Oral misoprostol and intracervical dinoprostone for cervical ripening and labor induction: a randomized comparison.
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Administration, Intravaginal↗
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Early abortion by mifepristone (RU 486) followed by vaginal gel (meteneprost) versus oral (misoprostol) prostaglandin.
The present study was conducted to compare the therapeutic regimens of low-dose mifepristone (200 mg) plus vaginal meteneprost versus oral misoprostol in terms of efficacy and safety for medical termination of early pregnancy. A randomized clinical trial was conducted by the Department of Obstetrics and Gynecology at the All India Institute of Medical Sciences, New Delhi. A total of 101 subjects were enrolled within 56 days of amenorrhea. A single dose of 200 mg of mifepristone (RU 486) was given and, 48 hr later, prostaglandin was administered as either 5 mg of 9 methylene PGE2 vaginal gel, meteneprost (classified as group I) or 600 microg of oral PGE1 derivative misoprostol (classified as group II). In group I, 50 subjects and in group II, 51 subjects were treated with the respective schedule. The success rate with mifepristone + misoprostol (group II) was 88.63% which was significantly higher than that with mifepristone + meteneprost (group I) which was 82% (p < 0.05). The average duration of bleeding in cases with complete abortion was 8.95+/-5.67 and 9.77+/-6.51 in group I and II, respectively. There were no serious side-effects. Only one subject in group I (2%) required blood transfusion for heavy bleeding. This study indicated that oral prostaglandin after a low dose of mifepristone (200 mg) could be developed into an effective method to terminate early pregnancy. Oral administration of both drugs would be a more convenient, feasible, private and acceptable regimen.
16,16-Dimethylprostaglandin E2↗
The development of evidence-based guidelines for over-the-counter treatment of vulvovaginal candidiasis.
OBJECTIVE: The purpose of this study was to develop evidence-based guidelines for over-the-counter (OTC) treatment of vulvovaginal candidiasis with non-prescription anti-fungal medicines purchased from community pharmacies. METHOD: A multidisciplinary guideline development group was recruited from the locality where the guidelines were to be tested. A Nominal Group Technique (NGT) was used to achieve formal consensus within the group regarding the issues that the guidelines would address. Guideline recommendations were developed from the results of two systematic literature reviews that assessed which symptoms were predictive of vulvovaginal candidiasis (using data from epidemiological studies) and estimated the relative effectiveness of oral and intra-vaginal anti-fungals using data from randomised controlled trials. MAIN OUTCOME MEASURES: Evidence-based guideline recommendations. The guideline statements were linked to the evidence using a standard hierarchy. RESULTS: The guideline development group met four times. The use of NGT was an effective way of achieving consensus on guideline content. Two systematic reviews carried out as part of the guideline development process identified evidence for the guidelines on the efficacy of OTC treatments and symptoms suggestive of vulvovaginal candidiasis. The guideline recommendations were presented as a booklet and a laminated algorithm. In summary, the guidelines highlighted symptoms suggestive of vulvovaginal candidiasis, and symptoms associated with other vaginal conditions that should be referred to the GP. The guidelines stated that oral treatment and intra-vaginal treatment are equally effective, and that selection of an anti-fungal should be based upon safety, cost and patient preference. Many of the recommendations were influenced by OTC license restrictions of each antifungal product. Contra-indications to, and special precautions with, antifungals were also listed. In addition, the guidelines stated that the male sexual partner does not require treatment unless symptomatic. CONCLUSION: There is sufficient evidence available to develop evidence-based guidelines for the treatment of vulvovaginal candidiasis in the community pharmacy setting. The NGT is a useful component in the guideline development process.
Administration, Intravaginal↗
Absorption and metabolism of nafarelin, a potent agonist of gonadotropin-releasing hormone.
Nafarelin, a potent gonadotropin-releasing hormone (GnRH) agonist, was absorbed rapidly into systemic circulation (time to reach peak concentration, 20 to 40 minutes) after intranasal but not after sublingual or vaginal administration. Serum elimination half-life was about 2 hours. Nasal absorption of nafarelin was increased by increasing the concentration of the drug in the dose solution and incorporating sodium glycocholate into the nasal formulation. An optimal formulation providing maximum nasal absorption of nafarelin was one containing 1.75 mg nafarelin per ml and 2% sodium glycocholate. Bioavailability of this nasal formulation relative to a single subcutaneous dose averaged 21%. The metabolism and excretion of nafarelin were determined in three subjects after subcutaneous administration of [14C]-nafarelin. Radioactivity was excreted in approximately equal amounts in urine and stool. Six metabolites accounted for most of the radioactivity in urine. Four metabolites were short peptide fragments of nafarelin and the other metabolites were naphthylalanine and 2-naphthylacetic acid.
