Blood Clot Risk for Women Taking Contraception

Background 

Birth control techniques may or may not increase the risk of blood clots. It is vital to understand the risk of developing blood clots due to the use of birth control techniques such as oral contraceptives and intrauterine devices (IUDs), particularly among women aged 25-40 years. Research conducted by Bateson et al. (2016) shows that from the population of 500 women aged 25 to 40 who use contraceptives, over 30% of those take oral contraceptive are at risk of developing venous thromboembolic. Venous thromboembolic (VTE) is a severe and life-threatening issue which cause complications to women if not treated early and include deep vein thrombosis (DVT) and pulmonary embolism (PE). Women with VTE review complications like thrombolytic stroke, myocardial infarction, and even pulmonary embolism (Lidegaard, Lokkegaard, Jensen, Skovlund and Keiding, 2012). Women are advised to seek better information from medical experts before taking birth control medication of implanted devices. Medical risk factors associated with venous thrombosis include cancer, surgery, trauma, prolonged immobilization, and post-partum. Other environmental and inherited risk factors that increase the chances of venous thromboembolic include a family history of thrombosis, smoking, and obesity. 

Studies offer different findings regarding each birth control technique. Women at the age of 18 to 45 taking oral contraceptives have a higher risk of suffering from venous thromboembolism (VTE) than those using the IUDs contraceptives (Bateson et al., 2016). The frequency of developing VTE nevertheless depends on the type of contraceptive used since the nature and levels of hormones in the contraceptives determine the risk of blood clots. De Bastos et al. (2014) found that high levels of estrogen in contraceptives increase the danger of a blood clot. The type of progestin in the contraceptives also determines the level of risk of a blood clot. Contraceptives containing progestin such as cyproterone acetate, drospirenone, gestodene, and desogestrel increase the risk of VTE. 

IUDs, however, contain only progestin, and studies show that IUDs do not generally increase the risk of blood clot among women (Lidegaard et al., 2011). More reviews are, nevertheless, required to examine the danger of blood clots related to IUDs arising from lack of extensive research in IUDs compared to studies in oral contraceptives. These findings demonstrate that women aged 25-45 face a higher risk of blood clots when using oral contraceptives than when using IUD. The type of progestin and level of estrogen in birth control techniques also influence the risk of a blood clot. 

Research shows that over 100 million women are using estroprogestative contraceptives (CC) to prevent unwanted pregnancies (McDaid et al., 2017). The contraceptives have a diverse effect on the cycle of women and increase the chances of blood clotting. Before administering any form of contraceptives, clinicians are advised to gather adequate information from the client regarding their smoking, body weight, and family history of DVT. 

Clinical Significance 

Various studies have confirmed the relationship between the use of oral contraceptives and a blood clot on women. The research aims to examine the risk factors of this clotting among women who use oral pills compared to women to use IUDs for contraception. The cases of develop ing VTE are higher in women who use third-generation OCCP (Bateson et al., 2016). The incidences of blood clot among women in the US is increasing with 3 to 9 out of 10,000 women using oral contraceptives developing the condition (“American College of Obstetricians and Gynecologists," 2012). The Women risk of developing VTE is higher in women who use drospirenone-containing OC pills. Many women are not aware of the risk factors associated with new oral contraceptives which combine various hormone progesterone with estrogen. The birth control patch used by many women in America contains a high level of estrogen, which increases cases of a blood clot in the kegs and lungs. The EBP project seeks to advise women on the importance of using progesterone-only-contraceptives like injections, implants, and intrauterine devices which have a low risk of causing a blood clot. When taking contraceptives, many women do not give their medical history to the clinician; hence, the increasing cases of blood clots. Research shows that women are unaware of the risk factors that increase cases of a blood clot when using oral contraceptives. Before administering any birth control to patients, the doctors need to put into consideration the age of the women, lifestyle like smoking, body weight, family history of a blood clot, immobility, and cancer. The risk factors will guide the clinician in advising the best contraceptive. 

