
The Chi square test was used to test the statistical significance of the results.
One-third of all cases with meconium stained liquor had thin MSL, which caused 19% of all cases of MAS. Meconium in the trachea was found in a significantly lesser number of infants with thin MSL than with thick MSL. The combined approach of intrapartum and endotracheal suction, which has proven efficacy in thick MSL, appeared to be useful even with thin MSL. Suctioned babies had a lesser incidence of MAS than non-suctioned babies had (Suresh & Sarkar, 1994).
Strengths and Limitations
The strength of this study lays in the sample size and randomized controlled trials (RCTs) nature of the sampling technique. It required a large sample size; obtaining statistically significant differences between the two samples would be easy if large differences were expected. However, researchers stated that even though suctioned babies had a lesser incidence of MAS than non-suctioned babies had, the difference did not reach statistical significance due to the small numbers of sample sizes. This is a limitation of this randomized controlled study (Suresh & Sarkar, 1994).
Further, this study that the combined approach of intrapartum and endotracheal suctioning appeared useful, even with thin MSL. Suctioned babies had fewer incidences of MAS than non-suctioned babies had (Suresh & Sarkar, 1994). This information is useful and supports this inquiry by recommend the intrapartum suctioning and endotracheal suctioning of the infants born through meconium-strained amniotic fluid.
Does DeLee Suction at the Perineum Prevent Meconium Aspiration Syndrome? By Falciglia, Henderschott, Potter, & Helmchen (1992).
Statement of Purpose
The purpose of this study was to determine the impact of early oronasopharyngeal DeLee suctioning at the perineum in the prevention of MAS and to confirm that MAS is a postnatal event.
This randomized controlled trial was conducted in a private tertiary care center averaging 5,800 deliveries annually. A consecutive sample of 438 infants with meconium-stained fluid was analyzed. There were 221 of these infants receiving early oronasopharyngeal Delee suctioning, while 217 infants received late suctioning (after chest delivery). Practicing obstetricians did not know the pediatric staff was conducting the study, and an independent observer documented whether obstetricians performed “early” or “late” oronasopharyngeal DeLee suctioning. Immediate postnatal tracheal suctioning was performed in both groups. (Falciglia, 1992)
Early oronasopharyngeal DeLee suctioning at the perineum does not affect the rate of MAS. Of 438 infants, 39 (9%) developed MAS. These infants had higher rates of fetal distress and lower Apgar scores (≤ 6) than infants without MAS had. Of the infants with MAS, 45% had renal failure during the first 20 hours of life. In spite of early oronasopharyngeal DeLee suctioning, 53% of the infants in this group had meconium below the vocal cords and MAS developed in 7% of the infants in this group. The time of oronasopharyngeal DeLee suctioning did not affect the rate of MAS or the presence of meconium below the vocal cords (Falciglia, 1992).
Strengths and Limitations
The strength of this study lays in its sample size and randomized controlled trials (RCTs) nature of the used select participants. It required a large sample size; obtaining statistically significant differences between the two samples would be easy if large differences were expected. Researchers did not clearly present the specific methods used or the mode of obtaining and selecting the samples. Furthermore, there was no evidence of how data was analyzed. These are the limitations in this study (Falciglia, 1992).
Researchers discovered that early oronasopharyngeal DeLee suctioning at the perineum does not affect the rate of MAS, and that the time of oronasopharyngeal DeLee suctioning did not affect the rate of MAS or the presence of meconium below the vocal cords (Falciglia, Henderschott, Potter, & Helmchen, 1992). Data from this study does not support this inquiry in suctioning the infants born through meconium-strained amniotic fluid.
The conceptual framework is a system of concepts, assumptions, expectations, beliefs, and theories that support and inform a research study. According to Polit and Beck (2012), the absent of conceptual framework can deduct the propositions that assert and explain relationships among concepts. Values of the conceptual framework also include providing the researcher with a premise for generating hypotheses, presenting an understanding of the phenomenon of interest, reflecting the assumptions and philosophical views of the model’s designer, and providing a perspective regarding interrelated phenomena (Polit & Beck, 2012).
