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This study compared the effect of preservative-containing (PC) and preservative-free (PF) prostaglandin analogue (PGA) formulations on the ocular surface, especially on the meibomian gland (MG) in patients with open-angle glaucoma (OAG). This is a retrospective study of treatment-naïve patients with OAG (n=80) and healthy controls (n=40). OAG patients were randomized into groups using either PC-PGA or PF-PGA for 12 months. All participants underwent ocular surface and MG examinations including their meibum score, meiboscore, and lid margin abnormality score (LAS). Eighty OAG patients were randomized into two groups (n=42 in PC, n=38 in PF). All PGA and control groups showed similar ocular surface and MG parameters at the baseline. Both PC- and PF-PGA groups showed increased meibum scores, meiboscores, and LASs at 12 months compared to the baseline (all p<0.05). At the 12-months visit, PC-PGA group showed severe OSDI, shorter TBUT, greater OSS, and worse MG parameters than those of the other two groups (all p<0.05). In addition, PF-PGA group showed worse meiboscores, meibum scores, and severe OSS scores than those of the control group (all p<0.05). Both PC and PF formulations can cause damage to the MG in patients using PGA. However, PC formulations induced more ocular discomfort, poorer ocular surface, and more severe MG loss compared to PF formulations. Therefore, it would be advisable to use PF formulations in patients with a preexisting or concomitant ocular surface disease or MGD.

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This study compared the effect of preservative-containing (PC) and preservative-free (PF) prostaglandin analogue (PGA) formulations on the ocular surface, especially on the meibomian gland (MG) in patients with open-angle glaucoma (OAG). This is a retrospective study of treatment-naïve patients with OAG (n=80) and healthy controls (n=40). OAG patients were randomized into groups using either PC-PGA or PF-PGA for 12 months. All participants underwent ocular surface and MG examinations including their meibum score, meiboscore, and lid margin abnormality score (LAS). Eighty OAG patients were randomized into two groups (n=42 in PC, n=38 in PF). All PGA and control groups showed similar ocular surface and MG parameters at the baseline. Both PC- and PF-PGA groups showed increased meibum scores, meiboscores, and LASs at 12 months compared to the baseline (all p<0.05). At the 12-months visit, PC-PGA group showed severe OSDI, shorter TBUT, greater OSS, and worse MG parameters than those of the other two groups (all p<0.05). In addition, PF-PGA group showed worse meiboscores, meibum scores, and severe OSS scores than those of the control group (all p<0.05). Both PC and PF formulations can cause damage to the MG in patients using PGA. However, PC formulations induced more ocular discomfort, poorer ocular surface, and more severe MG loss compared to PF formulations. Therefore, it would be advisable to use PF formulations in patients with a preexisting or concomitant ocular surface disease or MGD.

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Objective To explore effects of atorvastatin on the expressions of cyclooxygenase-2(COX-2) and membrane-associated prostaglandin E2 synthase-1 (mPGES-1) in the carotid atherosclerotic plaques of rabbits.Methods Totally 33 male New Zealand white rabbits(≥ 36months of age ) were assigned into normal control group (n=8) and animal model group with carotid atherosclerotic stenosis (n =25).The rabbit models were randomly divided into non-intervention group,celecoxib treatment group (15 mg · kg-1 · d-1,twice daily) and atorvastatin treatment group (5 mg · kg-1 · d-1,once daily) (n=8 each).Four weeks after treatment,the mRNA and protein expressions of COX-2 and mPGES-1 in carotid plaques were determined by RT-PCR and Western blot,respectively.Results The mRNA expressions of COX-2 (0.97±0.09,0.44±0.05,0.60±0.04vs.0.23±0.04,F=66.77,P＜0.01) and mPGES-1 (0.92±0.07,0.41±0.04,0.61±0.03 vs.0.17±0.03,F=54.87,P＜0.01)in carotid atherosclerotic plaques were significantly higher in non intervention group,celecoxib treatment group and atorvastatin treatment group than in normal control group.The mRNA expressions of COX-2 and mPGES-1 were decreased in celecoxib treatment group and atorvastatin treatment group as compared with non-intervention group ( both P ＜ 0.01 ).The protein expressions of COX-2 (0.89±0.06,0.42±0.07,0.62±0.04 vs.0.18±0.05,F=61.75,P ＜0.01) and mPGES-1(0.91±0.05,0.44±0.05,0.63±0.05 vs.0.21±0.04,F=86.44,P＜0.01)in carotid atherosclerotic plaques in non-intervention group,celecoxib treatment group and atorvastatin treatment group were increased as compared with those in normal control group.The mRNA and protein expressions of COX-2 and mPGES-1 were decreased in celecoxib treatment group and atorvastatin treatment group as compared with non-intervention group(all P＜0.01 ).The expressions of COX-2 and mPGES-1 in carotid atherosclerotic plaques were reduced in celecoxib treatment group as compared with atorvastatin treatment group (P ＜ 0.01).Conclusions As COX-2 inhibitor celecoxib,atorvastatin may inhibit the expressions of COX-2 and mPGES-1,and interfere with the inflammatory response which plays key role in the pathological progress of carotid atherosclerotic plaques,and thus slow the progress of carotid atherosclerosis.

