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Misoprostol
Kinds of Misoprostol Terms modified by Misoprostol Selected AbstractsUse of topical misoprostol to reduce radiation-induced mucositis: Results of a randomized, double-blind, placebo-controlled trialJOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, Issue 5 2006MJ Veness Summary Radiation-induced mucositis is an acute reaction of the mucosa of patients undergoing head and neck radiotherapy. It can have debilitating and dose-limiting consequences. There is no consensus on an accepted intervention that significantly reduces its severity. Misoprostol is a synthetic prostaglandin E1 analogue, with properties of a mucosal cytoprotectant. We designed a randomized, double-blind, placebo-controlled trial of misoprostol in patients with head and neck cancer. The aim of this study was to determine if topical misoprostol was effective in reducing the severity of radiation-induced mucositis in patients receiving radical dose radiotherapy. The effect of this intervention on a patient's general well-being was also investigated. The primary end-point of the study was the incidence of Radiation Therapy Oncology Group grade 3 mucositis. Between 1999 and 2002, 83 patients were recruited into the study at Westmead and Nepean Hospitals, Sydney. Forty-two patients were randomized to receive misoprostol and 41 to receive a placebo. Most patients received radiotherapy in the adjuvant setting (52 of the 83) and had either an oral cavity (42 of the 83) or an oropharyngeal (16 of the 83) cancer. We could not identify any significant difference in the incidence of severe mucositis based on whether patients were allocated to receive misoprostol or placebo. There was no significant difference in the mean area under the mucositis curve (13.2 vs 16.6; P = 0.1). Patients allocated to misoprostol did report slightly increased soreness (7.6 vs 6.9; P = 0.04) and a greater use of analgesics. However, this difference did not translate into a worse feeling of general well-being as measured by a simple visual analogue scale (5.8 vs 5.2; P = 0.3). In conclusion, we were unable to identify a reduction in radiation-induced mucositis in patients receiving misoprostol. There is a paucity of high-level evidence on potentially useful interventions and a continued need for new and innovative research, incorporating quality-of-life measurements, in patients experiencing radiation-induced mucositis. [source] Re: Misoprostol and uterine ruptureAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 6 2007Colin A. WALSH No abstract is available for this article. [source] Comparison of self-administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial design,BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 5 2008KS Oppegaard Objective, To compare the impact of 1000 micrograms of self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women before operative hysteroscopy. Design, Two separate but identical parallel, randomised, double-blind, placebo-controlled sequential trials, one in premenopausal women and one in postmenopausal women. The boundaries for the sequential trials were calculated on the primary outcomes of a difference of cervical dilatation ,1 mm, with the assumption of a type 1 error of 0.05 and a power of 0.95. Setting, Norwegian university teaching hospital. Sample, Eighty-six women referred to outpatient operative hysteroscopy. Methods, The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient operative hysteroscopy. Main outcome measures, Preoperative cervical dilatation (primary outcome), number of women who achieve a preoperative cervical dilatation ,5 mm, acceptability, complications and adverse effects (secondary outcomes). Results, In premenopausal women, the mean cervical dilatation was 6.4 mm (SD 2.4) in the misoprostol group and 4.8 mm (SD 2.0) in the placebo group, the mean difference in cervical dilatation being 1.6 mm (95% CI 0.5,2.7). Among the premenopausal women receiving misoprostol, 88% achieved a cervical dilatation of ,5 mm compared with 65% in the placebo group. Twelve percent of the women who received misoprostol were difficult to dilate compared with 32% who received placebo. Dilatation was also quicker in the misoprostol group. Misoprostol had no effect on cervical ripening in postmenopausal women compared with placebo, and 43% of the women were difficult to dilate. The trials were terminated after analysis of 21 postmenopausal women and 65 premenopausal women after reaching a conclusion on the primary outcome with only 28% of the number of women needed in a fixed sample size trial. Three of 45 women who received misoprostol experienced severe lower abdominal pain, and there was an increased occurrence of light preoperative bleeding in the misoprostol group. Most women did not experience misoprostol-related adverse effects. The majority (83% of premenopausal and 76% of postmenopausal women) found self-administered vaginal misoprostol at home to be acceptable. There were two serious complications in the premenopausal misoprostol group: uterine perforation with subsequent peritonitis and heavy postoperative bleeding requiring blood transfusion, but these were not judged to be misoprostol related. Complications were otherwise comparatively minor and distributed equally between the two dosage groups. Conclusions, One thousand micrograms of self-administered vaginal misoprostol 12 hours prior to operative hysteroscopy has a significant cervical ripening effect compared with placebo in premenopausal but not in postmenopausal women. Self-administered vaginal misoprostol of 1000 micrograms at home the evening before operative hysteroscopy is safe and highly acceptable, although a small proportion of women experienced severe lower abdominal pain. There is a risk of lower abdominal pain and light preoperative bleeding with this