Many women associate blood clot with other diseases and fail to seek immediate medical assistance. Clinicians and the patients should keep in mind that the use of combined oral contraceptives increases the risk of VTE as opposed to the use of Intrauterine devices (Bateson et al., 2016) . The clinical problem seeks to improve quality of care by educating women on the dangers of using COC compared to the use of IUDs. The project will outline the risk factors of VTE considered when choosing contraceptives. 

Purpose 

The purpose of the EBP project is to determine the risk of a blood clot associated with the use of oral contraceptives as opposed to using IUDs. Women aged 15-44 using contraceptives are likely to suffer from a VTE 1.5-7 times more than those not using contraceptives (Bateson et al., 2016, de Bastos et al. (2014), Lidegaard et al. (2011), and Practice Committee of the American Society for Reproductive Medicine, 2017). While many women are at risk of developing venous thromboembolism, the problem only affects a few of them. For instance, a study by Lidegaard et al. (2011) found the incidence of VTE to be nearly 4-16 women in every 10,000 women aged 15-44 using oral contraceptive annually. The project will use a PICOT format to examine the problem (Melnyk & Fineout-Overholt, 2011). Women aged 25 to 40 years who use contraceptives will be used to answer the research problem. 

PICOT Question 

Are women ages 25-40 (P) who take oral contraceptives (I) at greater risk for developing blood clots (O) compared with women ages 25-40 (P) who use IUDs for contraception (C) over a 5-year time frame (T)? 

Literature Review 

The research design for this project is a cross-sectional study design whereby a search strategy was used to gather evidence for making an inference. Literatures sources for study were gathered from databases of Cochrane, Medline, and CINAHL. Using a Boolean search strategy. It was agreed that sources not older than ten years published between 2011 and 2019 will be credible for review. Various keywords were used in the search for materials. The words applied include “oral contraceptives," “IUDs contraceptives," “ venous thromboembolism ," “blood clot," and “risk factors for oral contraceptives." 

Combination of these keywords revealed 284 articles from PubMed, 52 from Cochrane and 97 from CINAHL. The materials were further reviewed for accuracy and credibility through reading the abstract. After reviewing the titles and abstracts, 403 articles were dropped, leaving 40 articles for further review. From the list of 40 articles, 33 could not provide adequate information on the research question formulates leaving seven sources for use in the discussion. Three more sources were added to support and make clarification during the research making it a total of eight articles. The articles will be reviewed using the Critical Appraisal Skills Program (CASP) approach to aid in answering the PICOT question. The information gathered will be analyzed following the comparison of oral contraceptives and IUDs contraceptives. 

A systematic study was conducted by Suchon et al. (2016) on women using combined oral contraceptives (COC) to examine risk factors for VTE. The review was a systematic clinical study where data was collected and screening performed with an assessment of the ABO blood group. From the chosen population, 968 women had an experience of VTE while using COC, while 874 women using COC had no history of venous thromboembolism. The research put into consideration risk factors like family history, age, the period under contraceptives, and smoking. According to the research findings, the risk of developing VTE is higher in women using combined oral contraceptives. Also, risk factors like obesity and smoking have an impact on the ABO blood group and increase the risk of venous thromboembolism in women under COC. 

A similar study was conducted by McDaid et al. (2017) to examine whether women using COC are at danger of developing venous thrombosis. The study applied the Step-wise (logistic) model among 1622 women under combined oral contraceptives. From the selected population, 794 had developed a blood clot when using an oral contraceptive. The findings were arrived after conducting a test on polymorphisms and clinical parameters where four clinical risk factors and nine polymorphisms were identified. Results show that the risk of developing venous thrombosis is high among women using combined oral contraceptives. 