Administration, Intranasal↗
Inhibiting sexual transmission of HIV-1 infection.
The worldwide infection rate for HIV-1 is estimated to be 14,000 per day, but only now, more than 20 years into the epidemic, are the immediate events between exposure to infectious virus and the establishment of infection becoming clear. Defining the mechanisms of HIV-1 transmission, the target cells involved and how the virus attaches to and fuses with these cells, could reveal ways to block the sexual spread of the virus. In this review, we will discuss how our increasing knowledge of the ways in which HIV-1 is transmitted is shaping the development of new, more sophisticated intervention strategies based on the application of vaginal or rectal microbicides.
Administration, Intravaginal↗
Factors affecting the outcome of early medical abortion: a review of 4132 consecutive cases.
OBJECTIVE: To assess the outcome of a regimen of a reduced dose of mifepristone followed by one or two doses of vaginal misoprostol as a non-surgical method for termination of pregnancy. DESIGN: Prospective observational study. SETTING: Aberdeen Royal Infirmary, Aberdeen, Scotland. POPULATION: Women seeking abortion under the 1967 Abortion Act. METHODS: Factors influencing the outcome in a consecutive series of 4132 women undergoing early medical abortion in one Scottish teaching hospital since 1994. MAIN OUTCOME MEASURES: Complete abortion rates following one or two doses of misoprostol. The effect of age, gestation, previous pregnancy and previous termination on complete abortion rates following the medical regimen. RESULTS: Of the 4132 women, 95 (2.3%) aborted within 48 hours of mifepristone and a further 3942 (95.4%) achieved complete abortion following administration of one or two doses of misoprostol. Thus, the overall complete abortion rate was 97.7% (4037/4131). A total of 94 (2.3%) women required surgical intervention of whom 13 (0.3%) had a continuing pregnancy. Following change of the regimen to include the possibility of two doses of misoprostol the continuing pregnancy rates were significantly reduced (OR = 5.88) and gestation ceased to have an effect on overall efficacy. Women who had a previous abortion were more likely to have a failed medical abortion (OR = 2.09), while women with no previous termination, but a previous live birth were more likely to have a failed abortion (OR = 2.03). CONCLUSION: Mifepristone in combination with one to two doses of vaginal misoprostol is an effective regimen for early medical abortion. The option of administering two doses of misoprostol significantly reduced the ongoing pregnancy rates and abolished the effect of gestation on overall efficacy. Previous termination was the strongest predictor of failed medical abortion.
Abortifacient Agents, Nonsteroidal↗
Mifepristone and misoprostol versus dilation and evacuation for midtrimester abortion: a pilot randomised controlled trial.
OBJECTIVE: To test the feasibility of mounting a randomised controlled trial comparing mifepristone-misoprostol versus dilation and evacuation (D&E) for midtrimester abortion. DESIGN: Pilot randomised controlled trial. SETTING: University of North Carolina Hospitals, Chapel Hill, North Carolina. POPULATION: Women aged 18 years or older and without prior uterine operations who requested abortion at 14-19 menstrual weeks of gestation from January 2002 to January 2003. METHODS: Participants received either mifepristone 200 mg by mouth followed in two days by vaginal then oral misoprostol (Aberdeen regimen) or D&E after one or two days of laminaria preparation. Care was provided by residents under faculty supervision. MAIN OUTCOME MEASURES: Enrolment rate and acceptability of and adverse events associated with methods. RESULTS: The trial was stopped at one year because of slow enrolment. Of 47 women eligible for the trial, 29 (62%) declined participation, primarily because of a preference for D&E abortion. Among the 18 participants enrolled, nine were randomised to treatment with mifepristone-misoprostol and 9 to D&E. Compared with D&E, mifepristone-misoprostol abortion caused more pain and adverse events, although none was serious. CONCLUSIONS: Our findings concerning acceptability and adverse events should be considered hypothesis-generating; they may prove useful in planning a larger randomised controlled trial. Such a trial will be difficult to mount in the US. Hence, we suggest that it be done in a setting where labour-induction abortion is the norm.
Abortifacient Agents↗
Oral misoprostol (100 microg) versus vaginal misoprostol (25 microg) in term labor induction: a randomized comparison.