regimen, which is very cheap and easy to use. [source] Misoprostol and declining abortion-related morbidity in Santo Domingo, Dominican Republic: a temporal associationBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 9 2005Suellen Miller Objective To validate anecdotal reports that abortion-related complications decreased in the Dominican Republic after the introduction of misoprostol into the country. Design Retrospective records reviews and cross-sectional surveys, interviews and focus groups. Setting Family planning clinics, pharmacies, door-to-door canvassing and a tertiary care maternity hospital in Santo Domingo, Dominican Republic. Population Women of reproductive age in Santo Domingo, Dominican Republic. Methods Qualitative and quantitative methods were used. Individual interviews and focus groups of reproductive health professionals, non-governmental organisation leaders and women's group leaders (n= 50) were conducted to discover the role of misoprostol in the Dominican Republic. Local women (n= 157) were surveyed to determine their knowledge of misoprostol as an abortifacient and mystery client visits were made to 80 pharmacies in order to purchase misoprostol without a prescription. Sales data were obtained that documented when misoprostol was introduced to the Dominican Republic pharmacies. Hospital admissions for abortions from the prior eight years were reviewed and hospital emergency room consultation ledgers of 31,190 visits for the period 1994,2001 were reviewed for abortion complications. Main outcome measures Frequencies of maternal morbidities and knowledge of misoprostol. Results Mystery clients purchased misoprostol without a prescription in nearly 64% of pharmacies; staff provided little additional information or counselling. Reliable sales data documented the introduction of misoprostol in 1986. Abortion complications decreased from 11.7% of abortions in 1986 to 1.7% in 2001. The majority of professionals interviewed felt that knowledge of these findings should be made public. Conclusions The data were of too poor quality to validate the verbal reports reliably, but misoprostol appears to have been widely used over a period when abortion-related morbidity fell. It remains plausible that the use of misoprostol contributed to the reduction. [source] A randomised controlled trial of 6 and 12 hourly administration of vaginal misoprostol for second trimester pregnancy terminationBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 9 2005Yongyoth Herabutya Objective To compare the effectiveness of vaginal misoprostol administered 6 or 12 hourly for second trimester pregnancy termination. Design A randomised controlled trial. Setting University teaching hospital. Sample Two hundred and seventy-nine pregnant women at gestations between 14 and 26 weeks undergoing pregnancy termination. Methods Women were randomised to receive 600-,g misoprostol tablets vaginally either every 6 hours or every 12 hours until abortion occurred. Main outcome measures Induction,abortion interval, success rate within 24 and 48 hours and adverse effects. Results There was no significant difference in the median induction to abortion interval 6 hours (16 hours) and 12 hours (16 hours; P= 0.80). The total dose of misoprostol was higher in the 6-hour group (1800 vs 1200 ,g). The cumulative abortion rates within 24 hours were 74% and 67% and within 48 hours 94% and 92%, in the 6- and 12-hour groups, respectively. Fever was more common in the 6-hour group (53%) versus the 12-hour group (31%; P < 0.001). The incidence of nausea, vomiting, diarrhoea, severe bleeding and abdominal pain were similar. Conclusions Misoprostol (600 ,g) administered at 12-hour intervals was associated with fewer adverse effects and was as effective as a 6-hour interval. [source] Lichenoid drug eruption induced by misoprostolCONTACT DERMATITIS, Issue 4 2009Maria João Cruz No abstract is available for this article. [source] Sonographic appearance of the uterine cavity following administration of mifepristone and misoprostol for termination of pregnancyJOURNAL OF CLINICAL ULTRASOUND, Issue 6 2006Ofer Markovitch MD Abstract Purpose. To describe the sonographic appearance of the uterine cavity in women after administration of mifepristone and misoprostol for termination of pregnancy. Methods. Thirty-six women treated with mifepristone 600 mg followed by misoprostol 400 ,g 2 days later for termination of pregnancy were the subjects of the study. Gestational age as calculated from the last menstrual period was ,49 days. Pretreatment sonographic parameters, including gestational sac size and crown,rump length, were measured. The sonographic appearance of the uterine cavity was recorded and documented 6 hours (T-1) and 14 days (T-2) after administration of misoprostol. Results. The mean menstrual age of the patients was 42 days (range 31,49 days). The mean gestational age according to crown,rump length was 43 days (range 40,48 days). Sonographic examination performed atT-1 revealed 23 patients (62.9%) with a well-defined echogenic mass located in the uterine cavity, 2 patients (5.5%) with an intrauterine sac containing a nonviable embryo, and 11 patients (30.5%) with an endometrium thickness of 7,14 mm with no evidence of intrauterine contents. Doppler flow signals were detected in 15 of the 23 patients (65.2%) with an echogenic intrauterine mass. Sonographic examination performed at T-2 revealed 19 patients (52.8%) with a persistent echogenic intrauterine mass; Doppler flow could be detected in 15 of these patients (78.9%). Dilatation and curettage was required in 2 patients (5.6%) due to failure of treatment; all others regained normal menses. Conclusions. An intrauterine echogenic mass with well-defined borders, with or without Doppler flow signals, can be detected 2 weeks after administration of mifepristone and misoprostol