Cases of blood clot are at increase among women using Oral contraceptives, drawing the attention of clinicians and scientist. Baratloo et al. (2014), conducted a meta-analysis where various oral contraceptives were reviewed to examine their risk of causing blood clot on users. The study examined multiple generations of Oral Contraceptives to evaluate the occurrence of venous thromboembolism among the diverse generation. The method involves searching for various studies indicating thromboembolism combined with oral contraceptives from ISI Web of Science, CINAHL, Pubmed, EMBASE, and Scopus databases. The results were obtained from 17 case-control studies showed that all generations reveal risks of venous thromboembolism. The third generation showed a high risk of developing VTE. According to Baratloo et al. (2014), women who used the second and third generation of oral contraceptives reveal high of VTE. 

A comprehensive review of oral contraceptives was examined by Stegeman et al. (2013) to provide a comprehensive overview of the risk of a blood clot. The research used a systematic review and network meta-analysis of sources obtained from PubMed, Cochrane, Embase, CINAL, Web of Science, Academic Search Premier, and ScienceDirect. The study used a review method of observation where various studies were examined to show the effect of oral contraceptives in women. The results from 26 studies selected showed a reaction between the use of oral contraceptive and the development of venous thrombosis. According to the findings, the use of combined oral contraceptives increases the risk of venous thrombosis as opposed to the use of Intrauterine devices. 

Bateson et al. (2016) conducted a study to investigate the danger of developing VTE on women using drospirenone oral contraceptives. The sources were selected from Medline, Biosis, EMBASE, and the International Pharmaceutical Abstracts. The study involved a literature search on clinical studies in COSs where cases of VTE were reported. From a range of studies, 25 articles were selected for reviews and assessment. Results from the retrospective cohort studies showed an increase in the risk of VTE among women taking drospirenone-containing COC. 

Women using various combined oral conceptive reveal increased cases of a blood clot. De Bastos et al. (2014) also confirmed an existing relationship between the use of oral contraceptives and risk of venous thrombosis. The study involved a search of relevant articles from Pubmed, Embase, Web of Science, Cochrane, CINAHL, Academic Search Premier, and ScienceDirect databases. Studies selected were those showing relationship between VTE and COC. Therefore, the risk of developing VTE is determined by the level of ethinylestradiol and gestodene present in the oral contraceptive. 

Progestogen type and estrogen dose present in the oral contraceptive contribute to a blood clot. Lidegaard, Nielsen, Skovlund, Skjeldestad, and Løkkegaard (2011) conducted a cohort study to examine the risk of VTE from the use of oral contraceptives with different doses of estrogen and progesterone. The study involved historic registry of women aged 15 to 49 with no history of thrombotic disease. The study concluded that the risk of VTE increases with the level of desogestrel, gestodene, or drospirenone in the oral contraceptive. 

From the research on literature, it is evidenced that the risk of blood clot among women is associated with the use of oral contraceptives. Women who use combined oral contraceptives and have risk factors f family history, obesity, smoking, and trauma are at danger of developing a blood clot. The studies show a negative result of developing VTE on women who use other contraceptives like IUDs. Despite the increasing cases of blood clot among women, little information is known on the risk factors. The EBP project seeks to provide adequate information on risk factors of COC and ensure quality improvement through the use of other contraceptives like IUDs. 

Theoretical Framework 

For this EBP project, IOWA Model is used to promote quality of care and come up with adequate evidence for the research. According to Melnyk & Fineout-Overholt (2011), IOWA model is the suitable theoretical framework for this study since it integrates well-designed studies and clinician experts. IOWA model provides a step by step guide for solving clinical issues and match them with the best interventions. IOWA model was selected since it has been used severally by researchers making it easy for nurses to understand. IOWA model helps the nurses and health care providers to translate various study findings and at the same time, improve the outcome for the patients. The first step in IOWA is to identify the problem-focused-trigger, which requires EBP. The second step is to determine whether the problem is atop health problem. The issues that have higher volume and risk are usually given top priority. Upon identifying the priority, a team is selected to develop, evaluate, and implement EBP change (Melnyk & Fineout-Overholt (2011). The last step for this model is to gather research related to the desired change. 

