OBJECTIVE: Evaluate implementation of misoprostol for postabortion care (MPAC) in two African countries. DESIGN: Qualitative, program evaluation. SETTING: Twenty-five public and private health facilities in Rift Valley Province, Kenya, and Kampala Province, Uganda. SAMPLE: Forty-five MPAC providers, health facility managers, Ministry of Health officials, and non-governmental (NGO) staff involved in program implementation. METHODS AND MAIN OUTCOME MEASURES: In both countries, the Ministry of Health, local health centers and hospitals, and NGO staff developed evidence-based service delivery protocols to introduce MPAC in selected facilities; implementation extended from January 2009 to October 2010. Semi-structured, in-depth interviews evaluated the implementation process, identified supportive and inhibitive policies for implementation, elicited lessons learned during the process, and assessed provider satisfaction and providers' impressions of client satisfaction with MPAC. Project reports were also reviewed. RESULTS: In both countries, MPAC was easy to use, and freed up provider time and health facility resources traditionally necessary for provision of PAC with uterine aspiration. On-going support of providers following training ensured high quality of care. Providers perceived that many women preferred MPAC, as they avoided instrumentation of the uterus, hospital admission, cost, and stigma associated with abortion. Appropriate registration of misoprostol for use in the pilot, and maintaining supplies of misoprostol, were significant challenges to service provision. Support from the Ministry of Health was necessary for successful implementation; lack of country-based standards and guidelines for MPAC created challenges. CONCLUSIONS: MPAC is simple, cost-effective and can be readily implemented in settings with high rates of abortion-related mortality.
OBJECTIVE: To find out clinical presentation and outcome of unsupervised use of misoprostol as abortifacient among adolescents presenting with abortion complications. METHODS: Case series of thirty one adolescents that presented with abortion complications following unsupervised use of misoprostol. RESULTS: Over a period of 3 years, 31 adolescents were seen, with median age of 17 years. Twenty nine (93.5%) were unmarried and 22 (71%) were in secondary school. Pregnancy duration was 3months and above in 23 (74.2%) of the patients. The cumulative dose of misoprostol tablet ingested was 2 (400 µg) in 17 (54.8%) of the patients. Twenty three (74.2%) patients presented with incomplete abortion with mild sepsis while the remaining 8 (25.8%) patients were admitted and managed with incomplete abortion with severe sepsis. Treatments offered were manual vacuum aspiration in 23 (74.2%) patients, evacuation of retained product of conception under anaesthesia in 7 (22.6%) patients and 1 (3.2%) patient had laparotomy with uterine repair following inadvertent uterine perforation complicating curettage for incomplete abortion. Complications encountered were anaemia 67.7%, uterine perforation 3.2%, blood transfusion 9.7% and diarrhoea in 8 (25.8%) patients. CONCLUSION: Demedicalise abortion with misoprostol due to improper dosing protocol may be associated with incomplete abortion and its sequelae in an uninformed adolescent population. Establishment of adolescent friendly medical centre that offers post-abortion care will go a long way in alleviating this problem.
BACKGROUND: This study was conducted to compare the safety, effectiveness and acceptability of 400 mcg sublingual misoprostol and 600 mcg oral misoprostol for treatment of incomplete abortion. STUDY DESIGN: We used an open-label randomized controlled trial conducted from July 2005 to August 2006 in a large tertiary level maternity hospital in Antananarivo, Madagascar, and a large tertiary level hospital in Chisinau, Moldova. Three hundred consenting women seeking treatment for clinically diagnosed incomplete abortion with uterine size ≤12 weeks since last menstrual period were randomized to misoprostol either 600 mcg orally or 400 mcg sublingually. The primary outcome measure was the complete resolution of clinical signs and symptoms of incomplete abortion without need for surgical intervention. Women were seen for follow-up on Day 7 and, if necessary, on Day 14 to assess abortion status. The study was powered to detect a 7% difference in efficacy with a total of 142 women required in each arm. RESULTS: Efficacy rates were 94.6% and 94.5%, for the oral and sublingual routes, respectively (RR: 1.00, 95% CI=0.95–1.06, p=.98). At 1 week follow-up, more than 80% of women had completed abortions (77.8% oral and 84.8% sublingual, p=.12). Mean pain scores were 2.95 and 3.04, respectively, for the oral and sublingual groups. Side effects included abdominal pain, bleeding, headaches and dizziness/weakness with no differences reported between the two groups. Acceptability and satisfaction were high for both routes and women indicated a preference for medical versus surgical treatment if ever needed in the future. CONCLUSION: Both treatment regimens were very effective. Four hundred micrograms of sublingual misoprostol and 600 mcg oral misoprostol appear to have similar safety and effectiveness profiles when used for the treatment of incomplete abortion. A lower 400-mcg misoprostol dose may provide an alternative treatment option as well as have potential benefits in terms of cost.