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OBJETIVO: verificar a eficácia e a segurança de dinoprostone e misoprostol para indução do parto vaginal, com ou sem o uso de ocitocina em nulíparas. MÉTODOS: realizou-se estudo retrospectivo, observacional, envolvendo 238 pacientes que foram submetidas à indução do parto de janeiro de 2008 a fevereiro de 2010 com uso de misoprostol 25 mcg via vaginal ou pessário contendo 10 mg de dinoprostone. Desse grupo, foram selecionadas 184 pacientes, que apresentavam as seguintes características: nulíparas, gestação entre 37 e 42 semanas, feto único, apresentação cefálica, membranas íntegras e índice de Bishop < 3. Os resultados obstétricos e neonatais foram analisados e comparados entre ambos os grupos. A análise estatística foi realizada com o teste t, Chi quadrado e exato de Fisher, adotando-se como nível de significância valores p<0,05. RESULTADOS: a taxa de parto vaginal não foi estatisticamente diferente em pacientes que utilizaram misoprostol e dinoprostone (43,2 versus 50 por cento, p=0,35), respectivamente. O amadurecimento do colo foi superior no grupo com misoprostol (87,3 versus 75,6 por cento, p=0,04). Foi necessária a utilização da ocitocina em 58,8 por cento no grupo com misoprostol e 57,3 por cento no grupo com dinoprostone após o amadurecimento do colo. Falha de indução foi a principal indicação do parto cesárea em ambos os grupos, sem diferença estatística significante. Eventos adversos maternos e fetais, como taquissistolia e índices de Apgar foram similares. CONCLUSÃO: dinoprostone e misoprostol são eficazes para indução do parto vaginal, embora seja necessária a associação com ocitocina, apresentando perfil de segurança semelhante, sendo misoprostol mais eficiente no amadurecimento do colo uterino.

PURPOSE: to determine the efficacy and safety of dinoprostone and misoprostol for the induction of vaginal childbirth, with or without the use of oxytocin in nulliparous women. METHODS: in this retrospective observational study, 238 patients were subjected to the induction of delivery from January 2008 to February 2010 with the use of misoprostol 25 mcg by the vaginal route or a pessary containing 10 mg of dinoprostone. A total of 184 patients were selected, with the following characteristics: nulliparous, gestational age of 37-42 weeks, singleton pregnancies, cephalic presentation, intact membranes, and Bishop score < 3. Obstetric and neonatal data were analyzed and compared between groups. The Student t-test, chi-square test and Fisher's exact test were used for statistical analysis, with the level of significance set at p<0.05. RESULTS: the rate of vaginal childbirth did not differ significantly in patients who used misoprostol and dinoprostone (43.2 percent versus 50 percent; p = 0.35, respectively). The ripening of cervix was higher in the group treated with misoprostol (87.3 percent versus 75.6 percent, p=0.04). The use of oxytocin was necessary in 58.8 percent of the misoprostol group and 57.3 percent in the dinoprostone group after the ripening of cervix. Failed induction was the primary indication of caesarean section delivery in both groups, with no significant difference between them. Fetal and maternal adverse events, such as tachysystole and Apgar scores were similar. CONCLUSION: dinoprostone and misoprostol are both effective for vaginal childbirth induction, although they need to be combined with oxytocin. They showed a similar safety profile, with misoprostol being more efficient regarding cervical ripening.

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OBJETIVO: Avaliar a relação custo-efetividade dos análogos das prostaglandinas para o tratamento do glaucoma e da hipertensão ocular no estado de Minas Gerais, Brasil. MÉTODOS: Este estudo transversal avaliou o custo (preço máximo ao consumidor) das diferentes apresentações dos análogos de prostaglandinas (bimatoprosta, latanoprosta, travoprosta) em relação à sua efetividade na redução da pressão intra-ocular. Para cada uma das medicações, calculou-se o custo mensal, anual e em 5 anos para se obter uma redução percentual de 1 por cento e 20 por cento na pressão intra-ocular (PIO), assim como o custo mensal, anual e em 5 anos para se obter uma redução de 1 mmHg e 8 mmHg a partir da PIO inicial. RESULTADOS: O custo mensal para se obter uma redução de 1 por cento e 20 por cento da PIO foi, respectivamente, de R$ 1,35 e R$ 27,00 para a bimatoprosta 5 ml, R$ 1,50 e R$ 30,00 para a bimatoprosta 3 ml, R$ 1,53 e R$ 30,60 para a travoprosta e R$ 2,22 e R$ 44,40 para a latanoprosta. O custo mensal máximo para uma redução de 1 e 8 mmHg da PIO foi, respectivamente, de R$ 6,01 e R$ 48,08 para a bimatoprosta 5 ml, de R$ 6,67 e R$ 53,36 para a travoprosta, de R$ 6,70 e R$ 53,60 para a bimatoprosta 3 ml e de R$ 9,83 e R$ 78,64 para a latanoprosta. CONCLUSÃO: A medicação mais custo-efetividade foi a bimatoprosta, na apresentação de 5 ml. Aquela que se mostrou com a mais baixa relação custo-efetividade foi a latanoprosta. A travoprosta e a bimatoprosta na apresentação de 3 ml apresentaram resultados semelhantes, ficando em posição intermediária entre as demais.

