Anand Tamang

Can midlevel health-care providers administer early medical abortion as safely and effectively as doctors? A randomised controlled equivalence trial in Nepal

BACKGROUND Medical abortion is under-used in developing countries. We assessed whether early fi rst-trimester medical abortion provided by midlevel providers (government-trained, certified nurses and auxiliary nurse midwives) was as safe and effective as that provided by doctors in Nepal. METHODS This multicentre randomised controlled equivalence trial was done in fi ve rural district hospitals in Nepal. Women were eligible for medical abortion if their pregnancy was of less than 9 weeks (63 days) and if they resided less than 90 min journey away from the study clinic. Women were ineligible if they had any contraindication to medical abortion. We used a computer-generated randomisation scheme stratified by study centre with a block size of six. Women were randomly assigned to a doctor or a midlevel provider for oral administration of 200 mg mifepristone followed by 800 μg misoprostol vaginally 2 days later, and followed up 10-4 days later. The primary endpoint was complete abortion without manual vacuum aspiration within 30 days of treatment. The study was not masked. Abortions were recorded as complete, incomplete, or failed (continuing pregnancy). Analyses for primary and secondary endpoints were by intention to treat, supplemented by per-protocol analysis of the primary endpoint. This trial is registered with ClinicalTrials.gov, NCT01186302. FINDINGS Of 1295 women screened, 535 were randomly assigned to a doctor and 542 to a midlevel provider. 514 and 518, respectively, were included in the analyses of the primary endpoint. Abortions were judged complete in 504 (97.3%) women assigned to midlevel providers and in 494 (96.1%) assigned to physicians. The risk difference for complete abortion was 1.24% (95% CI -0.53 to 3.02), which falls within the predefined equivalence range (-5% to 5%). Five cases (1%) were recorded as failed abortion in the doctor cohort and none in the midlevel provider cohort; the remaining cases were recorded as incomplete abortions. No serious complications were noted. INTERPRETATION The provision of medical abortion up to 9 weeks’ gestation by midlevel providers and doctors was similar in safety and effectiveness. Where permitted by law, appropriately trained midlevel health-care providers can provide safe, low-technology medical abortion services for women independently from doctors. FUNDING UNDP/UNFPA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction (HRP), Department of Reproductive Health and Research (RHR), World Health Organization.

Factors associated with choice of medical or surgical abortion among women in Nepal

To investigate factors associated with womens choice of medical abortion (MA) or manual vacuum aspiration (MVA) in Nepal, where the government recently began offering MA services.

The role of auxiliary nurse-midwives and community health volunteers in expanding access to medical abortion in rural Nepal

