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The Impact of Oral Contraceptives and IUDs as Contraceptive Methods for Obese Women Ages 25-40
AN ASSIGNMENT
SUBMITTED IN PARTIAL FULFILLMENT OF THE REQUIREMENTS FOR THE
DEGREE OF MASTER OF SCIENCE IN NURSING
IN THE GRADUATE SCHOOL OF THE
TEXAS WOMAN’S UNIVERSITY
COLLEGE OF NURSING
BY
DANIELLE MITCHELL
NURS 5615: FAMILY HEALTH NURSING III
PROFESSOR CHAD CRAGER
JULY 16, 2023
The Impact of Oral Contraceptives and IUDs as Contraceptive Methods for Obese Women Ages 25-40
Introduction
Although women using contraceptive methods have relatively successful rates, many develop complications in their adult lives. The debate on the impact of obesity on women using contraception continues to invoke various options across the board. Understanding the extent to which hormonal and non-hormonal contraceptive devices contribute to complications in obese women is integral to developing measures that act as interventions for the most adverse methods. This paper aims to critically compare the impact of oral contraceptives and IUDs as contraceptive methods for obese women ages 25-40, assessing which of the two groups is at higher risk of developing blood clots.
Development of PICOT Question
Are obese women ages 25 to 40 (P) who take oral contraceptives at greater risk (I) for developing blood clots (O) compared with obese women ages 25 to 40 (P) who use IUDs for contraception (C) over a 5-year time frame (T)?
Significance and Need
Researchers widely acknowledge the association between obesity and the excess estrogen in hormonal contraceptive methods to pose cardiovascular risks. While even moderately healthy women suffer the risk of being affected by cardiovascular complications, obese women often have underlying issues that enhance the probability of the risks manifesting much earlier in their lives. This research is necessary to establish the connection between the oral contraceptive pill and blood clot formation in obese women.
Background
While exploring the connection between contraceptives, obesity, and chronic blood clots, it is important to understand whether oral contraceptive pills and IUDs are responsible for the same results. In this case, the major issues are the relationship between contraception in obesity and the formation of blood clots. In addition, how can obese women prevent the cardiovascular risks associated with contraceptive methods? The purpose of the study is to establish the etiology of blood clots in obese women who are under specific contraceptive treatments.
ACE Theoretical Model
The ACE theoretical model allows researchers to perform research in five critical stages: discovery, evidence summary, translation, integration, and evaluation. The evidence-based project (EBP) would require a qualitative approach to determine whether obese women under various contraception methods are at risk of having blood clots. In this case, using unstructured interviews as a qualitative research methodology, women would be assessed to determine the truth in this hypothesis. Evidence summary would allow the researchers to record all primary evidence condensing the information into meaningful syntheses (Khialani et al., 2020). The research would synthesize the raw data on obese women and the contraception indications, where new findings could be plausible. Translation of the material aims to provide the practitioners with a document they can implement. This means the research would have a final database they can refer to or share concerning the data received from the obese women population. Integration requires that practitioners implement the findings and mitigation procedures they find as they perform the study (Khialani et al., 2020). The researchers in the study would be inclined to suggest clinical practices that prevent obese women from experiencing heightened risks in using contraceptive methods meant to help them. Evaluating the material ensures that the EBP outcomes are desirable, or implementation can positively change the quality of care and improve patient and provider satisfaction. Ultimately, obese women should also be treated equitably, and if potential solutions exist, they should be implemented.
Search Strategy and Results
The search strategy started with defining the research question, which was “Are obese women ages 25 to 40 (P) who take oral contraceptives at greater risk (I) for developing blood clots (O) compared with obese women ages 25 to 40 (P) who use IUDs for contraception (C) over a 5-year time frame (T)?” This was followed by identifying the inclusion and exclusion criteria based on the PICOS framework. The population included obese women of reproductive age. The intervention studied was contraceptive use, and the comparison was oral or IUD use. The outcome was a blood clot, and the study design was either randomized controlled trials, observational studies, or reports published in English. A search for relevant keywords then followed this. Keywords used included contraceptive, obesity, blood clot, deep vein thrombosis, and pulmonary embolism. The search was done in different databases, including MEDLINE, EMBASE, Cochrane Library, PubMed, CINAHL, Web of Science, and Scopus.