OBJECTIVE: To compare the efficacy of vaginal misoprostol (25 microg) to oral misoprostol (100 microg) in labor induction at term. METHODS: One hundred and one women at term, with indications for labor induction and cervical Bishop's scores of less than 8, were randomly assigned to receive 100 microg of oral misoprostol or 25 microg vaginal misoprostol after random allocation. This could be repeated every 4 h to a maximum of five doses. The number delivering vaginally within 24 h of the induction was the main outcome measure. RESULTS: Of those who delivered vaginally (74.5% in the oral group vs. 72% in the vaginal group), significantly fewer women delivered within 24 h of induction in the oral group (42.1% vs. 72.2%, RR 0.6, 95% CI 0.4-0.9), with more women receiving more than one dose (45.7% vs. 16.7%, RR 2.7, 95% CI 1.2-6.0). More women in the oral group received oxytocin (68.6% vs. 44%, RR 1.6, 95% CI 1.1-2.2), and the induction to delivery interval was shorter in the vaginal group, although this was not statistically significant [28.9 h (SD 20.2) vs. 20.6 h (SD 16.1), mean difference - 8.3 h, 95% CI - 16.8 to 0.2]. There were no differences in the modes of delivery, uterine hyperstimulation rates or in the neonatal outcomes. CONCLUSION: Vaginal misoprostol in its currently recommended dose of 25 microg seems to be more efficacious than the 100 microg oral dose.
Administration, Intravaginal↗
Microbiological and pharmaco-toxicological profile of nifuratel and its favourable risk/benefit ratio for the treatment of vulvo-vaginal infections. A review.
Nifuratel (CAS 4936-47-4) is a furane-derivative provided with a strong trichomonicidal activity equivalent to that of metronidazole (CAS 443-48-1); it has a broad antibacterial spectrum of action, including both Gram-negative and Gram-positive organisms. It is active against Chlamydia trachomatis and Mycoplasma spp. and has also some degree of activity against Candida spp. and mycetes. Its broad spectrum of action, confirmed by in vitro and in vivo studies, covers virtually all the micro-organisms responsible for the infections of the genito-urinary tract. Nifuratel has a very safe toxicological profile. It is practically non-toxic in acute tests in mice and rats and is also well tolerated after repeated oral and intravaginal administrations. Nifuratel is devoid of teratogenic effects. The comparison among past and recent clinical studies confirms that, in contrast to metronidazole, no resistance phenomena to the treatment with nifuratel are reported. The drug can be used during pregnancy due to the absence of teratogenic effects. In conclusion, nifuratel shows a very favourable risk/benefit ratio for the treatment of patients with vulvo-vaginal infections.
Animals↗
[Measurement of skin thickness by high-frequency ultrasound to objectify the effects of hormone replacement therapy in the perimenopause].
AIM: The aim of this study was to show the influence of three different hormone replacement therapy regimes (HRT) by comparing the changes in skin thickness. METHOD: Skin thickness was measured using a high-frequency ultrasound system on the inner side of the left upper arm of perimenopausal women with a low oestradiol level (< 45 pg/ml). The patients were allocated to different groups: Group1 (n = 6) received oestradiol merely transdermally; Group 2 (n = 7) was given transdermal oestradiol as well as progesterone vaginally; Group 3 (n = 8) took oral oestradiol and vaginal progesterone; Group 4 (n = 3) served as the control group without therapy. RESULTS: The median value of skin thickness in all HRT-groups increased highly significantly (0.15 mm) after six months (0.91 mm before therapy versus 1.06 mm after six months of HRT), but there was no significant change in the control group. CONCLUSIONS: The study shows that HRT leads to an increase of skin thickness which can be demonstrated by a high-frequency ultrasound.
Administration, Cutaneous↗
Prolactin (PRL) response to oral or vaginal bromoergocriptine in hyperprolactinemic women.
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Administration, Intravaginal↗
Induction of abortion with mifepristone (RU 486) and oral or vaginal misoprostol.
BACKGROUND: Medical termination of pregnancy can be successfully performed with a combination of mifepristone (RU 486) and a prostaglandin analogue. We conducted a prospective, randomized trial to compare oral with vaginal administration of the prostaglandin E1 analogue misoprostol for first-trimester abortion in women treated initially with mifepristone. METHODS: The study population consisted of 270 women seeking abortion within 63 days after the onset of amenorrhea. The dose of mifepristone was 600 mg, and the dose of misoprostol was 800 micrograms. The study had two primary end points: expulsion of the conceptus without the need for a surgical procedure, and abortion within four hours after the administration of misoprostol. RESULTS: Expulsion of the conceptus without the need for a surgical procedure occurred in 95 percent of the women who received misoprostol vaginally and in 87 percent of those who received it orally (P = 0.03). The rate of continued pregnancy was 7 percent with the oral regimen and 1 percent with the vaginal regimen (P = 0.01). Ninety-three percent of the women receiving misoprostol vaginally had abortions within four hours, as compared with only 78 percent of the women receiving the drug orally (P < 0.001). Vomiting and diarrhea were reported more frequently by the women who received oral misoprostol than by those who received vaginal misoprostol (P = 0.04 and P = 0.002, respectively). CONCLUSIONS: After the administration of mifepristone, vaginal administration of misoprostol is more effective and better tolerated than oral administration for the induction of first-trimester abortion.