Abstract Medical abortion was introduced in Nepal in 2009, but rural women’s access to medical abortion services remained limited. We conducted a district-level operations research study to assess the effectiveness of training 13 auxiliary nurse-midwives as medical abortion providers, and 120 female community health volunteers as communicators and referral agents for expanding access to medical abortion for rural women. Interviews with service providers and women who received medical abortion were undertaken and service statistics were analysed. Compared to a neighbouring district with no intervention, there was a significant increase in the intervention area in community health volunteers’ knowledge of the legal conditions for abortion, the advantages and disadvantages of medical abortion, safe places for an abortion, medical abortion drugs, correct gestational age for home use of medical abortion, and carrying out a urine pregnancy test. In a one-year period in 2011–12, the community health volunteers did pregnancy tests for 584 women and referred 114 women to the auxiliary nurse-midwives for abortion; 307 women in the intervention area received medical abortion services from auxiliary nurse-midwives. There were no complications that required referral to a higher-level facility except for one incomplete abortion. Almost all women who opted for medical abortion were happy with the services provided. The study demonstrated that auxiliary nurse-midwives can independently and confidently provide medical abortion safely and effectively at the sub-health post level, and community health volunteers are effective change agents in informing women about medical abortion. Resumé L’avortement médicamenteux a été introduit en 2009 au Népal, mais l’accès des femmes rurales aux services est demeuré limité. Nous avons étudié les opérations au niveau d’un district pour évaluer l’efficacité de la formation de 13 infirmières sages-femmes auxiliaires comme prestataires de l’avortement médicamenteux, et de 120 femmes comme bénévoles de santé communautaire et agents d’orientation pour élargir l’accès des femmes rurales à l’avortement médicamenteux. Des entretiens ont été organisés avec des prestataires de service et des femmes ayant mené un avortement médicamenteux, et des statistiques de service ont été analysées. Par comparaison avec un district voisin où aucune intervention n’avait été réalisée, dans la zone d’intervention, on a constaté une hausse sensible de la connaissance des bénévoles de santé communautaire sur les conditions juridiques de l’avortement, les avantages et les inconvénients de l’avortement médicamenteux, les lieux sûrs pour l’avortement, les médicaments abortifs, l’âge gestationnel correct pour pratiquer un avortement médicamenteux à domicile et la réalisation d’un test de grossesse urinaire. Sur une période d’un an en 2011-2012, les bénévoles de santé communautaire ont effectué un test de grossesse pour 584 femmes et adressé 114 femmes qui voulaient avorter aux infirmières sages-femmes auxiliaires ; les infirmières sages-femmes auxiliaires ont prêté des services d’avortement médicamenteux pour 307 femmes dans la zone d’intervention. Aucune complication n’a exigé l’aiguillage vers un centre plus spécialisé, à l’exception d’un avortement incomplet. Presque toutes les femmes qui avaient opté pour l’avortement médicamenteux étaient satisfaites des services obtenus. L’étude a montré que les infirmières sages-femmes auxiliaires peuvent pratiquer efficacement, indépendamment et en confiance des avortements médicamenteux en toute sécurité au niveau des sous-centres de santé, et que les bénévoles de santé communautaire sont de précieux agents de changement pour renseigner les femmes sur l’avortement médicamenteux. Resumen Los servicios de aborto con medicamentos fueron introducidos en Nepal en 2009, pero el acceso de las mujeres rurales a dichos servicios continu ó siendo limitado. Realizamos un estudio de investigación operativa a nivel de distrito para evaluar la eficacia de capacitar a 13 enfermeras-obstetras auxiliares como prestadoras de servicios de aborto con medicamentos, y 120 voluntarias comunitarias en salud como comunicadoras y agentes de referencia para ampliar el acceso de las mujeres rurales a dichos servicios. Se realizaron entrevistas con prestadores de servicios y mujeres que recibieron servicios de aborto con medicamentos y se analizaron las estadísticas de los servicios. Comparado con un distrito aledaño donde no hubo intervención, en la zona de la intervención se vio un considerable aumento en los conocimientos de las voluntarias comunitarias respecto a las condiciones para un aborto legal, las ventajas y desventajas del aborto con medicamentos, lugares seguros para tener un aborto, fármacos para inducir el aborto, edad gestacional correcta para el uso domiciliario de los medicamentos para inducir el aborto, y realizar una prueba de embarazo en la orina. En el plazo de un año, 2011-12, las voluntarias comunitarias en salud realizaron pruebas de embarazo en 584 mujeres y refirieron a 114 mujeres a enfermeras-obstetras auxiliares para aborto; 307 mujeres en la zona de la intervención recibieron servicios de aborto con medicamentos de enfermeras-obstetras auxiliares. No hubo complicaciones que necesitaron referencia a una unidad de salud de mayor nivel, excepto un aborto incompleto. Casi todas las mujeres que optaron por tener un aborto con medicamentos estuvieron contentas con los servicios que recibieron. El estudio demostró que las enfermeras-obstetras auxiliares pueden proporcionar servicios de aborto con medicamentos de manera independiente, confiada, segura y eficaz, en un nivel inferior al puesto de salud, y las voluntarias comunitarias en salud son agentes de cambio eficientes para informar a las mujeres acerca del aborto con medicamentos.

Road map to scaling-up: translating operations research study’s results into actions for expanding medical abortion services in rural health facilities in Nepal

BackgroundIdentifying unsafe abortion among the major causes of maternal deaths and respecting the rights to health of women, in 2002, the Nepali parliament liberalized abortion up to 12 weeks of pregnancy on request. However, enhancing women’s awareness on and access to safe and legal abortion services, particularly in rural areas, remains a challenge in Nepal despite a decade of the initiation of safe abortion services.MethodsBetween January 2011 and December 2012, an operations research study was carried out using quasi-experimental design to determine the effectiveness of engaging female community health volunteers, auxiliary nurse midwives, and nurses to provide medical abortion services from outreach health facilities to increase the accessibility and acceptability of women to medical abortion. This paper describes key components of the operations research study, key research findings, and follow-up actions that contributed to create a conducive environment and evidence in scaling up medical abortion services in rural areas of Nepal.ResultsIt was found that careful planning and implementation, continuous advocacy, and engagement of key stakeholders, including key government officials, from the planning stage of study is not only crucial for successful completion of the project but also instrumental for translating research results into action and policy change. While challenges remained at different levels, medical abortion services delivered by nurses and auxiliary nurse midwives working at rural outreach health facilities without oversight of physicians was perceived to be accessible, effective, and of good quality by the service providers and the women who received medical abortion services from these rural health facilities.ConclusionsThis research provided further evidence and a road-map for expanding medical abortion services to rural areas by mid-level service providers in minimum clinical settings without the oversight of physicians, thus reducing complications and deaths due to unsafe abortion.