"Background: Pain 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/Design: We 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. Discussion: Although 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."
BACKGROUND: Management of failed medical second-trimester termination of pregnancy (TOP) is a challenge with best therapy Not determined. STUDY DESIGN: This was a cross-sectional study using retrospective record review of all women requesting medical TOP in the second trimester from January to June 2005. A comparative analysis was done to determine differences in demography, surgical methods and complications between two groups: (a) women who successfully aborted (first-admission group) and (b) women who failed to abort during their first admission (repeat-admission group). RESULTS: Study sample included 567 subjects [523 (92%) in the first-admission group and 44 (8%) in the repeat-admission group]. There were No significant differences in gestational age (p=.99), parity (p=.24) and previous history of cesarean section (p=.38) between the two groups. All of them successfully aborted, but the women in the repeat-admission Group 4 (9%) had more surgical interventions than those in the first-admission Group 6 (2%) (p<.0001). CONCLUSION: Failure to abort pregnancies in the second trimester with misoprostol is Not uncommon. Our hospital protocol of adequate counseling and early repeat admission with good clinical selection criteria might be an alternative in a resource-constraint environment where resources and skills to perform surgical dilatation and evacuation are not available.
"BACKGROUND: In low-resource settings, where abortion is highly restricted and self-induced abortions are common, access to post-abortion care (PAC) services, especially treatment of incomplete terminations, is a priority. Standard post-abortion care has involved surgical intervention but can be hard to access in these areas. Misoprostol provides an alternative to surgical intervention that could increase access to abortion care. We sought to gather additional evidence regarding the efficacy of 400 mcg of sublingual misoprostol vs. standard surgical care for treatment of incomplete abortion in the environments where need for economical Non-surgical treatments may be most useful. METHODS:A total of 860 women received either sublingual misoprostol or standard surgical care for treatment of incomplete abortion in a multi-site randomized trial. Women with confirmed incomplete abortion, defined as past or present history of vaginal bleeding during pregnancy and an open cervical os, were eligible to participate. Participants returned for follow-up one week later to confirm clinical status. If abortion was incomplete at that time, women were offered an additional follow-up visit or immediate surgical evacuation. RESULTS: Both misoprostol and surgical evacuation are highly effective treatments for incomplete abortion (misoprostol: 94.4%, surgical: 100.0%). Misoprostol treatment resulted in a somewhat lower chance of success than standard surgical practice (RR = 0.90; 95% CI: 0.89-0.92). Both tolerability of side effects and women's satisfaction were similar in the two study arms. CONCLUSION: Misoprostol, much easier to provide than surgery in low-resource environments, can be used safely, successfully, and satisfactorily for treatment of incomplete abortion. Focus should shift to program implementation, including task-shifting the provision of post-abortion care to mid- and low- level providers, training and assurance of drug availability."
"OBJECTIVE: To explore 400-μg sublingual misoprostol as primary treatment in lower-level facilities with No previous experience providing post-abortion care. METHODS: Women presenting with incomplete abortion were offered a single dose of 400-μg sublingual misoprostol. Incomplete abortion was defined as uterine size consistent with fewer than 12 weeks of gestation, open cervical os, and reports of past or present history of vaginal bleeding. Women returned to the clinic 1 week after misoprostol administration for follow-up. At that time, they were discharged if the uterine evacuation was a success or were offered a second follow-up visit or surgical completion if still incomplete. RESULTS: One-hundred women received misoprostol; outcome data were unavailable for 1 woman. Complete uterine evacuation was achieved for 97 (98.0%) women. Satisfaction was high, with nearly all women indicating that they were ""satisfied"" (n=57 [57.6%]) or ""very satisfied"" (n=41 [41.4%]) with their experience. Adverse effects were considered ""tolerable"" by 72 of 97 (74.2%) women. Ninety-seven of 99 (98.0%) participants indicated that they would choose misoprostol for incomplete abortion care in the future and 95 of 97 (97.9%) stated that they would recommend it to a friend. CONCLUSION: Misoprostol is a viable option for treatment of incomplete abortion at mid-level facilities. "