PURPOSE: Assess cost-effectiveness of glaucoma and/or ocular hypertension medical therapy using prostaglandin analogues in the state of Minas Gerais, Brazil. METHODS: This cross-sectional study evaluated the cost (average wholesale price) of different prostaglandin analogues (bimatoprost, latanoprost, travoprost) in relation to its effectiveness in reducing intra-ocular pressure. Monthly, annually and 5-year cost to achieve 1 percent and 20 percent of IOP reduction was calculated. Monthly, annually and 5-year cost to reduce 1 mmHg and 8 mmHg from baseline IOP was also calculated. RESULTS: Monthly cost to achieve 1 percent and 20 percent of IOP reduction was, respectively, R$ 1.35 and R$ 27.00 for bimatoprost 5 ml, R$ 1.50 and R$ 30.00 for bimatoprost 3 ml, R$ 1.53 and R$ 30.60 for travoprost and R$ 2.22 and R$ 44.40 for latanoprost. Monthly maximum cost to reduce baseline IOP 1 mmHg and 8 mmHg was, respectively, R$ 6.01 and R$ 48.08 for bimatoprost 5 ml, R$ 6.67 and R$ 53.36 for travoprost, R$ 6.70 and R$ 53.60 for bimatoprost 3 ml and R$ 9.83 and R$ 78.64 for latanoprost. CONCLUSION: Cost-effectiveness was better for bimatoprost 5 ml. The medication, which had the worst cost-effectiveness relationship, was latanoprost. Travoprost and bimatoprost 3 ml showed similar and intermediate results.

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OBJECTIVE: This study was undertaken to compare the effectiveness of mifepristone orally administered at 24 or 48 hours before first-trimester vacuum aspiration abortion with that of vaginally administered misoprostol as a cervical priming agent. STUDY DESIGN: In a randomized comparative trial 90 women who requested surgical termination of pregnancy were randomly assigned to receive 200 mg mifepristone orally 24 or 48 hours before the operation or 800 microg misoprostol vaginally 2 to 4 hours before the operation. The main outcome measures were baseline cervical dilatation, cumulative force required to dilate the cervix to 9 mm, and intraoperative blood loss. RESULTS: The baseline cervical dilatation was significantly greater among women who received mifepristone 48 hours before the operation (P =.02). This group also required the least mechanical force to dilate the cervix (P =.06). There were no significant differences among the 3 groups in the intraoperative blood loss, in the operating time, or in patient acceptability. Side effects such as hot flushes and headaches were significantly higher among women who received mifepristone 24 or 48 hours before the operation than among those who received misoprostol (P =.01 and P =. 002, respectively). CONCLUSION: Mifepristone is an effective cervical priming agent when orally administered 48 hours before vacuum aspiration for termination of first-trimester pregnancy. Because of its cost and availability in comparison with misoprostol, however, selective use may have to be considered.

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Medical abortion offers an important alternative to surgical abortion for women with early pregnancies who wish to avoid a surgical procedure. More than 3 million women worldwide have had medical abortions in the past decade alone. The best-studied regimens include mifepristone orally followed 36 to 48 hours later by a prostaglandin analog administered either orally or intravaginally. Because of political and social restrictions related to mifepristone, however, researchers have investigated alternative regimens, most notably methotrexate and misoprostol. Mifepristone regimens are approximately 95% effective for abortion at

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The clinical assessment of patients who request early medical abortion includes confirmation of the diagnosis of pregnancy and estimation of gestational age. Accurate gestational dating is essential, because the efficacies of medical abortion regimens decline as pregnancy advances. Whereas medical abortion researchers in the United States have relied on routine ultrasonography for gestational dating, abortion providers experienced with mifepristone and prostaglandin regimens outside the United States have reported high efficacy and safety primarily with clinical dating parameters. Diligent follow-up of patients allows clinicians to confirm that complete abortion has occurred without complications. In cases of uncertain outcome or suspected ectopic pregnancy, transvaginal ultrasonography and beta-human chorionic gonadotropin assays can assist in prompt diagnosis and management. As medical abortion with mifepristone and misoprostol becomes more prevalent in the United States, studies will be needed to further evaluate the effects of these modalities on medical abortion outcomes.

