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PubMed2005

Endometrial effects, bleeding control, and compliance with a new postmenopausal hormone therapy regimen based on transdermal estradiol gel and every-other-day vaginal progesterone in capsules: a 3-year pilot study.

In a 3-year prospective study, 30 postmenopausal women received transdermal E2 gel and every-other-day vaginal P in capsules. At study completion, endometrial thickness was significantly reduced as compared with baseline (2.7 +/- 0.5 vs. 3.4 +/- 0.9 mm), endometrial biopsy showed endometrial atrophy in all cases, and amenorrhea was achieved in 92.6% of cycles, while excellent patient satisfaction was achieved.

Administration, Cutaneous↗
PubMed1997

Uterine rupture during induction of labor at term with intravaginal misoprostol.

BACKGROUND: Misoprostol (prostaglandin E1) compares favorably with dinoprostone (prostaglandin E2) and oxytocin for labor induction at term. Excessive uterine activity has been reported using high-dose regimens, but no negative effect on outcomes has been observed. CASE: Labor was induced in a 34-year-old multipara at 39 weeks' gestation using intravaginal misoprostol tablets. Five hours after administration of the second 25-microgram dose, fetal bradycardia prompted emergency cesarean delivery. Hysterectomy and left salpingo-oophorectomy were necessary to control bleeding from a 15-cm posterior uterine wall rupture. CONCLUSION: Misoprostol can cause excessive uterine activity and uterine rupture.

Administration, Intravaginal↗
PubMed2006

Detection of Campylobacter jejuni in various lymphoid organs of broiler breeder hens after oral or intravaginal inoculation.

Two studies were conducted to determine whether Campylobacter jejuni could rapidly spread and reside in the internal organs of adult broiler breeder hens. In Study 1, university-housed broiler breeders at 22 wk of age were obtained and placed in individual cages. Each hen was intravaginally inoculated weekly from 23 to 32 wk of age with a characterized strain of C. jejuni. At wk 23, 27, and 32, 4 d postinoculation, the hens were euthanized, defeathered, and aseptically opened. In Study 2, university-housed broiler breeder hens were obtained at 42, 53, and 56 wk of age, placed in individual cages, and inoculated either orally or intravaginally with a characterized strain of C. jejuni. To reduce the possibility of cross-contamination among samples, the thymus, spleen, liver, and gallbladder were aseptically removed, prior to the ceca. In both studies, all samples were individually analyzed. In Study 1, at 23 wk of age, C. jejuni was recovered from 4/7 thymii, 2/7 spleens, 5/7 livers and gallbladders, and 6/7 ceca. At 27 wk of age, C. jejuni was recovered from 1/7 thymii and 1/7 ceca. At 32 wk of age, C. jejuni was recovered from 4/11 thymii, 1/11 livers and gallbladders, and 2/11 ceca. In Study 2, C. jejuni was recovered from 2/6 thymii and 5/6 ceca after oral inoculation and 1/6 spleens, 1/6 livers and gallbladders, and 4/6 ceca after vaginal inoculation of 43-wk-old hens. Campylobacter jejuni was recovered from 2/5 thymii, 3/5 spleens, 3/5 livers and gallbladders, and 2/5 ceca after oral inoculation of 53-wk-old hens and 1/5 thymii and 1/5 livers and gallbladders after vaginal inoculation. Campylobacter jejuni was recovered from 1/4 thymii, 2/4 livers and gallbladders, and 1/4 ceca and was not detected in any vaginally inoculated birds of 57-wk-old hens. This study provides evidence that C. jejuni can reside in the internal organs of broiler breeder hens following oral or intravaginal inoculation.

Administration, Intravaginal↗
PubMed2004

Oral misoprostol vs. vaginal gemeprost prior to surgical termination of pregnancy in nulliparae.