"BACKGROUND: Misoprostol has become a popular over the counter self-administered abortifacient in Ghana. This study aimed to compare the socio-demographic characteristics and clinical complications associated with misoprostol and Non-misoprostol induced abortions among patients admitted to a tertiary public health facility in Ghana. METHODS: This was a cross sectional study conducted at the gynaecological ward of Komfo Anomy Teaching Hospital (KATH), over a four-month period using a structured pre-tested questionnaire. Data were analysed using Chi-square, Fisher's exact and student t-tests. Factors associated with severe morbidity were examined using Poisson regression with robust error variance to estimate crude and adjusted relative risks (RRs) with 95% confidence intervals (CIs). P 0.05 was considered statistically significant. RESULTS: Overall, 126 misoprostol users and 126 misoprostol Non-users were recruited into the study. About 71% of the clients had self-induced abortions. Misoprostol users were more likely to be younger (p 0.001), single (p 0.001), nulliparos (p = 0.001), of higher educational background (p = 0.001), and unemployed (p 0.001), than misoprostol Non-users. Misoprostol users were more likely than Non-users to underg termination of pregnancy because the wanted to continue schooling (p 0.001) or were Not earning regular income to support a family (p = 0.001). Overall, 182 (72.2%) of the women (79.4% misoprostol users vs. 65.1% misoprostol Non-user; p = 0.01) suffered severe morbidity. Nulliparous women (adjusted RR, 1.28; 95% CI, 108-1.52) and those who had induced abortion after 12 weeks' gestation (adjusted RR, 1.36; 95% CI, 1.18-1.57) were at increased risks of experiencing severe morbidity. The association between mode of abortion induction and severe morbidity was Not statistically significant (p = 0.06). CONCLUSION: Self-induced abortions using misoprostol is a common practice among women in this study; nearly three quarters of them suffered severe morbidity. Nonetheless, severe morbidity among misoprostol users and Non-users did Not differ significantly but was directly related to the gestational age at which the induced abortions occurred. Health education on the dangers of self-induced abortions and appropriate use of medication abortion could help reduce complications associated with induced abortions in Ghana."
OBJECTIVE: Training midlevel providers (MLPs) to conduct surgical abortions and manage medical abortions has been proposed as a way to increase women's access to safe abortion. This paper reviews the evidence that compares the effectiveness and safety of abortion procedures administered by MLPs versus doctors. METHODS: A systematic search was conducted of published trials and comparison studies assessing the effectiveness and/or safety of abortion provided by MLPs compared to doctors. The Cochrane Central Register of Controlled Trials, EMBASE, MEDLINE, and Popline were searched. The primary outcomes of interest were: (1) incomplete or failed abortion; and (2) measures of safety (adverse events and complications) of abortion procedures administered by MLPs and doctors. Odds ratios (ORs) and their 95% confidence intervals (CIs) were calculated for each study. Data were synthesized in a narrative fashion. FINDINGS: Five studies were included in this review (n = 8539 women), comprising two randomized controlled trials (RCTs) (n = 3821) and three prospective cohort studies (n = 4718). In total, 4198 women underwent a procedure administered by an MLP, and 4341 women underwent a physician-administered procedure. Studies took place in the US, Nepal, South Africa, Vietnam, and India. Four studies used surgical abortion with maximum gestational ages ranging from 10 to 16+ weeks, while a medical abortion study had gestational ages up to 9 weeks. In RCTs, the effect estimates for incomplete or failed abortion for procedures performed by MLPs compared with doctors were OR = 2.00 (95% CI 0.85-4.68) for surgical abortion, and OR = 0.69 (95% CI 0.34-1.37) for medical abortion. Complications were rare among both provider types (1.2%-3.1%; OR = 1.80, 95% CI 0.83-3.90 for surgical abortions), and no deaths were reported. CONCLUSION: There were no statistical differences in incomplete abortion and complications for first trimester surgical and medical abortion up to 9 weeks performed by MLPs compared with physicians. Further studies are required to establish more precise effect estimates.
Unsafe abortion is a significant contributor to maternal mortality in Nigeria, and treatment of post-abortion complications drains public healthcare resources. Provider estimates of medications, supplies, and staff time spent in 17 public hospitals were used to estimate the per-case and annual costs of post-abortion care (PAC) provision in Ogun and Lagos states and the Federal Capital Territory. PAC with treatment of moderate complications (US $112) cost 60 more per case than simple PAC (US $70). In cases needing simple PAC, treatment with dilation and curettage (D&C, US $80) cost 18 more per case than manual vacuum aspiration (US $68). Annually, all public hospitals in these 3 states spend US $807 442 on PAC. This cost could be reduced by shifting service provision to an outpatient basis, allowing service provision by midwives, and abandoning the use of D&C. Availability of safe, legal abortion would further decrease cost and reduce preventable deaths from unsafe abortion.