for termination of pregnancy. Because most of the women in our study regained normal menses without further surgical intervention, this finding could indicate remnants of trophoblastic tissue evacuated spontaneously from the uterine cavity. Therefore, dilatation and curettage should be avoided in these cases, unless clinical symptoms or signs necessitate surgical intervention. © 2006 Wiley Periodicals, Inc. J Clin Ultrasound 34:278,282, 2006 [source] Monochloramine impairs mucosal blood flow response and healing of gastric lesions in rats: Relation to capsaicin-sensitive sensory neuronsJOURNAL OF GASTROENTEROLOGY AND HEPATOLOGY, Issue 3 2001Koji Takeuchi Abstract Aims: We examined the effects of monochloramine (NH2Cl) on the gastric mucosal blood flow (GMBF) response and the healing of ethanol-induced gastric lesions in rats. Methods: Rats fasted for 18 h were given the 99% ethanol p.o. for induction of gastric lesions, and were fed normally from 1 h later onwards. Monochloramine, at non-ulcerogenic doses (5~20 mmol/L), was given p.o. twice daily for 7 days, starting 2 h after ethanol treatment. Results: Gastric lesions caused by ethanol healed almost completely within 7 days with re-epithelialization. The repeated administration of NH2Cl significantly delayed the healing of ethanol-induced gastric lesions in a dose-dependent manner. The damaged mucosa showed a marked rise in H+ permeability, resulting in luminal acid loss, but this process was accompanied by an increase of mucosal blood flow. Monochloramine did not affect the increased mucosal H+ permeability observed in the stomach after damage by ethanol, but significantly inhibited the mucosal hyperemic response associated with luminal acid loss. Prior exposure of the mucosa to NH2Cl (20 mmol/L) did not affect the gastric hyperemic response caused by mucosal application of misoprostol (a prostaglandin E1 derivative) or NOR-3 (a nitric oxide donor), but totally attenuated the increase of GMBF in response to intragastric capsaicin. Impaired healing and GMBF responses were also observed in rats following chemical ablation of capsaicin-sensitive sensory neurons. Conclusions: These results suggest that NH2Cl impaired the healing of acute gastric mucosal lesions at low concentrations, and this action may be attributable, at least partly, to the impairment of gastric hyperemic response caused by the dysfunction of capsaicin-sensitive sensory neurons. [source] Use of topical misoprostol to reduce radiation-induced mucositis: Results of a randomized, double-blind, placebo-controlled trialJOURNAL OF MEDICAL IMAGING AND RADIATION ONCOLOGY, Issue 5 2006MJ Veness Summary Radiation-induced mucositis is an acute reaction of the mucosa of patients undergoing head and neck radiotherapy. It can have debilitating and dose-limiting consequences. There is no consensus on an accepted intervention that significantly reduces its severity. Misoprostol is a synthetic prostaglandin E1 analogue, with properties of a mucosal cytoprotectant. We designed a randomized, double-blind, placebo-controlled trial of misoprostol in patients with head and neck cancer. The aim of this study was to determine if topical misoprostol was effective in reducing the severity of radiation-induced mucositis in patients receiving radical dose radiotherapy. The effect of this intervention on a patient's general well-being was also investigated. The primary end-point of the study was the incidence of Radiation Therapy Oncology Group grade 3 mucositis. Between 1999 and 2002, 83 patients were recruited into the study at Westmead and Nepean Hospitals, Sydney. Forty-two patients were randomized to receive misoprostol and 41 to receive a placebo. Most patients received radiotherapy in the adjuvant setting (52 of the 83) and had either an oral cavity (42 of the 83) or an oropharyngeal (16 of the 83) cancer. We could not identify any significant difference in the incidence of severe mucositis based on whether patients were allocated to receive misoprostol or placebo. There was no significant difference in the mean area under the mucositis curve (13.2 vs 16.6; P = 0.1). Patients allocated to misoprostol did report slightly increased soreness (7.6 vs 6.9; P = 0.04) and a greater use of analgesics. However, this difference did not translate into a worse feeling of general well-being as measured by a simple visual analogue scale (5.8 vs 5.2; P = 0.3). In conclusion, we were unable to identify a reduction in radiation-induced mucositis in patients receiving misoprostol. There is a paucity of high-level evidence on potentially useful interventions and a continued need for new and innovative research, incorporating quality-of-life measurements, in patients experiencing radiation-induced mucositis. [source] Use of Cytotec (misoprostol) for Labor InductionJOURNAL OF OBSTETRIC, GYNECOLOGIC & NEONATAL NURSING, Issue 1 2001Michael Cullen MD The following letter concerns unapproved use of misoprostol for labor induction and is published as a follow-up to "The Nurse's Role in Misoprostol Induction A Proposal Protocol," by C. Wilson, (NovemberlDecember 2000) [source] Sublingual versus vaginal misoprostol for the management of missed abortionJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 3 2010Fateme Davari Tanha Abstract Aim:, To evaluate the efficacy of two routes of misoprostol administration (sublingual and vaginal) for the treatment of missed abortion. Methods:, Two hundred and twenty women with confirmed missed abortion who received 400 µg/6 h misoprostol either sublingually or vaginally, were included in this randomized control trial. All women were admitted to hospital for follow-up care for 2 days. If the pregnancy was not completely evacuated during this time, the patient underwent immediate surgical completion. Efficacy was defined as the percentage of women discharged from the study