Early pregnancy loss (EPL) is an obstetric complication that is defined as the involuntary ending of the pregnancy that occurs before 13 weeks of gestation and that occurs in an approximate of 10-20% of the clinically known pregnancies¹. The condition may be caused by many factors, such as chromosomal mutations, maternal infections, hormonal disproportions, fetal defects, and immunological causes². Irrespective of the etiology, EPL management is sought to attain full evacuation of retained products of conception and a minimal arrival of complications, as well as, maintain future fertility³.

Historically, the common method used to deal with early pregnancy loss was surgical evacuation either through manual vacuum aspiration (MVA) or dilation and curettage⁴. Surgical care has the benefits of predictability and high success of uterine evacuation⁵. Nonetheless, it has possible dangers, such as uterine perforation, cervical trauma, infection, intrauterine adhesions, and the psychological pain and suffering of invasive procedure. These disadvantages have encouraged clinicians and researchers to seek alternative that is less invasive, safer, and less expensive ^6,7.

Prostaglandin analogues, especially misoprostol, as a medical management method has become an option that is acceptable and feasible as a treatment of early pregnancy loss8. Misoprostol triggers uterine contractions and causes cervical dilation so that uterine content is expelled without resorting to anesthesia or hospital-based procedures9. It can be introduced in different modes of delivery such as oral, sublingual or vaginal and this gives it versatility and ease of use in clinical practice. In addition, women have increased autonomy, privacy, and psychological comfort that is valued in patient-centered care with the help of medical management10.

Several studies have also revealed that misoprostol can result in full uterine evacuation in a significant percentage of cases, but its effectiveness can be different, and it depends on dosage, administration route, and gestational age11,12. Medical management can take longer time to achieve than surgery and can be characterized by increased cases of unplanned surgery in cases of incomplete evacuation13. However, it also lowers the risks of procedures and healthcare expenses significantly and thus is a viable choice, particularly in low resource contexts14.

Although several international studies have compared surgical and medical management of early pregnancy loss, limited prospective data is available from resource-constrained public healthcare settings in Pakistan, particularly from Azad Kashmir. Variations in patient demographics, access to emergency services, counseling practices, and follow-up compliance may influence treatment outcomes and patient satisfaction. Therefore, locally generated data is essential to guide context-specific clinical decision-making and optimize patient-centered care. This study was conducted to provide real-world comparative evidence from a tertiary care center in Muzaffarabad.

Considering the rising trend of non-surgical treatment, as well as the controversial nature of their relative efficacy and safety, a well-organized clinical assessment is required to assess which approach would yield the most significant results in the case of early pregnancy loss. Hence, this research will focus on making a comparative study between the two approaches in terms of the success of treatment and the levels of safety. To compare the efficacy and the safety of medical management with misoprostol and surgical management of early pregnancy loss

Study Design and Setting

This prospective observational comparative study was conducted at the Department of Obstetrics and Gynecology, Abbas Institute of Medical Sciences (AIMS), Muzaffarabad.

Study Duration

The study was carried out over a period of six months, from February to August, 2022.

Study Population

A total of 160 women aged 18–40 years with a gestational age of ≤13 weeks and confirmed diagnosis of early pregnancy loss were included in the study.

Inclusion and Exclusion Criteria

Women aged 18–40 years with gestational age ≤13 weeks and confirmed early pregnancy loss. Women with intrauterine contraceptive device use, anemia (Hb <9.5 g/dL), known allergy or contraindication to misoprostol, prior pelvic infections, or bleeding disorders were excluded.

Sample Size Calculation, Sampling Technique and Randomization

The sample size was calculated using the WHO sample size calculator, with a significance level (α) of 0.05 and power of 80%, assuming 84% efficacy for misoprostol and 97% for surgical management15-17. Participants were enrolled consecutively and randomly allocated into two groups (n=80 each) using a lottery method. Group assignments were concealed in sealed envelopes to ensure allocation concealment.

Intervention Protocol

Group A: Medical Management (Misoprostol) Patients received 400 μg vaginal misoprostol every four hours for a maximum of five doses. Oxytocin infusion was administered if required.

Group B: Surgical Management (Manual Vacuum Aspiration) Patients underwent surgical evacuation via manual vacuum aspiration (MVA), performed by a resident under the supervision of a consultant.

Data Collection.