IOWA model in EBP is guided by the principle of quality improvement and patient’s centeredness. The model helps the nurses to gather adequate evidence from the clinics and patient to integrate into practice to improve the quality of care. The risk of developing blood clot includes endogenous individual characteristics like obesity, genetics, triggering factors like pregnancy, surgery, and immobility. Endogenous factors are the leading cause of VTE, followed by genetic factors and lastly environmental factors. For this study, IOWA model will help in answering the PICOT question. 

Methods – Research Design 

The EBP project design selected to identify blood clot risk among women taking contraceptives is qualitative design. The qualitative design will be in the form of an open-ended questionnaire where various women between the age of 25 to 40 will be given a standardized questionnaire to complete during a medical consultation. Information on VTE events, family and medical history, reproductive factors, treatments, medical comorbidities and, lifestyle like smoking, weight, and use of exogenous hormones will be included in the questionnaire. During the interview, information on risk factors that cause blood clot of venous thromboembolism will be gathered. 

Methods- Sample 

The participants for the study were selected through a convenience sample of patients where 1 78 women aged 25 to 40 who uses contraceptives were chosen. When choosing the sample population, pregnant women were excluded from the study. Half of the population were women taking oral contraceptives while the other half comprised of women under intrauterine devices. The sample population consisted of women confirmed episode of VTE and referred to Hemostasis unit. The participants for the study were selected through a convenience sample of nurses or patients. Data were collected for the first time of their visit to the unit and analyzed based on risk factors of VTE. Analysis of family followed an international recommendation of RCOG and HAS guideline. During the study, Oral and written information was provided to the selected women. The selected population of 178 women taking oral contraceptives and IUD will bring an accurate comparison of the risk factors of a blood clot resulting from the use of contraceptives. 

Methods – Setting 

The EBP project will be conducted in the Suburban of Lauderhill, FL in the county of Broward County state of Florida. Women between the age of 25 to 40 from of Lauderhill, FL, who visited University Hospital & Medical Center between 2015 and 2019. Before conducting this project, a letter of support will be obtained from the University Hospital & Medical Center to allow for the use of information available in the hospital database. A letter of consent is an original document written in clarity and conciseness to provide sufficient information on the EBP project. In this project, the letter of consent will be addressed to the review committee of Keiser University, stating the purpose of the study and its clinical relevance. The letter will seek permission to gather data from Hemostasis unit. Also, in the letter, the researcher will sign to adhere to the ethics of EBP study and keep the names of the patients anonymous. 

Methods - Research Protocol 

The actual project will commence after the identification of the participants. A consent letter bearing the signature Keiser University will be obtained to inform a potential participant about a research study and to document a participant's agreement to take part in the survey. The project will rely on clinical data, where 178 women taking contraceptives will be identified. Data will be collected from the first time the women visited the Hemostasis unit. The participants will fill in a questionnaire showing the medical history, family history, treatments, transient risk factors, weight and height, and smoking. 

The project is expected to last for eight weeks upon which the entire EBP plan will be implemented. IRB approval will be obtained through Keiser University before the commencement of any research of discovery or research of practice project. IRB approval letter is issued upon submission of evidence-Based Practice Form, IRB Application, and the permit documentation from the research site (Melnyk & Fineout-Overholt, 2011). IRB is essential in this project since it verifies whether the project meets or does not meet the definition of research. 

Methods-Data Analysis 

Results obtained from the questionnaire will be analyzed based on clinical and environmental characteristics. The status of age and smoking will be determined in time of VTE and time of collecting DNA. Body mass index (BMI) will be analyzed based on the first time of the patient’s consultation in homeostasis unit. On family history, results will be gathered and analyzed as positive when at least one first-degree relative has suffered VTE (Baratloo et al., 2014) . The latest version 26 of Statistical Package for the Social Sciences (SPPS), a software used to analyze complex statistical data thoroughly. 