without the need for surgical intervention. Results:, The effectiveness was high in the sublingual group and statistically different (sublingual 84.5%, vaginal 46.4% P = 0.000 RR = 0.54 95%CI = 0.442,0.681). The groups differed in terms of complications like bleeding (88.2% vs 65.5%), pain (85.5% vs 56.4%), diarrhea (69.1% vs 36.4%) and fever (23.6% vs 13.3%) in the sublingual group versus the vaginal group, but the mean time to expulsion was shorter (9.68 h SD = 5.51 95%CI = 8.61,10.57) in the sublingual group than the vaginal group (16.64 h SD = 14.01 95%CI = 13.8,19.48), P = 0.000. Women in the sublingual group were highly satisfied with the method. Conclusion:, Sublingual misoprostol for the medical management of missed abortion is more effective and more acceptable than the vaginal route. However, it showed more adverse effects. [source] Randomized comparison of dry tablet insertion versus gel form of vaginal misoprostol for second trimester pregnancy terminationJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 2 2008Saipin Pongsatha Abstract Aim:, To compare the effectiveness of vaginal misoprostol between dry tablet insertion and gel form for second trimester pregnancy termination. Methods:, A non-blinded block randomized controlled trial was conducted on 148 pregnant women with live fetuses in the second trimester undergoing pregnancy termination. They were randomly allocated to receive vaginal misoprostol (400 ,g) either dry tablet insertion (n = 72) or gel form (n = 76). The same dose was then repeated every 3 h if adequate uterine contraction was not achieved until 48 h after the initiation of misoprostol. If abortion did not occur within this period, the treatment was considered a failure and other technique of termination was then given based on the decision of the attending physicians and the cervical status. Results:, The mean induction,abortion interval in group 1 (20.9 ± 12.3 h) was not significantly different from that in group 2 (17.7 ± 10.2 h). The mean total dose of misoprostol was also not significantly different between the two groups (group 1, 1556.9 ,g; group 2, 1350.9 ,g), but the adverse effects of misoprostol (chill and diarrhoea) were more common in the gel group. Conclusion:, Tablet insertion or gel form of vaginal misoprostol have similar effectiveness but the gel form was associated with more common adverse effects. [source] Oral misoprostol for the prevention of primary post-partum hemorrhage during third stage of laborJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 6 2007Christopher A. Enakpene Abstract Aim:, To assess the effectiveness of oral misoprostol compared with methylergometrine in the prevention of primary post-partum hemorrhage during the third stage of labor. Methods:, This was a randomized controlled trial of 864 singleton low-risk pregnant women. The outcomes were total blood loss, duration of the third stage of labor and peripartal change in hematocrit. Comparisons were by the ,2 -test and Student t -test. Relative risks were calculated for side-effects profile. A P -value of less than 0.05 was statistically significant. Results:, The biodata of all the participants were similar. The mean blood loss for the misoprostol and methylergometrine groups was 191.6 ± 134.5 mL and 246.0 ± 175.5 mL, respectively (95% CI: ,79.3 to ,39.5 mL). The mean duration of the third stage of labor was 19.6 ± 2.4 min and 9.4 ± 3.3 min in the misoprostol and methylergometrine groups, respectively (95% CI: 9.82,10.58 min). More subjects had blood loss >500 mL, 42 (9.7%) versus 6 (1.4%), and peripartal hematocrit change greater than 10%, 38 (8.8%) versus 5 (1.2%), in the methylergometrine group than in the misoprostol group, respectively. Also, more subjects received additional oxytocic in the methylergometrine group, compared to the misoprostol group (80 [18.5%] versus 33 [7.6%] patients, respectively). Conclusions:, Orally administered misoprostol was more effective in reducing blood loss during the third stage of labor than intramuscular methylergometrine. However, there were more subjects in the misoprostol group in whom duration of the third stage of labor was greater than 15 min and who also had manual placental removal than in the methylergometrine group. [source] Utility of misoprostol for labor induction in severe pre-eclampsia and eclampsiaJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 5 2004Shamsun Nahar Abstract Objectives:, To determine the effectiveness and safety of misoprostol in severe pre-eclampsia and eclampsia patients with unripe cervix. Methods:, A prospective observational study was carried out in 135 severe pre-eclampsia and eclampsia patients who required termination of pregnancy at the Department of Obstetrics and Gynecology, Khulna Medical College Hospital, Khulna, Bangladesh during January 2002 to October 2003. Fifty micrograms of misoprostol was used every 4 h in cases of unripe cervix (Bishop score , 6) in severe pre-eclampsia and eclampsia patients. Maternal and perinatal outcome as well as any complications were recorded. Results:, In severe pre-eclampsia and eclampsia patients vaginal delivery occurred in 79.3 and 80.5% of cases, and cesarean section was performed in 20.6 and 19.4% of cases, respectively. The maximum required responsive dose was 50,150 µg. Oxytocin augmentation was required in 29.3 and 35% of cases, respectively. Induction to delivery time was median 8 h, interquartile ranges 4.2,8.2 h in the severe pre-eclampsia group, and median, 9 h,, interquartile, ranges, 6.8,12.5 h, in, the, eclampsia, group,, and, average, hospital, stay, was, 3.4 ± 1.8, and 3.7 ± 1.7 days, respectively. The only maternal complications were hyperstimulation which occurred in 6.8 and 5.1% of cases, respectively. Neonatal death occurred in five (11.3%) and eight cases (12.1%), respectively. Conclusion:, Intravaginal misoprostol