BACKGROUND: To compare the efficacy and side-effects of intravaginal gemeprost with those of oral misoprostol for cervical ripening prior to first-trimester pregnancy termination in nulliparous women. METHODS: Retrospective analysis of surgical terminations of pregnancy performed before 90 days of gestation. Intravaginal gemeprost 1 mg or oral misoprostol 800 micro g was administered 2 h before the procedure. RESULTS: In total, 746 women were enrolled into the study, 84 received intravaginal gemeprost and 662 oral misoprostol. Median baseline cervical dilatation was significantly greater in women who received misoprostol before the operation than in those who received gemeprost (7 mm vs. 3 mm; p < 0.0001). The incidence of fever, vomiting and diarrhea was not different between the two groups. The incidence of abdominal pain with request for pain medication, emergency admission to operating room due to vaginal bleeding, hospital stay longer than 24 h and surgical repair of cervical injury due to Hegar dilatation was significantly higher among the gemeprost group than the misoprostol group. CONCLUSIONS: In cervical priming prior to first-trimester pregnancy termination in nulliparous women, oral misoprostol is more effective and is associated with fewer side-effects and complications than intravaginal gemeprost.

Abortifacient Agents, Nonsteroidal↗
PubMed1995

Treatment of bacterial vaginosis: a comparison of oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream.

BACKGROUND: Treatment options for bacterial vaginosis are numerous. The purpose of this study was to compare the efficacy of oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream for the treatment of bacterial vaginosis using traditional clinical and laboratory methods, as well as a new DNA probe test. We also determined the percentage of patients receiving each treatment who developed posttreatment vaginal candidiasis, a potential complication of treating bacterial vaginosis. METHODS: One hundred one women in whom bacterial vaginosis was diagnosed by standard criteria were randomly assigned to receive: oral metronidazole 500 mg twice daily for 1 week, 0.75% metronidazole vaginal gel 5 g twice daily for 5 days, or 2% clindamycin vaginal cream 5 g once daily for 7 days. Women with coexisting vulvovaginal candidiasis or vaginal trichomoniasis were excluded. Tests of cure by vaginal saline wet prep and potassium hydroxide microscopic examinations, Gram's stain, pH and DNA probe tests for Gardnerella vaginalis and Candida species were scheduled 7 to 14 days following treatment. RESULTS: There were no statistically significant differences in cure rates for oral metronidazole (84.2%), metronidazole vaginal gel (75.0%), or clindamycin vaginal cream (86.2%) (chi 2 = 1.204, df = 2, P = .548) using traditional clinical and laboratory criteria. Cure rates were lower based on DNA testing, indicating that Gardnerella vaginalis may remain after a clinical cure. This would explain cases of recurrent disease. Posttreatment vulvovaginal candidiasis was experienced by 12.5% of subjects treated with oral metronidazole, 14.8% of subjects treated with clindamycin vaginal cream, and 30.4% of subjects treated with metronidazole vaginal gel (chi 2 = 2.607, df = 2, P = .272). CONCLUSIONS: Oral metronidazole, metronidazole vaginal gel, and clindamycin vaginal cream achieved nearly equivalent cure rates for the treatment of bacterial vaginosis. Patients treated with these agents experienced similar rates of posttreatment vulvovaginal candidiasis, but those using the intravaginal products reported being more satisfied with the treatment.

Administration, Intravaginal↗
PubMedDate not supplied

[Cervical ripening and induction of labor in term pregnancy using prostaglandin E2. Controlled clinical study comparing the intracervical and intravaginal routes].

106 term pregnant patients with unfavorable local condition (B.S. less than or equal to 5) and indication to induction of labour because of mother or fetus problems, were randomized for a controlled clinical trial. 52 patients (group A) received 0.5 mg. of PGE2 in 2 ml of tylose gel intracervically. 48 patients (group B) received 3.0 mg. of PGE2 in 5 ml of tylose gel intravaginally. 6 patients were excluded because of violation of protocol. The aim of our study was to evaluate the best method of cervical ripening before a classical induction with amniotomy and oxytocin. Our results show that intracervical PGE2 gel seems to have a better effect on the ripening of the cervix than the intravaginal one if we only consider the proposition of softening success (group A 14/52; group B 6/48). If the evaluation of the effect on the cervical ripening is made according to modification of Bishop's score after gel application, the situation seems inverted because the medians values of the modifications have obtained respectively for group A and B a variation of 2.0 and 3.0 points. Moreover the intravaginal way showed a significantly higher incidence of collateral effects.