For this project, SPSS’s Text Analytics for Surveys program will be used to analyze responses from the questionnaire (open-ended survey questions). The researcher will use the open-ended survey responses helps in analyzing the closed-ended questions obtained in EBP project (Allen-Greil, 2012). The methods involve analyzing data step by step through reading every response and putting comments into one multiple buckets. The review will identify a trend in VTE for patients taking contraceptives, taking into consideration the risk factors. Once the pattern is identified, a summary of the finding is written for easy understanding of the results. A statistical test using Chi-square is used to evaluate the heterogeneity of the studies (Melnyk & Fineout-Overholt, 2011). In this project, p < 0.1 defines the statistical significance, and the meta-analysis will be conducted based on the random effect model. The results from various studies will be pooled and overall OR calculated to show the odds of affliction with women who use controlled oral contraceptives compared to those using intrauterine devices. 

Timeline 

The entire EBP project will take eight weeks, where the final results will be obtained and analyzed. 

Week 1	Preparation of forms and tools, explanation of EBP project, and consent form.
Week 2 to 4	Collection of data from the selected population.
Week 5 to 7	Analyzing data and evaluating findings from EBP project
Week 8	Writing a report on the EBP project recommending for future research areas.

References 

Allen-Greil, D. (2012). Measuring, analysing and reporting. na. 

American College of Obstetricians and Gynecologists. (2012). Risk of venous thromboembolism among users of drospirenone-containing oral contraceptive pills. Committee Opinion No. 540.  Obstet Gynecol ,  120 , 1239-42. https://www.acog.org/Clinical-Guidance-and-Publications/Committee-Opinions/Committee-on-Gynecologic-Practice/Risk-of-Venous-Thromboembolism 

Baratloo, A., Safari, S., Rouhipour, A., Hashemi, B., Rahmati, F., Motamedi, M., ... & Haroutunian, P. (2014). The risk of venous thromboembolism with different generation of oral contraceptives; a systematic review and meta-analysis.  Emergency ,  2 (1), 1. 

Bateson, D., Butcher, B. E., Donovan, C., Farrell, L., Kovacs, G., Mezzini, T., ... & Baber, R. (2016). Risk of venous thromboembolism in women taking the combined oral contraceptive: A systematic review and meta-analysis.  Australian family physician ,  45 (1/2), 59. 

de Bastos, M., Stegeman, B. H., Rosendaal, F. R., Vlieg, A. V. H., Helmerhorst, F. M., Stijnen, T., & Dekkers, O. M. (2014). Combined oral contraceptives: venous thrombosis.  Cochrane Database of Systematic Reviews , (3). 

Lidegaard, Ø., Nielsen, L. H., Skovlund, C. W., Skjeldestad, F. E., & Løkkegaard, E. (2011). Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9.  Bmj ,  343 , d6423. 

McDaid, A., Logette, E., Buchillier, V., Muriset, M., Suchon, P., Pache, T. D., ... & Michaud, J. (2017). Risk prediction of developing venous thrombosis in combined oral contraceptive users.  PloS one ,  12 (7), e0182041. 

Melnyk, B. M., & Fineout-Overholt, E. (Eds.). (2011). Evidence-based practice in nursing & healthcare: A guide to best practice . Lippincott Williams & Wilkins. 

Stegeman, B. H., de Bastos, M., Rosendaal, F. R., van Hylckama Vlieg, A., Helmerhorst, F. M., Stijnen, T., & Dekkers, O. M. (2013). Different combined oral contraceptives and the risk of venous thrombosis: systematic review and network meta-analysis.  Bmj ,  347 , f5298. 

Suchon, P., Al Frouh, F., Henneuse, A., Ibrahim, M., Brunet, D., Barthet, M. C., ... & Morange, P. E. (2016). Risk factors for venous thromboembolism in women under combined oral contraceptive.  Thrombosis and haemostasis ,  115 (01), 135-142.