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Background: Medical abortion with mifepristone and misoprostol can be provided up to 63 days' gestation in India. This accounts for 67.5 percent of all abortions in the country. We conducted an assessment to determine the availability of medical abortion medicines, specifically the combi-pack, in India. Methods: We applied the World Health Organization landscape assessment protocol at the national level. The assessment protocol included a five-step adaptation of an existing availability framework, including online data collection, desk review, country-level key informant interviews, and an analysis to identify barriers and opportunities to improve medical abortion availability. The assessment was conducted between August and March 2021. Results: Medicines for medical abortion are included in the national essential drug list and available with prescription in India. The assessment identified 42 combi-pack products developed by 35 manufacturers. The quality of medical abortion medicines is regulated by national authorities; but as health is devolved to states, there are significant inter-state variations. This is seen across financing, procurement, manufacturing, and monitoring mechanisms for quality assurance of medical abortion medicines prior to distribution. There is a need to strengthen supply chain systems, ensure consistent availability of trained providers and build community awareness on use of medical abortion medicines for early abortions, at the time of the assessment. Conclusion: Opportunities to improve availability and quality of medical abortion medicines exist. For example, uniform implementation of regulatory standards, greater emphasis on quality-assurance during manufacturing, and standardizing of procurement and supply chain systems across states. Regular in-service training of providers on medical abortion is required. Finally, innovations in evidence dissemination and community engagement about the recently amended abortion law are needed. Plain language summary: Medical abortion is popular in India and benefits from a liberal legal context. It is important to understand the availability of quality abortion medicines in the country. Using the World Health Organization country assessment protocol and availability framework for medical abortion medicines we examined the availability of these medicines from supply to demand. We used this information to identify opportunities for increasing availability of quality-assured medical abortion medicines. We found that the context for medical abortion varies across states. Strengthening procurement and supply chain management, with a greater emphasis on quality-assurance and regulation of manufacturing should be instituted at the state-level. Training is also needed to increase provider knowledge of the latest national guidelines and laws to ensure respectful and person-centered services. Finally, the public should be informed about medical abortion as a safe and effective choice, especially for early abortions. [ABSTRACT FROM AUTHOR]

Background Leiomyoma of the uterus is a benign tumour essentially composed of smooth muscle tissue and variable amount of fibrous connective tissue. Itis the most common our of the uterus and is found in 20 % of women in the reproductive age group. The symptoms include menstrual disturbances, commonly menorrhagia and dysmenorrhea. Mifepristone on the other hand is a progesterone receptor modulator with mainly antagonistic properties. Objectives: To study the effect of Mifepristone daily for 3 months on improvement of fibroid related symptoms and on the size of uterine fibroid and evaluate its role as a surgical substitute in patients who have fibroid associated anaemia, small to medium fibroids, women who want to preserve uterus and in cases where fibroids are unresectable or surgery is difficult. Materials and methods: It was an institutional based prospective study. It was conducted in Eden Building, Department of Gynaecology and Obstetrics in Medical College and Hospital, Kolkata, West Bengal, India. After receiving the clearance from the ethical committee study was conducted within 18 months period (March 2021 to September 2022).105 patients were included in this study. The data were entered in MS Excel spreadsheet and analysis was done using Statistical Package for Social Sciences (SPSS) version 21.0. Result: The mean age of the study population was 33.19 years. Menorrhagia was the predominant symptom among 48.6%. Majority of the subjects had intramural fibroid (37.1%). The mean PBAC score and Numeric pain rating scale score decreased significantly at the end of 3monthstherapy. Theme anuterine volume, fibroid volume decreased and endometrial thickness and mean Hb level increased significantly at the end of3monthstreatment. Conclusion: It can be concluded that at the end of 3 months, there was significant reduction in fibroid related symptoms, uterine and fibroid volume and improvement in haemoglobin level. [ABSTRACT FROM AUTHOR]

Background: Medical abortion is safer than surgical abortion. Several studies have shown that combination of antiprogesterone drug mifepristone and prostaglandin misoprostol can increase complete abortion rate in medical management of first-trimester miscarriage compared to misoprostol alone. Letrozole, an aromatase inhibitor, has emerged as an alternative to mifepristone for induction of medical abortion as mifepristone is expensive and not registered in many countries. Aims and Objectives: The aim of the present study was to evaluate the safety and efficacy of combined regimen of letrozole and misoprostol in first-trimester medical abortion compared to misoprostol alone. Materials and Methods: It was a comparative observational study conducted at R. G. Kar Medical College, a tertiary care hospital in West Bengal, India. The study population was the antenatal mothers booked at antenatal clinic willing for termination of pregnancy at <12 weeks of gestational age. Participants were allocated, 39 in each group in a nonrandomized manner. Patients in one group (Group A) were posted for medical abortion with combination regimen of tablet letrozole (10 mg) once daily for 3 days followed by application of tablet misoprostol 800 mcg sublingually on day 4. In other group (Group B), patients were on misoprostol-only regimen with the application of tablet misoprostol 800 mcg sublingually. Results: Induction-abortion time was significantly less in the letrozole group (11±0.79 h) than the misoprostol group (13.23±0.81 h), P=0.0001. Complete abortion rate was significantly higher in the letrozole group compared to misoprostol group (84.62% and 64.10%, respectively, P=0.03). 15.38% patients in the letrozole group and 35.90% patients in the misoprostol group had excessive vaginal bleeding and the difference was statistically significant, P=0.03. The duration of vaginal bleeding was also significantly less in the letrozole group (2.45±0.29 days) than the misoprostol group (2.82±0.37 days), P<0.0001. Incidence of side-effects was comparable and the severity of side-effects was not significantly different between the groups. Conclusion: Letrozole and misoprostol combination regimen leads to significant increase in complete abortion rate and also significant reduction of the duration of vaginal bleeding, induction-abortion time, and need for surgical intervention when compared to misoprostol regimen. [ABSTRACT FROM AUTHOR]

