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PubMed2005

Termination of pregnancy in patients with previous cesarean section.

OBJECTIVE: To evaluate the safety and efficacy of termination of pregnancy using mifepristone and misosprostol at more than 15 weeks' gestation in patients with uterine scar due to previous cesarean section. MATERIALS AND METHODS: This retrospective study was conducted in a tertiary maternity ward between January 2000 and October 2004. A total of 252 women at more than 15 weeks' gestation underwent termination of pregnancy including 50 women with uterine scar due to previous cesarean section (Group 1) and 202 control patients (Group 2) without known uterine scar. Abortion was induced with mifepristone and a prostaglandin analogue. Women between 15 and 34 weeks' gestation received misoprostol intravaginally every 3 h at doses of 200 microg (Group 1) or 400 microg (Group 2). Women at more than 34 weeks' gestation received Prostin E2 vaginal gel. Main end points were hemorrhage, fever, retained placenta, occurrence of complications including uterine rupture and dehiscence, and final outcome. RESULTS: A total of 13 (26%) patients in Group 1 and 79 (39.1%) in Group 2 were at more than 24 weeks' gestation. The abortion failure rate was 2% (1/50) in Group 1 and 0.5% (1/202) in Group 2 (p = .28). The median induction-to-delivery interval was 8.5 h (range, 3.0-114.2 h) for Group 1 and 9.0 h (range, 1.3-124.3 h) in Group 2 (p = .26). One case of uterine rupture and one case of dehiscence were observed, both in women in Group 1. The incidence of hemorrhage was not significantly different between Group 1 and Group 2 (2% vs. 0.9%, respectively, p = .56). The incidence of retained placenta was higher in the Group 1 (70% vs. 52.5%, respectively, p = .025). CONCLUSION: In this retrospective series of women who underwent abortion at 15-35 weeks' gestation using mifepristone and a prostaglandin analogue for labor induction abortion, history of cesarean section was not associated with higher morbidity except risk of uterine rupture. However, dose and interval of misoprostol should be determined. A larger study is needed before drawing definitive conclusions about the safety of these regimens.

Abortifacient Agents, Nonsteroidal↗
PubMed1997

Treatment of male partners and recurrence of bacterial vaginosis: a randomised trial.

OBJECTIVE: To test the efficacy of treatment with clindamycin of a partner on the recurrence rate of bacterial vaginosis in women within 3 months from diagnosis. SUBJECTS: Eligible for the study were sexually active women with one current sexual partner, who were aged 18-45 years, with a clinical diagnosis of bacterial vaginosis and whose partner agreed to be treated. METHODS: A double blind, randomised, controlled trial was conducted comparing the effect of treating the partner with either clindamycin capsules or placebo on the reduction of the recurrence rate of bacterial vaginosis. Women were treated with clindamycin 2% vaginal cream, administered intravaginally once daily at bedtime for 7 consecutive days. The partners were randomly allocated to clindamycin hydrochloride capsules, 150 g by mouth four times daily for 7 consecutive days, or a placebo. A total of 139 couples were randomised--69 were treated with clindamycin vaginal cream group and 70 with placebo. One, 4, and 12 weeks after the end of treatment the patients and their partners were examined; vaginal discharges were examined to check for clue cells, vaginal pH was determined, and a KOH test carried out. RESULTS: Overall, 131 women out of the 139 who entered the study were cured (94.2%, lower 95% confidence interval 79.8, based on Poisson's approximation). There was no difference in the cure rate among women whose partner received clindamycin or placebo (chi(2) p = not significant). A total of 55 couples (26 in the clindamycin and 29 in the placebo group) withdrew from the study during the follow up period. Of the 69 women whose partner received clindamycin, 22 (31.9%) reported "recurrence" or persistence. The corresponding number was 21 (30%) of the 70 women whose partner received placebo (chi(2) p = not significant). Of the 84 couples in which the woman was cured by the first week's visit and who completed the study; there were five recurrences (11.6%) among the 43 women whose partner received clindamycin and nine (22.0%) of the 41 whose partner received placebo (chi(2) p = not significant). CONCLUSION: This study indicates that vaginal clindamycin is effective and safe in the treatment of bacterial vaginosis, but it does not support the suggestion that male treatment markedly reduces the short term recurrence rate.

