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PubMed2002

Early intrauterine pregnancy failure: a randomized trial of medical versus surgical treatment.

OBJECTIVE: The purpose of this study was to determine whether medical treatment of early pregnancy failure represents a reasonable alternative to surgical therapy. STUDY DESIGN: Patients who were diagnosed with pregnancy failure before 12 weeks of gestation were randomly assigned to receive either medical (intravaginal misoprostol) or surgical therapy (dilatation and curettage). In the medical arm of the study, 800 microg of misoprostol was placed within the posterior vaginal fornix. Patients subsequently were seen 24 and 48 hours after the initial dosing; intravaginal misoprostol was readministered only if ultrasound images revealed evidence of persistent pregnancy tissue. By 72 hours after initial study entry, if either a gestational sac or placental tissue was present, the medical treatment was considered a failure, and uterine curettage was performed. Statistical analysis was performed with the two-tailed unpaired t test, chi(2) analysis, Fisher exact test, and Mann-Whitney U test; a probability value of <.05 was considered statistically significant. RESULTS: A total of 50 women were enrolled, with 2 patients in the surgical arm experiencing spontaneous pregnancy loss before their scheduled procedures. Twenty-five women received medical therapy; 25 women were randomized to surgical procedure. Fifteen patients in the medical group (60%; 95% CI, 0.41-0.79) had successful pregnancy termination and did not require curettage. There were no significant differences between the medical and surgical groups with respect to either posttreatment hematocrit level or the time needed to achieve negative human chorionic gonadotropin test results. CONCLUSION: Intravaginal misoprostol is an effective agent for the treatment of early pregnancy failure. Medical treatment of early pregnancy failure represents a reasonable alternative to immediate surgical therapy.

Abortifacient Agents, Nonsteroidal↗
PubMed2003

Dinoprostone versus misoprostol: a randomized study of nulliparous women undergoing induction of labor.

BACKGROUND: The objectives of the study were to compare the efficacy and safety of intravaginal misoprostol and intravaginal dinoprostone for induction of labor and to quantify the clinical response to suspicious cardiotocographic (CTG) readings. METHODS: One hundred and ninety-one patients were randomized to receive either 50 micro g misoprostol initially then a further identical dose 6 h later or 2 mg dinoprostone initially followed by 1 mg 6 h later, over a period of 24 h. If not in labor after 24 h, then both arms of the study would thereafter receive dinoprostone alone as per hospital protocol. RESULTS: The induction to delivery interval (1047 vs. 1355 min, p = 0.01), delivery within 12 h (35.4% vs. 18.9%, p = 0.02) and delivery within 24 h (83.3% vs. 63.3%, p = 0.01) were all shorter in the misoprostol arm. There were no differences in rates of oxytocin augmentation (p = 0.47), tachysystole (p = 0.32) and hyperstimulation syndrome (p = 0.82). There was an increase in the median number of times a doctor was called to advise on a suspicious CTG in the misoprostol group (1 vs. 2 occasions, p = 0.052), but there was no difference in neonatal outcome. CONCLUSIONS: Intravaginal misoprostol led to a shorter, more efficient labor, and although there was more anxiety related to the CTG, there was no increase in neonatal adverse effects.

Administration, Intravaginal↗
PubMed1990

Pre-induction cervical ripening with prostaglandin E2 gel: intracervical versus intravaginal route.

The aim of our study was to evaluate the best method for cervical ripening before a classical induction with amniotomy and oxytocin. One hundred term pregnant patients who presented an unfavorable cervix and an indication for the induction of labor were assigned randomly to either 0.5 mg prostaglandin (PG) E2 gel intracervically (N = 52) or 3 mg PGE2 gel intravaginally (N = 48). The intravaginal gel had a greater effect on cervical ripening according to a modification of the Bishop score than did intracervical gel, but it had a higher incidence of side effects.

Administration, Intravaginal↗
PubMed2006

Clinical study comparing probiotic Lactobacillus GR-1 and RC-14 with metronidazole vaginal gel to treat symptomatic bacterial vaginosis.