Purpose: To examine the association between self-managed abortion and the self-reported experience of abortion complications in India, a country with a high incidence of self-managed abortion.Patients and Methods: The study used a cross-sectional multivariable logistic regression analysis of data from the National Family Health Survey (NFHS-4) of 2015– 2016 to compare the odds of self-reported complications experienced during abortion between self-managed and clinician-managed abortions in India.Results: On average, self-managed abortions occurred earlier in gestation than clinician-managed abortions, 7.8 weeks and 11.3 weeks, respectively (p < 0.001). Self-managed abortion was associated with fewer self-reported abortion-related complications than clinician-managed abortions when adjusted for covariates not including gestational age (Adjusted Odds Ratio (aOR) 0.82, 95% confidence interval (CI) 0.69, 0.97). However, once adjusted for gestational age, there was no longer a clinically meaningful or statistically significant difference in the odds of self-reported complications between self-managed and clinician-managed abortions (aOR = 0.98, 95% CI 0.81, 1.18).Conclusion: These findings suggest that people in India are using safe methods to self-manage abortions and support the hypothesis that self-managed abortion can improve access to abortion and reproductive choice without increasing risk. [ABSTRACT FROM AUTHOR]

Background: Uterine fibroid is a common concern due to associated heavy menstrual bleeding and anemia negatively affecting women's life. The prevalence of uterine fibroid in India is upto 20-30% in reproductive females. Though surgical treatment still remains the mainstay of the treatment, medical methods had evolved over the years with the advent of many effective oral drugs. Methods: This comparative, interventional study conducted in the Gynaecological outpatient department of Nil Ratan Sircar Medical College and Hospital, Kolkata from March 2020 to August 2021. This study total of 21 patients in each group i.e. 42 women aged 20-50 years with leiomyoma uterus on USG who were fulfilling the inclusion and exclusion criteria were included in this study. Statistical data were analysed by using Microsoft Excel and SPSS V.20 software. Results: Age of the treated patients ranged between 33 to 50 years and maximum number of patients were in the age group between 41 to 45 years (40.5%). Maximum numbers of patients belonged to lower socioeconomic status; 38.1% and 47.6%. In both groups maximum fibroids were intramural in location; (61.9%) and (71.4%). Maximum number of patients had solitary fibroids (54.8%). Mean age of women in Mifepristone group & Ormeloxifene group were 39.76 ± 3.820 years and 41.48 ± 4.966 years respectively. The baseline mean Hb was 9.46 ± 0.45 gm% and 9.48 ± 0.39 gm% in the mifepristone group & ormeloxifene group respectively. The baseline mean PBAC score was 226.84 ± 28 and 213.16 ± 32.02 in the mifepristone group & ormeloxifene group respectively. The baseline mean fibroid size was 5.91 ± 1.54 cm and 5.38 ± 1.34 cm in the mifepristone group & ormeloxifene group respectively. The baseline mean fibroid volume was 72.43 ± 23.44 cc and 73.19 ± 21.56 cc in the mifepristone group & ormeloxifene group respectively. The baseline mean RI was 0.53 ± 0.16 and 0.58 ± 0.18 in the mifepristone group & ormeloxifene group respectively. The baseline mean ET was 7.03 ± 1.37 mm and 7.9 ± 1.87 mm in the mifepristone group & ormeloxifene group respectively. Conclusions: Mifepristone is more efficacious for the medical management of uterine fibroids as it significantly decreases the uterine fibroid size and volume along with reduction of menstrual blood. [ABSTRACT FROM AUTHOR]