Administration, Intravaginal↗
PubMed2004

Personal digital assistants used to document compliance of bacterial vaginosis treatment.

OBJECTIVE: The objective of this study was to estimate patient compliance with oral and vaginal metronidazole treatment of bacterial vaginosis using personal digital assistants (PDAs) and paper diaries. GOAL: The goal of this study was to assess a novel compliance documentation approach. STUDY: After each dose of intravaginal or oral metronidazole, 71 subjects recorded the time on a paper diary and answered questions on a PDA. All PDA entries were unknowingly time-date-stamped. Subjects returned for 2- and 6-week posttreatment examinations. Compliance was calculated using a repeated-measures multivariate analysis of variance (ANOVA). RESULTS: Mean patient compliance rates within the oral metronidazole group were greater with the paper diary compared with the PDA (68.3% and 50.0%, respectively, P = 0.001). The observed rate of compliance agreement for PDA versus paper diary was 69.0% (kappa = 0.4). The majority of noncompliant subjects reported they were compliant with the PDA and paper diary. CONCLUSIONS: PDAs could more accurately document true compliance rates and could be reasonable instruments to assess compliance in intravaginal antimicrobial drug or contraceptive trials.

Administration, Intravaginal↗
PubMed2007

Efficacy and safety of six hourly vaginal misoprostol versus intracervical dinoprostone: a randomized controlled trial.

OBJECTIVE: To compare the efficacy and safety of intravaginal misoprostol versus dinoprostone cervical gel for cervical ripening and labour induction. METHODS: We carried out an experimental clinical trial in which we enrolled 130 cervical consecutive patients with cervical ripening, randomly assigned to one of the following two treatment groups: (1) intravaginal misoprostol and (2) intracervical dinoprostone gel. A total of 50 microm of misoprostol was placed in the posterior vaginal fornix every 6 h for a maximum period of 24 h and 0.5 mg of dinoprostone was administrated in the uterine cervix every 6 h, for a maximum period of 24 h. The primary outcome measure was the number (rate) of women who went to vaginally deliver within 24 h of the protocol initiation. RESULTS: Among 130 patients evaluated, 65 were allocated to the misoprostol group and 65 to the dinoprostone group. The proportion of vaginal delivery within 24 h was significantly higher in the misoprostol group (75%) than in the dinoprostone group (53.8%) (RR = 1.40, 95% CI [1.07-1.45], P = 0.02). There was no significant difference between the mean time interval of delivery in the misoprostol group and the dinoprostone group (14.9 vs.15.8 h) (P = 0.51). The Bishop score was significantly higher in the misoprostol group, 6 h after the onset of the study (1.38; relative risk, 95% CI [1.02-1.85], P = 0.03). The Caesarean delivery rate for fetal distress was higher in the dinoprostone group (21 vs. 10.8%, P = 0.15). The tachysystole (Misoprostol 6.1% vs. dinoprostone 4.6%, relative risk 1.15, 95% CI [0.6-2.24]) and hyperstimulation syndrome rates (Misoprostol 7.6% vs. dinoprostone 4.6%, relative risk 1.26, 95% CI [0.72-2.24]) were slightly increased in the misoprostol group than in the dinoprostone group without reaching the level of statistical signification. CONCLUSION: Misoprostol as used in this protocol is more effective than cervical dinoprostone gel application in the cervical ripening and labour induction. There is a tendency for an increase in the rate of tachysystole and hyperstimulation syndrome.

Administration, Intravaginal↗
PubMed2003

The effect of oral versus vaginal misoprostol on cervical dilatation in first-trimester abortion: a double-blind, randomized study.