Through an online database search, 21 studies were obtained. It is also important to note that some of these studies were obtained by searching through the reference lists of the already obtained studies. After excluding all the duplicates and those not perfectly aligned with the research topic, 12 studies remained. With further screening, including a full-text review of each article, 6 studies were finally considered for review in this project. See the appendix for the figure showing a brief breakdown of the different studies considered for review.
Level of Evidence
The Johns Hopkins Nursing Evidence-Based Practice rating scale was adopted in evaluating the references used whereby:
Level I: Evidence based on well-randomized and controlled trial
Level II-1: Evidence gained through well-organized controlled trial, not including randomization.
Level II-2: Evidence based on an analytic study of case-control or well-organized cohort should be from either multiple research groups or centers.
Level II-3: Evidence is achieved without intervention or various time series.
Level III: Evidence is obtained from expert opinions’ committees, case reports, and descriptive studies.
Meta-analyses or systematic reviews were categorically considered, provided they assessed pertinent evidence and followed a firm methodological process.
The following scale explored the evidence strength:
Grade A: Has adequate evidence backing the recommendation.
Grade B: The recommendations are supported by fair evidence.
Grade C: The recommendation is based on insufficient evidence.
Literature Review
The studies showed a strong relationship between the risk of developing blood clots and the use of different methods of contraception among obese women between 25 and 40 years. These studies were assessed using the Johns Hopkins Nursing Evidence-Based Practice (JHNEBP) Rating Scale, a tool used to evaluate research studies’ quality and determine their evidence level. One study was carried out to gain a more comprehensive understanding of the risk of objective confirmed venous thrombosis with oral contraception in obese women relative to those without contraceptives (Rambaran, K., & Alzghari, S. K. 2020). Conducting this study was based on the understanding that while women use oral and hormonal contraception worldwide, they have been strongly linked to venous thromboses such as cerebral venous thrombosis, pulmonary emboli, and deep vein thrombosis. This systematic review was carried out by searching PubMed from inception to April 2018 for relevant articles published in English. While the researchers retrieved 1,962 publications, only 15 were considered for review. The results herein showed that obese women who used oral contraceptives were at a higher risk than nonusers of developing blood clots (Rambaran, K., & Alzghari, S. K. 2020). This study explained the current statistics showing that over 400 women in the US die every year related to their use of oral contraception. This study suggests the need for women to be educated about the risks involved in contraception for better decision-making and management of any complications that may arise. Because this study was a systematic review, it was assigned a score of one on the JHNEBP rating scale.
These results are similar to another study conducted to explore the relationship between combined oral contraception and the risk of venous thromboembolism. This study was inspired by the understanding that even though the prevalence of venous thromboembolism remains relatively low, more so among younger women of reproductive age, it has been noted that combined oral contraceptives significantly increase the risk of this health problem (Khialani et al., 2020). This even becomes more prevalent in women with obesity. The study was carried out as a systematic review in which an electronic search obtained 1,254 studies. Still, the researcher considered only 86, which aligned with the inclusion criteria (Khialani et al., 2020). The result of this study indicated that even though venous thromboembolism is a considerably rare condition, the risk of obese women developing it significantly increases when they use oral contraceptives.
