European Journal of Cardiovascular Medicine

Medical abortion, utilizing medications such as mifepristone and misoprostol has revolutionized early pregnancy termination, offering a non-invasive alternative to surgical abortion. When administered under medical supervision, medical abortion demonstrates high efficacy rates (up to 98% in early gestations) and a favorable safety profile, with complications being relatively infrequent and manageable [1, 2]. The World Health Organization (WHO) and various national guidelines endorse medical abortion as a safe and effective method when protocols are followed, including proper gestational age assessment, exclusion of contraindications, and provision of adequate counseling and follow-up [3].

However, the increasing over-the-counter availability of medical abortion pills in many regions, particularly in settings with restrictive abortion laws or limited access to healthcare, has led to a rise in self-medication among pregnant women [4]. While increased access to abortion medication can be seen as a positive step towards reproductive autonomy, unsupervised self-administration poses significant risks. Without prior medical consultation, women may not receive accurate gestational age assessment, may have undiagnosed contraindications (such as ectopic pregnancy or certain medical conditions), and lack access to crucial counseling on the process, potential complications, and necessary follow-up care [5].

This study was designed to investigate the impact of self-administered abortion pills on women seeking care in a tertiary hospital setting. By examining the spectrum of complications, required interventions, and patient demographics, this research aims to quantify the burden on tertiary healthcare facilities and emphasize the importance of supervised medical abortion practices.

Study Design and Setting:

This prospective observational study was conducted in the Department of Obstetrics and Gynecology at Kempegowda Institute of Medical Sciences (KIMS), Bengaluru, a tertiary care hospital in India. The study spanned 12 months, from October 2023 to September 2024. The study was approved by the Institutional Ethics Committee, and all participants provided written informed consent.

Study Population:

The study population included pregnant women presenting to the Department of OBG at KIMS, Bengaluru, who sought medical attention for complications arising from self-administered medical abortion pills without prior medical consultation.

Inclusion criteria:

·         Women who had used medical abortion pills (mifepristone and/or misoprostol) without direct medical supervision prior to presentation.

·         Gestational age up to 24 weeks at the time of abortion pill use.

·         Willingness to participate in follow-up examinations and interviews to assess outcomes and complications.

Exclusion criteria:

·         Women who did not provide informed consent.

·         Women who had used medical abortion pills under direct medical supervision (i.e., after consultation with a healthcare provider).

·         Known allergies or adverse reactions to mifepristone or misoprostol.

Data Collection and Analysis:

Data were collected prospectively upon presentation to the hospital. The data collection process involved:

·         Patient Records: Review of hospital records for clinical details, presenting complaints, medical history, and interventions performed.

·         Surveys and Interviews: Structured questionnaires and interviews were conducted with participants to gather information on demographics, gestational age (self-reported and clinically assessed), source of abortion pills, medications used, dosage, route of administration, and reasons for self-administration (though reasons are not detailed in the provided results).

·         Clinical Assessment: A detailed clinical history was taken, followed by a thorough physical examination and an ultrasound examination to confirm gestational age, assess for completeness of abortion, and identify any complications such as ectopic pregnancy or retained products of conception.

Collected data were entered and analyzed using statistical software. Descriptive statistics, including frequencies and percentages, were used to summarize demographic characteristics, presenting complaints, complications, outcomes, and interventions.

Demographic Characteristics:

A total of 74 women were enrolled in the study. The age distribution is shown in Table 1. The majority of women were in the 21-25 age group (37.8%), followed by 26-30 years (21.6%). Most participants were multigravida (67.5%) compared to primigravida (32.4%).

Table 1: Age and Parity Distribution of Study Participants

Gestational Age at Presentation:

The distribution of gestational age at the time of presentation to the hospital is presented in Table 2. The largest proportion of women presented between 12-20 weeks of gestation (55.4%), followed by those less than 12 weeks (36.4%). A smaller percentage presented between 21-24 weeks (8.1%).

Table 2: Gestational Age at Presentation

Socioeconomic Factors and Drug Source:

The educational and occupational backgrounds, along with the sources of abortion pills, are shown in Table 3. The majority of women had completed higher secondary education (44.5%) or were graduates (39.1%). Most were homemakers (68.9%). Pharmacists were the most common source of abortion pills (43.2%), followed by husbands (25.6%) and friends (22.9%).

Table 3: Education, Occupation, and Source of Abortion Pills

Presenting Complaints and Anemia:

The most common presenting complaint was bleeding per vagina (66.21%), followed by passage of products of conception (16.21%) and pain abdomen (10.81%) (Table 4). A significant proportion of women were anemic, with 50% exhibiting moderate anemia (Hb 7-9.9 g/dL) and 8.1% with severe anemia (Hb <7 g/dL).

 Table 4: Presenting Complaints and Anemia Status

Outcomes and Interventions:

Incomplete abortion was the most frequent outcome (81%), followed by missed abortion (10%) and unaffected abortion (6%) (Table 5). Ectopic pregnancy was diagnosed in 3% of cases. The primary intervention was suction and evacuation (75.67%), indicating the need for surgical management in a substantial proportion of cases. Anemia correction was required in 33.7% of women, and laparotomy was performed in 3% of cases, likely for ectopic pregnancy management or complications from incomplete abortion.