Abortion, Induced↗
Pregnancy failure and misoprostol--time for a change.
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Abortifacient Agents, Nonsteroidal↗
Oral versus vaginal misoprostol for induction of labor: a double-blind randomized controlled trial.
OBJECTIVE: To determine the efficacy of oral misoprostol (50 microg) administered every 3 hours compared to vaginal misoprostol (50 microg) administered every 6 hours for induction of labor. STUDY DESIGN: In this double-blind randomized trial, 126 women received misoprostol (50 microg) either orally every 3 hours or vaginally every 6 hours for induction of labor. Outcomes included time from induction to delivery, oxytocin augmentation, incidence of hyperstimulation and tachysystole, mode of delivery, and neonatal outcomes. RESULTS: Median time to delivery was shorter in those women who were receiving vaginal misoprostol (vaginal 14.3 hours vs oral 23.1 hours; P =.0004) and more women in the oral group required oxytocin augmentation of labor (73% vs 42%) (RR, 1.98; 95% CI, 1.29 to 3.06). The incidence of hyperstimulation was similar between the groups, but there was an increased incidence of tachysystole in the vaginal group (26.5% vs 9.7%)(RR, 2.74; 95% CI, 1.16 to 6.51). There was no difference between the groups with respect to mode of delivery or neonatal outcome. CONCLUSION: Vaginal misoprostol administered every 6 hours is more effective for induction of labor than oral misoprostol administered every 3 hours. The higher rates of tachysystole with use of vaginal misoprostol in the current study warrant further investigation.
Administration, Intravaginal↗
A comparison of various routes and dosages of misoprostol for cervical ripening and the induction of labor.
OBJECTIVE: The purpose of this study was to compare the efficacy of different routes of misoprostol administration for cervical ripening and the induction of labor. STUDY DESIGN: Three hundred thirty women at > or = 32 weeks gestation with a Bishop score < or = 6 and an indication for induction were randomized to 1 of 3 double-blinded groups: (1) 25 microg orally administered misoprostol plus 25 microg vaginally administered misoprostol, (2) orally administered placebo plus 25 microg vaginally administered misoprostol, or (3) 25 microg orally administered misoprostol plus vaginally administered placebo. Doses were repeated every 4 hours until onset of labor or a maximum of 12 doses were given. The primary outcome of the trial was vaginal delivery within 24 hours of the initiation of induction. Secondary outcomes were the time from induction to delivery, need for oxytocin augmentation, mode of delivery, frequency of side effects, and neonatal and maternal outcome. Analysis of variance, chi-square test, and logistic regression were used for analysis. RESULTS: There were no significant differences in maternal characteristics or indications for induction. The percentage of women who achieved vaginal delivery within 24 hours was highest in the vaginally administered misoprostol group: 67% compared with 53% in the oral-plus-vaginal group (P < .05) and 36% in the oral group (P < .05). The median time to vaginal delivery was shorter in the vaginal and oral-plus-vaginal misoprostol groups, 13.5 hours and 14.3 hours, respectively, when compared with 23.9 hours in the oral group (P < .05). The rate of cesarean delivery was lowest in the vaginal misoprostol group (17% compared with 30% in the oral-plus-vaginal group and 32% in the oral group; P < .05). Uterine tachysystole occurred least frequently in the oral misoprostol group (10% compared with 32% in the vaginal group and 34% in the oral-plus-vaginal group; P < .05). Uterine hyperstimulation also occurred least frequently in the oral misopro-stol group (4% compared with 15% in the vaginal group and 22% in the oral-plus-vaginal group; P < .05). CONCLUSION: At the doses studied, induction of labor with vaginally administered misoprostol is more efficacious than either oral-plus-vaginal or oral-only route of administration.
Administration, Intravaginal↗
A randomized controlled trial comparing two protocols for the use of misoprostol in midtrimester pregnancy termination.