Administration, Intravaginal↗
PubMed1997

Multicenter comparison of clotrimazole vaginal tablets, oral metronidazole, and vaginal suppositories containing sulfanilamide, aminacrine hydrochloride, and allantoin in the treatment of symptomatic trichomoniasis.

BACKGROUND AND OBJECTIVES: Trichomonas vaginalis is a common vaginal pathogen. Oral metronidazole is the drug of choice for the treatment of trichomoniasis. Oral metronidazole, however, may cause unpleasant side effects and is contraindicated during the first trimester of pregnancy. In vitro studies and preliminary clinical data have suggested that intravaginal clotrimazole may be effective against this pathogen. GOALS: To compare the efficacy of clotrimazole vaginal tablets, oral metronidazole, and vaginal suppositories containing sulfanilamide, aminacrine, and allantoin (AVC suppositories) in the treatment of women with symptomatic trichomoniasis. STUDY DESIGN: In a multicenter, open-label trial conducted in 1982 and 1983, 168 symptomatic women with microscopically evident vaginal trichomoniasis were randomized to receive any of 2 g of metronidazole as a single oral dose, two 100-mg clotrimazole vaginal tablets once a day for 7 days, or vaginal suppositories containing 1.05 g of sulfanilamide, 14 mg of aminacrine hydrochloride, and 140 mg of allantoin (AVC suppositories) twice a day for 7 days. Wet mounts and cultures were repated at 1 to 2 and 4 to 6 weeks after completion of treatment. RESULTS: The number of patients who had positive cultures after treatment were 40/45 (88.9%) in the clotrimazole group, 35/43 (81.4%) in the AVC suppository group, and 9/45 (20%) in the metronidazole group (P < 0.001). All treatments were associated with a reduction in reported symptoms. Oral metrohidazole was more effective in reducing symptoms than either of the topical preparations. Adverse events, mostly mild or moderate in severity, were reported by 7 (14.6%) of 48 patients who had received oral metronidazole and 4 (7.8%) of 51 women who used AVC suppositories. There were no adverse events reported by the 50 women who used clotrimazole vaginal tablets. CONCLUSIONS: Oral metronidazole was more effective in eradicating T. vaginalis than clotrimazole vaginal tablets or AVC vaginal suppositories. All three regimens reduced symptoms; oral metronidazole was more effective in reducing symptoms than either topical preparation.

Administration, Intravaginal↗
PubMed2006

Open, non-controlled clinical studies to assess the efficacy and safety of a medical device in form of gel topically and intravaginally used in postmenopausal women with genital atrophy.

Menopause is often associated with vaginal atrophy and related symptoms, such as vaginal dryness, burning, itching, and dyspareunia, decrease in libido and in general a decrease in the quality of life. The common treatment up to the 1990's has been the oral hormone replacement therapy (HRT), but this treatment has been consequently re-considered due to its adverse effects. Topical estrogenic products have been subsequently developed to minimize the systemic adverse effects of the oral HRT, but they are still considered at risk in case of prolonged use. As an alternative, two clinical trials were performed to investigate the effects of a medical device in the form of a gel, containing hyaluronic acid, liposomes, phytoestrogens from Humulus lupulus extract, and Vitamin E, with the aim of testing its safety and efficacy in post-menopausal women with urogenital atrophy. The first pilot study confirmed in 10 women the good safety profile, both locally and systemically, of the device applied on the external genitals at the dose of 1-2 g/day for 30 days. The second study was carried out, according to a multicenter, open, non-controlled design, in 100 post-menopausal women assigned to the vaginal application of 2.5 g of gel/day for 1 week followed by two applications/week for 11 weeks. The primary end-point was the evaluation of vaginal dryness assessed by a Visual Analogue Scale both by the investigator and the subject. Secondary endpoints were the evaluation of all other symptoms and signs associated with atrophic vaginitis (itching, burning, dyspareunia, vaginal inflammation/oedema and rash assessed by a 4-point scale and presence of vaginal abrasions and disepithelialisation), and the recording of adverse events during the study. At the end of the treatment, an overall judgment on the efficacy and safety of the device was made by the investigator and a judgment on the acceptability of the treatment was made by the subjects. The results showed a marked effect of the tested product on the vaginal dryness and on all other symptoms and signs with statistically significant reductions since the first week of treatment. No treatment-related adverse events were complained by the subjects and the treatment course showed a high level of acceptability by the subjects. This device could be considered an effective and safe alternative treatment of genital atrophy in post-menopausal women, especially when HRT is not recommended.