Nonetheless, different from other studies, the researchers assert that the benefits of the different oral contraceptives in preventing pregnancies are significantly greater than the risks for obese women (Khialani et al., 2020). This study included a review of different studies, and for this reason, it was assigned a rate of one on the JHNEBP rating scale. Another study was carried out to update current knowledge on the relationship between oral contraceptive pills and cerebral venous sinus thrombosis risk. The study also aimed to examine the impact of other forms of hormonal contraceptives, duration, type, and health condition of the woman on this relationship (Abdalhabib et al., 2022). Carrying out this study was based on the understanding that while there is a pool of studies that have examined the relationship between oral contraceptives and the risk of blood clots among obese women, several other defining aspects have not been factored in, and this limits the scope of understanding of this topic (Abdalhabib et al., 2022). This study was in the form of a systematic review and meta-analysis in which a search was performed to identify a series of published articles on the relationship between the use of hormonal contraceptives and the risk of blood clots among obese women between 15 and 50 years of age (Abdalhabib et al., 2022). The researchers reviewed only 11 of the 861 studies identified from the search. The results of this review show that using oral contraceptive pills significantly increases the risk of obese women of reproductive age developing cerebral venous sinus thrombosis (Abdalhabib et al., 2022). However, the researchers quickly note that the available data remains inadequate to draw definitive conclusions regarding how the duration of the use of contraceptives affects this relationship. Nonetheless, it remains evident that oral contraceptives significantly increase the likelihood of obese or overweight women developing blood clots. Falling back on the JHNEBP rating scale, this study was rated one since it extensively reviewed data from other studies.
Some studies have been conducted in a way that they compare the level of risk of blood clots identifiable with different approaches to contraception. One such study by LaVasseur et al. (2022) was carried out to examine the differences in the risk of thrombosis identifiable with different methods of contraception and their interaction with different patient-centered factors. This study was based on the understanding that different methods of contraception have been closely linked to venous thromboses. The risk of thrombosis is identifiable in hormonal contraceptive agents and in cases where intrauterine devices are used. This study involved conducting a narrative review of a series of studies regarding contraceptives and the risk of blood clots (LaVasseur et al., 2022). The study results indicated that different contraceptive types have different risk levels of blood clots for obese women. However, it is important to note that the results indicated that the risk of developing blood clots is significantly higher in obese women who use oral contraceptives.
This is based on the idea that these women have a higher body mass index while alone is a risk factor for blood clots (LaVasseur et al., 2022). However, the risk even increases because oral contraceptives contain hormones that increase the risk of blood clots, more so in women with other risk factors such as a family history of blood clots, smoking, or obesity. Conversely, the risk of developing blood clots is relatively lower among obese women who use IUDs. This is because these IUDs do not contain any hormones that can increase the risk of blood clots (LaVasseur et al., 2022). Since this study was a systematic review, it was assigned a score of one on the JHNEBP rating scale. These different results suggest that the risk of a blood clot is significantly higher among obese women using oral contraceptives than their counterparts who use IUDs.
Analysis of Literature
The article “Assessment of risk factors for deep vein thrombosis associated with natural anticoagulants and fibrinolytic regulatory proteins. Blood Coagulation & Fibrinolysis” by Abdalhabib et al., 2022, investigates deep vein thrombosis (DVT) as a critical disease in Africa by investigating its risk factors paying attention to its natural anticoagulants and fibrinolytic regulatory proteins. The study is designed to understand the specific roles these regulatory proteins play in the development of the disease among the Sudanese. A case-control study was utilized which is a suitable design when investigating this kind of problem. The findings presented would have been more convincing if data had been collected from more than one facility for the indicated year. The researchers also investigated the right parameters descriptive of deep vein thrombosis in terms of its regulatory proteins. In this study, 5.5% of the participants were determined to have Protein C deficiency and 8.5% of participants were victims of protein S deficiency. 3% were diagnosed with antithrombin III deficiency. The deficiency of regulatory proteins is portrayed as a common cause of DVT among the Sudanese population. The findings also demonstrate that early assessment of risk factors is important in improving treatment outcomes of DVT. Overall, the article is straightforward and precise in the way information is presented.
The article “Hormonal therapies and venous thrombosis: Considerations for prevention and management. Research and Practice in Thrombosis and Haemostasis” by LaVasseu et al., 2022, seeks to investigate venous thrombosis as one complication of hormonal therapy. The study pays attention to the risk of developing thrombosis in persons using hormonal contraceptive agents. The researchers used a narrative review is data collection which is an ideal method considering that challenges experienced when collecting data on hormone‐related thrombosis risks. The results create an impression that thrombosis risk tends to increase with an increment in oestrogen dosage. It was found that thrombosis rates increase with age in women aged above 30 years with an incidence rate of 2–3.7 events/10 000 women using oestrogen. It was also found that thrombosis risks increases 10.2 folds in women using third generation contraceptives. However, the study does not identify effective management of complications of hormone therapy in patients diagnosed with prothrombotic illnesses. This failure is unfortunate considering that prothrombotic illnesses have shown an increase in the recent times with the recent Covid-19 pandemic. The article generally calls for more research into thrombosis-related complications and risk factors.