OBJECTIVE: Our purpose was to compare the efficacy of oral misoprostol with that of vaginal misoprostol for midtrimester termination of pregnancy. STUDY DESIGN: Women seen for midtrimester pregnancy termination were randomly assigned to receive either misoprostol orally in a dose of 200 microg every hour for 3 hours followed by 400 microg every 4 hours or vaginally in a dose of 400 microg every 4 hours. The protocol was followed for 24 hours, after which time further management was at the discretion of the attending physician. The primary outcome measure was the induction-to-delivery interval. Sample size was calculated a priori. Statistical analysis was performed with the t test for continuous variables and the chi(2) test for categorical variables. P <.05 was considered significant. RESULTS: One hundred fourteen women were randomized, with 49 receiving vaginal misoprostol and 65 receiving oral misoprostol. The two groups were comparable with respect to maternal age, parity, indication for pregnancy termination, gestational age, and maternal weight. The mean induction-to-delivery interval was significantly shorter for the vaginal group (19.6 +/- 17.5 hours vs 34.5 +/- 28.2 hours, P <.01). Length of stay was also shorter in the vaginal group (32.3 +/- 17.3 hours vs 50.9 +/- 27.9 hours, P <.01). Significantly more patients in the vaginal group were delivered within 24 hours (85.1% vs 39.5%, P <.01), and more patients in the oral group required changes in the method of induction when they were undelivered after 24 hours (38.2% vs 7%, P <.01). The only complication was an increase in febrile morbidity in the vaginal group (25% vs 6.7%, P =.046). This did not result in an increased use of antibiotics, and all the fevers resolved post partum without further complications. CONCLUSIONS: Vaginal administration of misoprostol resulted in a shorter induction-to-delivery interval. The shorter length of stay should result in improved patient care.
Abortifacient Agents, Nonsteroidal↗
Oral misoprostol or vaginal dinoprostone for labor induction: a randomized controlled trial.
OBJECTIVE: The objective of the study was to compare the effectiveness, safety, and side effects of low-dose oral misoprostol with vaginal dinoprostone for cervical ripening and labor induction. STUDY DESIGN: Women with Bishop score 6 or less admitted for labor induction at term were eligible for this randomized controlled trial. Exclusion criteria were multiple pregnancy, breech, fetal distress, or previous uterine scar. The allocation to the oral misoprostol group (20 microg given every 2 hours increased to 40 microg depending on uterine contractions) or to the vaginal dinoprostone group (2 mg twice, 6 hours apart) was contained in a sealed, opaque, and consecutively numbered envelope. RESULTS: Two hundred women (100 in each group) were included. The proportion of vaginal delivery within 24 hours was 56% in the misoprostol group and 62% in the dinoprostone group (relative risk 0.90, 95% CI 0.72-1.14). The risk of cesarean section was 18% and 19%, respectively. The median interval to delivery, calculated from survival analysis, was longer in the misoprostol group (1305 minutes) compared with the dinoprostone group (1080 minutes). The log-rank test was not significant (P =.35). Uterine hyperstimulation occurred in 9% of women in the misoprostol group compared with 14% in the dinoprostone group (P =.27). The only significant difference in neonatal outcomes was a more frequent presence of thick meconium in the misoprostol group (P =.03). CONCLUSION: We found no difference in terms of effectiveness and safety between low-dose oral misoprostol and vaginal dinoprostone used for induction of labor. This regimen avoids the excessive uterine contractility noted in previous studies, where higher doses of misoprostol were administered at longer intervals.
Administration, Intravaginal↗
Mifepristone and misoprostol and methotrexate/misoprostol in clinical practice for abortion.
OBJECTIVE: The purpose of this study was to evaluate the efficacy, side-effect profile, and follow-up rates in women who obtain a medical abortion in a nonresearch setting. STUDY DESIGN: From December 1, 2000, to June 30, 2001, we prospectively followed 218 women who had been evaluated in our private office for medical abortion. Women received either mifepristone 200 mg orally followed 1 to 2 days later by self-administered misoprostol 800 microg vaginally or methotrexate 50 mg/m(2) intramuscularly followed 3 to 7 days later by self-administered misoprostol 800 microg vaginally. RESULTS: Of the 174 women who had a medical abortion, 148 women (85%) chose mifepristone/misoprostol, and 26 women (15%) chose methotrexate/misoprostol. In women up to 49 days of gestation, complete abortion occurred by the first follow-up visit in 82 of 86 women (95%; 95% CI, 89-99) and in 21 of 25 women (84%; 95% CI, 64-95) women, respectively. In women who used mifepristone/misoprostol from 50 to 63 days of gestation, complete abortions occurred in 56 of 59 women (95%; 95% CI, 86-99) women. Four women (2%; 95% CI, 1-6) were lost to follow-up. CONCLUSION: Medical abortion with mifepristone/misoprostol and with methotrexate/misoprostol can be provided in a nonresearch setting with efficacy similar to that reported in the medical literature for research protocols.
Abortifacient Agents, Nonsteroidal↗