The Normalization Process Model (NPM) was developed by May and colleagues (Elwyn, Légaré, Weijden, Edwards, & May 2008). It is a theoretical model that assists in explaining the processes by which complex interventions become routinely embedded in health care practice. NPM offers a framework for process evaluation and for comparative studies of complex interventions. In addition, it focuses attention on factors that promote or inhibit the routine, and are empirically demonstrated to affect the implementation and integration of complex interventions in health care (May, Finch, Mair, Ballini, Dowrick, Eccles, Gask, MacFarlane, Murray, Rapley, Rogers, Treweek, Wallace, Anderson, Burns, & Heaven, 2007).
A key concept relative to this study is that infants born through meconium-stained amniotic fluid who do not receive suctioning of the upper airway before delivering the shoulders and after birth processes possibly have more incidences of meconium aspiration syndrome (MAS). Using NPM as a framework helps the researcher review the outcomes. It forges a better understanding regarding benefits contained in suctioning the upper airway of infants born through meconium-stained amniotic fluid before the shoulders are delivered and after the birth process, compared with no suctioning of infants.
The participated patients’ criteria are as follows:
- A gestational age of 37 weeks or longer
- Birth through meconium-stained amniotic fluid
- Vaginal delivery
The incidence of MAS, which includes signs and symptoms such as cyanosis, end-expiratory grunting, nasal flaring, tachypnea, barrel chest in the presence of air trapping, auscultated rales and rhonchi (in some cases), and characteristic radiographic abnormalities, will be investigated through this study.
PATIENTS’ CRITERIA INTERVENTION OUTCOMES
Chapter 3: Quantitative Research Proposal
The proposed design for this quantitative analysis is a cross-sectional comparative study involving a survey. According to Polit and Beck (2008) ‘quantitative researchers use mechanisms designed to control the study. Control involves imposing conditions on the research situation so that biases are minimized and precision and validity are maximized’ (Polit & Beck, 2008, p. 16).
Importantly, these writers clarified that nursing research focuses more on human beings, who happen to be a more complex and diverse population. Therefore, complexities must be controlled, minimized or eliminated altogether, than studied directly. It means narrowing the population as well as research topic. Further, being a scientific research method it can create sedimentation in projection just a narrow view of the phenomenon (Polit & Beck, 2008, p. 16).
This quantitative research proposal will be used to collect data for exploring outcomes pertaining to suctioning of the upper airway in infants born through meconium-stained amniotic fluid. The process will be compared with before the shoulders are delivered and after the birth process in relation to the application of no suctioning techniques in these infants as the control. Research studies reveal that infants born through MSAF underwent orophasyngeal and nasopharyngeal suctioning before the delivery of the shoulders and after the birth process did not establish benefits in the prevention and reduction of incidences of MAS. This researcher suggests that the incidences of MAS may be increased without suctioning before the delivery of the shoulder and after the birth process.
Threats to internal external validity
Obvious threats to internal and external validity are linked to whether variables used in this research study have been operationalized accurately to measure concepts researched. For example concepts/variables such as suctioning before shoulder delivery and no suctioning must be accounted for through application of statistical measurements. According to Polit and Beck (2008) quantitative studies require that variables be operationalized by giving them values (Polit & Beck, 2008, p. 60).
As it pertains to this research internal validity is established when variables identified in the hypothesis or research question are measured in context of ‘Midwife Management of Infants Born through Meconium-Stained Amniotic Fluid’ For internal validity to exist there must be accurate statistical measurements. Therefore, this researcher would employ pretested instruments in measuring variables in the form of a questionnaire (See Appendix B). Since this is a survey external validity cannot be extended beyond the boundaries of this study in establishing generality.
This study would embrace a non-probability purposive sampling technique whereby a subset of the entire population will be used to select subjects from a population of midwives. A notable disadvantage of purposive sampling according to Polit and Beck (2008) is that there will always be validity issues in answering research questions, even with the best designs and research procedure. The strength lies in being able to capture a wide cross section of midwives thereby engaging a larger sample (Polit and Beck, 2008).