Administration, Intravaginal↗
PubMed1996

A comparison of differing dosing regimens of vaginally administered misoprostol for preinduction cervical ripening and labor induction.

OBJECTIVE: Our purpose was to compare two dosing regimens of vaginally administered misoprostol for preinduction cervical ripening and induction of labor. STUDY DESIGN: Five hundred twenty-two patients with indications for induction of labor and unfavorable cervices were randomly assigned to one of two dosing regimens of vaginally administered misoprostol. Twenty-five microgram tablets of misoprostol were placed in the posterior vaginal fornix either every 3 hours to a maximum of eight doses or every 6 hours to a maximum of four doses. The maximal period of cervical ripening was 24 hours regardless of the number of misoprostol doses administered. Medication was not given after either spontaneous rupture of membranes or the beginning of active labor. RESULTS: Among 522 patients enrolled, 261 were randomized to receive misoprostol every 3 hours and 261 to receive misoprostol every 6 hours. The average interval from start of induction to vaginal delivery was shorter in the 3-hour dosing group (1311.74 +/- 785.14 minutes) than in the 6-hour dosing group (1476.96 +/- 805.30 minutes) (p < 0.05). Oxytocin augmentation of labor occurred more commonly in the 6-hour dosing group (51.4%) than in the 3-hour dosing group (41.8%) (p < 0.05) [corrected]. There were no significant differences between routes of delivery. Overall, 108 patients (20.8%) were delivered by cesarean section. There was a slightly higher prevalence of tachysystole (six or more uterine contractions in a 10-minute window for two consecutive 10-minute periods) in the 3-hour group (14.6%) than in the 6-hour group (11.2%), but this difference was not statistically different. There were no significant differences in the frequency of uterine hyperstimulation or hypertonus. There was no significant difference between groups in the frequency of abnormal fetal heart rate tracings, meconium passage, 1- or 5-minute Apgar scores < 7, neonatal resuscitations, or admissions to the neonatal intensive care unit. CONCLUSIONS: Vaginally administered misoprostol is an effective agent for cervical ripening and induction of labor. Patients with the 6-hour dosing schedule had longer intervals to delivery, more frequently required oxytocin augmentation, and had more failed inductions than did patients with 3-hour dosing. Further investigation to characterize the safety of misoprostol is needed.

Administration, Intravaginal↗
PubMed2003

Endocrine events during the periestrous period and the subsequent estrous cycle in ewes after estrus synchronization.

The aim of the present study was to investigate the endocrinology of the periestrus period and that of the subsequent estrous cycle in ewes synchronized during the breeding season. Animals were treated for 14 days with either MAP intravaginal sponges or subcutaneous progesterone implants, followed by administration of 500 IU PMSG at the time of withdrawal. The time to estrus occurrence following progestagen withdrawal differed significantly between groups (45.3+/-2.7h for the MAP and 21.5+/-1.2h for the implant group, P<0.001). Estradiol levels around estrus did not differ between groups, but a significant difference was detected for the interval from peak estradiol to estrus, with a shorter interval for the implant group (26.7+/-0.7 and 2.7+/-0.9h, P<0.001). Progesterone implants shortened the interval from removal to LH surge, compared to the MAP group (31.2+/-4.4 and 56.5+/-3.6h, respectively, P<0.05). An earlier response was also observed for the interval from estradiol peak to LH peak in the implant group (12.1+/-3.3 and 37+/-2h, respectively, P<0.005), but no difference was observed for the interval from estrus to LH surge. Progesterone levels, particularly during the Days 6 to 10 of the subsequent estrous cycle were significantly higher (P<0.05) in the implant group. It is concluded that the kind of progesterone treatment may affect the time of estrus and the LH peak as well as the progesterone levels of the subsequent cycle.