Bacterial vaginosis (BV) is particularly common in black women, and in Nigeria it is often caused by Mycoplasma, as well as Atopobium, Prevotella and Gardnerella sp. Antimicrobial metronidazole oral therapy is poorly effective in eradicating the condition and restoring the Lactobacillus microbiota in the vagina. In this study, 40 women diagnosed with BV by discharge, fishy odor, sialidase positive test and Nugent Gram stain scoring, were randomized to receive either two dried capsules containing Lactobacillus rhamnosus GR-1 and Lactobacillus reuteri RC-14 each night for 5 days, or 0.75% metronidazole gel, applied vaginally twice a day (in the morning and evening). Follow-up at day 6, 15 and 30 showed cure of BV in significantly more probiotic treated subjects (16, 17 and 18/20, respectively) compared to metronidazole treatment (9, 9 and 11/20: P=0.016 at day 6, P=0.002 at day 15 and P=0.056 at day 30). This is the first report of an effective (90%) cure of BV using probiotic lactobacilli. Given the correlation between BV and HIV, and the high risk of the latter in Nigeria, intravaginal use of lactobacilli could provide women with a self-use therapy, similar to over-the-counter anti-yeast medication, for treatment of urogenital infections.

Administration, Intravaginal↗
PubMed2005

Phase I safety study of Praneem polyherbal vaginal tablet use among HIV-uninfected women in Pune, India.

Praneem polyherbal formulations containing purified extracts of Azadirachta indica (neem tree) have shown activity against HIV and sexually transmitted disease pathogens in studies in vitro. The product also has contraceptive properties. This has prompted its development as a possible microbicide. We evaluated the safety of Praneem polyherbal tablet use among HIV-uninfected women. Twenty eligible women were enrolled in a Phase I open-label study requiring 14 days of consecutive intravaginal use of Praneem polyherbal tablets. Nine (45%) participants experienced 17 episodes of genital irritation. Transient genital itching was reported by eight (40%) participants, burning micturation by two (10%) and lower abdominal pain, genital burning and intermenstrual spotting by one (5%) each. On colposcopy, petechial haemorrhage was observed in two participants, one on day 7 and the other on day 14, and both were resolved without any treatment. There were no serious adverse events. Praneem polyherbal tablets were found to be safe for once daily intravaginal use for 14 consecutive days in sexually active HIV-uninfected women and a Phase II study may be taken up as a priority.

Administration, Intravaginal↗
PubMed2001

Vaginal misoprostol for induction of labor: 25 vs. 50 microg dose regimen.

OBJECTIVE: To compare the efficacy and safety of two regimens of vaginal misoprostol for induction of labor. METHOD: In a randomized study, 185 women undergoing induction of labor were allocated to Group A (n=93), to be given 25 microg misoprostol and Group B (n=92), to be given 50 microg misoprostol. Intravaginal misoprostol was given every 4 h until the onset of labor. A maximum of six doses was administered. RESULTS: Abnormal uterine contractions were more common in Group B compared to Group A: 33 (35.86%) vs. 10 (10.75%) cases, and significantly more women in Group B required tocolysis (9.78 vs. 3.23%). The induction-delivery interval (mean+/-S.D.) was 17.18+/-8.48 h in Group A and 9.37+/-5.87 h in Group B (P<0.05). Oxytocin infusion was used in 37.63% of women in Group A and 26.08% in Group B (P>0.05). The cesarean section rate was 17.20% in Group A and 14.13% in Group B (P>0.05). Cesarean for failed IOL was more common in Group A: 7 of 16 (43.8%) vs. 3 of 13 (23.1%) cesarean deliveries (P<0.05). Postpartum hemorrhage occurred in 9.78% of women in Group B compared to 2.15% in Group A (P<0.05). There was a trend for more neonatal complications in Group B, but this did not reach significance. CONCLUSIONS: Although a dose of 50 microg of misoprostol results in a significantly shorter induction-delivery interval with less need for labor augmentation, there was an increased risk of uterine contractile abnormalities and postpartum hemorrhage. A regime using 25 microg of misoprostol every 4 h can induce labor safely and effectively.

Administration, Intravaginal↗
PubMed1980

Two-stage carcinogenesis in NMRI mice: intravaginal application of 7,12-dimethylbenz[a]anthracene as initiator followed by the phorbol ester 12-O-tetradecanoylphorbol-13-acetate as promoter.