The article “Gamer’s thrombosis: A review of published reports” by Rambaran & Alzghari, 2020, investigates thrombosis as a common condition reported in elderly people that develops in healthy adolescents. Published articles were reviewed to collect relevant data on the relationship of immobility and increased risk of developing the VT. 12 out of the 26 articles used in this study revealed instances where immobility led to the development of venous thromboembolism, where 2 were fatalities reported. 15 patients were also determined to have recurrent VT. The risk of developing VT was identified to be 2.33 for obesity which represents a confidence interval of 95%. These results obtained confirm that, indeed, immobile people are at a high risk of developing thrombosis. Obesity, use of birth control and cigarette smoking are some risk factors identified that can easily be modified. Commonly, obese people are highly immobilized. The recommendation for screening for venous thromboembolism in gamers is justifiable owing to the prolonged sitting hours.
The article “Obesity and contraceptive use: impact on cardiovascular risk” by Rosano et al., 2022, considers obesity and contraceptives containing oestrogen as confirmed risk factors for cardiovascular disease. The researchers are concerned that obese women still receive hormonal products containing oestrogen. The study uses a narrative review making it possible to identify the latest research, current research and contentious issues about overweight and cardiovascular risk. The results confirm that overweight women using oral contraceptives are 12-24 times more likely to have venous thromboembolism comparing them with non-obese women that are not on contraceptives. Specifically women using combined oral contraceptives with a BMI index above 25 had the VT risk increased by 12-fold. These findings reveal the importance of clinicians considering the body weight and BMI indexes of a person when administrating contraceptives containing estrogen. The study also indicates that Progestin-only products are safer alternatives for use in obese patients. Overall, the article is specific in the way it highlights the dangers associated with the use of oral contraceptives by obese women.
The article “A safe and effective contraceptive method for women with obesity in the postpartum period” by Sultanmuratova et al., 2022, investigates the safety levels of using drospirenone-containing combined oral contraceptive in women of reproductive age determined to be overweight. The study used an appropriate inclusion criterion in selecting sixty five obese women participants on contraceptives. 39 participants were diagnosed with polycystic ovary syndrome. These are fertile women who cannot ovulate. 32 people showed clinical signs indicating that they were infertile while laboratory investigations of 22 had people indicated that they had functional hyperprolactinemia. An impression is created that oral contraceptives poses a major risk on young women in terms of complications of their reproductive system based on the results obtained. The researchers succeed to reveal the importance of considering the lipid profile levels and body when administering oral contraceptive pills. In general, the article insists on the importance of proper screening of women before administering contraceptives to minimize infertility risk.
The article “Hormonal contraceptives and the risk of venous thrombosis. In Seminars in thrombosis and hemostasis” by Khialani et al., 2020, seeks to reveal how the risk of developing venous thrombosis (VT) is influenced by the kind of progestogen contained in oral contraceptives. The study considers that the component ethinyl estradiol has counteracting effects that minimize the chances of developing VT. The findings create a good understanding of how novel oestrogens are developed and determined to have a reduced risk of VT. The study succeeds to reveal the VT risk of combined oral contraceptives but fails to identify the risks associated with other methods such as injectable contraceptives and vaginal rings. Additional conditions that put a person at a risk of developing venous thrombosis were identified. Inherited thrombophilia is an outstanding underlying condition indicated to increase the susceptibility to VT in women using combined oral contraceptives. The incidence rate of VT is 0.36% in cases of mild thrombophilia and 0.64% in severe cases. However, the rates increase with up to 6 folds in persons using high dosage of combined hormonal contraceptives containing DRSP. It is unfortunate that the authors were not able to identify VT risk in women who end up switching combined oral contraceptives. However, it is hypothesized that switching from a low to a high dosage of combined oral contraceptives increases the risk of developing the condition. In general, the researchers are justified by suggesting the importance of identifying high-risk women in a bid to recommend alternative contraceptive methods they should consider using.