is well tolerated and very effective for the induction of labor in severe pre-eclampsia and eclampsia patients with unripe cervix. [source] Vaginal misoprostol for cervical priming before dilatation and curettage in postmenopausal women: A randomized controlled trialJOURNAL OF OBSTETRICS AND GYNAECOLOGY RESEARCH (ELECTRONIC), Issue 3 2004Soysuwan Bunnasathiansri Abstract Aim: To investigate the efficacy of vaginal misoprostol for cervical priming before dilatation and curettage in postmenopausal women. Methods: Forty-four postmenopausal women with indication for dilatation and curettage were randomly assigned to receive either 400 µg of misoprostol or placebo vaginally 6 h before dilatation and curettage. The main outcome measures were the number of women who required cervical dilatation, cervical width, time taken to dilate to Hegar 6 and other complications. Results: The mean cervical diameter (4.59 millimeters in the misoprostol group vs 4.41 millimeters in the placebo group) was comparable between the two groups. A similar number of women in the misoprostol group and in the placebo group required cervical dilatation (12 vs 16, P = 0.35). The operative times for both groups were similar. The incidence of side-effects was comparable in both groups. There were two uterine perforations in the misoprostol group (2 vs 0). Conclusion: There was no significant benefit from applying 400 µg vaginal misoprostol 6 h prior to dilatation and curettage in postmenopausal women. [source] Prevention of non-steroidal anti-inflammatory drug gastrointestinal complications , review and recommendations based on risk assessmentALIMENTARY PHARMACOLOGY & THERAPEUTICS, Issue 10 2004F. K. L. Chan Summary The incidence of non-steroidal anti-inflammatory drug-related ulcer complications remains high despite the availability of potent anti-ulcer drugs and selective cyclo-oxygenase-2 inhibitors. Non-steroidal anti-inflammatory drug-related ulcer complications can be minimized by prospective assessment of patients' baseline risk, rational choice and use of non-steroidal anti-inflammatory drugs, and selective use of co-therapy strategies with gastroprotectives. Current recommendations regarding strategies using anti-ulcer drugs and cyclo-oxygenase-2 inhibitors for prevention of clinical non-steroidal anti-inflammatory drug upper gastrointestinal events are largely derived from studies using surrogates such as endoscopic ulcers, erosions, and symptoms in low- to average-risk patients. Conclusions based on surrogate and potentially manipulatable end-points are increasingly suspect with regard to applicability to clinical situations. This article reviews the risks associated with non-steroidal anti-inflammatory drugs including aspirin and includes the effect of the patients' baseline risk, and the confounding effects of Helicobacter pylori infection. In addition, uncertainties regarding the clinical efficacy of anti-ulcer drugs and cyclo-oxygenase-2 inhibitors against non-steroidal anti-inflammatory drug-related ulcer complications are put into perspective. We propose management strategies based on the risk category: low risk (absence of risk factors) (least ulcerogenic non-steroidal anti-inflammatory drug at lowest effective dose), moderate risk (one to two risk factors) (as above, plus an antisecretory agent or misoprostol or a cyclo-oxygenase-2 inhibitor), high risk (multiple risk factors or patients using concomitant low-dose aspirin, steroids, or anticoagulants) (cyclo-oxygenase-2 inhibitor alone with steroids, plus misoprostol with warfarin, or plus a proton pump inhibitors or misoprostol with aspirin), and very high risk (history of ulcer complications) (avoid all non-steroidal anti-inflammatory drugs, if possible or a cyclo-oxygenase-2 plus a proton pump inhibitors and/or misoprostol). The presence of H. pylori infection increases the risk of upper gastrointestinal complications in non-steroidal anti-inflammatory drug users by two- to fourfold suggesting that all patients requiring regular non-steroidal anti-inflammatory drug therapy be tested for H. pylori. [source] The Challenge of Cross-Cultural Clinical Trials Research: Case Report from the Tibetan Autonomous Region, People's Republic of ChinaMEDICAL ANTHROPOLOGY QUARTERLY, Issue 3 2005VINCANNE ADAMS Efforts to conduct Western clinical research in non-Western medical settings with little or no familiarity with such methodologies are on the rise, but documented accounts of the ways that biomedical science requires negotiation and translation across cultures are not plentiful. This article adds to this literature through analysis of an NICHD-funded collaborative research effort in women's health carried out in the Tibetan Autonomous Region of the People's Republic of China. The research involved a feasibility study for an eventual clinical trial comparing Tibetan medicine with misoprostol for preventing postpartum hemorrhage in delivering women. It explores strategies of negotiation and translation in and around notions of the scientific method, informed consent procedures, randomization, blinding, placebo, and concepts of medical standardization. [source] Mifepristone and second trimester pregnancy termination for fetal abnormality in Western Australia: Worth the effortAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 1 2010Jan E. DICKINSON Objective:, To determine the impact on the process of second trimester medical termination for fetal abnormality following the introduction of adjunctive mifepristone in an Australian tertiary hospital. Methods:, All second trimester medical terminations for fetal abnormality between July 2006 and June 2009 were prospectively identified. Two temporal therapeutic cohorts were created: the first (1 July 2006 to 31 December 2007) using vaginal misoprostol alone and the second (1 January 2008 to 30 June 2009) using mifepristone