Μg Of Misoprostol Research Articles

Low Dose Vaginal Misoprostol in the Management of Women with Intrauterine Fetal Death

Objectives The study was conducted to assess the effectiveness and side effects of vaginal misoprostol (Vagiprost® tablet) in termination of second and third trimester pregnancy complicated with intrauterine fetal death. Design A prospective observational cohort study. Setting Tanta University Hospital. Patients The study was carried out on 324 women with fetal demise in the second and third trimesters. Cases were collected during the period from January 2008 to December 2009. Intervention All patients were subjected to history taking, physical examination, Bishop Scoring. Application of 25 μg misoprostol in the posterior fornix of the vagina, this will be repeated every 4 hours over 24 hours. The adverse effects, progress, and outcomes were assessed. Results the success rate was 90% and 45% in women with third and second trimesters respectively. The mean induction-termination interval was 8.95 ± 2.63 and 15.3 ± 5.37 hours for women with third and second trimesters respectively. The induction termination interval correlated negatively with the duration of gestation. Approximately, 90% of second trimester and 55% of third trimester women required oxytocin augmentation. The mean value of total required dose of misoprostol was 166.3 ± 7.5 and 120 ± 28.79 μg for women with second and third trimesters respectively. Conclusion Vagiprost appears to be a safe, effective, practical, and inexpensive method for termination of third trimester pregnancy complicated with of intrauterine fetal death (IUFD), its effects increase with parity and duration of gestation.

Randomized Trial of Oral Misoprostol Before Endometrial Biopsy

ObjectiveTo determine if the use of oral misoprostol in women undergoing endometrial biopsy reduces procedural discomfort. MethodsWomen undergoing endometrial biopsy were randomized to receive either 400µg misoprostol or a vitamin B6 placebo orally 12 hours prior to the procedure, and were stratified based on menopausal status. The primary outcome was procedural discomfort on a visual analogue scale (0–10). Secondary outcomes included the need to dilate the cervix or use a tenaculum, and side effects. Subgroup analyses were planned for premenopausal and postmenopausal women separately. Sample size calculation was based on detecting a 50% reduction in pain, with α = 0.05 and β = 0.10, in the premenopausal group. ResultsA total of 72 women (49 premenopausal and 23 postmenopausal) were enrolled; 35 received misoprostol (23 premenopausal and 12 postmenopausal) and 37 received placebo (26 premenopausal and 11 postmenopausal). There were no significant differences in procedural discomfort (misoprostol vs. placebo 5.8 ± 2.9 vs. 5.5 ± 3.2, P = 0.77; premenopausal women 4.9 ± 3.3 vs. 5.1 ± 33.1, P = 0.85; postmenopausal women 7.1 ± 1.9 vs. 7.1 ± 12.3, P = 0.99), need to dilate the cervix (6.1% vs. 5.6%, P = 0.93) or use a tenaculum (44.1% vs. 48.6%, P = 0.70). Significantly more women in the misoprostol group experienced nausea (31.4% vs. 2.7%, P = 0.001), diarrhea (20.0% vs. 2.7%, P = 0.02), abdominal pain (22.9% vs. 5.4%, P = 0.03), menstrual-like cramping (42.9% vs. 2.7%, P < 0.001) and vaginal bleeding (11.4% vs. 0%, P = 0.03). ConclusionThe use of 400 µg oral misoprostol 12 hours prior to endometrial biopsy did not reduce procedural discomfort and was associated with more side effects than use of placebo. This finding was noted in all women as well as among subgroups of premenopausal and postmenopausal women.

Labor Induction with 25-μg Misoprostol Vaginal Capsules

Aim: To evaluate the success rate and the safety profile of labor induction with a new misoprostol formulation – vaginal capsules of 25 μg of misoprostol. Methods: Labor induction was performed in 250 singleton term pregnancies; 149 (59.6%) were nulliparous. Vaginal capsules of 25 μg of misoprostol were placed in the posterior vaginal fornix every 6 h. Success rate, contractility and fetal heart rate abnormalities and fetal outcomes were evaluated. Results: The success rate of labor induction was 97.6%. The average number of vaginal administrations was 1.5. The mean interval between induction and active labor was 10 h and 20 min and the average length of labor was 15 h and 35 min. The cesarean section rate was 18.8%. There were 15 cases of tachysystole, 3 cases of hypertonus and 1 case of hyperstimulation syndrome. There were no adverse neonatal outcomes. Conclusions: This study allowed to conclude that labor induction with vaginal capsules of 25 μg of misoprostol is associated with an excellent success rate and safety profile.

