Efficacy Of Misoprostol Research Articles

An approach to evaluate the efficacy of vaginal misoprostol administered for a rapid management of first trimester spontaneous onset incomplete abortion, in comparison to surgical curettage

The purpose of this study is to evaluate the efficacy and safety of the medical method in the management of first trimester spontaneous onset incomplete abortion, by using misoprostol vaginal tablets, in comparison to surgical evacuation, with an intention of completing the procedure within 24 h. In this prospective, randomised study of 100 women admitted with features suggestive of incomplete abortion, 50 women received misoprostol vaginal tablets, while another 50 underwent suction curettage of products of conceptus. They were followed up after 24 h of last dosage of misoprostol or surgical intervention. Statistical analysis was done with respect to efficacy, safety and procedure-related side effects. In this study, when analysed after 24 h of treatment allocation, the efficacy of misoprostol was 91.3%, and the efficacy of the surgical method was 96%, with the statistical difference being insignificant. Procedure-related blood loss and pain perception between the two groups were statistically insignificant. However, the incidence of fever in the misoprostol group statistically appeared higher. Misoprostol could be a safe and easily accessible alternative to surgical evacuation, in cases of first trimester spontaneous onset incomplete miscarriage, and could be administered by the patient herself at home.

Interruption of nonviable pregnancies of 24–28 weeks' gestation using medical methods: Release date June 2013 SFP Guideline #20133

The need to interrupt a pregnancy between 24 and 28 weeks of gestation is uncommon and is typically due to fetal demise or lethal anomalies. Nonetheless, treatment options become more limited at these gestations, when access to surgical methods may not be available in many circumstances. The efficacy of misoprostol with or without mifepristone has been well studied in the first and earlier second trimesters of pregnancy, but its use beyond 24 weeks' gestation is less well described. This document attempts to synthesize the existing evidence for the use of misoprostol with or without mifepristone to induce labor for nonviable pregnancies at gestations of 24–28 weeks. The composite evidence suggests that a regimen combining mifepristone and misoprostol may shorten the time to expulsion, though the overall success rates are similar to those seen with misoprostol-only regimens.

Misoprostol for prevention of post partum hemorrhage in puerperas

Objective To explore the clinical efficacy of misoprostol in the prevention of postpartum hemorrhage.Methods 300 puerperas who had been hospitalized during the period of January 2011 to December 2012 were randomly divided into two groups.The study group (150 patients) were received misoprostol for prevention of postpartum hemorrhage,while the control group (150 patients) received routine therapy with oxytocin.Postpartum hemorrhage volume postpartum blood pressure,and time to hemostasis,and efficacy of therapies were compared between the two groups.Results The amount of bleeding (205.3 ±42.7)ml was smaller and time to hemostasis (8.6 ± 3.2)h was shorter in the study group than in the control group,with a significant statistical difference (P＜0.05).Only one patient in the study group developed massive bleeding of 500 ml,with a effectiveness rate of prevention of 99.3％; while 12 patients occurred bleeding of 500 ml,with a effectiveness rate of 92.0％; the difference between the groups was statistically significant (P＜0.05).Conclusions Misoprostol can effectively reduce the incidence of postpartum hemorrhage,and it is safe and efficious. Key words: Misoprostol; Postpartum hemorrhage; Oxytocin

Rethinking WHO Guidance

I write due to concern that persons who wish to restrict misoprostol use, because of personal biases against termination of pregnancy, might attempt to use the article by Chu, Brhlikova, and Pollock to influence policy. The safety and efficacy of misoprostol has been demonstrated in hospital settings, and does not merit debate. The authors review only four studies of misoprostol use in community and home births. Studies of community and home births are difficult, comparison with placebo is deemed unethical by many, and blinding of misoprostol use is essentially impossible due to the shivering. The one study, by Hoj, which utilized a placebo found a significant difference in severe blood loss, the outcome (other than death) which is most critical. The authors attempt to discredit studies due to exclusion of high risk patients. The exclusion criteria listed for the Mobeen study include planning not to deliver at the birth center, previous Cesarean section, and ‘unlikely to deliver vaginally’, conditions which would appropriately and ethically mandate referral for hospital delivery. The excluded women would be at increased risk of uterine rupture, which is not primarily treated with uterotonics. They note that Mobeen's study shows that PPH rates in both groups decreased as the study progressed, and hypothesized this was due to later-recruited midwives being more skilled. This supports the use of misoprostol by less-skilled birth attendants, rather than not using it at all, if one wants to decrease PPH. Oxytocin alone does not always work, whether for induction of labor or prevention or treatment of hemorrhage. Those of us who attend births in the developed world often use misoprostol in addition to oxytocin. I would hate to have misoprostol withdrawn from my pharmacopeia in the USA. The issue is not whether WHO should keep misoprostol on the essential drug list, but rather who should be allowed access to misoprostol, which is an issue that each nation should decide, depending on its own national needs and priorities.