priming prior to the administration of misoprostol. The primary outcome was to evaluate the impact of mifepristone priming upon the duration of pregnancy termination. Results:, During the study period, 388 women with prenatally recognised fetal anomalies between 14 and 24 weeks gestation underwent medical termination: 189 with misoprostol alone and 199 with mifepristone priming followed by misoprostol. There was no difference between the groups for maternal age, parity or prior caesarean delivery. The median abortion duration was 15.5 h (interquartile ranges (IQR) 11.2,22.7) in the misoprostol group and 8.6 h (IQR 5.6,13.8) in the mifepristone primed group (P < 0.001). In both the groups, nulliparity and advancing gestation were associated with a significant prolongation of the abortion interval. Duration of hospitalisation was significantly longer in the misoprostol alone group (31.5 h (27,48.9) vs 27.2 h (22,31.5), misoprostol vs mifepristone priming, respectively, P < 0.001). Conclusions:, The introduction of mifepristone priming prior to second trimester medical termination with misoprostol has resulted in a significant reduction in the duration of the termination procedure and length of inpatient stay. These observed benefits of mifepristone provide objective support for the decision to permit use of this medication in Australia. [source] Treatment of suction termination of pregnancy-retained products with misoprostol markedly reduces the repeat operation rateAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 5 2009Dennis G. CHAMBERS A six-year audit of clinical outcomes following the treatment of suction termination of pregnancy-retained products of conception symptoms with 200 µg of misoprostol orally or sublingually three times a day for six doses showed that it was 93% effective and it reduced the repeat dilation and curettage rate by 79.6% (P < 0.001). [source] Outcomes for subsequent pregnancy in women who have undergone misoprostol mid-trimester termination of pregnancyAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 2 2009Vadim MIRMILSTEIN In Australia, the most common method of mid-trimester termination of pregnancy (TOP) is by medical induction with the prostaglandin E 1 analog misoprostol. This study was undertaken to compare the pregnancy outcomes of women who had undergone a misoprostol mid-trimester TOP in their last pregnancy with those of a similar cohort of women without a history of misoprostol TOP. This study suggests a possibility that medical mid-trimester TOP with misoprostol increases the risk of preterm or very preterm delivery in a subsequent pregnancy but larger studies are needed to confirm or dismiss this. [source] First trimester abortion with mifepristone and three doses of sublingual misoprostol: a pilot studyAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 6 2005Kishor C. SINGH Abstract Objective:, To evaluate the efficacy and safety of a medical abortion regimen with multiple doses of sublingual misoprostol 24 h after mifepristone. Methods:, The regimen was designed on the basis of pharmacokinetics of various routes of administration of misoprostol. Forty women 8 weeks' gestation were given mifepristone 200 mg orally, followed 24 h later by three doses of misoprostol 200 µgm sublingually 6 h apart. They were followed up on day 3 and day 14 with transvaginal ultrasound. Pain and bleeding were assessed using a visual analogue scale and acceptability, by a questionnaire. Results:, Abortion outcome was assessed in terms of onset of pain and vaginal bleeding, time of expulsion of products and duration of vaginal bleeding. Seventy-five per cent of women experienced pain within 2 h after first dose of misoprostol. Bleeding began at a mean of 1.41 h after pain and expulsion at a mean of 6.1 h after first dose of misoprostol. Complete expulsion was confirmed in all women (100%) by ultrasound on day 14. The longest duration of bleeding was 12 days (mean 7.2 days) with 87.5% bleeding for < 10 days. Acceptability was 100% but 70% perceived pain to be moderate and 67.5% bleeding to be light or slightly more than menses. Conclusions:, Medical abortion using three doses of sublingual misoprostol administered 24 h after mifepristone appears to be the most appropriate in terms of pharmacokinetics of the drugs. This pilot study associates the regimen with a short abortion process, which appears to be safe, highly efficacious and acceptable. [source] Introduction of early medical abortion in New Zealand: An audit of the first 67 casesAUSTRALIAN AND NEW ZEALAND JOURNAL OF OBSTETRICS AND GYNAECOLOGY, Issue 4 2005Carol SHAND Abstract Background:, In New Zealand, mifepristone became available in 2001, but because of uncertainty about the law, the first 67 cases were carried out under a very strict protocol. Once the prostaglandin had been administered it was necessary that the woman remain in the unit until the products of conception (POC) had been passed and, if this had not occurred within 8 h, she underwent suction curettage. Aims:, To demonstrate that an early medical termination of pregnancy (EMTOP) service could be offered as a safe option for women, despite the constraints of the law. Methods:, An audit of patient notes was carried out on the first 67 patients undergoing an EMTOP at the Level J Unit (LJU), Wellington Hospital. Data collected included age, ethnicity, parity, previous abortions, gestational age, length of time between the administration of mifepristone and misoprostol, length of time after administration of misoprostol to the completion of abortion, whether a fetal sac was seen, analgesia required, extent of heavy bleeding and any adverse effects. Patient characteristics were compared with those of the 3052 women who underwent surgical termination during the same time period. Data were analysed using EpiInfo 2000 (Centers for