Since this is a non- probability sampling technique no specific calculations will be made in selecting a representative sample. This rests solely on the researcher’s discretion as to an adequate sample size for this project. Some surveys usually employ a large sample of the population. Therefore, in my estimation a sample of 250 midwives could be a representative one for this study. Participants would be told that their involvement is voluntary. They have the right to withdraw at any time or leave questions unanswered. Contact information will be provided for questions or inquiries regarding the study (See appendix B).The inclusion criteria will be midwives who can read and write English; exclusion all nurses who have not specialized as midwives and midwifes who cannot read and write English.
According to Polit and Beck (2008) ethical considerations require that interventions used in conducting the study ensure rights of participants are protected (Polit & Beck, 2008, p.67). In this study it would be midwives filing questionnaires.
Permission will be obtained from the Philadelphia University Institutional Review Board to conduct the study in a sample of midwives in active duty. Consent forms must be signed prior to the study. Each form will be electronically signed using an encrypted code embedded in the email document. Goals of the research and how to contact the researcher should question arise would be printed at the bottom of the consent form. All information pertaining to the study ‘Midwife Management of Infants Born through Meconium-Stained Amniotic Fluid’ would be provided tom participants.
Data collection procedure
Data for this study will be obtained through application of a questionnaires instrument, which will be conducted by Survey Monkey. The participants are midwives in the USA where the lists will be obtained via www.midwife.org. A cover letter and questionnaires will be sent via regular mail with a provided stamped envelope. The time frame will be set for 3 months for the midwives to response. If the survey was returned to after 3 months, a reminder will be sent out and again 1 month later.
Description of Measures
Self-report is the specific measure adapted for this data collection process (Polit & Beck, 2008). According to Polit and Beck (2008) this measure is very useful a wide cross section of the population can be reached easily (Polit & Beck, 2008). A major disadvantage, however, the process can compromise reliability and thereby hinder validity since answers t questions may be inaccurate. These inaccuracies could be deliberate or through mis understanding the question.
Four questions were developed on the questionnaire. Validity and reliability issues have been resolved through pre-testing the instruments to a sample of midwives prior to the beginning of this study. Face validity according to Polit and Beck requires that each question has th probability of giving the correct response (Polit & Beck, 2008) (See appendix B).
Data analysis plan for each research question/hypothesis
Data analysis encompasses statistical measurements of research questions / hypothesis outlined in the introductory chapter of this thesis. Before this begins data cleaning software must be applied to assist in removing duplicating information ad extraneous data. There are always instances when respondents will offer unnecessary information when open ended responses are required. As such, Statistical Package for the Social Sciences (SPSS) will be used to manage data collection procedures in this study (Polit & Beck, 2008).
Analysis of data quality would be conducted by applying frequency counts/descriptive statistics. This involves calculation of mean, median and standard .With respect to establishing normality of data frequency histograms, normal probability plots, kurtosis, and skewness could be employed. In linking associations correlations and scatter plots are frequent techniques applied to case study experiment data analysis process. Specific to this study bivariate association will be adapted. This has been chosen because it involves the analysis of two distinct variables X and Y in this comparative analysis between ‘underwent oropharyngeal and nasopharyngeal suctioning before delivery and postnatal suctioning in an effort to clear the airway and no suctioning (Babbie, 2009).
Strengths and Limitations of this Study
Strengths and weakness with regards to this study are considered from two distinct perspectives. First the study itself and secondly the research design chosen to gather data. Exploring the elements about ‘Midwife Management of Infants Born through Meconium-Stained Amniotic Fluid’ has scientific significance based on the literature review findings during an exposition of various pieces of documents related to the topic. Herein lays the strength of this study because it is expected to yield new knowledge and clarify discrepancies in management. However, a solid weakness can be the extent to which this knowledge could be applied and disseminated to captivate the attention of evidence-based analysts for it to become protocol sensitive for application within the science.