Effect of mifepristone on the corpus luteum in early pregnancy

The antiprogestin mifepristone is widely used for medical termination of pregnancy (TOP). Previous studies have suggested that the mechanism of mifepristone is based on its action in the endometrium and myometrium. The aim of this study was to evaluate the possible effects of mifepristone on corpus luteum activity. This was a prospective, longitudinal controlled study to which 20 patients undergoing medical TOP (study group) and 20 patients with normal ongoing pregnancy (control group) were recruited. Medical TOP was induced with 200 mg of mifepristone followed by 0.8 mg of misoprostol 2 days later. Three-dimensional ultrasound examinations and hormone assays (progesterone, human chorionic gonadotropin, and 17-hydroxyprogesterone) were performed in both groups on the day of, and 2 days after, administration of mifepristone. Total volume (vascularized + non-vascularized) of the dominant (containing corpus luteum) and non-dominant ovary and serum hormone levels were measured. After administration of mifepristone, a decrease in serum progesterone levels was observed with a simultaneous decrease in the non-vascularized volume of the dominant ovary in the study group. No such changes were observed in the control group. The observations indicate that, in addition to trophoblastic tissue, the corpus luteum is also the target of mifepristone.

Use of Misoprostol for Management of Unsatisfactory Colposcopy in the Adolescent: A Case Report and Review of the Literature

Study Objective To document the ability to use a prostaglandin analogue to achieve satisfactory colposcopy in a patient with cervical stenosis and unsatisfactory colposcopy. Design Case report. Results Satisfactory colposcopy was achieved by using 100 mg of Misoprostol orally, administered the night before the planned colposcopic evaluation. Conclusion In the presence of persistent atypia in an adolescent female with an unsatisfactory colposcopy, consider using a prostaglandin analogue for adequate evaluation of the endocervix, prior to proceeding with an ablative or excisional therapy.

Misoprostol priming prior to second trimester medical abortion

Misoprostol priming prior to second trimester medical abortion

The effect of oxytocin infusion and misoprostol on neonatal bilirubin levels

To investigate the association of neonatal bilirubin levels with oxytocin and misoprostol use for labour induction. A total of 100 neonates were included in the study. The first group consisted of 50 healthy babies of women who had received oxytocin infusion and the second group consisted of 50 healthy babies of women who had received 25μg misoprostol every 4h placed in the posterior fornix for labour induction. Bilirubin and haematocrit levels were measured in all on days 1 and 4 of the neonatal period. The levels of bilirubin in the oxytocin group were significantly higher than those in the misoprostol group on day 1 [4.42±0.27mg/dl versus 3.55±0.28mg/dl (P=0.035)] while they were higher also on day 4 but was not significantly so [7.47±0.63mg/dl versus 6.86±0.65mg/dl (P=0.525)]. The mean haematocrit levels on day 1 were 50.62±1.23 and 58.04±1.30 in groups 1 and 2, respectively, with a significant difference between them. The levels were 52.31±1.27 and 58.96±1.14 on day 4 and the difference was again significant. P<0.05 indicated statistical significance. Labour induction with misoprostol and oxytocin does not seem to have harmful effects on bilirubin levels in the neonate.

Assessing the global availability of misoprostol

Objective To assess the worldwide availability of misoprostol. Documenting the extent of misoprostol use in obstetrics-gynecology is difficult because the drug typically is unregistered for such indications. Methods Data for 2002–2007 on annual sales (measured in weight) to hospitals and retail pharmacies, plus manufacturer prices per 200-µg misoprostol, were analyzed for medications containing misoprostol alone or combined with a nonsteroidal anti-inflammatory drug (NSAID); regional and country-specific trends were identified. Consumer prices per pill are documented for all formulations of registered medications. Results Of the misoprostol sold worldwide, 70% was misoprostol-NSAID-combination drugs; of this, 91% was sold in North America and Western Europe. Asia sold the most misoprostol-only drugs; sales increased dramatically in Bangladesh (by 128%) and India (646%), where various low-price brands are sold. Misoprostol sales decreased in Latin America but increased in the Middle East-North Africa and Sub-Saharan Africa; these regions generally had low amounts sold per population. Conclusion Availability is improving in some low-income regions where misoprostol could significantly reduce maternal deaths due to postpartum hemorrhage and unsafe abortion.