Disease Control and Prevention, Atlanta, GA) and Chi square tests for significance. Results:, Successful completion of EMTOP occurred in 63 of 67 cases (94%). Only four cases (6%) required completion by suction curettage and this was performed for legal and financial reasons, rather than for medical reasons. Clinical events requiring management, mainly bleeding problems, occurred in 11 patients (16%). Conclusions:, EMTOP with mifepristone and misoprostol was successfully introduced and the experience provides useful data for others contemplating a similar service. [source] Titrated low-dose vaginal and/or oral misoprostol to induce labour for prelabour membrane rupture: a randomised trialBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 12 2008L Bricker Objective, To evaluate the clinical effectiveness and safety of titrated low-dose misoprostol for induction of labour (IOL) in the presence of prelabour rupture of membranes (PROM). Design, Randomised controlled trial. Setting, Maternity units in the UK (9) and Egypt (1). Population, Women >34 weeks of gestation with PROM, singleton viable fetus and no previous caesarean section. Methods, Subjects randomised to IOL with a titrated low-dose misoprostol regimen (oral except if unfavourable cervix, where initial dose vaginal) or a standard induction method, namely vaginal dinoprostone followed by intravenous oxytocin if the cervix was unfavourable or intravenous oxytocin alone if the cervix was favourable. Main outcome measures, Primary outcome measures were caesarean section and failure to achieve vaginal delivery within 24 hours. Analysis was by intention to treat. Results, The trial did not achieve the planned sample size of 1890 due to failure in obtaining external funding. Seven hundred and fifty-eight women were randomised (375 misoprostol and 383 standard). There were less caesarean section (14 versus 18%, relative risk [RR] 0.79; 95% CI 0.57,1.09) and less women who failed to achieve vaginal delivery within 24 hours in the misoprostol group (24 versus 31%, RR 0.79; 95% CI 0.63,1.00), but the differences were not statistically significant. Subgroup analysis showed that with unfavourable cervix, misoprostol may be more effective than vaginal dinoprostone. There was no difference in hyperstimulation syndrome. There were more maternal adverse effects with misoprostol, but no significant differences in maternal and neonatal complications. Conclusions, Titrated low-dose misoprostol may be a reasonable alternative for IOL in the presence of PROM, particularly in women with an unfavourable cervix. Safety and rare serious adverse events could not be evaluated in a trial of this size. [source] Using telemedicine for termination of pregnancy with mifepristone and misoprostol in settings where there is no access to safe servicesBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 12 2008J Haldane No abstract is available for this article. [source] Author response to: Using telemedicine for termination of pregnancy with mifepristone and misoprostol in settings where there is no access to safe servicesBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 12 2008R Gomperts No abstract is available for this article. [source] Author response to: Comparison of self-administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial designBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 9 2008KS Oppegaard No abstract is available for this article. [source] Comparison of self-administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial designBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 9 2008D Tsivos No abstract is available for this article. [source] Comparison of self-administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial design,BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 5 2008KS Oppegaard Objective, To compare the impact of 1000 micrograms of self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women before operative hysteroscopy. Design, Two separate but identical parallel, randomised, double-blind, placebo-controlled sequential trials, one in premenopausal women and one in postmenopausal women. The boundaries for the sequential trials were calculated on the primary outcomes of a difference of cervical dilatation ,1 mm, with the assumption of a type 1 error of 0.05 and a power of 0.95. Setting, Norwegian university teaching hospital. Sample, Eighty-six women referred to outpatient operative hysteroscopy. Methods, The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient operative hysteroscopy. Main outcome measures, Preoperative cervical dilatation (primary outcome), number of women who achieve a preoperative cervical dilatation ,5 mm, acceptability, complications and adverse effects (secondary outcomes). Results, In premenopausal women, the mean cervical dilatation was 6.4 mm (SD 2.4) in the misoprostol group and 4.8 mm (SD 2.0) in the placebo group, the mean difference in cervical dilatation being 1.6 mm (95% CI 0.5,2.7). Among the premenopausal women receiving misoprostol, 88% achieved a cervical dilatation of ,5 mm compared with 65% in the placebo group. Twelve percent of the women who received misoprostol were difficult to dilate compared with 32% who received placebo. Dilatation was also quicker in the misoprostol group. Misoprostol had no effect on cervical ripening in postmenopausal women compared with placebo, and 43% of the women were difficult to dilate. The trials were terminated after analysis of 21 postmenopausal women and 65 premenopausal women after reaching a conclusion on the primary outcome with only 28% of the number of women needed in a fixed sample size trial. Three of 45 women who received misoprostol experienced severe lower abdominal pain, and there was an increased occurrence of light preoperative bleeding in the misoprostol group. Most women did not experience misoprostol-related