OBJECTIVES: To determine the effect of oral versus vaginal misoprostol on cervical dilatation in first-trimester intrauterine evacuation or menstrual regulation (MR). DESIGN AND METHODS: A total of 120 patients were randomly assigned to a double-blind prestudy. Four groups, each consisting of 30 cases, were administered one of four regimens: 200 microg misoprostol orally, 200 microg misoprostol intravaginally, placebo orally, or placebo intravaginally, 10 h before MR, respectively. Age, number of births and abortions, birth methods, date of last delivery and last abortion were recorded. The gestational age was determined by ultrasonography. Prior to MR, data regarding the time of the application of the drug, the presence of placenta in the cervical canal, the degree of cervical dilatation, the duration of MR and patients' complaints were recorded. The MRs were performed by the same physician. The statistical analyses were evaluated with the chi(2) test and Fisher's exact test in the Aegean University Science Faculty Department of Statistics. RESULTS: In the oral misoprostol group, four patients had cervical bleeding and one had intracervical placenta. In the intravaginal misoprostol group, cervical bleeding was observed in seven patients and intracervical placenta was recorded in four cases. Cervical bleeding was observed in one case and intracervical placenta was also observed in one case in the oral placebo group. Cervical dilatation reached 8 mm in seven patients in the oral misoprostol group and in three patients in the intravaginal group, with none in the placebo group. Symptoms such as pelvic pain, headache and nausea were observed in 11 cases in the oral and 14 cases in the vaginal misoprostol groups. CONCLUSIONS: Different methods of misoprostol administration may not be equivalent in terms of efficacy and side-effects. Therefore, we decided to extend the study to include more patients so as to achieve statistically significant results.

Abortifacient Agents, Nonsteroidal↗
PubMed2006

Vaginal and rectal topical microbicide development: safety and efficacy of 1.0% Savvy (C31G) in the pigtailed macaque.

BACKGROUND: A 1.0% gel formulation of C31G, a surfactant, has been shown to have in vitro antiviral and antibacterial activity. GOAL: The goal of this study was to evaluate the safety and efficacy of vaginal and rectal applications of 1.0% Savvy (C31G) in the nonhuman primate model. STUDY DESIGN: The safety of repeated 1.0% C31G application was evaluated by microflora, pH, vaginal biopsy, colposcopy, and rectal lavage. Efficacy in preventing chlamydial infection was documented by culture, nucleic acid amplification tests, and serology. RESULTS: Repeated applications of Savvy (1.0% C31G) were not associated with significant changes in pH, microflora, or inflammatory infiltrates on tissues. No significant differences in epithelial desquamation were noted after rectal product use compared with placebo. Four of 6 animals were protected from chlamydial infection after pretreatment with Savvy. C31G was shown to be safe to both vaginal and rectal mucosal tissues and to the microflora with repeated daily use. CONCLUSION: Savvy has an acceptable safety profile after repeated vaginal and rectal use. A single intravaginal application of 1.0% C31G provided partial protection from acquiring cervical chlamydial infection.

Administration, Intravaginal↗
PubMed1997

[Streptococcus group B and pregnancy: the therapeutic role of topical intravaginal clindamycin].

OBJECTIVE: To evaluate the clinical and therapeutic efficacy of 2% clindamycin vaginal cream in pregnant women heavily colonized with group B streptococci (GBS). STUDY DESIGN: A prospective, clinical trial in which carriers of group B streptococci were randomized to receive topical intravaginal clindamycin or oral amoxicillin. PATIENTS: We randomized 105 pregnant women: 55 received 2% clindamycin vaginal cream (100 mg/day for 7 days) and 50 oral amoxicillin (2 g/day for 7 days). INTERVENTIONS: Patients were treated during pregnancy, none of them received intrapartum chemoprophylaxis. On the other hand, all the neonates, within 24 hours from delivery, were studied from the microbiological point of view, carrying out auricolar, nasal, oropharyngeal and umbilical cultures. RELIEFS: The eradication of the microorganism was evaluated by performing a vaginal culture after 6 weeks from the beginning of antibiotic therapy. RESULTS: The eradication rate of the microorganism was significantly higher in women treated with topical clindamycin compared with the group receiving oral amoxicillin (71% versus 36%; p < 0.05). The neonatal outcome was similar in the two groups in terms of gestational age at delivery and mean birthweight. None of the neonates was admitted to the neonatal intensive care unit and no cases of neonatal sepsis were recorded. CONCLUSIONS: From our experience we can conclude that, during pregnancy, a treatment with topical intravaginal clindamycin may be useful in the eradication of GBS.