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Mifepristone at a dose of 600 mg followed by 400 microg misoprostol orally has been used for early abortion by hundreds of thousands of women with success rates at 49 days' gestation. A lower mifepristone dose of 200 mg and in-home self-administration of misoprostol both appear safe and effective. Although most research protocols have used ultrasonography to confirm gestational age, the method can be provided safely without routine reliance on ultrasonography. Acceptability of the method to care providers and to patients has been high in all studies. The introduction of medical abortion into general medical practice in the United States will teach us much about the practical aspects of service provision.

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Alternatives to regimens with mifepristone and a prostaglandin analog for medical abortion emerged because of the need for accessible, effective, and safe options in areas of the world where mifepristone was unavailable. Studies of oral or intramuscular methotrexate combined with misoprostol have demonstrated complete abortion rates in the same range as mifepristone regimens at

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Side effects are an expected part of medical abortion; some, such as pain and bleeding, result from the abortion process itself and are generally managed with orally administered analgesics and counseling. True medication side effects most commonly include nausea, vomiting, diarrhea, and warmth or chills. Complications of medical abortion usually represent an extreme or severe side effect. Large series have reported transfusion rates of <1%. Because of the infrequency of uterine instrumentation, postabortal endometritis appears to be rare with medical abortion. As with early surgical abortion, the clinician must remain aware of the possibility for ectopic pregnancy. Overall approximately 2% to 10% of patients will require surgical intervention for control of bleeding, resolution of incomplete expulsion, or termination of a continuing pregnancy. Understanding the types of side effects and complications that can occur will enable the clinician to counsel patients properly as well as to understand when medical intervention is necessary during the medical abortion process.

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OBJECTIVE: We sought to compare the acceptability of suction curettage abortion with that of medical abortion with mifepristone and misoprostol in American women. STUDY DESIGN: We performed a prospective, serially enrolled, cohort analysis. The study population consisted of 152 subjects receiving mifepristone and misoprostol and 174 subjects undergoing suction curettage abortion aged > or =18 years with intrauterine pregnancies of up to 63 days' estimated gestation. Questionnaires regarding expectations and experiences were administered before the abortion and at the 2-week follow-up visit. RESULTS: Subjects undergoing medical abortions reported significantly greater satisfaction than those undergoing surgical abortions (mean rank, 121 vs 149; P <.01) but were no more likely to recommend the method they had just experienced to a friend (97% vs 93.3%). If a future abortion was required, however, 41.7% of subjects undergoing surgical abortions indicated they would opt for a medical abortion, whereas only 8.6% of subjects receiving medical abortions would choose a surgical abortion (P <.001). Failure of the abortion decreased satisfaction in the medical group and increased the likelihood of choosing a surgical abortion for a subsequent procedure (P <.001). Surgical subjects who experienced more anxiety than expected during the abortion were more likely to choose a medical procedure for a subsequent abortion (P <.01). CONCLUSION: Women receiving mifepristone and misoprostol were more satisfied with their method and more likely to choose the same method again than were subjects undergoing surgical abortion. Failure of a medical abortion and increased anxiety during surgical abortion were associated with preference for the alternative technique in a future procedure.

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The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, i.e., 200 mg, and vaginal misoprostol 800 microg to induce abortion in subjects < or =56 days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women > or =18 years, < or =63 days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 microg vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the < or =56 days pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up. Complete medical abortions occurred in 97% of subjects < or =56 days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the < or =56 days pregnant and 92% in the 57-63 days pregnant group bled within 4 h of using vaginal misoprostol. Comparing subjects < or =56 days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs 29%, p = 0.002) and vomiting (33% vs 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. One subject in the < or =56 day group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 day group, 91% of subjects in both groups reported that the overall procedure was acceptable. In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 microg at 48 h were highly effective and acceptable to women < or =63 days pregnant, thereby expanding the number of women who can access a medical abortion.