Dependent and Independent Variables
The independent variable is obese women under observation in response to their chosen contraceptive methods. Another independent variable is the age bracket of the obese women under observation and a specific time frame for the observation, five years. The dependent variables include the methods of contraception that the women choose to undertake and the formation of blood clots during the observation phase. The variables would be used to assess the routines and health implications of the population under observation and whether there would be a significant gap in the risks suffered by both groups of obese women.
Clinical Implication
From the study, we can see that IUDs are much better alternatives, allowing women to be comfortable with their weight and use contraception methods that do not place them at any risk of developing cardiovascular implications, which can be applied by specialists in the future while deciding on the best and safest contraceptive to give to clients. Moreover, through this work, patients can identify the best cause of action while deciding on contraceptives.
Conclusion
Therefore, while the use of contraceptives is a new normal in the modern age, it is essential to understand the risks that obese women aged between 25 and 40 are exposed to for opting for either oral or IUDs contraceptive methods. The paper conducted a systematic review, which boiled down to six articles, after elimination based on the specifics of the research, and using the key terms. After a critical evaluation of the literature, it was evident that oral contraceptives pose a high risk to obese women with a greater risk of blood clots and, thus, risk of cardiovascular arrest. Conversely, IUDs contraceptives had minimal risk on the patients, thus becoming the best alternative for obese women.
References
Abdalhabib, E. K., Jackson, D. E., Alzahrani, B., Elfaki, E., Hamza, A., Alanazi, F., Ali, E. I., Algarni, A., & Ibrahim, I. (2022). Assessment of risk factors for deep vein thrombosis associated with natural anticoagulants and fibrinolytic regulatory proteins. Blood Coagulation & Fibrinolysis, 33(3), 149–152. https://doi.org/10.1097/mbc.0000000000001116
LaVasseur, C., Neukam, S., Kartika, T., Bannow, B. S., Shatzel, J., & DeLoughery, T. G. (2022). Hormonal therapies and venous thrombosis: Considerations for prevention and management. Research and Practice in Thrombosis and Haemostasis, 6(6), e12763.
Khialani, D., Rosendaal, F., & van Hylckama Vlieg, A. (2020, November). Hormonal contraceptives and the risk of venous thrombosis. In Seminars in thrombosis and hemostasis (Vol. 46, No. 08, pp. 865-871). Thieme Medical Publishers, Inc…
Rambaran, K., & Alzghari, S. K. (2020). Gamer’s thrombosis: A review of published reports. Ochsner Journal, 20(2), 182–186. https://doi.org/10.31486/toj.19.0058
Rosano, G. M., Rodriguez‐Martinez, M. A., Spoletini, I., & Regidor, P. A. (2022). Obesity and contraceptive use: impact on cardiovascular risk. ESC heart failure.
Sultanmuratova, G. U., Babadjanova, G. S., Nazarbayev, J. B., & Kerimova, N. M. (2022). A safe and effective contraceptive method for women with obesity in the postpartum period. American Journal of Medicine and Medical Sciences 2022, 12(8): 836-839. https://doi.org /10.5923/j.ajmms.20221208.15
Appendix
Citation of SR
Objective, Aim, Purpose
Search Strategy
Inclusion/Exclusion Criteria
Data Extraction and Analysis
Results
Recommendation/ Implication
Level of Evidence
LaVasseur, C., Neukam, S., Kartika, T., Bannow, B. S., Shatzel, J., & DeLoughery, T. G. (2022). Hormonal therapies and venous thrombosis: Considerations for prevention and management. Research and Practice in Thrombosis and Haemostasis, 6(6), e12763
the differences in thrombosis risk of the many hormonal preparations available and their interaction with patient‐specific factors.