Administration, Intravaginal↗
PubMed2000

Vaginal misoprostol 600 microg for early abortion.

The objective of this study was to evaluate the efficacy and safety of the vaginal self-administration of 600 microg misoprostol up to a maximum administration of three doses in a 24-h period, one every 8 h, for abortion up to 9 weeks' gestation. A group of 90 voluntary women with gestations from 35 to 63 days participated in the study. All women who aborted received a single additional dose of 600 microg misoprostol. Outcome measures included successful abortion (complete abortion without requiring surgical procedure) and side-effects. Complete abortion occurred in 57/89 (64%, 95% confidence interval 53-74%) subjects. The mean expulsion time was 7.4 +/- 3.8 h (median 7.2 h, range 3-20 h) for all women who aborted within the first 24 h of the administration of misoprostol. Thirty-two cases failed to abort, 28 cases due to failure of the method, of which 24 had a negative cardiac rhythm after the third dose, and four cases due to the doctor's decision. The results obtained in this study led us to the conclusion that the 600-microg misoprostol dose regimen was not adequate to produce a high or an acceptable abortive efficacy.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

First-trimester pregnancy termination with 800 microg of vaginal misoprostol every 12 h.

The objective of the study was to evaluate the efficacy and safety of 800 microg of misoprostol every 12 h, for a period of 36 h for pharmacological abortion. A group of 162 volunteer women with gestations between 50 and 63 days received misoprostol every 12 h up to a maximum of three doses for abortion. Outcome measures assessed included: successful abortion (complete abortion without requiring surgery), side effects, and a decrease in hemoglobin, mean time of vaginal bleeding, mean expulsion time and mean time of returning of menses. Complete abortion occurred in 148 of 162 (91%, 95% confidence interval 87.95) patients. The mean decrease in hemoglobin was statistically significant (p = 0.001). Vaginal bleeding lasted 8.0 +/- 3.2 days, spotting 8.0 +/- 3.5 days, and total bleeding 16 +/- 4.0 days. The mean expulsion time was 8.5 +/- 4.0 h. According to the observed outcomes, 800 microg of misoprostol vaginally could be a valid method to terminate pregnancies up to 9 weeks of gestation.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

A randomised controlled trial of 6 and 12 hourly administration of vaginal misoprostol for second trimester pregnancy termination.

OBJECTIVE: To compare the effectiveness of vaginal misoprostol administered 6 or 12 hourly for second trimester pregnancy termination. DESIGN: A randomised controlled trial. SETTING: University teaching hospital. SAMPLE: Two hundred and seventy-nine pregnant women at gestations between 14 and 26 weeks undergoing pregnancy termination. METHODS: Women were randomised to receive 600-microg misoprostol tablets vaginally either every 6 hours or every 12 hours until abortion occurred. MAIN OUTCOME MEASURES: Induction-abortion interval, success rate within 24 and 48 hours and adverse effects. RESULTS: There was no significant difference in the median induction to abortion interval 6 hours (16 hours) and 12 hours (16 hours; P= 0.80). The total dose of misoprostol was higher in the 6-hour group (1800 vs 1200 microg). The cumulative abortion rates within 24 hours were 74% and 67% and within 48 hours 94% and 92%, in the 6- and 12-hour groups, respectively. Fever was more common in the 6-hour group (53%) versus the 12-hour group (31%; P < 0.001). The incidence of nausea, vomiting, diarrhoea, severe bleeding and abdominal pain were similar. CONCLUSIONS: Misoprostol (600 microg) administered at 12-hour intervals was associated with fewer adverse effects and was as effective as a 6-hour interval.

Abortifacient Agents, Nonsteroidal↗
PubMed2000

Comparison of usefulness of estradiol vaginal tablets and estriol vagitories for treatment of vaginal atrophy.