Abortion Incidence and Unintended Pregnancy in Nepal

CONTEXT Although abortion has been legal under broad criteria in Nepal since 2002, a significant proportion of women continue to obtain illegal, unsafe abortions, and no national estimates exist of the incidence of safe and unsafe abortions. METHODS Data were collected in 2014 from a nationally representative sample of 386 facilities that provide legal abortions or postabortion care and a survey of 134 health professionals knowledgeable about abortion service provision. Facility caseloads and indirect estimation techniques were used to calculate the national and regional incidence of legal and illegal abortion. National and regional levels of abortion complications and unintended pregnancy were also estimated. RESULTS In 2014, women in Nepal had 323,100 abortions, of which 137,000 were legal, and 63,200 women were treated for abortion complications. The abortion rate was 42 per 1,000 women aged 15-49, and the abortion ratio was 56 per 100 live births. The abortion rate in the Central region (59 per 1,000) was substantially higher than the national average. Overall, 50% of pregnancies were unintended, and the unintended pregnancy rate was 68 per 1,000 women of reproductive age. CONCLUSIONS Despite legalization of abortion and expansion of services in Nepal, unsafe abortion is still common and exacts a heavy toll on women. Programs and policies to reduce rates of unintended pregnancy and unsafe abortion, increase access to high-quality contraceptive care and expand safe abortion services are warranted.

Medical abortion can be provided safely and effectively by pharmacy workers trained within a harm reduction framework: Nepal

OBJECTIVES To examine the treatment efficacy, safety and satisfaction of women using medical abortion (MA) pills provided by pharmacists following an education intervention based on a harm reduction approach. STUDY DESIGN This was an operations research study over a six-month period in 2015, using a non-inferiority design. We provided training to dispense MA pills, based on a harm reduction approach, to a group of pharmacy workers in Makwanpur district (GROUP 2). We compared selected outcomes with women who bought the pills from pharmacy workers in Chitwan district (GROUP 1), who had received similar training in 2010. The primary endpoint measured in 992 women in both districts was complete abortion within 30 days of using the pills. We assessed the efficacy of MA (self-reported complete abortion) and safety (no reported adverse event). To determine complete abortion, we asked women about passage of the products of conception, cessation of abdominal cramps, vaginal bleeding, need for manual vacuum aspiration or repeated doses of misoprostol. We used a four-point Lickert Scale to determine level of satisfaction with MA use. Pearson Chi-Square test was used to examine any differences in proportion of complete abortions between women who were served by the two groups of pharmacy workers. RESULTS The difference in the rate of complete abortions between the two groups of women, 96.9% and 98.8%, was not statistically significant. The women reported no serious complications, and there was little difference in their satisfaction levels. CONCLUSIONS Trained pharmacy workers dispensed MA safely and effectively to the satisfaction of almost all women clients, and the positive results of training had continued several years later. IMPLICATIONS The role of pharmacy workers as providers of correct and complete information on safe and effective use of MA needs to be recognized and policies formulated to allow them to provide MA drugs for first trimester use.

Two prophylactic medication approaches in addition to a pain control regimen for early medical abortion < 63 days’ gestation with mifepristone and misoprostol: study protocol for a randomized, controlled trial

BackgroundPain is often cited as one of the worst features of medical abortion. Further, inadequate pain management may motivate some women to seek unnecessary clinical care. There is a need to identify effective methods for pain control in this setting.Methods/DesignWe propose a randomized, placebo-controlled trial. 576 participants (288 nulliparous; 288 parous) from study sites in Nepal, South Africa and Vietnam will be randomly allocated to one of three treatments: (1) ibuprofen 400 mg PO and metoclopramide 10 mg PO; (2) tramadol 50 mg PO and a placebo; or (3) two placebo pills, to be taken immediately before misoprostol and repeated once four hours later. All women will be provided with supplementary analgesia for use as needed during the medical abortion. We hypothesize that women receiving prophylactic analgesia will report lower maximal pain scores in the first 8 h following misoprostol administration compared to women receiving placebos for medical abortion through 63 days’ gestation. Our primary objective is to determine whether prophylactic administration of ibuprofen and metoclopramide or tramadol provides superior pain relief compared to analgesia administration after pain begins, measured during the first eight hours after misoprostol administration. Secondary objectives include identifying covariates associated with higher reported pain scores; determining any impact of the study medicines on medical abortion success; and, qualitatively exploring women’s physical experiences of medical abortion, especially related to pain, and how can they be improved. Data sources include medical records, participant symptom diaries and interview data obtained on the day of enrollment, during the medical abortion, and at follow-up. Participants will be contacted via telephone on day 3 and return for follow-up will occur approximately 14 days after mifepristone, concluding study participation. A subset of 42 women will also be invited to undergo in-depth qualitative interviews following study completion.DiscussionAlthough pain is one of the most common side effects encountered with medical abortion, little is known about optimal pain management for this process. This multi-arm trial design offers an efficient approach to evaluating two prophylactic pain management regimens compared to use of pain medication as needed.Trial registrationACTRN12613000017729 (Prospectively registered 8/1/2013).