PIP: The aim of this study was to compare the effectiveness, side effects, and acceptability of one-third the standard dose of mifepristone, i.e. 200 mg, and vaginal misoprostol 800 mcg to induce abortion in subjects 56 or fewer days pregnant with subjects 57-63 days pregnant. A prospective multicenter trial enrolled healthy women aged 18 years or older, 63 or fewer days pregnant, and wanting an abortion. Women received mifepristone 200 mg orally, followed by misoprostol 800 mcg vaginally, and returned 1-4 days later for ultrasound evaluation. A second dose of misoprostol was administered, if necessary. Surgical intervention was indicated for continuing pregnancy, excessive bleeding, or persistent products of conception 5 weeks later. Of 1137 subjects, 829 were in the 56 days or fewer pregnant group and 308 in the 57-63 days pregnant group. In all, 34 subjects had surgical intervention and 16 were lost to follow-up. Complete medical abortions occurred in 97% of subjects 56 or fewer days pregnant and 96% in the 57-63 days pregnant group. In all, 88% of subjects in the 56 days or fewer pregnant and 92% in the 57-63 days pregnant group bled within 4 hours of using vaginal misoprostol. Comparing subjects 56 or fewer days pregnant with 57-63 days pregnant, there was less diarrhea (20% vs. 29%, p = 0.0002) and vomiting (33% vs. 44%, p = 0.001), although side effects were acceptable to 82% of subjects in both groups. 1 subject in the 56 or fewer days group required a transfusion for delayed excessive bleeding. Although bleeding (p = 0.01) and pain (p = 0.02) were less acceptable in the 57-63 days group. 91% of subjects in both groups reported that the overall procedure was acceptable. In summary, low-dose mifepristone 200 mg and home administration of vaginal misoprostol 800 mcg at 48 hours were highly effective and acceptable to women 63 or fewer days pregnant, thereby expanding the number of women who can access a medical abortion.

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PIP: This review focuses on advances in the medical termination of pregnancy during the early period of the first trimester, when most abortions are performed. The drugs are used to terminate pregnancy act by inhibiting the synthesis of progesterone, inducing myometrial contractions, antagonizing the action of progesterone, or inhibiting trophoblast development. Among the drugs used in medical abortion are epostane, prostaglandins (including misoprostol and gameprost), combined methotrexate and misoprostol, tamoxifen-misoprostol regimen, mifepristone and prostaglandin, and antiprogestin and prostaglandins. The efficacy, side effects, and contraindications of these drugs in the medical termination of pregnancy are discussed. In general, medical abortion is associated with higher rates of prolonged bleeding, nausea, vomiting, and pain as compared to surgical abortion. However, medical termination of pregnancy has a high rate of efficacy in women with early pregnancies. In addition, medical abortion is safe and acceptable to women, and it does not require anesthesia. Lastly, women who choose medical abortion must have access to a center where suction curettage is available, should heavy bleeding occur and blood transfusion is required.^ieng

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The purpose of this study was to compare the outcome and side effects of using the drugs methotrexate and misoprostol, alone or in combination, to induce abortion. A total of 108 subjects who had requested elective termination of pregnancy and medical abortion at 9 weeks gestation or less were randomized into three groups. The first group received 50 mg/m2 intramuscular (i.m.) methotrexate on day 1 and, if the hCG level had risen by > 50% of the initial level on day 4, a second dose was given. They were then followed-up at weekly intervals up to day 21. Group 2 received 800 micrograms vaginal misoprostol on day 1 and, if ultrasound showed a gestational sac on day 4, they received a repeat dose and were re-examined on day 7. Group 3 received 50 mg/m2 methotrexate intramuscularly followed 3 days later by 800 micrograms vaginal misoprostol and were re-examined on day 7. Complete abortion occurred in 25 (69%) of the 36 subjects in group 1, 21 (58%) of the 36 subjects in group 2, and 32 (89%) of the 36 subjects in group 3. The complete abortion rate in group 3 was significantly higher than that of both group 1 and group 2 (p < 0.05). The incomplete abortion rate was significantly higher in group 2 as compared with both of the other groups (p < 0.05). There were significant differences between the mean gestational age of the successful abortions and the failures in group 1 (no abortion occurred at more than 49 days gestation), but not in groups 2 or 3. Vaginal bleeding in subjects who successfully aborted began within 16 +/- 4 days in group 1 after the first dose, and within 24 h in 18 (86%) of the 21 subjects in group 2 and 27 (84%) of the 32 subjects in group 3 after the misoprostol dose. The drugs caused no serious or prolonged side effects. The combination of methotrexate and misoprostol is a more effective abortifacient regimen than when either drug is used alone.

PIP: A randomized controlled study was performed to assess the efficacy of intramuscular (im) methotrexate and vaginal misoprostol, either alone or in combination, for abortion among 108 women at 63 days¿ gestation or less. The subjects were those who had requested elective termination of pregnancy and medical abortion at 9 weeks¿ gestation or less and were randomized into three groups. Group 1 took 50 mg/sq. m im methotrexate on day 1 and a second dose was given if the human chorionic gonadotropin level had increased by 50% of the initial level on day 4. Weekly intervals were done until day 21. Group 2 took 800 mcg vaginal misoprostol on day 1 and a repeat dose was given if ultrasound showed a gestational sac on day 4. Reexamination was done on day 7. Group 3 took 50 mg/sq. m im methotrexate, which was followed 3 days later by 800 mcg vaginal misoprostol; subjects were reexamined on day 7. In group 1, complete abortion occurred in 69% of the subjects; in group 2, in 58% of the subjects; in group 3, in 89% of the subjects. Complete abortion rate was higher in group 3 than in groups 1 and 2. Therefore, the combination of methotrexate and misoprostol is a more effective abortifacient regimen than either drug is alone.