In this study a new modification of the systemic 2-stage carcinogenesis experiment is described. Tumors were induced in NMRI-mice using a single intravaginal application of the carcinogen 7,12-dimethylbenz[a]anthracene (DMBA) (initiator) followed by intravaginal treatment with 12-O-tetradecanoylphorbol-13-acetate (TPA) (promotor) as a cocarcinogen over a period of 52 weeks. The substances were applied using small tampons. Development of preneoplastic lesions or neoplasias was not found in the group of untreated control animals (n = 50) and in TPA treated animals (n = 50). However, mice which had been treated with TPA alone showed pronounced hyperplasia. When DMBA was applied without subsequent treatment with TPA (n = 100), formation of preneoplastic lesions was frequently observed. Fibroepitheliomas (papillomas), carcinomas and sarcomas, typically located intravaginally and at the external region of the vagina, were observed after the combined treatment with DMBA and TPA (n = 100). In addition, benign as well as malignant tumors were found, mainly in the forestomach, in DMBA treated animals and more frequently after application of DMBA and TPA. Tumors of the lung and leukemias were identified more frequently in comparison to the normal spontaneous tumor rate in NMRI mice, and were probably in part caused by the promoting substance TPA. On the other hand, no significant tumor formation in the mammary gland and in the ovaries was observed after DMBA/TPA application. The tumors observed in these organs were, however, caused by treatment with the carcinogen DMBA only. This new modification of the 2-stage experiment, i.e. the direct intravaginal application of initiating and promoting substances, has special relevance for the elucidation of the mechanisms involved in the development of carcinomas located at the portio vaginalis uteri in humans.

9,10-Dimethyl-1,2-benzanthracene↗
PubMed2005

Effect of a CIDR insert and flunixin meglumine, administered at the time of embryo transfer, on pregnancy rate and resynchronization of estrus in beef cattle.

The objectives of this study were to evaluate the effects of flunixin meglumine (FM), an inhibitor of PGF(2alpha) synthesis, and insertion of an intravaginal progesterone-releasing device (CIDR), on pregnancy rates in beef cattle embryo transfer (ET) recipients, and to examine the effect of a CIDR after embryo transfer on the synchrony of the return to estrus in non-pregnant recipients. Cows (n=622) and heifers (n=90) at three locations were assigned randomly to one of four groups in a 2x2 factorial arrangement of treatments with FM administration (500 mg i.m.) 2-12 min prior to ET, and insertion of a CIDR (1.38 g progesterone) immediately following ET as main effects. Fresh or frozen embryos (Stage=4 or 5; Grade=1 or 2) were transferred on Days 6-9 of the estrous cycle and CIDR devices were removed 13 days after ET. Recipients at Location 2 only were observed for signs of return to estrus. Recipients that returned to estrus at Location 2 were either bred by AI or received an embryo 7 days after estrus. Following the initial ET, there was an FMxlocation interaction on pregnancy rate (P<0.01; Location 1, 89% versus 57%; Location 2, 69% versus 64%; Location 3, 64% versus 67% for FM versus no FM, respectively). Pregnancy rates of embryo recipients were not affected by CIDR administration (P>0.05; 65% with CIDR, 70% without CIDR), however, the timing of the return to estrus was more synchronous (P<0.01) for recipients given a CIDR. Pregnancy rate of recipients bred following a return to estrus did not differ between cows receiving or not receiving a CIDR for resynchronization (P>0.13). Effects of FM on pregnancy rate were location dependent and CIDR insertion at ET improved synchrony of the return to estrus.

Administration, Intravaginal↗
PubMed2001

Suppository-mediated DNA immunization induces mucosal immunity against bovine herpesvirus-1 in cattle.

Mucosal surfaces are the primary sites for the transmission of infectious agents including viruses, so effective vaccines generally should induce mucosal immunity. Furthermore, noninvasive delivery is desirable because of the ease of application, the high degree of patient compliance, and the improved safety for patients and clinicians due to the elimination of needles. Unfortunately, most of the conventional vaccines are parenterally administered and result in systemic rather than mucosal immunity. Here we present the first report of mucosal immunity by noninvasive DNA immunization in a target species. As an approach to induce mucosal immunity against bovine herpesvirus-1, cows were immunized intravaginally with suppositories containing plasmid coding for glycoprotein D. Serum IgG, as well as IgA both in the serum and in the nasal fluids, were detected, which supports the contention of a common mucosal immune system. This level of immunity was of sufficient magnitude to minimize weight loss and significantly reduce the duration of virus shedding after intranasal viral challenge, which demonstrates the efficacy of suppository-based administration of DNA vaccines to target species. As this is a very practical method of delivery, it has great potential to be applied as vaccine or therapy in a variety of species.

Administration, Intravaginal↗
PubMed1995

Review of the endometrial safety during intravaginal treatment with estriol.