adverse effects. The majority (83% of premenopausal and 76% of postmenopausal women) found self-administered vaginal misoprostol at home to be acceptable. There were two serious complications in the premenopausal misoprostol group: uterine perforation with subsequent peritonitis and heavy postoperative bleeding requiring blood transfusion, but these were not judged to be misoprostol related. Complications were otherwise comparatively minor and distributed equally between the two dosage groups. Conclusions, One thousand micrograms of self-administered vaginal misoprostol 12 hours prior to operative hysteroscopy has a significant cervical ripening effect compared with placebo in premenopausal but not in postmenopausal women. Self-administered vaginal misoprostol of 1000 micrograms at home the evening before operative hysteroscopy is safe and highly acceptable, although a small proportion of women experienced severe lower abdominal pain. There is a risk of lower abdominal pain and light preoperative bleeding with this regimen, which is very cheap and easy to use. [source] Comparison of self-administered vaginal misoprostol versus placebo for cervical ripening prior to operative hysteroscopy using a sequential trial design,BJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 6 2007KS Oppegaard Objective, To compare the impact of 1000-microgram self-administered vaginal misoprostol versus self-administered vaginal placebo at home on preoperative cervical ripening in both premenopausal and postmenopausal women prior to outpatient resectoscopy. Design, Randomised, double-blind, placebo-controlled sequential trial. Setting, Norwegian university teaching hospital. Sample, Premenopausal and postmenopausal women referred to outpatient resectoscopy. Methods, The women were randomised to either 1000 micrograms of self-administered vaginal misoprostol or self-administered vaginal placebo the evening before outpatient resectoscopy. Main outcome measures, Preoperative cervical dilatation, acceptability and complications. Results, (a) Intraoperative findings and distribution of cervical dilatation in the two treatment groups. Values are given as median (range) or n (%). (b) Acceptability in the two treatment groups. Values are given as completely acceptable, n (%); fairly acceptable, n (%); fairly unacceptable, n (%) and completely unacceptable, n (%). (c) Pain in the two treatment groups. Pain was measured with a visual analogue scale score, scale ranges from 0 (no pain) to 10 (unbearable pain). Values are given as median (range). (d) Occurrence of adverse effects in the two treatment groups. Values are given as n (%). (e) Complications, given as n (%). [source] Randomised controlled trial comparing the efficacy of same-day administration of mifepristone and misoprostol for termination of pregnancy with the standard 36 to 48 hour protocolBJOG : AN INTERNATIONAL JOURNAL OF OBSTETRICS & GYNAECOLOGY, Issue 2 2007J Guest Objective, To determine the efficacy of oral mifepristone followed by vaginal misoprostol 6 hours later compared with the standard 36- to 48-hour regimen for medical termination of pregnancy. Design, Single centre, two arm, parallel, open randomised controlled trial. Setting, Medical termination service at a teaching hospital. Sample, Four hundred and fifty women undergoing medical termination of pregnancy at up to 63 days of gestation. Methods, Eligible women were randomised to receive mifepristone 200 mg orally followed by vaginal misoprostol 800 micrograms either 6 hours (n= 225) or 36,48 hours (n= 225) later. All participants were invited to attend for a follow-up pelvic ultrasound scan within 7 days following the misoprostol administration. For those women in whom products of conception remained at the follow-up ultrasound scan, expectant management ensued with weekly follow-up ultrasound scans until the termination was complete. They could elect to undergo an evacuation of uterus at any stage following the scan. Those women with a nonviable gestation sac at the follow-up scan were offered a further dose of vaginal misoprostol 800 micrograms or suction termination of pregnancy. Women with a continuing pregnancy were managed with surgical termination. Main outcome measure, Successful medical abortion defined as no requirement for medical or surgical intervention beyond the initial dose of misoprostol. Results, One hundred and sixty-five women (79%) in the 6-hour group and 197 women (92%) in the 36- to 48-hour group had a successful termination at first follow-up ultrasound or presumed on the basis of other considerations (those not seen for ultrasound but deemed successful by negative pregnancy test, products passed on ward or long-term assessment of notes). Twenty-two women (10%) in the 6-hour regimen required up to three further ultrasound scans after 7 days following the mifepristone administration in order to ensure that the termination process was complete. None of these women required a suction evacuation of uterus. In the 36- to 48-hour regimen, ten (5%) women had up to two further ultrasound scans to confirm a complete termination without the need for a surgical evacuation of uterus. Therefore, the overall successful termination rate in the 6-hour regimen was 89% (187/210) compared with 96% (207/215) in the 36- to 48-hour regimen (relative risk = 0.92, 95% CI 0.84,0.98). Repeat administration of misoprostol or surgical treatment was required in 23 women (11%) in the 6-hour group and 8 women (4%) in the 36- to 48-hour group. A viable pregnancy was found in five women (2%) in the 6-hour group and in three women (1%) in the 36- to 48-hour group. Conclusions, Oral mifepristone 200 mg followed by vaginal misoprostol 800 micrograms after 6 hours is not as effective at achieving a complete abortion compared with the 36- to 48-hour protocol. [source] | |||||||||||||||||||||||||