Large pharmacy databases, biomarker studies, centralized hospital registries, cohort studies, and case-control studies
Thematic analysis
Different types of contraceptives have different levels of risk of blood clots for obese women.
When contemplating contraception, clinicians must factor in different prothrombotic risk factors to make more informed decisions
Level 1
Khialani, D., Rosendaal, F., & van Hylckama Vlieg, A. (2020, November). Hormonal contraceptives and the risk of venous thrombosis. In Seminars in thrombosis and hemostasis (Vol. 46, No. 08, pp. 865-871). Thieme Medical Publishers, Inc…
Understanding hormonal contraceptives and the risk of venous thrombosis
from inception to April 2018
of objectively confirmed venous thrombosis in healthy women taking oral contraceptives
Switching COCs, even when switching from a high- to a low-risk COC, increases the risk of VT
It is important to identify women at risk of VT and advise them on alternative contraception methods.
Level 1
Abdalhabib, E. K., Jackson, D. E., Alzahrani, B., Elfaki, E., Hamza, A., Alanazi, F., Ali, E. I., Algarni, A., & Ibrahim, I. (2022). Assessment of risk factors for deep vein thrombosis associated with natural anticoagulants and fibrinolytic regulatory proteins. Blood Coagulation & Fibrinolysis, 33(3), 149–152. https://doi.org/10.1097/mbc.0000000000001116
To assess the roles of natural anticoagulants and fibrinolytic regulatory factors in the development of DVT in Sudanese patients.
A search through PMC
Factors for deep vein thrombosis associated with natural anticoagulants
Thematic analysis
The early assessment of risk factors, including the measurements of natural inhibitors, can predict the occurrence of DVT before it is actually detected in patients.
Risk factors should be assessed early enough to prevent occurrence of DVT
LevelI
Rambaran, K., & Alzghari, S. K. (2020). Gamer’s thrombosis: A review of published reports. Ochsner Journal, 20(2), 182–186. https://doi.org/10.31486/toj.19.0058
To explore the relationship between combined oral contraception and the risk of venous thromboembolism
PubMed, Scopus, Web of Science, and EBSCO for articles
Thematic analysis
Modifiable risk factors included cigarette use, being overweight, birth control use, and prolonged immobility. Anticoagulation was the principal treatment modality in patients presenting with gaming thrombosis
Strongly encourage screening gamers for possible VTEs if clinically warranted.
Level 1
Rosano, G. M., Rodriguez‐Martinez, M. A., Spoletini, I., & Regidor, P. A. (2022). Obesity and contraceptive use: impact on cardiovascular risk. ESC heart failure.
Discuss the latest evidence, ongoing research, and controversial issues on the synergistic effect of obesity and contraceptive use in terms of cardiovascular risk
The electronic database search in PubMed
Cardiovascular risks, mainly VTE risks, increase between 12 and 24 times compared with non-obese non-COC users.
Exercise caution with the use of COCs in patients with overweight and obesity, choosing the safest alternatives when prescribing hormonal contraception due to the rising global prevalence of obesity.
Level II
Sultanmuratova, G. U., Babadjanova, G. S., Nazarbayev, J. B., & Kerimova, N. M. (2022). A safe and effective contraceptive method for women with obesity in the postpartum period. American Journal of Medicine and Medical Sciences 2022, 12(8): 836-839. https://doi.org /10.5923/j.ajmms.20221208.15
This study aims to determine the safety of drospirenone-containing combined oral contraceptives (OC) in overweight/obese women of reproductive age.
The electronic database search in PubMed
The study included 65 women of reproductive age who were prescribed OC with 30 µg of ethinyl estradiol and 3 mg of drospirenone for 3 months for therapeutic and preventive purposes. The main parameters evaluated were lipid and carbohydrate metabolism
According to the study results, a favorable effect of low-dose OC pills on body weight and lipid profile was revealed without significant changes in carbohydrate metabolism. Conclusion. Therefore, this method of contraception may be recommended for overweight/obese patients to control fertility in the postpartum period.
Additional control should be carried out in patients with impaired carbohydrate metabolism.
Level II
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