Background: In India, despite of the fact that abortion facility is available legally under MTP act 1971, women seeking termination of pregnancy often ignore the legal status of abortions and have unsafe abortions. Medical abortion in the first trimester is safe, efficient and approved method of MTP, but should always be taken under the supervision of a registered medical practitioner. The unsupervised use of drug should be stopped as this can endanger life. Objective: To assess the effects of self-administered use of over the counter pill and compare it with the supervised use of mifepristonemisoprostol for medical termination of pregnancy in a tertiary care hospital; and to study its impact on women's health. Methodology: The study was conducted in the Department of Obstetrics & Gynaecology at a tertiary care hospital of North India over one year period. 322 patients fulfilling the inclusion and exclusion criteria were taken up for the study. Data was compared and analysed in patients with history of self consumption of medical abortion pills versus supervised pills intake. Result: Majority of the patients were young, belonged to the urban area and were Hindu by religion (p<0.0001). Only 66.3% patients in the unsupervised group followed the correct regimen as compared to the supervised group where all the patients followed the correct regimen. The complication rate was 73.1% in unsupervised group as compared to 42.6% in supervised group (p<0.0001). There was significant statistical difference between both groups in respect to success and failure rate with p<0.0001. Conclusion: This study shows urgent need for legislation and restriction of drugs used for medical termination of pregnancy. Drugs should be made available via health care facilities under supervision to reduce maternal mortality and morbidity due to indiscriminate use of these pills. [ABSTRACT FROM AUTHOR]

Background: Over-the-counter (OTC) sale of medical abortion (MA) inducing drugs is a common practice. Exploring its impact on women's health and the barriers to avail free MA services at hospital by these women is essential to improve upon policy decision. Methods: A prospective observational study included 112 women following ingestion of MA drugs from nonformal providers. Demography, clinical details, and reasons for not availing free abortion services at hospital were recorded. Results: Among 112 women, mean age was 28.63 (SD 4.7) years. Seventy one (63.39%) women were from rural region; 70.54% were educated below high school; 44 (39.28%) had prior induced abortion; 62.5% had never used any contraception. Majority (101; 90%) took two drugs (Mifepristone and Misoprostol), 28 (25%) used correct dosage. Drugs were consumed beyond 9 weeks of gestation by 25 (22.4%) women. Abnormal vaginal bleeding was commonest 105 (93.75%) presentation. Haemorrhagic shock was noted in 21 (18.75%) women, while 21 (18.7%) women required blood transfusion. "Easy and quick availability of these drugs OTC" was the commonest statement for not attending hospital. Conclusion: Easy and quick availability of OTC drugs, distance to hospital were major barriers. Incorrect dosage and lack of gestational age calculation were two most common errors in the risk assessment protocol. Expanding provider base, by training midlevel providers, can overcome these and unmask the full potential of MA to make abortion safer. [ABSTRACT FROM AUTHOR]

Objective: Previous studies have demonstrated quality concerns with misoprostol. Mifepristone, however, has not been extensively assessed for quality. Between 2020 and 2021, Concept Foundation and the International Planned Parenthood Federation conducted a study to determine the quality of these medical abortion drugs in low- and middle-income countries (LMIC)., Methods: The collection of batch samples of misoprostol and mifepristone was carried out by trained sampling agents in selected LMIC. Single drug packs and combipacks were sampled. A World Health Organization prequalified laboratory conducted testing method verifications and subsequent sample analysis. Tests included identification, assay, related substances, and content uniformity for misoprostol, and identification, assay, related substances, and dissolution for mifepristone., Results: Samples were collected from Burkina Faso, Cambodia, Democratic Republic of Congo, India, Kyrgyzstan, Moldova, Nepal, Nigeria, Pakistan, Uganda and Vietnam. Sixty-four pooled batch samples were tested, consisting of 31 combipacks, 26 misoprostol-only and seven mifepristone-only products. Overall, 54.7% of samples were non-compliant with one or more of the specifications, representing 51.6% of combipack products, 57.1% of misoprostol tablets analyzed and 23.7% of mifepristone tablets. One falsified misoprostol-only product was found., Conclusion: The present study confirms that a significant problem still exists in relation to the quality of medical abortion drugs in LMIC. For misoprostol, our findings suggest that historical concerns around primary packaging may have been largely resolved but that manufacturing processes for both finished product and active pharmaceutical ingredient need to be improved. The present study also provides evidence of mifepristone quality issues., (© 2023 The Authors. International Journal of Gynecology & Obstetrics published by John Wiley & Sons Ltd on behalf of International Federation of Gynecology and Obstetrics.)

In the article, the authors discuss the legal issues over the use of medication abortion (MA) that determine the access of women to quality and affordable abortifacient drugs. Also cited are the safety and effectiveness of pregnancy termination at home using MA, the ability of women to self-care after abortion, and the practices of women in using MA in countries like India and Mexico.