To gain more insight into whether intravaginal treatment of local urogenital complaints with the mild-acting oestrogen estriol is capable of inducing proliferation of the endometrium, the results of the clinical studies that have been published over the years have been pooled. Of a total of 19 studies that initially had been selected, four were excluded from the analysis because no baseline biopsies were available, two because endometriae had been evaluated using methods other than with histology, and one study because a sustained-release preparation was used. Pooling of 12 studies (214 subjects) revealed a reasonable amount of long-term data on intravaginal estriol treatment with 61 evaluable biopsies after 6 months and 58 after 12 months. In addition, 13 biopsies were available after 2 years. It appeared that intravaginal estriol treatment using the recommended dosages did not result in endometrial proliferation. All 337 post-baseline biopsies that have been reported in the literature were classified as atrophic. It can be concluded that single daily treatment with intravaginal estriol in the recommended doses in postmenopausal women is safe and without an increased risk of endometrial proliferation or hyperplasia. Consequently, there is no need to add sequential progestogens with these preparations and no withdrawal bleedings will be induced.

Administration, Intravaginal↗
PubMed2004

Comparison of four synchronization protocols for fixed-time bovine embryo transfer in Bos indicus x Bos taurus recipients.

The objective was to evaluate the effects of 400 IU of eCG given on Days 5 or 8 of an estrus synchronization protocol with progesterone-releasing intravaginal devices (PRID) and estradiol benzoate (EB), in recipients for fixed-time embryo transfer. A secondary objective was to determine the effects of injectable progesterone (given concurrent with EB treatment). Three-hundred-and-four crossbred Bos taurus x Bos indicus beef heifers were randomly assigned to one of four treatment groups (2 x 2 factorial design). At unknown stages of the estrous cycle (Day 0), all heifers received a progesterone-releasing intravaginal device (PRID), plus 2mg of EB i.m., with or without a concurrent treatment of 50mg of progesterone i.m. Heifers were further subdivided to receive 0.15 mg of d-cloprostenol (PGF) i.m. and 400 IU of eCG i.m. on Days 5 or 8. In all heifers, intravaginal devices were removed on Day 8 and 1mg of EB was given i.m. on Day 9 (Day 10 was arbitrarily considered the day of estrus). On Day 17, all heifers with >1 CL or a single CL with a diameter > or =18 mm (based on ultrasonographic examination), received an in vitro produced (IVP) embryo by non-surgical transfer. On Day 17, there was an effect of day of eCG administration on the number of CL (1.35 +/- 0.08 versus 1.13 +/- 0.04, for Day 5 versus Day 8, respectively; P = 0.02) and (in a subset of 154 heifers) mean (+/-S.E.M.) plasma progesterone concentrations (2.41 +/- 0.26 versus 1.74 +/- 0.19 ng/mL; P = 0.03). Although the proportion of recipients transferred/treated and pregnant/transferred did not differ among groups, the proportion of recipients pregnant/treated tended (P = 0.1) to be higher in heifers treated with eCG on Day 5 versus Day 8 (47.0% versus 40.7%, respectively). Progesterone treatment had no significant effect. In conclusion, treatment with eCG (and D-cloprostenol) on Day 5 significantly increased the number of CL and plasma progesterone concentrations and tended to increase pregnancy rates, although progesterone treatment had no significant effect.

Administration, Intravaginal↗
PubMed2006

Dendritic cell-mediated induction of mucosal cytotoxic responses following intravaginal immunization with the nontoxic B subunit of cholera toxin.

The use of the nontoxic B subunit of cholera toxin (CTB) as mucosal adjuvant and carrier-delivery system for inducing secretory Ab responses has been documented previously with different soluble Ags. In this study, we have evaluated this approach for inducing CTL responses against a prototype Ag, OVA, in the female genital mucosa. We report here the ability of an immunogen comprised of CTB conjugated to OVA (CTB-OVA) given by intravaginal (ivag) route to induce genital OVA-specific CTLs in mice. Using adoptive transfer models, we demonstrate that ivag application of CTB-OVA activates OVA-specific IFN-gamma-producing CD4 and CD8 T cells in draining lymph nodes (DLN). Moreover, ivag CTB induces an expansion of IFN-gamma-secreting CD8+ T cells in DLN and genital mucosa and promotes Ab responses to OVA. In contrast, ivag administration of OVA alone or coadministered with CTB failed to induce such responses. Importantly, we demonstrate that ivag CTB-OVA generates OVA-specific CTLs in DLN and the genital mucosa. Furthermore, genital CD11b+ CD11c+ dendritic cells (DCs), but not CD8+ CD11c+ or CD11c- APCs, present MHC class I epitopes acquired after ivag CTB-OVA, suggesting a critical role of this DC subset in the priming of genital CTLs. Inhibition studies indicate that the presentation of OVA MHC class I epitopes by DCs conditioned with CTB-OVA involves a proteasome-dependent and chloroquine-sensitive mechanism. These results demonstrate that CTB is an efficient adjuvant-delivery system for DC-mediated induction of genital CTL responses and may have implications for the design of vaccines against sexually transmitted infections.