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OBJECTIVE: To compare the efficacy of vaginal misoprostol and dinoprostone vaginal gel for induction of labour at term. DESIGN: A single-blind randomised comparative trial. SETTING: Induction and labour wards of a UK teaching hospital. PARTICIPANTS: Two hundred and eleven pregnant women at term in whom induction of labour was indicated, and with no contra-indication to the use of prostaglandins for the induction of labour. INTERVENTION: The women were randomly assigned to receive vaginal administration of either misoprostol 50 microg four hourly (to a maximum of four doses) or dinoprostone gel 1 mg six hourly (to a maximum of three doses). MAIN OUTCOME MEASURES: Time from induction to delivery, oxytocin requirement in labour, analgesic requirement, mode of delivery, neonatal outcome. RESULTS: The misoprostol group had a highly significant reduction in median induction-delivery interval compared with the dinoprostone group (14.4 hours vs 22.9 hours; P < 0.00001). In addition, more women delivered after only one dose (77% vs 49%; P < 0.0001, OR 3.51, 95% CI 1.94-6.35), and within 12 and 24 hours. There was a reduced need for oxytocin augmentation in labour (21% vs 47%; P < 0.0001, OR 0.30, 95% CI 0.16-0.54). There was no difference in analgesia requirement in labour, or in mode of delivery. There were no adverse neonatal outcomes associated with the use of misoprostol. Women in the misoprostol group experienced more pain in the interval between induction and being given analgesia in labour, but this did not reach statistical significance. CONCLUSIONS: Misoprostol 50 microg vaginally is a more effective induction agent than 1 mg dinoprostone vaginal gel, with no apparent adverse effects on mode of delivery, or on the fetus. The higher pain scores in the misoprostol group must be balanced against the reduction in time spent having labour induced, and the reduction in need for intravenous oxytocin augmentation. Further randomised studies must continue to exclude the possibility of rare adverse side effects.

PIP: This study aimed to compare the efficacy of vaginal misoprostol and dinoprostone vaginal gel for induction of labor at term. 211 women were assigned to receive vaginal administration of either misoprostol or dinoprostone gel doses. Results showed that there were no maternal demographic differences between the two groups and no cases in which labor could not be induced. In the misoprostol group, the induction interval was 14.4 hours, and more women delivered after a single dose (77% vs. 49%, P 0.0001; or 3.51, 95% CI 1.94-6.35) within 12 or 24 hours. In the dinoprostone group, the induction interval was 22.9 hours; the median induction interval of the two groups was U = 3238, P 0.00001. The oxytocin augmentation requirement of labor was significantly less in the misoprostol group (21% vs. 47%, P 0.0001; OR 0.30, 95% CI 0.16-0.54), and in those cases requiring oxytocin, the median total dose used was less (0.96 U) compared to the dinoprostone group (1.86 U) (U = 3886, P = 0.002). There were no differences between the groups in analgesia used during labor or in mode of delivery. Median patient pain scores were higher in the misoprostol group. Findings indicate that 50 mcg misoprostol vaginally is a highly effective induction agent with no apparent adverse effects on the outcome of labor. There is a need for further studies to establish the safety of misoprostol.