Sublingual misoprostol 100 microgram versus 200 microgram for second trimester abortion: a randomised trial

Objectives To compare the efficacy of repeated doses of 100 μg vs. 200 μg misoprostol given sublingually for induction of second trimester abortion.Methods One hundred and sixty-two women at 15–22 weeks' gestation were randomized to receive every 2 h either 100 μg (group 1; n = 81) or 200 μg (group 2; n = 81) misoprostol sublingually. The primary outcome measure was the abortion rate within 24 h. The secondary outcome measures were the induction-abortion interval, the total misoprostol dose required, and side effects of the regimen.Results There was no significant difference between the two groups with regard to the abortion rates within 12 h (43.2% in group 1 vs. 48.1% in group 2; p = 0.52; relative risk [RR]: 0.81; 95% confidence interval [CI]: 0.4–1.5) and 24 h (92.6% in group 1 vs. 91.4% in group 2; p = 0.77; RR: 1.11; 95% CI: 0.37–3.6). The induction-abortion intervals in the two groups were of similar length (885 minutes in group 1 vs. 912 minutes in group 2; p = 0.72). When the total dose of misoprostol was compared between the two groups, women belonging to group 2 on average had received significantly more misoprostol than those in group 1 (1274 ± 592 μg [7 ± 3 doses] vs. 614 ± 432 μg [6 ± 4 doses], respectively; p = 0.000).Conclusions Sublingual administration of repeated doses of 100 μg misoprostol for abortion induction appears to be equally effective to that of repeated doses of 200 μg.

Pre-induction cervical ripening with 25 μg and 50 μg vaginal misoprostol in 181 nulliparous parturients

Objective. To evaluate the effect of intravaginally misoprostol at start dosages of 25 μg and 50 μg when used for pre-induction cervical ripening among nulliparous parturients.Methods. Our observational study involves all cases of partus induction consecutively registered in a Norwegian hospital between September 2002 and August 2006, with the following inclusion criteriae: nulliparous, singleton pregnancies ≥37 weeks, an unfavourable cervix (Bishop score ≤6), viable fetus >2499 g, received misoprostol vaginally every 6 h upto four times. Seventy-six women started with 25 μg (25 μg-group) and 105 started with 50 μg (50 μg-group). All continued with 25 μg. Primary outcome was vaginal delivery within 48 h after the first misoprostol dose. Secondary outcome was caesarean section performed within 96.Results. Vaginal delivery within 48 h after the initial dose occurred more often in the 25 μg-group than in the 50 μg-group (75 vs. 58%, p = 0.018). The rate of caesarean section was lower in the 25 μg-group than in the 50 μg-group (19 vs. 33%, p = 0.043). These differences remained significant after adjusting for confounders.Conclusion. Our findings support the notion that the dose of 25 μg misoprostol is as at least as efficient as 50 μg in nulliparous parturients.

Increasing women's choices in medical abortion: A study of misoprostol 400 μg swallowed immediately or held sublingually following 200 mg mifepristone

Objectives To assess the efficacy and acceptability of two misoprostol regimens (400 μg oral or sublingual) following mifepristone for medical abortion.Methods Women seeking abortion with gestations of 56 days or less since onset of their last menstrual period were offered medical abortion as an alternative to a surgical procedure. A total of 207 eligible and consenting women were given mifepristone (200 mg oral) and the option of taking 400 μg misoprostol either orally or sublingually two days later, with the option of home-use. Two weeks later, treatment success, satisfaction, and the frequency and acceptability of side effects were assessed.Results Most women (97.6%) opted for home use of misoprostol and almost three quarters selected the oral route. Overall efficacy, acceptability of side effects and satisfaction were high in both groups. The success rate was lower after sublingual than after oral administration but not significantly so (91.3% vs. 96.3%, p = 0.23, RR: 0.93, 95% CI = 0.85–1.02). The frequency and average duration of side effects in both groups were comparable except for pain/cramps and fever/chills, which were more frequently associated with the sublingual route.Conclusions This study re-emphasises the feasibility of integrating medical abortion into health services in Turkey and the potential to increase choices for women.

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.

Comparison of two doses and two routes of administration of misoprostol after pre-treatment with mifepristone for early pregnancy termination