Administration, Intravaginal↗
PubMed1997

Efficacy of methotrexate and misoprostol for early abortion.

BACKGROUND: Medical termination of pregnancy (medical abortion) as an alternative to surgical abortion has many advantages since it does not require anesthetics and there is no risk of cervical laceration or uterine perforation. In the present study, we evaluated the efficacy of methotrexate and intravaginally administered misoprostol for early abortion. METHODS: The study population consisted of 32 women seeking abortion of a normal intrauterine pregnancy of 8 weeks or less documented by ultrasound. The dose of methotrexate was 50 mg/m2 intramuscularly and the dose of misoprostol was 800 micrograms intravaginally. The final outcome of treatment was evaluated on day 14 or 16, and an abortion was considered successful if pregnancy was terminated without a surgical procedure. RESULTS: Abortion occurred in only 23 (71.8%) of 32 women. There were 9 failures (28.1%); 3 were ongoing pregnancies (9.3%) and 6 were incomplete abortions (18.7%) requiring suction curettage. After the exclusion of treatment failures, the mean duration of vaginal bleeding was 16.3 +/- 2 days. No serious side effects occurred as a result of methotrexate and misoprostol treatment. CONCLUSION: The use of methotrexate and intravaginal misoprostol for the termination of pregnancy requires larger studies to determine the safety and efficacy of this medical abortion, a comparison with RU 486 in prospective controlled randomized trials is necessary.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

Trends in prescribing for vulvovaginal candidiasis in the United States.

PURPOSE: To describe trends in visits to office-based physicians in the United States by females 15-64 years of age for vulvovaginal candidiasis and related antifungal prescribing. Since January 1991, intravaginal antifungal medications have been available over-the-counter in the United States to treat vulvovaginal candidiasis. METHODS: Data from the 1985 through 2001 National Ambulatory Medical Care Surveys (NAMCS) were examined. NAMCS is an annual national probability sample survey that collects data on the utilization of services provided by office-based physicians. RESULTS: The average annual visit rates for symptoms of vaginitis and a diagnosis of vulvovaginal candidiasis decreased by 55 and 72%, respectively. The intravaginal antifungal prescribing rate for vulvovaginal candidiasis declined by 41%. No trend was found for total antifungal prescribing; however, during the late 1990s, fluconazole was prescribed at approximately one-third of visits with a diagnosis of vulvovaginal candidiasis. CONCLUSION: These data suggest an increased trend in self-diagnosis and use of over-the-counter intravaginal antifungal medications. The shift from prescribing intravaginal antifungal preparations to fluconazole raises concern about the possible development of azole drug resistance. Educational efforts are needed to counter potential misuse of these medications that may contribute to increased infection with innately azole resistant non-albicans Candida species and chronic infection.

Administration, Intravaginal↗
PubMed1995

Intravaginal clindamycin treatment for bacterial vaginosis: effects on preterm delivery and low birth weight.

OBJECTIVE: Our goal was to evaluate whether treatment of bacterial vaginosis during pregnancy with 2% clindamycin vaginal cream reduces the incidence of either preterm delivery or low birth weight or of both. STUDY DESIGN: A multicenter, double-blind, randomized, placebo-controlled trial in Indonesia compared a 2% clindamycin vaginal cream with a placebo cream. Women seeking prenatal care at 14 to 26 weeks of gestational age who had bacterial vaginosis (Gram stain score > 6 and pH of vaginal fluid > 4.5) were invited to participate. Of the 745 women enrolled, 681 (91.4%) women were followed up through delivery. RESULTS: Clindamycin vaginal cream was an effective treatment for bacterial vaginosis. Two weeks after completion of the treatment, 85.5% of the women were cured. The rate of preterm delivery (< 37 weeks) was 15.0% for clindamycin patients and 13.5% for placebo patients (odds ratio 1.1, 95% confidence interval 0.7 to 1.7). The rate of low birth weight was 9.0% for clindamycin patients and 6.8% for placebo patients (odds ratio 1.3, 95% confidence interval 0.8 to 2.4). CONCLUSIONS: Treatment of bacterial vaginosis with clindamycin vaginal cream did not reduce preterm delivery or low birth weight. Although clindamycin vaginal cream is an effective treatment for bacterial vaginosis, intravaginal treatment would not be effective against bacterial vaginosis-associated microorganisms harbored in the upper genital tract. Systemic treatment may be required to eradicate upper tract infection to reduce preterm delivery.

Administration, Intravaginal↗