Administration, Intravaginal↗
PubMed2001

Vaginal prostaglandin (PGE2 and PGF2a) for induction of labour at term.

BACKGROUND: Prostaglandins have been used for induction of labour since the 1960s. Initial work focused on prostaglandin F2a as prostaglandin E2 was considered unsuitable for a number of reasons. With the development of alternative routes of administration, comparisons were made between various formulations of vaginal prostaglandins. This is one of a series of reviews of methods of cervical ripening and labour induction using standardised methodology. OBJECTIVES: To determine the effects of vaginal prostaglandins E2 and F2a for third trimester cervical ripening or induction of labour in comparison with placebo/no treatment or other vaginal prostaglandins (except Misoprostol). SEARCH STRATEGY: The Cochrane Pregnancy and Childbirth Group trials register, the Cochrane Controlled trials register and bibliographies of relevant papers. Last searched: November 2000. SELECTION CRITERIA: The criteria for inclusion included the following: (1) clinical trials comparing vaginal prostaglandins used for third trimester cervical ripening or labour induction with placebo/no treatment or other methods listed above it on a predefined list of labour induction methods; (2) random allocation to the treatment or control group; (3) adequate allocation concealment; (4) violations of allocated management not sufficient to materially affect conclusions; (5) clinically meaningful outcome measures reported; (6) data available for analysis according to the random allocation; (7) missing data insufficient to materially affect the conclusions. DATA COLLECTION AND ANALYSIS: A strategy has been developed to deal with the large volume and complexity of trial data relating to labour induction. This involved a two-stage method of data extraction. The initial data extraction was done centrally, and incorporated into a series of primary reviews arranged by methods of induction of labour, following a standardised methodology. The data was then extracted from the primary reviews into a series of secondary reviews, arranged by category of woman. To avoid duplication of data in the primary reviews, the labour induction methods were listed in a specific order, from one to 23. Each primary review included comparisons between one of the methods (from two to 23) with only those methods above it on the list. MAIN RESULTS: In total, 94 studies were considered; 42 have been excluded and 52 included examining a total of 9402 women. Vaginal prostaglandin E2 compared with placebo or no treatment reduced the likelihood of vaginal delivery not being achieved within 24 hours (18% vs. 99%, RR 0.19, 95% CI 0.14,0.25), the caesarean section rates were not different between groups although the risk of uterine hyperstimulation with fetal heart rate changes was increased (4.6% vs. 0.51%, RR 4.14, 95% CI 1.93, 8.90). Comparison of vaginal prostaglandin F2a with placebo showed no increase in caesarean section rates but the cervical score was more likely to be improved (15% vs. 60%, RR 0.25, 95% CI 0.13,0.49), and the risk of oxytocin augmentation reduced (53.9% vs. 89.1%, RR 0.60, 95% CI 0.43,0.84) with the use of vaginal PGF2a. There were insufficient data to make meaningful conclusions for the comparison of vaginal PGE2 and PGF2a. PGE2 tablet, gel and pessary appear to be as efficacious as each other. Lower dose regimes, as defined in the review, appear as efficacious as higher dose regimes. REVIEWER'S CONCLUSIONS: The primary aim of this review was to examine the efficacy of vaginal prostaglandin E2 and F2a. This is reflected by an increase in successful vaginal delivery rates in 24 hours, no increase in operative delivery rates and significant improvements in cervical favourability within 24-48 hours. Further research is needed to quantify the cost-analysis of induction of labour with vaginal prostaglandins, with special attention to different methods of administration.

Administration, Intravaginal↗
PubMed1993

New approaches for the treatment of bacterial vaginosis.