A randomized controlled trial for cervical priming using vaginal misoprostol prior to hysteroscopy in women who have only undergone cesarean section

To evaluate the efficacy of misoprostol administrated vaginally on cervical priming and its complications prior to diagnostic or operative hysteroscopy in women who have undergone at least one cesarean section and who have never delivered vaginally before and/or had other transcervical procedure. A total of 55 patients undergoing hysteroscopy for various intra-uterine lesions were included in this study and were randomly allocated to two groups finally. Thirty patients in the study group were given 200 μg misoprostol vaginally 12 h before the procedure, whereas 25 patients in the control group did not receive any cervical priming. The countered outcome included the cervical width detected with Hegar dilatators and complication rates. Mean cervical width was greater in the study group (6.6 ± 1.3) than in the control group (5.1 ± 0.9). Complications and failure rates were lower in the study group. Application of 200 μg misoprostol vaginally 12 h before hysteroscopy softens the cervix, reduces cervical resistance and consequently the need for cervical dilatation, with only mild side effects.

Misoprostol Vs Mifepristone and Misoprostol in Second Trimester Termination of Pregnancy

The present study was conducted with the aim to assess and comparatively evaluate the safety and efficacy of misoprostol alone and mifepristone with misoprostol for second trimester termination of pregnancy. The study was conducted on 200 selected cases, divided in two groups of 100 cases each. In the study group mifepristone was given 200mg 12h before intravaginal insertion of 600μg of misoprostol followed by 400μg every 3h up to a maximum of 5 doses or until the abortion occurs, whichever occurs early. In the control group only misoprostol was inserted in the same dose regime. The results were analyzed. The success rate in both regimens was 100%. Mean induction abortion interval from the insertion of the first misoprostol tablet was significantly shorter in the mifepristone pretreated group 6.72±2.26h as compared to 12.93±3.4h in the misoprostol alone group (P<0.001). The mean blood loss was slightly higher in the control group. The mean dose of the misoprostol required was significantly less in the study group 1,186±291.64μg as against 1,736±320.20μg (P<0.001). The side effects observed in both the groups were similar mainly nausea vomiting, fever, abdominal cramps. Pretreatment with mifepristone 12h before intravaginal misoprostol significantly improves the induction abortion interval.

Safety and Efficacy of Misoprostol and Dinoprostone as Cervical Ripening Agents

The study compares safety and efficacy of misoprostol and dinoprostone as cervical ripening agents. Patients with term, vertex, singleton pregnancy and Bishop score of 4 or less were randomly assigned to receive misoprostol pessary (n=35, 50 microg intravaginally) or dinoprostone gel (n=31, 0.5 mg intracervically) at 6 hourly intervals. If there were no progress in cervical dilatation or effective uterine contraction even after maximum dose, patients were taken for cesarean section. Patients who achieved Bishop's score more than 7 but the delivery was not progressing, were augmented with oxytocin drip. No uterine hyperstimulation was observed in both groups. However, abnormal fetal heart rate was observed in 3(8.6%) cases in misoprostol group and 2 (6.5%) in dinoprostone group. There was no statistically significant difference in meconium passage in two groups. Apgar score less than 7 at 1 minute was seen in 6 (19.4%) and 11 (31.4%) neonates in dinoprostone and misoprostol group respectively. However Apgar score less than 7 at 5 minutes was found in only one neonate of dinoprostone treated patient. Both drugs were found to be equally effective in improving Bishops score with no significant difference in mean induction to delivery time. Cesarean section was done among 32.3% and 28.6% respectively in dinoprostone and misoprostol groups. There was significant reduction in the need for oxytocin augmentation in misoprostol (37.1%) group than in dinoprostone (67.7%) group. Vaginal misoprostol is an effective, safer and cheaper alternative to dinoprostone as a cervical ripening agent in underdeveloped countries.