Background and Objectives: In India, the uterine fibroid is a common indication of hysterectomy. An effective option for medical treatment may decrease the morbidity associated with hysterectomy. We aimed to evaluate the effect of mifepristone (25 mg), progesterone antagonist, on uterine fibroids in perimenopausal women. Methods: Fifty-four perimenopausal women of age ≥18 years having symptomatic uterine fibroids were selected from Gynecology OPD and given 25 mg mifepristone once daily continuously for 2–4 cycles of 3 months each. Variables such as baseline fibroid size, position, and hemoglobin were measured and followed at 3, 6, 9, and 12 months. The data were entered in MS EXCEL spreadsheet and analysis was done using Statistical Package for Social Sciences (SPSS) version 21.0. A P value of <0.05 was considered statistically significant. Results: Majority were intramural fibroids (70.37%) followed by submucosal in 16.67%. Size of fibroids ranged from <3 to >7 cm; the majority of fibroids were in 5–7 cm size. No significant association of location with the size of fibroid was found. Out of 54 cases included in the study, change in size in uterine fibroids was observed in 98.14% cases. There was an increase in hemoglobin, from 8.6 g% at baseline to 9.7 g% at 12 months. Conclusion: Mifepristone resulted in a reduction in uterine fibroids size and an increase in hemoglobin at the end of 12 months. It may be an option for uterine leiomyoma treatment, as it is given orally, cost-effective and has minimal side effects. [ABSTRACT FROM AUTHOR]

Background: Pregnancy loss is a distressing problem and retention of dead fetus in utero has its own ill effects on physical, psychological, and social aspects, and hence, it is better to recommend medical induction, provided this can be safely undertaken. Aims: The aim of this study is to compare the efficacy, tolerability, induction-delivery interval, and perceived stress scores between induction methods in late intrauterine fetal death (IUFD) with misoprostol alone and mifepristone with misoprostol combination in a rural population of Eastern India. Materials and Methods: This pilot study was conducted on 125 patients after taking institutional ethical clearance and informed consent of the patients in a time span of 1 year. Group 2 patients received 200 mg of mifepristone per orally and observed for 48 h, followed by 50 μg misoprostol administered in the posterior vaginal fornix, and repeated 6th hourly up to a maximum of four doses. Group 1 received 50 μg misoprostol per vaginally 6 hourly for four doses. Induction-delivery interval was calculated. Perceived stress level was calculated on admission and before discharge. Results: Significantly lower induction-delivery interval was observed in Group 2 as compared to Group 1 with P < 0.001. There was no significant difference of Cohen's perceived stress scores on admission, but the difference was significantly lower in Group 2 on discharge with the value of P = 0.03. Group 1 had significantly lower hospital stay in days as compared to Group 2 of patients with P < 0.001. Conclusions: Patients with IUFD administered misoprostol per vaginally only may require shorter hospital stay as compared to patients administered with oral mifepristone followed by misoprostol vaginally but the delivery induction time increases significantly and may increase perceived stress levels which may have short- and long-term negative psychological impact. [ABSTRACT FROM AUTHOR]

Objective: To compare oral mifepristone (400 mg) with trans-cervical balloon catheter for induction of labor (IOL) in post date women with previous one cesarean section (CS).Methods: In this randomized trial, post date pregnant women (gestation 40 weeks 5 days), with previous one low segment CS (no previous vaginal delivery) were induced either with oral mifepristone (400 mg) or balloon catheter [Foley's catheter (16 Fr); bulb filled with 30 ml normal saline]. They were re-assessed 24 and 48 h later. If at any time Bishop Score was >6; amniotomy was done, followed by oxytocin infusion. Primary outcome of the study was labor onset after first manoeuvre. Secondary outcomes were cervical ripening, need of oxytocin, vaginal delivery and CS, in two groups.Results: From June 2012 to September 2015, we enrolled 107 women. Out of these, 57 received oral tablet mifepristone (400 mg) and 50 were inserted with balloon catheter. Labor onset after first manoeuvre was statistically significantly more in mifepristone group (37/57 vs. 13/50, respectively; p value 0.000). Bishop Score after 24 h was better in balloon catheter (p value 0.000). More women with balloon catheter required oxytocin for IOL (37/50 vs. 20/57, respectively; p value 0.000) along with higher dose [840 (320) mU vs 560 (120) mU, respectively, p value 0.000]. Failure of induction was statistically significantly higher in balloon catheter group (8 out of 50 vs. 2 out of 57, respectively, p value 0.043). There was no statistically significant difference in normal delivery or CS in either group (p value 0.242 and 0.331, respectively).Conclusion: Oral mifepristone (400 mg) is associated with statistically significantly higher incidence of labor onset in post date pregnant women with previous one CS, as compared to balloon catheter. Both methods are primarily for cervical ripening and oxytocin should not be delayed in the absence of onset of labor.Clinical Trial Registration: Clinical Trials Registry-India, www.ctri.nic.in , CTRI/2012/05/003634. [ABSTRACT FROM AUTHOR]