BackgroundIt is not known whether a 400 μg dose of misoprostol has a similar efficacy as an 800 μg dose when administered sublingually or vaginally 24 hours after 200 mg mifepristone.MethodsIt is proposed to undertake a placebo-controlled, randomized, non-inferiority trial (3% margin of equivalence) of the two misoprostol doses when administered sublingually or vaginally using factorial design. A total of 3008 pregnant women (< 63 days of gestational age) who request legal termination of pregnancy will be recruited for the trial at 16 clinics in ten countries providing abortion services. Eligible women willing to join the study will be allocated randomly to one of the four treatment groups within each centre. Women in all treatment groups will first receive 200 mg mifepristone, followed 24 hours later by either 400 μg or 800 μg misoprostol, administered either sublingually or vaginally. The dose and route of administration of misoprostol will be blinded to women, each woman receiving four tablets vaginally and four tablets sublingually, two or four of which are 200 μg tablets of misoprostol and the rest are placebo tablets.The four treatment regimens will be compared in terms of: (i) their efficacy to induce complete abortion; (ii) induction-to-abortion interval when possible; (iii) the frequency of side effects; and (iv) women's perceptions. The initial judgment of the outcome of treatment is made at the follow-up visit on day 15 of the study and the final assessment four weeks later. It is estimated that the clinical phase will require 12–14 months for data collection.To compare the two routes and two doses, relative risks (RR) of failure to achieve a complete abortion and failure to terminate pregnancy and the two-sided 95% CIs will be calculated by standard methods, as well as risk differences and two-sided 95% CIs. The latter will be used to test the non-inferiority hypotheses (at 2.5% level of significance) for achieving complete abortion. The factorial structure will be taken into account in the analysis after testing the interaction.Trial registrationISRCTN87811512

Medical treatment with misoprostol for early failure of pregnancies after assisted reproductive technology: a promising treatment option

To assess the success rate of misoprostol to induce abortion in early pregnancy failure and to define the factors associated with success of treatment. Prospective study. University-affiliated tertiary medical center. Two hundred twenty women with the diagnosis of blighted ovum or missed abortion with a crown-rump length (CRL) up to 25 mm (<9 w). Treatment protocol included two doses of 800 microg misoprostol given vaginally and orally in intervals of 24 to 72 hours. Failure was defined as surgical intervention because of retained gestational sac, severe pain or bleeding, or suspected retained products of gestation after menstruation. The treatment was successful in 77.2% (170/220) of the patients. Success rate was 72.5% (121/167) for pregnancies achieved spontaneously and 92.4% (49/53) among women who conceived after assisted reproductive technology (relative risk = 3.65: 95% confidence interval 1.378 to 9.667). Multivariate analysis showed that the risk of failure of medical abortion increased significantly for patients who had had at least five previous pregnancies (of them, three or more abortions) as compared with patients with one or two previous pregnancies only, and for those who conceived spontaneously as compared with pregnancies after ovulation induction. Medical treatment in early missed abortion is recommended especially for women with low gravidity and for those who conceived after assisted reproductive technology.

Efficacy of simultaneous use of mifepristone and misoprostol for early abortion

For early medical abortion, the most widely accepted regimens involve oral mifepristone in either a 200or 600mg dose, followed 2 days later by misoprostol. A recent study has reported that the rate of complete expulsion with medical abortion remains unchanged even if the interval between administration of mifepristone and misoprostol decreased to between 6 and 8 hours [1]. Other research has revealed a high rate of complete abortion when the 2 drugs are used concurrently [2−4]. The aim of this study was to determine the complete abortion rate with concurrent use of mifepristone and vaginal misoprostol. The study received approval from the Institutional Review Board and written informed consent was obtained from all participants. Successful abortion was defined as complete medical abortion without surgical intervention. From November 2005 to October 2007, a total of 144 pregnant women underwent medical abortion. All eligible women had an intrauterine pregnancy at 49 days of gestation or less confirmed by vaginal ultrasound. The method used was oral administration of 200 mg mifepristone (Apano; Lotus Pharmaceutical Co., Taipei, Taiwan) and immediate intravaginal placement of 600 μg misoprostol (Cytotec; Pfizer, New York, NY, USA). Participants returned 3 days after administration of the combination. After being questioned regarding side effects, vaginal ultrasound was performed. All participants were scheduled for a second follow-up visit on day 14 after the

Early termination of pregnancy by single-dose 800 μg misoprostol compared with surgical evacuation

To assess the efficacy, safety, and acceptability of early termination of pregnancy by vaginal administration of a single dose of misoprostol. Healthy women seeking abortion in an institutional research environment in a tertiary-care hospital. Prospective randomized controlled clinical trial. One hundred forty women seeking termination of pregnancy up to 49 days' gestational age were alternatively assigned to undergo medical or suction termination. Saline-soaked prostaglandin E(1) analogue, misoprostol (800 microg), was administered vaginally in group I, and group II underwent suction evacuation. Transvaginal sonography was performed on two subsequent visits to assess outcome. Efficacy, side effects, complications, and acceptability were assessed in both groups. Complete abortion rate between the misoprostol and the surgical group was 94.2% versus 95.5%, respectively. Side effects were fewer in the misoprostol group and it had a higher acceptability rate. Single dose of vaginal misoprostol alone has a success rate comparable with surgical method for termination of early pregnancy. Side effects were fewer in women who received misoprostol, and the method was well accepted.