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OBJECTIVE: To determine, from the best available evidence, the effectiveness and safety of misoprostol administered vaginally or orally for third trimester cervical ripening or induction of labour. METHODS: Clinical trials of misoprostol used for cervical ripening or labour induction in the third trimester were identified from the register of randomised trials maintained by the Cochrane Pregnancy and Childbirth Group. All identified trials were considered for inclusion in the review according to a prespecified protocol. Primary outcomes were chosen to address clinical effectiveness (delivery within 24 hours) and safety (uterine hyperstimulation, caesarean section, serious maternal and neonatal morbidity) and were determined a priori. All meta-analyses were based on the intention-to-treat principle. In the absence of heterogeneity the summary statistics have been expressed as typical relative risk (RR) and 95% confidence interval (CI). RESULTS: Vaginal misoprostol: one small study showed that the use of misoprostol results in more effective cervical ripening and reduced need for oxytocin when compared with placebo. When compared with oxytocin, vaginal misoprostol was more effective for labour induction. The relative risk of failure to achieve vaginal delivery within 24 hours was 0.48 (95% CI 0.35 to 0.66). However, the relative risks for uterine hyperstimulation with and without fetal heart rate abnormalities were 2.54 (95% CI 1.12 to 5.77) and 2.96 (95% CI 2.11 to 4.14), respectively. In three out of four trials which studied women with intact membranes and unfavourable cervices, failure to achieve vaginal delivery within 24 hours was reduced with misoprostol when compared with other prostaglandins (RR 0.71, 95% CI 0.62 to 0.81). Vaginal misoprostol was associated with increased uterine hyperstimulation both without fetal heart rate changes (RR 1.67, 95% CI 1.30 to 2.14) and with associated fetal heart rate changes (RR 1.45, 95% CI 1.04 to 2.04). There was also an increase in meconium stained amniotic fluid following vaginal misoprostol (RR 1.38, 95% CI 1.06 to 1.79). Oral misoprostol: one small trial suggests that, when compared with placebo, oral misoprostol reduces the need for oxytocin and shortens the time between induction and delivery. Compared with other prostaglandins one small trial showed a reduced need for oxytocin with oral misoprostol. Two trials compared oral with vaginal misoprostol using different doses. No significant differences were evident. CONCLUSIONS: Overall, misoprostol appears to be more effective than conventional methods of cervical ripening and labour induction. Although no differences in perinatal outcome were shown, the studies were not sufficiently large to exclude the possibility of uncommon serious adverse effects. In particular the increase in uterine hyperstimulation with fetal heart rate changes following misoprostol is a matter for concern. It is possible that, if sufficient numbers are studied, an unacceptably high number of serious adverse events including uterine rupture and asphyxial fetal deaths may occur. The data at present are not robust enough to address the issue of safety. Thus, though misoprostol shows promise as a highly effective, inexpensive and convenient agent for labour induction, it cannot be recommended for routine use at this stage. Lower dose misoprostol regimens should be investigated further.

PIP: The effectiveness and safety of misoprostol administered vaginally or orally for cervical ripening and labor induction in the third trimester of pregnancy were reviewed. Trials were identified from the register of randomized trials maintained by the Cochrane pregnancy and childbirth group. Findings showed that misoprostol doses ranging from 25 mcg 3-hourly to 50 mcg 4-hourly and 100 mcg 6- 12-hourly were more effective than oxytocin or dinoprostone recommended doses. The rate of cesarian section varied following vaginal misoprostol. However, there were increased rates of uterine hyperstimulation both with and without associated fetal heart rate changes. A lower dosage of vaginal misoprostol (25 mcg 6-hourly) was less effective than a higher one (25 mcg 3-hourly), with reduced rates of uterine hyperstimulation. Findings suggest that vaginal doses of 25 mcg misoprostol 3-hourly are more effective than conventional methods of cervical ripening and labor induction. The increase in uterine hyperstimulation with fetal heart rate changes following administration of misoprostol is a matter of concern. There is a possibility that an unacceptably high number of serious adverse events such as uterine rupture and asphyxial fetal deaths may occur if sufficient numbers are studied. Though misoprostol may show some promise as an effective agent for labor induction, it cannot be recommended for routine use. Lower-dose misoprostol regimens should be investigated further.

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Increased access to medical methods of abortion could significantly reduce maternal mortality, especially in developing countries. In light of the political and commercial difficulties in distributing the abortifacient mifepristone, the widely studied mifepristone-misoprostol regimen may not be sufficiently available in the near future. Thus, researchers have begun to look for alternative regimens, including regimens using misoprostol alone. This article reviews the current available evidence on the potential of a misoprostol-alone regimen for medical abortion. Although the data are varied and difficult to compare, recent studies indicate that a misoprostol-alone regimen could be safe and effective as a method of medical abortion. Misoprostol is widely marketed around the world for its other indications and is inexpensive, stable in tropical climates, easy to transport, and simple to administer. A misoprostol-alone regimen of medical abortion could thus greatly improve the access to safe medical abortion services by women in developing countries.

PIP: Studies have been conducted to examine the potential of misoprostol alone for early termination of pregnancy. These studies were done by Norman et al. (1991), Creinin and Vittinghoff (1994), Bugalho et al. (1996), Koopersmith and Mishell (1996), Carbonell et al. (two studies: 1997, 1998), and Jain et al. (1998). The designs, population sampling methods and regimens varied from study to study. Thus, comparison of results has been difficult. Overall, though, findings indicate that a misoprostol-alone regimen could be safe and effective as a method of medical abortion. This regimen could greatly improve access to safe medical abortion services for women in developing countries, which in turn would lead to a significant reduction in maternal mortality.