For this study to become evidence based material evidence based scientist must be convinced that the research design adequately represented the cases under review. Application of statistical measurements was accurate to declare assumptions and make valid conclusions; samples correctly represented the population under review and all subjective data discarded from the research. Hence, the strength of a quantitative study is that it allows researchers to make conclusions based on scientific evidence as against qualitative designs, which are more subjective in data analysis. No measurements are used to test hypothesis or research questions. This is the notable strength of the design utilized in this research presentation.
However, surveys can be misleading if the most appropriate procedures are not employed.
While survey monkey is a reliable tool for constructing instruments such as questionnaries; the margin of error must be calculated during data analysis though application of reliable data cleaning software. Besides, ethical issues involved in accessing IP addresses of respondents anonymity and confidentiality may be compromised.
Plan for disseminating findings
This is a very controversial issue occurring in the practice of contemporary obstetric nursing management. As such, my first approach at dissemination of findings from this research would be the Journals of Obstetric Gynecologic and Neonatal Nursing. Obstetric Nursing Conferences are held yearly across the country. This research paper could be presented as a workshop discussion.
American College of Nurse-Midwives. (2010). Midwifery strategies for liability risk reduction postdates pregnancy/post maturity. Retrieved September 28, 2012, from http://www.midwife.org/
Babbie, E. (2009).The Practice of Social Research (12th edition). New York Wadsworth Publishing
Elwyn, G., Légaré, F., Weijden, T., Edwards, A., & May, C. (2008). Arduous implementation: Does the normalisation process model explain why it’s so difficult to embed decision support technologies for patients in routine clinical practice. Implementation Science, 3(57), doi: 10.1186/1748-5908-3-57
Falciglia, H., Henderschott, C., Potter, P., & Helmchen, R. (1992). Does delee suction at the perineum prevent meconium aspiration syndrome?. American Journal of Obstetrics & Gynecology, 167(5), 1243-1249. Retrieved from http://www.ncbi.nlm.nih.gov/pubmed/1442972
Fanaroff, A. A. (2008). Meconium aspiration syndrome: historical aspects. Journal of Perinatology, 28, S3-S7.
Gungor, S., Kurt, E., Teksoz, E., Goktolga, U., Ceyhan, T., & Baser, I. (2006). Oronasopharyngeal suction versus no suction in normal and term infants delivered by elective cesarean section: A prospective randomized controlled trial. Gynecologic and Obstetric Investigation, 61, 9-14. doi: 10.1159/000087604
Healthy People. (2012). Topics & Objectives Index – Healthy People. Retrieved October 15, 2012, from http://www.healthypeople.gov/2020/topicsobjectives2020/default.aspx
Kattwinkel, J. (2008). Neonatal resuscitation guidelines for ILCOR and NRP: evaluating the evidence and developing a consensus. Journal of Perinatology, 28, S27-S29.
May, C., Finch, T., Mair, F., Ballini, L., Dowrick, C., Eccles, M., Gask, L., & Heaven, B. (2007). Understanding the implementation of complex interventions in health care: the normalization process model. BMC Health Services Research, 7(148), doi:10.1186/1472 6963-7-148
Polit, D., & Beck, C. (2011). Nursing research: Generating and assessing evidence for nursing practice. (9 ed.). Philadelphia, PA: Lippincott Williams & Wilkins.
Suresh, G., & Sarkar, S. N. (1994). Delivery room management of infants born through thin meconium stained liquor. Indian pediatrics, 31, 1177-1181. Retrieved from http://indianpediatrics.net/oct1994/1177.pdf
Vain, N., Szyld, E., Prudent, L., Wiswell, T., Aguilar, A., Vivas , N., & , (2004). Oropharyngeal and nasopharyngeal suctioning of meconium-stained neonates before delivery of their shoulders: multicenter, randomized controlled trial. The Lancet, 364, 597-602.