Comparison of four regimens of misoprostol after methotrexate for early abortion

⁎ Corresponding author. 1013-750 West Broadway, Vancouver, BC, Canada. Tel.: +1 604 709 5611; fax: +1 604 873 8304. E-mail address: ewiebe@interchange.ubc.ca (E. Wiebe). following methotrexate must be used. A review of studies using regimens of methotrexate followed by misoprostol or misoprostol alone found that failure rates were lower with the combined regimens [1]. The major disadvantage of methotrexate compared with mifepristone regimens is the slower speed of action. [2]. A study of misoprostol-only regimens found that the highest success rates were obtained using 800 μg misoprostol within 24 h [3]. The present study was a retrospective sequential cohort comparison trial of abortions induced in women with a pregnancy of 49 days of gestation or less, documented by endovaginal ultrasound. All women were treated similarly, with 50 mg/m2 methotrexate (Novopharm, Toronto, Canada) followed 1–5 days later by vaginal misoprostol (Apotex, Weston, Canada). Four groups of different doses of misoprostol were established: Group 1 with 800 μg once; Group 2 with 600 μg 3 times 24 h apart; Group 3 with 600 μg 3 times in 24 h (4–12 h apart); and Group 4 with 800 μg 3 times in 24 h seroprevalence. It is hoped that further expansion of TOP services in South Africa will effect a sustained reduction in maternal deaths related to septic abortion. References

Selection of Appropriate Prostaglandin for the Induction of Labor at Term is More Predictive for the Achievement of Delivery within 24 Hours than Pre-assessed Cervical Parameters - A Prospective, Randomized Trial

Objective: To compare the efficacy of vaginal misoprostol and dinoprostone gel for induction of labor at term and to evaluate the predictive value of pre-assessed Bishop score and sonographic estimated cervical length. Methods: One hundred and seven patients were prospectively randomized to receive either 50 µg misoprostol vaginally every 12 hours, or 2 mg of dinoprostone gel for nulliparae with an unfavorable cervix. 1 mg was given in case of multiparity or nulliparity with a Bishop score of > 5, according to the RCOG guidelines. Primary outcome was the achievement of vaginal delivery within 24 hours. Secondary outcome parameters included the induction to delivery interval, mode of delivery, drug related side effects, and the predictive value of the Bishop score and sonographic estimated cervical length. Results: The probability of delivering within 24 hours was more than threefold higher with misoprostol than with dinoprostone: odds ratio [OR]: 3.23; 95 percent confidence interval [CI]: 1.14 - 9.16, p: 0.03. In contrast, predictive values of both cervical parameters for delivery within 24 hours were not significant (Bishop score: [OR]: 1.28; [CI: 0.92 - 1.77], p: 0.14, cervical length: [OR]: 0.98; [CI: 0.92 - 1.03], p: 0.40). No difference was observed in the induction to delivery interval between both groups, and no correlation between cervical parameters and induction to delivery interval. Conclusion: Vaginal misoprostol is an effective, safe and cost-effective alternative to dinoprostone for cervical ripening and labor induction. The preinduced assessed cervical parameters showed poor predictive values for estimation of delivery within 24 hours and no correlation with the induction to delivery interval.

Mifepristone and misoprostol versus Dilapan and sulprostone for second trimester termination of pregnancy

Objective. To compare two methods for second trimester termination of pregnancy: mifepristone and misoprostol versus Dilapan® and sulprostone.Methods. This was a randomized study involving 16 patients with a singleton live fetus with congenital malformations or genetic disorders. Eight patients were treated with 200 mg mifepristone orally followed by 200 μg misoprostol vaginally 3 hourly and eight patients received a sulprostone infusion after cervical dilatation with Dilapan.Results. Mifepristone and misoprostol had a mean induction interval of 17.8 hours and sulprostone and Dilapan 20.9 hours. The mean induction interval did not differ significantly. Mean hospital stay was shorter in the patients treated with misoprostol: 2.1 vs. 3.3 days (p = 0.02) with a 95% confidence interval of −2.1 to 0.3.Conclusion. Mifepristone and misoprostol did not reduce the induction interval significantly compared to the sulprostone and Dilapan treatment for second trimester pregnancy termination. Hospital admission was significantly shorter in patients treated with mifepristone and misoprostol.

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