Safety and efficacy of oral versus vaginal misoprostol use for induction of labour at term.

To compare the safety and efficacy of Misoprostol through oral and vaginal routes for induction of labour at term. Quasi-experimental study. Department of Gynaecology and Obstetrics (Unit-IV), Liaquat University Hospital, Jamshoro, Pakistan, from January to December 2004. Eighty term patients who met the inclusion criteria were selected for induction of labour with (50 microg) Misoprostol, either by oral or vaginal route. The patients were allocated in two groups-A and B, using non-probability convenient sampling technique. The dose was repeated at an interval of 6 hours upto maximum dose of 150 microg. Improvement in Bishop's score, analgesic requirements, route of delivery, maternal complications, neonatal outcomes were noted. The commonest indication in group-A was premature rupture of membranes in 16 patients (40%) and in 8 (20%) patients of group-B. Mean improvement in Bishop's score after 6 hours was greater in group-A (3.6 +/- 3.09) than group-B (3.3 +/- 3.45, p=0.70). Induction to delivery interval was less in group-A (6.7 +/- 4.4 hours) than group-B (7.5 +/- 4.3 hours, p=0.41). Oxytocin augmentation was required more in group-B as compared to group-A. Normal vaginal deliveries were achieved in 95% of group-A and in 80% of group-B. The dose of 50 microg was effective in 31(77.5%) patients of group-A as compared to 24 (60.0%) patients of group-B, while 100 microg was needed in 6 (15.0%) patients of group-A as compared to 13 (32.5%) patients in group-B. There was no significant difference between both the groups with regard to analgesic requirement, instrumental delivery, maternal complications and neonatal outcome. Safety and efficacy was comparable between low-dose vaginal and oral Misoprostol uses for induction of labour. However, oral route was better with respect to treatment interval, number of doses required and route of delivery. Both routes of administration can alternatively be used for induction of labour in developing countries where cost of drug does matter.

T1318 Incidence of Small Bowel Injury By Low-Dose Enteric-Coated Aspirin, and Efficacy of Misoprostol in Treating It - A Pilot Study with Capsule Endoscopy

T1318 Incidence of Small Bowel Injury By Low-Dose Enteric-Coated Aspirin, and Efficacy of Misoprostol in Treating It - A Pilot Study with Capsule Endoscopy

Transvaginal ultrasound measurement of cervical length and efficacy of misoprostol in first‐trimester pregnancy failure

The aim of this study was to assess the role of cervical length measurement in predicting successful treatment, by misoprostol administration, of early (first-trimester) pregnancy failure. A prospective study was conducted of all patients who agreed to medical treatment of pregnancy failure. Cervical length and other sonographic variables were measured using pelvic ultrasound before medical treatment began. Measurements were compared between the group with successful medical treatment and the group in whom treatment failed. In 125 women included in the study, the success rate of misoprostol treatment was 64.8%. There were no significant differences between the groups with successful and failed treatment for cervical length (29.9 +/- 9.3 vs. 30.4 +/- 6.8 mm, P = 0.75), distance between gestational sac and 'virtual' cervical internal os (23.9 +/- 13 vs. 26.6 +/- 13 mm, P = 0.26), crown-rump length (8.7 +/- 9.7 vs. 6.7 +/- 8.6 mm, P = 0.25), or gestational sac diameter (31.3 +/- 14 vs. 30.1 +/- 15 mm, P = 0.73). Cervical length does not predict the success of misoprostol treatment of first-trimester pregnancy failure.