Data were collected using a structured proforma designed to record demographic characteristics, clinical findings, treatment outcomes, complications, and patient satisfaction. The primary outcome, efficacy, was assessed by confirming complete uterine evacuation through ultrasound at 72 hours’ post-intervention. Secondary outcomes included complications such as bleeding, abdominal pain, and infection, which were systematically recorded. Patient satisfaction was also evaluated using the same proforma. All participants were followed up at 72 hours after the intervention for assessment of treatment outcomes and detection of any adverse effects.

Statistical Analysis

Data were analyzed using SPSS version 25. Continuous variables were expressed as mean ± standard deviation, while categorical variables were presented as frequencies and percentages. The Chi-square test was applied to compare efficacy and complications between groups. A p-value of ≤0.05 was considered statistically significant. Stratified analyses were performed for age, gestational age, parity, and residential status to control for potential confounding variables.

Ethical Approval and Informed Consent

Ethical approval was obtained from the Ethical Review Committee of AIMS. Written informed consent was obtained from all participants prior to enrollment

The demographic data of 160 patients (80 in each group) in medical (Group A) and surgical (Group B) management are shown in Table 1. The age average of the participants was similar in both groups-27.75 ± 2.50 years in group A and 28.15 ± 2.72 years in group B. Equally, the average gestational age of the misoprostol and surgical management was 8.89 and 8.98 respectively with a standard error of 1.44 weeks and 1.72 weeks respectively showing there was no significant difference in the baseline characteristics. Group A and B also had a similar mean parity, which was 1.11 ± 1.17 in the misoprostol group and 1.24 ± 1.30 in the surgical group, respectively, and the distribution of the two cohorts was balanced with 46.25% and 58.75% cities, respectively

Table 1: Demographic Characteristics of Patients in Both Groups (n = 160)

Table 2 provides comparison of the efficacy of treatments of two management methods of early pregnancy loss. In the misoprostol group, 67 of 80 patients (83.75%) achieved complete uterine evacuation without further intervention, compared to 75 of 80 patients (93.75%) in the surgical group. The difference in success rates between the two groups was statistically significant (p = 0.045), indicating higher efficacy in the surgical management group

Table 2: Comparison of Efficacy in Both Groups (n = 160)

Figure 1 demonstrates the prevalence of the side effects of each of the treatment modalities. Complications were observed in 15 patients (18.75%) in the misoprostol group and 8 patients (10.00%) in the surgical group. In particular, excessive bleeding was observed in 6 (7.50%) and 3 (3.75%) in misoprostol and surgical groups, respectively; abdominal pain in 10 (12.50%) and 5 (6.25%) and fever or infection in 4 (5.00%) and 2 (2.50%) in misoprostol and surgical groups, respectively. Although complications were overall mild and self-limited, a numerically higher frequency of minor adverse events was observed in the medical management group. It is interesting to note that patients do develop over one form of complication.

Table 3 provides the stratified efficacy, according to age, gestational age, parity and residential status. In the majority of subgroups, higher success rates were observed in the surgical management group compared to the misoprostol group, but not always they were statistically different. The difference in efficacy was only significant in patients with a gestational age of 10 weeks or less (p = 0.045), in which misoprostol had 82.35% success rates as opposed to 93.75% with surgical intervention. Surgical management reported 100% success amongst women with >30 years of age and those with parity >2, misoprostol yielded above 85% success. These findings suggest that both procedures are effective; however, surgical management demonstrated consistently higher success rates across most clinical subgroups

Table 3: Stratification of Efficacy with Respect to Age, Gestational Age, Parity, and Residential Status in Both Groups (n = 160)

Overall satisfaction was reported by 64 patients (80.00%) in the misoprostol group and 72 patients (90.00%) in the surgical group (Figure 2). Perceived convenience was higher among those receiving misoprostol, with 70 patients (87.50%) compared to 61 patients (76.25%) in the surgical group. Tolerable pain was experienced by 60 patients (75.00%) in the misoprostol group and 68 patients (85.00%) in the surgical group. Psychological comfort was noted in 67 patients (83.75%) treated with misoprostol and 58 patients (72.50%) who underwent surgery. Preference for the same method in future was expressed by 62 patients (77.50%) in the misoprostol group and 70 patients (87.50%) in the surgical group, while 66 (82.50%) and 73 (91.25%) patients, respectively, said they would recommend the method to others. Overall dissatisfaction was reported by 16 patients (20.00%) in the misoprostol group and 8 patients (10.00%) in the surgical group.