Background: Abortion services were legalized in India in 1972, however, the access to safe abortion services is restricted, especially in rural areas. In 2002, medical abortion using mifepristone-misoprostol was approved for termination of pregnancy, however, its use has been limited in primary care settings. Methods: This paper describes a service delivery intervention for women attending with unwanted pregnancies over 14 years in four primary care clinics of Rajasthan, India. Prospective data was collected to document the profile of women, method of abortion provided, contraceptive use and follow-up rates after abortion. This analysis includes data collected during August 2001-March 2015. Results: A total of 9076 women with unwanted pregnancies sought care from these clinics, and abortion services were provided to 70 % of these. Most abortion seekers were married, had one or more children. After 2003, the use of medical abortion increased over the years and ultimately accounted for 99 % of all abortions in 2014. About half the women returned for a follow-up visit, while the proportion using contraceptives declined from 74 % to 52 % from 2001 to 2014. Conclusions: The results of our intervention indicate that integrating medical abortion into primary care settings is feasible and has a potential to improve access to safe abortion services in rural areas. Our experience can be used to guide program managers and service providers about reducing barriers and making abortion services more accessible to women. [ABSTRACT FROM AUTHOR]

Introduction: Although home use of misoprostol for early medical abortion is considered to be safe, effective and feasible, it has not become standard service delivery practice. The aim of this study was to compare the efficacy, safety, and acceptability of home use of misoprostol with clinic misoprostol in a low-resource setting.Material and Methods: This was a secondary analysis of a randomized controlled trial conducted in six primary care clinics in India. Women seeking medical abortion within up to nine gestational weeks (n = 731) received mifepristone in the clinic and were allocated either to home or clinic administration of misoprostol. Follow-up contact was after 10-15 days.Results: Of 731 participants, 73% were from rural areas and 55% had no formal education. Complete abortion rates in the home and clinic misoprostol groups were 94.2 and 94.4%, respectively. The rate of adverse events was similar in both groups (0.3%). A greater proportion of home users (90.2%) said that they would opt for misoprostol at home in the event of a future abortion compared with clinic users (79.7%) who would opt for misoprostol at the clinic in a similar situation (p = 0.0002). Ninety-six percent women using misoprostol at home or in the clinic were satisfied with their abortion experience.Conclusions: Home-use of misoprostol for early medical abortion is as effective and acceptable as clinic use, in low resource settings. Women should be offered a choice of this option regardless of distance of their residence from the clinic and communication facilities. [ABSTRACT FROM AUTHOR]

Background & objectives: Uterine myoma is a common indication for hysterectomy in India. An effective medical treatment option may reduce hysterectomy associated morbidity. This study was undertaken to evaluate efficacy and safety of low dose mifepristone in medical management of myoma and to compare two doses - 10 vs. 25 mg/day. Methods: In this randomized clinical trial, women with symptomatic myoma or myoma>5cm were included. Uterine size >20 wk, fibroids >15 cm were excluded. Pictorial blood loss assessment chart (PBAC) score was used to assess menstrual-blood-loss and visual analog scale (VAS) for other symptoms. Haemogram, liver function test, ultrasound with doppler and endometrial histology was performed. Patients were randomized and were given oral mifepristone as 25 mg/day in group 1 and 10 mg/day in group 2 for 3 months. Patients were followed at 1, 3 and 6 months. Results: Seventy patients in group 1 and 73 in group 2 completed treatment. Mean PBAC score reduced from 253 to 19.8 and from 289.2 to 10.4 at 1 and 3 months in groups 1 and 2, respectively. At 3 months, 67 of 70 (95.7%) patients of group 1 and 66 of 73 (90.4%) of group 2 developed amenorrhoea which reverted after median 34 (range 4-85) days. Mean myoma volume decreased by 35.7 per cent (from 176.8 to 113.7cm³) and 22.5 per cent (from 147.6 to 114.4 cm³) at 3 months in groups 1 and 2, respectively. Side effects seen were leg cramps in 7 of 70 (10%) and 5 of 73 (6.8%) and hot-lushes in 5 of 70 (7.1%) and 5 of 73 (6.8%) in groups 1 and 2, respectively. Repeat endometrial-histopathology did not reveal any complex hyperplasia or atypia in either group. Interpretation & conclusions: Mifepristone (10 and 25 mg) caused symptomatic relief with more than 90 per cent reduction in menstrual blood. Greater myoma size reduction occurred with 25 mg dose. Amenorrhoea was developed in 90-95 per cent patients which was reversible. It can be a reasonable choice for management of uterine leiomyoma as it is administered orally, cost-effective and has mild side effects. [ABSTRACT FROM AUTHOR]

CONTEXT: The availability of trained abortion providers is limited in India. Allowing ayurvedic physicians and nurses to perform medication abortions may improve women's access to the procedure, but it is unclear whether these clinicians can provide these services safely and effectively. METHODS: Allopathic physicians, ayurvedic physicians and nurses (10 of each), none of whom had experience in abortion provision, were trained to perform medication abortions. In 2008-2010, these providers performed medication abortions in five clinics in Bihar and Jharkhand for 1,225 women with a pregnancy of up to eight weeks' gestation.A two-sided equivalence design was used to test whether providers'assessments of client eligibility and completeness of abortion matched those of an experienced physician "verifier," and whether medication abortions performed by nurses and ayurvedic physicians were as safe and effective as those done by allopathic physicians. RESULTS: Failure rates were low (5-6%), and those for nurses and ayurvedic physicians were statistically equivalent to those for allopathic physicians. Provider assessments of client eligibility and completeness of abortion differed from those of the verifier in only a small proportion of cases (3-4% for eligibility and 4-5% for completeness); these proportions, and rates of loss to follow-up, were statistically equivalent among provider types. No serious complications were observed, and services by all three groups of providers were acceptable to women. CONCLUSION: Findings support amending existing laws to improve women's access to medication abortion by expanding the provider base to include ayurvedic physicians and nurses. [ABSTRACT FROM AUTHOR]