Efficacy of misoprostol and ranitidine in the prevention of duodenal ulcer relapse and its correlation with endogenous gastric prostanoid synthesis

We determined endogenous gastric prostaglandin synthesis and its correlation with the prevention of duodenal ulcer relapse by misoprostol and ranitidine. Sixty-one patients with recent endoscopically healed duodenal ulcer were randomly allocated in a double-blind fashion for one year of treatment with misoprostol 400 micrograms nocte, ranitidine 150 mg nocte or placebo. Patients were followed every two months. Endoscopy was repeated at six and 12 months or beforehand, if relapse was suspected. Antral and fundic biopsies, 3-4 from each region, were obtained at each endoscopy for determination of prostaglandin synthesis. During the one year of treatment, 11 out of the 12 placebo treated patients flared up, as opposed to 10 out of 25 and four out of 24 misoprostol and ranitidine treated patients, respectively. The difference between all treatment groups was significant (P less than 0.0001). In all subjects who flared up, pretrial endogenous antral and fundic prostaglandin E2 synthesis were not different from their respective synthesis in those who did not relapse.

Small bowel enteropathy associated with chronic low-dose aspirin therapy

In April, 2005, a 79-year-old Chinese man presented with severe iron defi ciency anaemia (haemoglobin 67 g/L). He had no history of peptic ulcer disease and there were no signs or symptoms of gastrointestinal bleeding or disease. He had had a myocardial infarction in 1999, and had been taking aspirin 80 mg daily since then; he was not using any non-steroidal anti-infl ammatory drugs (NSAIDs) or herbal preparations. Upper and lower gastrointestinal endoscopy failed to identify any bleeding lesions. He was supportively transfused, and misoprostol 400 μg daily was empirically added. In the subsequent 7 months, he had a progressive drop in haemoglobin from 106 g/L (post-transfusion) to 54 g/L. He developed bilateral ankle oedema, with serum albumin concentration dropping from 39 g/L to 23 g/L. There was no proteinuria and the cause of hypoalbuminaemia was suspected to be loss from the gastrointestinal tract. A technetium-99m-labelled human serum albumin scan, which is purported to be a sensitive test for a protein losing enteropathy, was normal. Small bowel capsule endoscopy (Olympus, Tokyo, Japan), however, showed multiple small bowel ulcers, particularly in the ileal region (fi gure A and B). In view of the possible link between aspirin therapy and small bowel enteropathy, aspirin was withheld. A repeat capsule endoscopy 3 months later showed a few small healing erosions only (fi gure C and D). When last seen in July, 2006, our patient remained asymptomatic with no oedema or anaemia (haemoglobin 122 g/dL), and his serum albumin was 41 g/L. Small bowel injury is increasingly recognised to be an important complication of NSAID therapy. NSAIDs cause varying degrees of small bowel injury from increased intestinal permeability, intestinal infl ammation, protein loss, blood loss, and ulcerations, to perforation and diaphragm-like strictures. In our study, comparing the gastrointestinal tolerability of celecoxib with diclofenac and a proton pump inhibitor, we found that 30% of the serious gastrointestinal events were distal to the duodenum with one death due to small bowel perforation. Post-hoc analysis of a large-scale clinical outcome trial showed that lower gastrointestinal events accounted for 40% of all serious gastrointestinal events in patients on NSAIDs. The diffi culty in assessing the severity of NSAIDenteropathy was previously hampered by the lack of reliable tests for examining the small bowel. With the advent of capsule endoscopy and double balloon enteroscopy, small bowel injury can now be directly visualised. Capsule endoscopy corroborates the high prevalence of NSAID-enteropathy demonstrating that about 70% of regular NSAID users have small bowel erosions and ulcers. Here we illustrate a case of severe enteropathy induced by low-dose aspirin that has many striking similarities with NSAID-enteropathy. Although aspirin at anti-infl ammatory drug doses can cause stomach and duodenal ulcers, it is generally believed that aspirin does not cause any small bowel damage based on intestinal permeability and faecal infl ammatory marker studies. Our observation not only challenges the safety of aspirin on small bowel mucosa but also raises questions about the effi cacy of misoprostol as a prophylactic treatment against enteropathy. Low-dose aspirin, used for cardiovascular prophylaxis, is one of the most commonly prescribed medications worldwide. The demonstration of a severe form of enteropathy with this drug suggests the need to defi ne the extent of this potential problem. Increasing clinical awareness and appropriate early investigation are needed to establish the proper diagnosis.