Whitfield, J. M., Charsha, D. S., & Chiruvolu, A. (2009). Prevention of meconium aspiration syndrome: an update and the Baylor experience [Online exclusive]. Proceedings (Baylor University. Medical Center). Retrieved from http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2666857/pdf/bumc0022-0128.pdf
Wiswell, T., Gannon, C., Jacob, J., Goldsmith, L., Szyld, E., Weiss, K., Schutzman, D., & Cleary, G., Filipov, P., Kurlat, I., Caballero, C., Abassi, S., Sprague, D., Oltorf, C., & Padula, M. (2000). Delivery room management of the apparently vigorous meconium- stained neonate: Results of the multicenter, international collaborative trial. Pediatrics, 105(1), 1-7.
XU, H., Wei, S., & Fraser, W. D. (2008). Journal of Perinatology. Obstetric approaches to the prevention of meconium aspiration syndrome, 28, S14-S18.
Yurdakok, M. (2011). Meconium aspiration syndrome: do we know?. The Turkish Journal of Pediatrics, 53, 121-129.
Appendix A: Cover letter
My name is Tarika White and I am a graduate student at Philadelphia University. As you are aware, meconium aspiration syndrome (MAS) can lead to morbidity and mortality among infants born through meconium-strained amniotic fluid (MSAF). This occurs in approximately 10-15% of all deliveries. Approaches towards prevention of MAS have changed over time, and this remains one of the most common challenges for midwives and other healthcare providers. In this my final project, I am reviewing the outcomes and benefits upper airway suctioning of infants born through meconium-stained amniotic fluid before the shoulders are delivered and after the birth process, compared to no suctioning of infants.
Since you are unique healthcare providers, I am inviting your participation in this research project by asking you to complete the attached surveys. The following questionnaire will require approximately 5 minutes of your time. There is no compensation for responding or any known risk involved. In order to ensure that all information remains confidential, please do not include your name. Copies of the project will be provided to my Philadelphia University instructor. If you choose to participate in this project, please answer all questions listed as honestly as possible and return the completed questionnaires promptly in provided stamped envelope. Participation is strictly voluntary and you may refuse to participate at any time.
Thank you for taking the time to assist me in my educational endeavors. The data collected will provide useful information regarding prompt and appropriate care for MAS-affected infants, thereby minimizing the effects of MAS and improving infant outcomes. If you would like a summary copy of this study please complete the ‘Request for Information Form’ and return it to me in a separate envelope. Completion and return of the questionnaire will indicate your willingness to participate in this study. If you require additional information or have questions, please contact me at the email address listed below.
The Request for Information Form
Please send a copy of the study results to the address listed below.
Please do not return this form with your survey.
Midwifery Management of Infants Born Through
Meconium-Stained Amniotic Fluid
Management of Infants Born Through Meconium-Stained Amniotic Fluid Questionnaire
- If you have to deliver an infant born through meconium-stained amniotic, what would be first thing you do to help the baby as soon as baby head or body delivered?
(a) Perform bulb suction of the infant as soon as the head delivered.
(b) Hand the baby to neonatal team as soon as the body delivered without any attempt to suction the baby.
- Do you believe that a baby born through meconium-stained amniotic fluid needs to be suctioned as soon as the head is delivered?
- In the past 12 months, how many babies you delivered needed to be admitted in the neonatal intensive care unit (NICU)?
- Less than 5
- More than 30
- Based on question no.3 responses how many babies you delivered were diagnosed with meconium aspiration syndrome?
- Less than 5
- More than 30
Appendix C: Feasibility
|Week 1||Submit Proposal||500||Cost incurred in printing documents and surveys|
|Week 2||Obtain approval from Philadelphia University IRB; hospital electronic management staff||1,000||Cost incurred in transportation and time to make initial contacts|
|Week 3||Contact persons to assist in project execution||3,000||Recruiting survey assistants to expedite process.|
|Week 4||Submit proposal to Philadelphia University IRB
|4,000||This is the proposed cost as it relates to my salary for conducting this research in 30 day period|