BACKGROUND: Atrophic vaginitis is a common condition. This study compared the usefulness of estradiol vaginal tablets (EVT) and estriol vagitories (EV) in treatment of atrophic vaginitis. METHODS: Ninety-six postmenopausal women with symptoms of atrophic vaginitis were treated for 24 weeks with either EVT or with EV. Patients used the medication daily for the first 2 weeks of the study, and twice-weekly thereafter. RESULTS: Both EVT and EV were effective in treating vaginal atrophy and patients in both treatment groups experienced a significant improvement in vaginal symptoms such as itching, irritation, dryness, and dyspareunia. At the end of the study three (6%) EVT treated women reported leakage and none needed to use sanitary towels. Among the EV treated women 31 (65%) reported leakage and 14 (29%) required sanitary protection. Furthermore, 90% in the EVT group perceived the medication as hygienic compared to 79% in the EV group, and 49% in the EVT group indicated that the product was easy to use compared to 28% in the EV group. Endometrial thickness was increased (1.1 mm with EVT and 0.5 mm on EV) in both treatment groups during the first 2 weeks of the study, but returned to baseline levels when the frequency of drug application was reduced to twice-weekly. CONCLUSIONS: Estradiol vaginal tablets provides an effective alternative to traditional forms of local estrogen therapy.

Administration, Intravaginal↗
PubMed2000

Cardiovascular effects of intravaginal misoprostol in the mid trimester of pregnancy.

OBJECTIVE: Our aim was to evaluate the cardiovascular effects of high-dose intravaginal misoprostol administration by means of transthoracic electrical bioimpedance monitoring. STUDY DESIGN: Healthy women undergoing mid trimester pregnancy interruption with intravaginal misoprostol were eligible for this prospective observational study. Baseline blood pressure was obtained for 1 hour and transthoracic electrical bioimpedance monitoring was performed before misoprostol administration, 600 microg vaginally. Posttreatment assessments were made every 15 minutes for a total of 4 hours, with patients in a left lateral recumbent position. Heart rate, mean arterial pressure, cardiac index, stroke index, systemic vascular resistance index, and end-diastolic volume index were determined. Measurements were averaged for 30-minute intervals and reported as mean +/- SD. Statistical analyses included the paired t test and repeated-measures analysis of variance. RESULTS: Nine women consented to have transthoracic electrical bioimpedance monitoring, and no statistically significant changes in any of the measured cardiac parameters for the 4-hour monitoring interval were noted. Direct comparisons between the pretreatment and 2-hour posttreatment intervals (reported time peak of blood misoprostol levels) also revealed no significant differences in the cardiovascular index values. CONCLUSION: High-dose intravaginal misoprostol in the mid trimester does not alter maternal cardiac function as measured by transthoracic electrical bioimpedance.

Abortifacient Agents, Nonsteroidal↗
PubMed2005

Immunotherapeutic approaches to enhance protective immunity against Candida vaginitis.

Protective host defense mechanisms against vaginal Candida infections are poorly understood. While cell-mediated immunity (CMI) is the predominant host-defense mechanism against most mucosal Candida infections, no protective role for systemic or local Candida-specific CMI or antibodies has been identified against vaginal candidiasis. Rather, evidence exists for immunoregulation in vaginal tissue, which may inhibit a more profound protective Th1-type response. This study evaluated immunotherapy and gene therapy approaches in the murine model to potentially overcome immunoregulation and promote enhanced protection against vaginal candidiasis. In the first set of studies, the intravaginal and systemic administration of Thl-type cytokines and anti-IL-10 and anti-TGF-beta antibodies failed to enhance protection against a vaginal Candida infection. In a second set of studies, the novel intravaginal administration of Adenoviruses encoding Th1-type cytokines (IFN-gamma and IL-12) and the chemokine, MCP-1, showed substantial, but transient (24 h) expression of each in vaginal tissue and draining lymph nodes, even with a second administration. Unfortunately, treatment with these Adenoviral vectors did not enhance protection against experimental vaginitis. Construction of a new vector encoding IFN-gamma with a stronger promoter produced substantial IFN-gamma in vitro, but lower amounts in vivo and no extended expression. Taken together, while gene therapy can be used to induce cytokine expression in vaginal tissue, there appear to be strong regulatory mechanisms that additional manipulations or alternative approaches will have to overcome if protection against vaginitis is to be enhanced.

Animals↗