Safety and efficacy of misoprostol for second-trimester pregnancy termination: Effect of prior cesarean section

TERMINATION: EFFECT OF PRIOR CESAREAN SECTION LARA FRIEL, MEREDITH ROCHON, CYNTHIA GYAMFI, ADAM JACOBS, Mount Sinai School of Medicine, Obstetrics, Gynecology, and Reproductive Science, New York, New York OBJECTIVE: To assess the safety and efficacy of misoprostol for secondtrimester pregnancy termination in patients with a prior cesarean section using a meta-analysis of published studies. STUDY DESIGN: Studies were identified using a medline search from 19662004, limited to english language and human subjects.

Misoprostol vs. oxytocin for induction of labor at term

Efficacy of misoprostol was studied for induction of labor at term. Seventy patients were randomized to Group A ( n=36, oral misoprostol 50 μg four hourly to maximum of 5 doses) and B ( n=34, continuous oxytocin infusion). Induction-delivery interval was shorter with misoprostol (7.7±2.8 h against 14.3±4.8 h with oxytocin) but the rates of vaginal delivery, cesarean, neonatal outcome variables were similar. Hence, misoprostol is an effective agent for induction of labor at term.

A randomized trial that compared intravaginal misoprostol and dinoprostone vaginal insert in pregnancies at high risk of fetal distress

Objective The purpose of this study was to compare the safety and efficacy of misoprostol and dinoprostone in pregnancies at high risk of fetal distress. Study design Medical indications for the induction of labor with postdate pregnancy or intrauterine growth restriction were randomized. A sequential design that was based on the triangular test was used. Results At the fourth interim analysis, which included 140 patients, the trial was stopped because no significant difference was found in neonatal safety between misoprostol and dinoprostone, which was assessed on arterial cord pH <7.20 (14.3% vs 10.0%, respectively; P = .60). Neonatal tolerance was similar in the 2 groups, with no difference in the cesarean delivery rate for fetal distress or in the incidence of meconium-stained amniotic fluid. Time to vaginal delivery was shortened by misoprostol ( P = .03). Conclusion Misoprostol and dinoprostone are equally safe for the induction of labor in pregnancies that are at high risk of fetal distress; however, misoprostol allowed the earlier induction of labor than did dinoprostone.

Efficacy of misoprostol in the treatment of tinnitus in patients with diabetes and/or hypertension

Objective: To determine the efficacy of the prostaglandin E1 analogue misoprostol in the treatment of tinnitus in diabetic and/or hypertensive patients. Design: Double-blind, randomized, placebo-controlled trial. Settings: Tertiary care referral center. Methods: The subjects were 42 patients with hypertension and/or diabetes mellitus who had chronic tinnitus and had experienced tinnitus symptoms for a minimum of 6 months. Twenty-eight patients were randomly assigned to Group I (misoprostol treatment), and 14 patients to the Group II (placebo treatment). Misoprostol therapy was started at 200 μg per day, and was increased 200 μg every 7 days until a dose of 800 μg per day was reached. The same numbers of placebo tablets were given to the control group using the same schedule. Both groups were treated for 1 month. The changes in objective and subjective tinnitus findings from baseline to 1 month were assessed, and the group results were compared. The χ 2-test, student’s t-test and paired-samples t-test were used to analyze the study. Results: At the completion of treatment, objective assessment showed that tinnitus loudness decreased in 13 (46%) of the 28 patients in the experimental group, whereas this was observed in only two (14%) of the 14 subjects in the placebo group. Subjective tinnitus scoring revealed improvement rates of 29 and 14% for the misoprostol and placebo groups, respectively. When t-test relating to difference between rates were performed, the difference between improvement rate for tinnitus loudness of the experimental group and control group was found to be statistically significant ( P=0.05), but difference between improvement rate based on subjective tinnitus scoring was insignificant ( P=0.22). Conclusion: Misoprostol is an effective and safe treatment for chronic tinnitus in hypertensive and/or diabetic patients. Our results are encouraging, but further studies of larger series are needed.