Objectives To study the safety of second trimester abortion in women with previous uterine scar. Methods We screened the records of 518 women who underwent an abortion between 12 and 20 weeks' gestation at the Postgraduate Institute of Medical Education and Research, Chandigarh, India, from January 2000 to December 2010. Methods used for abortion were: (i) vaginal misoprostol with or without pre-treatment with mifepristone, and (ii) intracervical dinoprostol gel or vaginal misoprostol ± extra-amniotic saline ± oxytocin infusion. Seventeen women, aborted by means of a hysterotomy, were excluded from further analysis. Results Of the remaining 501 women, 44 had a uterine scar (Group 1) and 457 had none (Group 2). In Group 1, 40/44 (91%) and in Group 2, 452/457 (99%) women aborted successfully. The mean induction-abortion interval (IAI) was similar in the two groups (15.03 ± 10.69 hours and 12.52 ± 9.0 hours in Groups 1 and 2, respectively; p == 0.083). There were three uterine ruptures, 1/44 (2%) in group 1 and 2/457 (0.4%) in group 2 ( p == 0.132, NS); all three women had received mifepristone followed by vaginal misoprostol. Conclusion In women with a scarred uterus, midtrimester abortion may be successfully achieved using any of the aforementioned regimens. [ABSTRACT FROM AUTHOR]

Objective: To assess the efficacy and acceptability of home administration of misoprostol for early medical abortion in Indian family planning clinics.Methods: In this prospective cohort study, consenting pregnant women (n=599) with amenorrhea of 8 weeks or less seeking termination of pregnancy received 200mg of oral mifepristone followed 48 hours later with 400microg of oral misoprostol, administered either at home or at the clinic.Results: Almost all women (88.4%) chose to take misoprostol home. There was no statistical difference in success rates between home and clinic users (89.0% vs 92.4%, Pearson chi(2)=0.7; P=0.395). Most women in both the home (90.7%) and clinic (92.3%) groups were satisfied or very satisfied with the procedure.Conclusion: Home administration of misoprostol is safe and feasible for introduction into medical abortion services in India. [ABSTRACT FROM AUTHOR]

This article gives an overview of what is known about second trimester abortions in India, including the reasons why women seek abortions in the second trimester, the influence of abortion law and policy, surgical and medical methods used, both safe and unsafe, availability of services, requirements for second trimester service delivery, and barriers women experience in accessing second trimester services. Based on personal experiences and personal communications from other doctors since 1993, when I began working as an abortion provider, the practical realities of second trimester abortion and case histories of women seeking second trimester abortion are also described. Recommendations include expanding the cadre of service providers to non-allopathic clinicians and trained nurses, introducing second trimester medical abortion into the public health system, replacing ethacridine lactate with mifepristone-misoprostol, values clarification among providers to challenge stigma and poor treatment of women seeking second trimester abortion, and raising awareness that abortion is legal in the second trimester and is mostly not requested for reasons of sex selection. Cet article étudie l'avortement du deuxième trimestre en Inde, notamment les raisons pour lesquelles les femmes le demandent, l'influence de la législation et de la politique relatives à l'avortement, les méthodes chirurgicales et médicamenteuses utilisées, sûres ou non, la disponibilité des services, les besoins en prestation de services au deuxième trimestre et les obstacles que les femmes rencontrent pour accéder aux services. Sur la base de mon expérience et de communications personnelles avec d'autres médecins depuis 1993, quand j'ai commencé à pratiquer des avortements, je décris également les réalités pratiques de l'avortement du deuxième trimestre et les histoires des femmes qui souhaitent avorter à ce stade. Il est recommandé d'élargir le cadre de prestataires de services et d'y inclure des cliniciens non allopathiques et des infirmières qualifiées, d'introduire l'avortement du deuxième trimestre dans le système de santé publique, de remplacer le lactate d'éthacridine par la mifépristone et le misoprostol ; il faut aussi clarifier les valeurs chez les soignants pour lutter contre la stigmatisation et le traitement médiocre réservé aux femmes qui veulent avorter au deuxième trimestre, et faire savoir que l'avortement est légal à ce stade et n'est en général pas demandé pour des raisons de sélection du sexe du bébé. En este artículo se resume los conocimientos del aborto en el segundo trimestre en la India, incluidos los motivos por los cuales las mujeres buscan abortos en el segundo trimestre, la influencia de las leyes y políticas de aborto, los métodos quirúrgicos y médicos utilizados, tanto seguros como inseguros, la disponibilidad de los servicios, los requisitos para la prestación de los servicios y las barreras que encuentran las mujeres al tratar de acceder dichos servicios. A raíz de mis experiencias personales y comunicaciones personales con otros médicos desde 1993, cuando empecé a proporcionar servicios de aborto, las realidades prácticas del aborto en el segundo trimestre y las historias de casos de mujeres que buscan abortos en el segundo trimestre también se describen. Las recomendaciones son: ampliar el tipo de prestadores de servicios a médicos no alopáticos y enfermeras capacitadas, incorporar los servicios de aborto con medicamentos en el segundo trimestre en el sistema de salud pûblica, cambiar el lactato de etacridina por mifepristona-misoprostol, aclarar valores entre los prestadores de servicios para cuestionar el estigma y el mal trato de las mujeres que buscan abortos en el segundo trimestre y crear mayor conciencia de que el aborto es legal en el segundo trimestre y, por lo general, no se solicita por motivos de selección del sexo. [ABSTRACT FROM AUTHOR]