Table 5: Outcomes and Interventions

This study provides valuable insights into the impact of self-administered abortion pills in a tertiary care setting. The high prevalence of incomplete abortion (81%) among women presenting with complications underscores the risks associated with unsupervised medical abortion. Incomplete abortion necessitates further medical intervention, often surgical, to prevent complications such as hemorrhage, infection, and retained products of conception [6]. The fact that 75.67% of women required suction and evacuation highlights the significant burden on hospital resources and the potential for increased morbidity.

Bleeding per vagina was the most common presenting complaint, aligning with known complications of medical abortion, especially when not managed under supervision. Without proper guidance, women may misinterpret normal bleeding patterns or delay seeking care for excessive bleeding, potentially leading to significant blood loss and anemia, as evidenced by the high rates of moderate to severe anemia in this study.

The gestational age distribution indicates that a substantial proportion of women self-administered abortion pills in the later stages of the first trimester and early second trimester (12-20 weeks). Medical abortion efficacy decreases and complication rates may increase with advancing gestational age [7]. Self-managing abortion at later gestations without medical assessment and support could contribute to higher rates of incomplete abortion and other complications.

Interestingly, pharmacists were identified as the most frequent source of abortion pills, suggesting relatively easy access outside of formal prescription pathways. This accessibility, while potentially beneficial in improving abortion access in some contexts, also contributes to the problem of unsupervised use. The role of husbands and friends as sources also points to informal networks through which these medications are being obtained.

The finding of ectopic pregnancy in 3% of cases, while seemingly small in number, is clinically significant. Ectopic pregnancy is a contraindication to medical abortion, and misdiagnosis or delayed diagnosis due to lack of pre-abortion assessment can have severe, even life-threatening consequences [8]. This highlights a critical risk of self-administered abortion without prior medical consultation.

Implications for Patient Care and Resource Allocation:

The high rate of complications, particularly incomplete abortion, translates directly into increased demand for tertiary care services. The need for suction and evacuation, anemia correction, and management of other complications places a significant burden on hospital resources, including operating room time, medical personnel, blood bank supplies, and post-abortion care facilities. This has implications for resource allocation within healthcare systems, particularly in resource-constrained settings where tertiary care facilities may already be under pressure.

Furthermore, the psychological impact on women experiencing complications from self-administered abortion should not be overlooked. Unplanned hospital visits, surgical interventions, and potential complications can cause significant anxiety and distress. Access to post-abortion counseling and support is crucial in these situations.

As a single-center observational study conducted in a tertiary care hospital, the findings may not be fully generalizable to other settings or to the broader population of women who self-administer abortion pills. Women who experience complications severe enough to warrant hospital presentation may represent a specific subset, and the experiences of those who self-manage abortion successfully at home without complications are not captured. The study relies on self-reported data regarding gestational age and medication use, which may be subject to recall bias or inaccuracies.

Future research should address the limitations of this study and further explore the complexities of self-administered abortion. Multi-center studies with larger sample sizes could provide more scalable data. Qualitative research is needed to understand women's motivations for choosing self-administered abortion and their experiences with the process. Studies should also investigate the long-term physical and psychological health outcomes of self-administered abortion. Research is needed to evaluate the effectiveness of different public health interventions aimed at improving access to safe abortion services and reducing the risks associated with unsupervised self-medication.

This study highlights the substantial risks associated with self-administered abortion pills, as evidenced by the high prevalence of complications among women presenting to a tertiary care hospital. Incomplete abortion and bleeding are major concerns, leading to significant healthcare utilization and a burden on hospital resources. While medical abortion is a safe and effective method under medical supervision, unsupervised self-administration carries risks that necessitate urgent attention.

The findings underscore the critical need for public health interventions to ensure safer abortion practices. These interventions should focus on:

·         Improving access to supervised medical abortion services: Ensuring that women have access to affordable, accessible, and respectful abortion care within the formal healthcare system is paramount. This includes expanding the availability of trained providers and facilities offering medical abortion.

·         Public education and awareness: Comprehensive public health campaigns are needed to educate women about the importance of medical supervision for abortion, the potential risks of self-administration, and the availability of safe and legal abortion services.

·         Regulation and responsible medication access: While access to abortion medication is crucial, strategies to ensure responsible access and minimize unsupervised use should be explored. This may involve strengthening pharmacy regulations while ensuring women can still access necessary medications through appropriate channels.

·         Strengthening post-abortion care services: Tertiary care hospitals and primary healthcare facilities need to be prepared to manage complications arising from both supervised and unsupervised abortions, ensuring timely and effective post-abortion care, including counseling and family planning services.

Ultimately, ensuring women's reproductive health and rights requires a multi-faceted approach that prioritizes access to safe, legal, and comprehensive abortion care, coupled with robust public health education and support systems.

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2.       National Abortion Federation. 2023 Clinical Policy Guidelines for Abortion Care. Washington, DC: National Abortion Federation; 2023.

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7.       von Hertzen H, Huong NT, Piaggio G, Bayalag M, Cabezas E, Fang AH, et al. WHO Research Group on Postovulatory Methods of Fertility Regulation. Misoprostol dose and route after mifepristone for early medical abortion: a randomized controlled noninferiority trial. BJOG. 2010 Sep;117(10):1186-96. doi: 10.1111/j.1471-0528.2010.02636.x. Epub 2010 Jun 18. PMID: 20560941.

8.       Barnhart KT. Clinical practice. Ectopic pregnancy. N Engl J Med. 2009 Jul 23;361(4):379-87. doi: 10.1056/NEJMcp0810384. PMID: 19625718.