Safety and efficacy of misoprostol for induction of labour in a semi-urban hospital setting

Most studies on the use of misoprostol for induction of labour have been carried out in well-endowed hospitals in developed countries with state-of-the-art monitoring equipment. There is need for more studies to be conducted in facilities with limited resources, if more patients are to benefit from the low cost and effectiveness of the drug. Following Ethical Committee approval, 152 women had labour induced in our maternity unit using intravaginal misoprostol. The patients were monitored clinically using the WHO model partograph with digital palpation of uterine contractions and intermittent auscultation of fetal heart with a pinard stethoscope. One hundred and thirty-five (88.8%) of the women had a vaginal delivery, while nine (5.9%) had a caesarean section for various obstetric indications. Eight cases of uterine hyperstimulation were noted but none of uterine rupture. We conclude that misoprostol can be used safely for induction of labour in less endowed hospital settings such as in developing countries, using basic clinical tools for monitoring.

Mukosaprotektive Therapie unter Langzeitmedikation mit nichtsteroidalen Antirheumatika

Due to the extraordinary high prevalence of peptic lesions in the upper gastrointestine in the long-term treatment with nonsteroidal anti-inflammatory drugs, a prophylaxis in patients belonging to high-risk groups is essential. Misoprostol, proton pump inhibitors and histamine 2-receptor antagonists have been evaluated in prospective studies. The efficacy of Misoprostol is well documented, though its use in prevention is frequently limited due to side effects. Proton pump inhibitors are also well established, especially in the therapy of nonsteroidal anti-inflammatory drugs associated peptic ulcers and in consecutive secondary prevention. The histamine 2-receptor antagonist Famotidine in a high oral dosage is able to reduce the frequency of peptic lesions too, but not to the same degree as Misoprostol and proton pump inhibitors. It is very likely that helicobacter pylori eradication without any further mucosaprotective therapy will only decrease the incidence of upper gastrointestinal bleeding in low dose Aspirin application. In spite of controversial studies this eradication seems to be a useful additional therapy for ulcer prophylaxis in high risk groups. Selective Cyclooxygenase-2 inhibitors may become a promising alternative, from a pathophysiological perspective. However, to date there has been a lack of clear comparative studies with common nonsteroidal anti-inflammatory drugs plus mucosaprotecting agents. Daily therapy costs are higher with a Cyclooxygenase-2 inhibitor than using the traditional nonsteroidal anti-inflammatory drugs together with either proton pump inhibitors, histamine 2-receptor antagonists or Misoprostol--a fact that should be considered in primary therapeutic decisions. In the following review we will present the most important results of the different prophylactic and therapeutic modalities. On the basis of placebo-controlled, prospective studies on the one hand and the recommendations of the scientific societies on the other, a guideline for daily clinical practice will be suggested.

The Effect of Dosing Interval on the Efficacy of Misoprostol in the Prevention of Aspirin-Induced Gastric Injury

The Effect of Dosing Interval on the Efficacy of Misoprostol in the Prevention of Aspirin-Induced Gastric Injury

Intracervical misoprostol and prostaglandin E 2 for labor induction

Objectives: To compare the safety and efficacy of misoprostol with PGE 2 for induction of labor by intracervical administration. Methods: Eighty-six women with indications for labor induction at term were randomly assigned to two groups. Each woman received either 50 μg of misoprostol or 0.5 mg of prostaglandin E 2 intracervically. If labor was not initiated after 4 h, the same dose was repeated every 4 h to a maximum of 200 μg of misoprostol or 1.5 mg of PGE 2 until adequate labor was achieved. Results: Forty-three women were allocated to the misoprostol group and 43 to the prostaglandin E 2 group. Misoprostol was more effective than PGE 2 in producing cervical changes ( P<0.025). Delivery within 12 h after the first administration occurred more often in the misoprostol group than in the PGE 2 one (85% vs. 56%, P<0.05). Less patients in the misoprostol group required oxytocin augmentation than in the PGE 2 one (16.3% vs. 39.5%, P<0.05). Uterine tachysystole and hyperstimulation occurred more frequently in the misoprostol group (44.1%) than in the PGE 2 group (18.7%) ( P<0.05). Nevertheless, no statistically significant differences were noted between the two groups including mode of delivery and neonatal or maternal adverse outcome. The interval from induction to vaginal delivery was significantly shorter in the misoprostol group (480±172 min vs. 657±436 min, P<0.01). Conclusions: Compared with prostaglandin E 2, intracervical misoprostol is more effective in cervical ripening and labor induction at term. The higher frequency of uterine hypercontractility associated with the use of misoprostol did not increase the risk of adverse intrapartum and neonatal outcomes.