In the current research, early pregnancy loss surgically treated was shown to be successful at a higher rate (93.75%) than medical treatment using misoprostol (83.75%) with the disparity being statistically significant (p = 0.045). All these findings point to the fact that although both procedures are useful, surgical evacuation is more certain in the total uterine evacuation. Saaqib et al., stated that surgical management has a high success rate (100%) but its complications are more as compared to medical management18. We have also found that other researchers like Rausch et al., (2012) in a large multicentric randomized trial, which involved 652 women, stated that surgical management has been found to be more effective than medical management using misoprostol with a success rate of 97 percent versus 84 percent in management of early pregnancy loss19. In a similar fashion, Zhang et al. (2005) also found that surgery was more successful in complete evacuation (97) than medical management using misoprostol (84) in the case of early pregnancy loss20.

Misoprostol in our case reported 83.75% success rate, which is similar to other clinical reports as the efficacy of misoprostol was reported between 80 and 90 percent according to the dose and the mode of administration. A survey conducted by Sonalkar et al. (2020) has found that vaginal misoprostol 800 Projectiles are effective in the treatment of early pregnancy failure at a rate of 87 percent21. Similarly, Robledo et al. (2007) found an 84% success rate using a similar regimen implying that minor changes in dosages, patient factors and follow-up times can have an overall effect22.

Although the comparative effectiveness of surgical versus medical management is well-established internationally, locally generated data remains limited in resource-constrained settings. Our findings provide prospective evidence from a tertiary care public hospital, offering insight into real-world outcomes, patient satisfaction, and context-specific complications. Although the efficacy of the medical method is slightly reduced to that of surgery, it does not require anesthesia, use of operating theatres and risks of procedures; therefore, it is a convenient option when resources are limited.

The total complication rate of our study was 18.75 per cent in the misoprostol group and 10.00 per cent in the surgical group. There was excessive bleeding in 7.5 as compared to 3.75, abdominal pain in 12.5 as compared to 6.25, and fever or infection in 5.0 as compared to 2.5 cases respectively. These results lead to the conclusion that though both approaches are safe, medical treatment reflects a better incidence of mild and self-limited side effects. The results obtained by us are similar to the results provided by Tang and Ho (2006), who reported that medical management with misoprostol in cases of early pregnancy failure was overall safe and well tolerated with side effects that were mild and self-limiting mainly consisting of abdominal pains and transient fever23.

In our research, stratified analyses indicated that the efficacy difference was most notable in pregnancy with a gestation of 10 weeks or less (p = 0.045) in which surgical operation was successful in 93.75 percent of cases as opposed to 82.35 percent with misoprostol. This observation is consistent with the study conducted previously, who had found that lower gestational age was a predictor of reduced misoprostol efficacy with slight significance24, 25. All in all, our evidence appears to be validated by the global view on misoprostol as an effective and less invasive alternative to early pregnancy loss, but surgical evacuation has not been supplanted yet by providing the most reliable outcomes in terms of full evacuation of the uterus. These findings reinforce existing international evidence while providing region-specific insight relevant to public sector healthcare settings in Pakistan, highlighting the practical implications for patient counseling and context-specific management of early pregnancy loss.

Strengths and Limitations

The strengths of the study are that it has a prospective observational design with a well-defined sample, 160 patients who are divided into two groups medical and surgical management with a balanced baseline between ages, gestational age, parity, and residential status. The selection bias was reduced with the help of random assignment of subjects, and the outcome validity was reinforced through the use of structured follow-up and objective confirmation that full evacuation of the uterus occurred through ultrasound. The fact that they included patient satisfaction and adverse effect profiles was a holistic approach to assessing efficacy only. Limitations are however limited to the single-center setting, which might limit generalisability, a relatively short period of follow-up (72 hours) that might not have identified long-term complications/reproductive outcomes, as well as the exclusion of women with some comorbidities, which may restrict its applicability to the wider patient populations

Both medical management with misoprostol and surgical evacuation are safe and effective for early pregnancy loss. Surgical evacuation demonstrated higher efficacy (93.75% vs. 83.75%) and a slightly lower rate of minor complications compared to misoprostol. Medical management, while slightly less effective, offers advantages in terms of convenience, psychological comfort, and minimal invasiveness, making it a viable option in resource-limited settings or for patients preferring non-surgical treatment. Clinical decision-making should be individualized, considering gestational age, patient preference, safety profile, and availability of surgical resources.

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