Objective The objective of this study was to determine if a repeat dose of misoprostol following mifepristone or a single dose of misoprostol increases the efficacy of medical termination of pregnancy. Design Randomised, placebo controlled trial. Setting K.E.M. Hospital, Pune, India, and the Health Centre, Larsen and Toubro Limited, Mumbai, India. Sample A total of 300 women seeking an abortion with amenorrhoea of 8 weeks or less. Methods Women were randomised to receive one or two doses of 400 microgram oral misoprostol at the clinic 48 hours after administration of 200 mg mifepristone. Main outcome measure Complete abortion without surgical intervention. Results The repeat administration of misoprostol 400 microgram improved the complete abortion rate from 86 to 92% and significantly reduced the rate of continuing pregnancy from 7 to 1%. Almost all the women who were administered the additional dose of misoprostol were either very satisfied (58%) or satisfied (37%) with the method. Conclusion While an additional oral dose of 400 microgram misoprostol did not significantly increase the rate of complete abortion without surgical intervention, the additional dose did significantly reduce the rate of continuing pregnancies without compromising the acceptability and ease of use of the method. [ABSTRACT FROM AUTHOR]

Objective: To determine the complications rate of termination of pregnancy (TOP) and the risk factors for complications following TOP.Methods: Retrospective observational study of the records of 1287 women who underwent TOP in the Department of Obstetrics and Gynaecology of the Postgraduate Institute of Medical Education and Research, Chandigarh, India, between 1997 and 2001. First-trimester abortion was performed in 1088 women (85%) and second-trimester abortion in 199 women (15%). Most women (76%) were aged between 26 and 30 years; they were educated and requested TOP primarily to limit the number of their children or to space their births. A malformed fetus was the indication for TOP in 5.9% cases, and 16% of the women had medical disorders associated with the pregnancy. Suction evacuation was the method of choice for first-trimester abortion (88%); dinoprostone gel and extra-amniotic saline solution plus oxytocin infusion were the primary methods (71%) for second-trimester abortion.Results: Uterine perforation occurred in 1 patient (0.09%) after a first-trimester abortion. The total rate of complications was 3.79% after first-trimester and 4.0% after second-trimester abortions. Excessive hemorrhage and retained placenta were chief complications associated with second-trimester abortion. Incomplete abortion (1.5%) and minor infection were seen in 2.3% patients. The rate of complications was higher among parous women. Postabortion insertion of a CuT intrauterine device increased the need for a second course of antibiotics.Conclusion: Termination of pregnancy is safe if adequate care is taken while performing the procedure. [ABSTRACT FROM AUTHOR]

As several important policy questions remain regarding the use of medical abortion in developing countries, we investigated the safety, efficacy, and acceptability of mifepristone-misoprostol abortion in the outpatient family planning departments of two urban hospitals and one rural hospital in India. Nine-hundred women (with gestations of ≤63 days in the urban sites and ≤56 days in the rural site) received 600 mg mifepristone followed 48 h later by 400 μg oral misoprostol in the clinic. Four point four percent or fewer urban women and 1.0% rural women were lost to follow-up. Perfect and typical-use failure rates were low at all sites. While rural women reported fewer side effects at all sites, the vast majority of women were satisfied with their medical abortions. Medical abortion can be offered safely, effectively, and acceptably in the outpatient family planning departments of urban and rural hospitals in India. [Copyright &y& Elsevier]

