Discussion 3 IRB, Coursework Example

Study Abstract

Preterm births are a difficult experience for many mothers because these conditions pose greater risk and possible harm to their children. Therefore, it is important to recognize the potential risks associated with preterm births, which many include limited or inadequate prenatal care (Debiec et.al, 2010). This level of care is important for all expectant mothers, regardless of race or ethnicity; therefore, when prenatal care is not practiced in the recommended manner, there is a much greater risk of complications, including preterm births (Vintzileos et.al 2002). It may be difficult for some persons with inadequate insurance benefits to obtain the appropriate prenatal care, but all possible efforts must be made to provide patients with the desired level of care throughout the pregnancy (ACOG, 2012). In this context, preterm births may be directly attributed to poor or limited prenatal care that does not address the primary concerns associated with pregnancy and how to achieve a healthy pregnancy (ACOG, 2012). Therefore, a study is necessary to evaluate the relationship between preterm births and prenatal care and if lack of prenatal care has a significant impact on preterm birth rates.

Statement of Purpose and Background

Preterm births continue to be a serious health concern for pregnant women throughout the United States. This issue impacts approximately 500,000 babies, which involves 1 child in every 9 pregnancies (CDC, 2013). The Centers for Disease Control and other organizations have established the critical nature of prenatal visits and adherence to doctor’s orders in order to maximize the prevention of preterm births (CDC, 2013). Although this condition is complex and may occur under a variety of circumstances, basic prenatal care and compliance with established recommendations plays a significant role in preventing these occurrences (CDC, 2013).

For the purposes of this evaluation, I will emphasize the impact of prenatal visits and compliance in the prevention of preterm births for many pregnant women. I will observe the pregnancy patterns and outcomes of pregnant women who are patients at a women’s clinic in a nearby suburb. I will evaluate whether or not preterm births are likely to be reduced in response to routine prenatal care and doctor’s visits throughout the pregnancy in regular intervals. This

Will involve the examination of data related to pregnancies as provided by the clinic and the rate of preterm births that occur, along with the rates of compliance with recommended guidelines for prenatal care.


Characteristics of the Subjects

Study participants will include pregnant women between the ages of 21-40 who are patients at the women’s clinic. These patients will speak English, will include many different ethnicities, and will include patients from a variety of educational and work backgrounds to obtain a more diverse sample for data analysis.

Selection Criteria

Study participants will be selected randomly from a database of patients who have experienced preterm births over the past 18 months. These patients are required to have visited the women’s clinic at least once throughout the duration of the pregnancy and prior to hospitalization for giving birth.

Special or Vulnerable Populations

This study will not include any population groups that are classified as vulnerable because the participants have already given birth. Therefore, they are able to provide informed consent as required in order to participate in the study in the desired manner.

Recruitment Source

All subjects chosen for the study will be selected from a population that are patients at a women’s clinic in a surrounding suburb. This location is appropriate for the study because it has a diverse population of women who have given birth over the past 18 months.

Recruitment Methods

The recruitment will take place by obtaining permission to evaluate patients who have given birth over the past 18 months, using existing database resources. Random patients will be chosen for consideration who have experienced preterm labor during the propose timeframe. Each participant will be provided with a small gift card incentive to participate and to share their experiences. Patients will be interviewed to address their experiences, along with specific data regarding doctor visits and other prenatal activities that took place prior to preterm birth. Each participant will be provided with a gift card for their full participation.

Informed Consent Process

Since I am the primary researcher in the study, I will address any possible risks and the use of specific patient data through discussions with each participant. If these participants agree to participate in the study, they will be provided with a consent form that summarizes their participation and their responsibilities to the study from start to finish. Possible risks and benefits will be identified and upon agreement to participate, consent forms will be signed.

Study Location

The study will take place in the women’s clinic offices within a designated conference room area. Each participant will be interviewed individually so information sharing will not go beyond the interview. In addition, current patient care will not be compromised in any way while data collection processes are taking place.

Potential Problems

It is possible that study participants will be uncomfortable with the subject matter and may not want to share the details of their preterm birth experiences with a stranger. Therefore, the desired number of study participants might not be achieved through recruitment. In addition, there is a potential for patients to drop out of the study, thereby distorting the data that has been collected.


American Congress of Obstetricians and Gynecologists (2012). Facts are important: prenatal care  is important to healthy pregnancies. Retrieved from http://www.acog.org/~/media/Departments/Government%20Relations%20and%20Outreach/20120221FactsareImportant.pdf?dmc=1&ts=20130923T1528296370

Centers for Disease Control and Prevention (2013). Preterm birth. Retrieved from http://www.cdc.gov/reproductivehealth/maternalinfanthealth/pretermbirth.htm

Debiec, K.E., Paul, K.J., Mitchell, C.M., and Hitti, J.E. (2010). Inadequate prenatal care and risk of preterm delivery among adolescents: a retrospective study over 10 years. American Journal of Obstetrics and Gynecology, 203(2), 122.e1-6.

Vintzileos, A.M., Ananth, C.V., Smulian, J.C., Scorza, W.E., and Knuppel, R.A. (2002). The impact of prenatal care in the United States on preterm births in the presence and absence of antenatal high-risk conditions. American Journal of Obstetrics and Gynecology, 187(5), 1254-1257.