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The purpose of this study was to compare tamoxifen to methotrexate, with respect to effectiveness, when followed by misoprostol to induce abortion. In the first phase, 198 women presenting for medical abortion at < 7 weeks gestation were randomized to receive either 40 mg of tamoxifen, followed 2 to 3 days later by 800 micrograms of misoprostol self-administered vaginally or 50 mg/m2 of methotrexate, followed 5 to 7 days later by the same dose of misoprostol. In the second phase, 200 women were randomized to receive 20 mg tamoxifen twice daily for 4 days, followed by 800 micrograms misoprostol or the same regimen of methotrexate and misoprostol as in phase 1. The main outcome measure was success rate determined by the number of women who aborted without surgery. In phase 1, the success rate was higher in the methotrexate group (93.0%) compared to the tamoxifen group (85.7%) (p = 0.045). In the tamoxifen group, nine of 98 women had incomplete abortions with symptoms requiring a surgical aspiration, compared to one of 100 women in the methotrexate group. In phase 2, the success rates were 90.9% in the methotrexate group compared to 84.7% in the tamoxifen group (p = 0.20). The side effects were less in the tamoxifen group in phase 1 but not in phase 2. When tamoxifen is given as a single dose, it is less effective than methotrexate but when it is given 20 mg twice daily for 4 days, there is no significant difference. Tamoxifen does not appear to have any benefits over methotrexate.

PIP: This study aims to compare the effectiveness of tamoxifen with that of methotrexate when each is used in combination with misoprostol for abortion. In the 1st phase of the study, 198 medical abortion cases at 7 weeks gestation were randomized to receive either 40 mg of tamoxifen followed by 800 mcg of misoprostol after 2-3 days or 50 mg/sq. m of methotrexate followed by the same dose of misoprostol after 5-7 days. In the 2nd phase, 20 mg tamoxifen twice daily for 4 days was administered to 200 women, followed by 800 mcg misoprostol or the same methotrexate and misoprostol regimen as in phase 1. The number of women who experienced abortion without surgery was determined to measure the success rate. The success rate in phase 1 was higher in the methotrexate group (93.0%) than in the tamoxifen group (85.7%) (p = 0.045). About 9 in 98 women in the tamoxifen group and 1 in 100 women in the methotrexate group had incomplete abortions, indicating surgical aspirations. In the 2nd phase, the success rates were 90.9% in the methotrexate group and 84.7% in the tamoxifen group (p = 0.20). There were fewer side effects in the tamoxifen group during the 1st phase but not in the 2nd phase. Tamoxifen was seen to be less effective than methotrexate if given in a single dose. There was no significant difference when tamoxifen was given in 20 mg doses twice daily for 4 days. There were no advantages observed in tamoxifen over methotrexate.

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OBJECTIVE: To compare the effectiveness of vaginal misoprostol pre-treatment with standard gemeprost pre-treatment in first trimester pregnancy termination. DESIGN: A prospective randomised study. POPULATION: One hundred and ninety-nine women scheduled for day case termination of pregnancy during the first trimester. METHODS: Cervical priming with a vaginally applied 200 microg tablet of misoprostol for at least four hours, compared with a 1.0 mg vaginal suppository of gemeprost for at least three hours before vacuum aspiration. MAIN OUTCOME MEASURES: The prostaglandin effect on baseline cervical dilatation was the main outcome. Others were occurrence of pre-operative pain and need for analgesia, pre-operative side effects such as nausea, vomiting and diarrhoea, presence of blood in the vagina and blood loss during the operation. RESULTS: There was no significant difference in the dilatation ability of misoprostol or gemeprost, nor in the pre-operative use of analgesics. The frequency of nausea and diarrhoea was significantly less common in the misoprostol treated women. CONCLUSIONS: Vaginally applied misoprostol is as effective as gemeprost in cervical priming prior to first trimester vacuum aspiration. Misoprostol was associated with fewer side effects than gemeprost.

PIP: The effectiveness of vaginal misoprostol pretreatment in first-trimester abortion was compared with that of the standard gemeprost pretreatment regimen in a prospective randomized study conducted at Helsinki City Maternity Hospital (Finland) during 1996-97. 188 women scheduled for vacuum aspiration abortion were assigned to undergo cervical priming with a vaginally applied 200 mcg tablet of misoprostol for at least 4 hours (n = 95) or a 1 mg gemeprost vaginal suppository for at least 3 hours (n = 93). The mean duration of prostaglandin pretreatment was 221 minutes in the gemeprost group and 288 minutes in the misoprostol group. 14% of women in the gemeprost group and 5% in the misoprostol group needed pain medication. There were no uterine perforations, cervical ruptures, or incomplete evacuations in either group. Nausea and diarrhea were significantly more frequent in the gemeprost group. The effects of the two analogues were similar in terms of cervical softening, as determined by baseline cervical dilatation, and the presence of blood in the vagina. Overall, the misoprostol treatment was found to be as effective as the more costly gemeprost regimen, with even fewer side effects. Use of a 400 mcg vaginal dose of misoprostol could be considered to reduce the time required to reach peak plasma concentrations.

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