Objective: Understanding the price components of the mifepristone/misoprostol (combi-pack) for medical abortion to improve access is critical for identifying strategies to reduce product costs for quality-assured formulations and expanding its availability and use. Methods: We constructed a cost of goods sold analysis using data collected from manufacturing companies in Bangladesh, China and India supported by publicly available information related to the product formulation, active pharmaceutical ingredients (API), manufacturing location, manufacturer profiles and other individual model components. Key model components were the active pharmaceutical ingredients (quality-assured or not), excipients, labour cost, operating cost and packaging. Results: Combi-pack direct production cost ranges from US$1.08 for finished products which are not quality assured to US$3.05 for products containing quality assured active pharmaceutical ingredients, which means that with a 30% administrative fee applied to those prices, it could be made available between US$1.40 and US$3.97 depending on location, manufacturer's profile, optimal market situation and the quality of the active pharmaceutical ingredients. The main model component impacting on the cost range is the purchase price of mifepristone active pharmaceutical ingredient and the current differential between quality-assured material supported by adequate documentation and API for which quality assurance cannot be demonstrated. Compared to India cost of goods sold is lower in Bangladesh primarily due to lower operating costs, including the cost of labour. Conclusions: It is feasible to lower the cost of quality-assured combi-packs, through reducing mifepristone API cost and selection of the manufacturing location. However, manufacturers need to be incentivised to achieve WHO pre-qualification with a carefully built business case and require support in identifying and sourcing competitively priced material and manufacturing products to the necessary standard. [ABSTRACT FROM AUTHOR]

Abstract: Objective: To explore Indian abortion providers’ knowledge of medical abortion (MA), their personal experiences and practices of providing medical abortion, and their attitudes toward providing MA to eligible women who were poor, uneducated, and/or from rural areas. Methods: In selected districts of India''s Bihar and Maharashtra states, interviews were conducted with 270 physicians who were certified as abortion providers, using a structured questionnaire. Results: The providers’ knowledge of the gestational limit, the recommended doses of mifepristone and misoprostol, and other aspects of the approved protocol was far from universal. Only about two-thirds of these physicians authorized to perform MA actually performed it. Although they all counseled women about the procedure before they took mifepristone, the matters discussed were often limited to pain management and possible complications. Contraception was usually not discussed until the follow-up visit. Most providers thus missed the opportunity to provide sustained counseling to their MA patients, and did not counsel them about the need to protect themselves in the 2weeks following the administration of mifepristone. Moreover, many providers were reluctant to offer MA to poor, uneducated, and/or rural women. Conclusions: These findings shed light on the need to raise awareness and dispel misgivings about MA among certified providers of abortion services. By placing emphasis on the method''s safety and effectiveness, additional training to these would increase their confidence about offering MA to eligible women. [Copyright &y& Elsevier]

Reports the efficacy of mifepristone administration in India. Provision of the drug to out-patient family planning clinics; Observation of fewer side-effects; Safety and acceptability of medical abortion.

Objective: To test the effectiveness and acceptability of an outpatient medical abortion protocol with 200 mg mifepristone and 400 mcg sublingual misoprostol at 64-70 days' last menstrual period (LMP) and compare it to the already known efficacy of the 57-63 days' LMP gestational age range., Study Design: We conducted a prospective, comparative open-label trial in six hospitals and clinics in Ukraine, Georgia, India and Tunisia. We enrolled 714 reproductive age women with pregnancies 57 to 70 days who presented requesting abortion. Medical abortions were managed with the current service delivery protocol (200 mg oral mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol). Data on safety, efficacy and acceptability were collected. The main outcome measure was complete abortion without surgical intervention at any point., Results: A total of 703 cases were analyzable for efficacy. Success rates did not differ significantly in the two groups [57-63-day group: 94·8%; 64-70-day group: 91.9%; Relative Risk (RR): 0.79 (0.61-1.04)]. Ongoing pregnancy rates also did not differ significantly (57-63 days: 1.8%; 64-70 days: 2.2%; RR: 1.10 (0.65-1.87)]., Conclusion: A medical abortion regimen of 200 mg mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol is effective through 70 days' gestation and may be offered within existing outpatient abortion services., Implications: A regimen of 200 mg mifepristone followed in 24-48 h by 400 mcg sublingual misoprostol is effective up to 70 days' LMP. The findings have important implications for expanding access to outpatient medical abortion services in settings where the cost of misoprostol is of concern or a two-pill misoprostol regimen is the standard of care., (Copyright © 2014 The Authors. Published by Elsevier Inc. All rights reserved.)

Objective: We investigated safety, efficacy, and acceptability of an oral regimen of medical abortion compared with surgical abortion in three developing countries., Study Design: Women (n = 1373) with amenorrhea < or = 56 days chose either surgical abortion (as provided routinely) or 600 mg of mifepristone followed after 48 hours by 400 micrograms of misoprostol. This is the appropriate design for studying safety, efficacy, and acceptability among women selecting medical abortion over available surgical services., Results: The medical regimen had more side effects, particularly bleeding, than did surgical abortion but very few serious side effects. Failure rates for medical abortion, although low, exceeded those for surgical abortion: 8.6% versus 0.4% (China), 16.0% versus 4.0% (Cuba), and 5.2% versus 0% (India). Nearly half of failures among medical clients were not true drug failures, however, but surgical interventions not medically necessary (acceptability failures or misdiagnoses). Women were satisfied with either method, but more preferred medical abortion., Conclusion: Medical abortion can be safe, efficacious, and acceptable in developing countries.