OBJECTIVE: Review alternative approaches to oral metronidazole for the treatment of bacterial vaginosis. STUDY DESIGN: Assessment of clinical trials on the treatment of bacterial vaginosis with regimens other than 5 to 7 days of metronidazole. RESULTS: Single-dose metronidazole, 2 gm orally, is as effective as 5- to 7-day courses of oral metronidazole, with cure rates in the 80% to 90% range. Oral clindamycin results in more than a 90% clinical cure rate. Intravaginal clindamycin cream 2% and intravaginal metronidazole gel 0.75% are associated with clinical cure rates similar to those for oral metronidazole. CONCLUSIONS: Single-dose metronidazole, oral clindamycin, intravaginal clindamycin cream, and intravaginal metronidazole gel are effective and safe alternatives to a 5- to 7-day course of oral metronidazole for the treatment of bacterial vaginosis.

Administration, Intravaginal↗
PubMed2005

Placebo-controlled randomized comparison of vaginal with rectal misoprostol in the prevention of postpartum hemorrhage.

AIM: To compare vaginally administered misoprostol to rectally administered misoprostol and placebo in a prospective randomized placebo-controlled study. METHODS: One hundred and fifty women with singleton vaginal deliveries were randomized (50 women in each arm) to receive 400-microg misoprostol tablets (crushed and suspended in a microenema) intravaginally, or 400-microg misoprostol tablets rectally, or two placebo lactose tablets rectally. The medication was administered immediately after delivery of the placenta. Women with profuse hemorrhage and delayed placental separation (>30 min) were excluded. Our outcome measures were postpartum blood loss 1 h after administration, and change in hemoglobin and hematocrit values from baseline to postpartum day 1. Analysis of variance and chi-squared tests were used to compare the outcome variables between groups. RESULTS: One hundred and twenty-six women were available for analysis. Baseline characteristics were similar across the groups. The number of excluded subjects, the estimated blood loss, and the drop in hemoglobin and hematocrit values did not differ between the three groups (P > 0.05). CONCLUSIONS: Misoprostol administered vaginally or rectally at a dosage of 400 microg following placental separation was not effective for decreasing postpartum bleeding in women without excessive hemorrhage.

Administration, Intravaginal↗
PubMedDate not supplied

Effects of estradiol with oral or intravaginal progesterone on risk markers for breast cancer in a postmenopausal monkey model.

OBJECTIVE: To evaluate the effects of oral estradiol given with either oral or intravaginal micronized progesterone (P4) on risk biomarkers for breast cancer in a postmenopausal monkey model. DESIGN: This experiment was a two-way crossover study in which 20 ovariectomized adult female cynomolgus macaques were treated (in equivalent doses for women) with oral estradiol (1 mg/d) + oral micronized P4 (200 mg/d) or intravaginal P4 delivered by Silastic rings (6- to 10-mg/d release rate). Hormone treatments lasted 2 months and were separated by a 1-month washout period. The primary outcome measure was breast epithelial proliferation. RESULTS: Serum P4 concentrations were significantly greater in subjects receiving oral P4 (10.9 ng/mL) compared with intravaginal P4 (3.8 ng/mL) at 2 to 3 hours after oral dosing (P<0.0001) but not at 24 to 28 hours after oral dosing (2.9 ng/mL for oral P4 vs 3.2 ng/mL for intravaginal P4 at 2 months, P=0.19). Serum estradiol concentrations were significantly lower after oral P4 than after intravaginal P4 (P<0.05 for all time points). Oral P4 resulted in significantly decreased body weight (-2.5%) compared with intravaginal P4 (+3.6%) (P=0.0001). Markers of breast proliferation, sex steroid receptor expression, and endometrial area did not differ significantly between oral P4 and intravaginal P4 treatments (P>0.1 for all). CONCLUSIONS: Despite different pharmacodynamic profiles, oral and intravaginal P4 had similar effects on biomarkers in the postmenopausal breast.

Administration, Intravaginal↗
PubMed1996

Local intravaginal vaccination of the female genital tract.

In a clinical trial the authors tested whether local intravaginal or oral vaccination would stimulate a mucosal immune response in the female genital tract. The whole cell/B subunit (CTB) oral cholera vaccine was used. Two groups of previously unimmunized volunteers were given three doses of vaccine at 2-week intervals: a first group of seven women received oral immunizations and a second group of seven women were immunized locally in the genital tract by mixing the vaccine with a well defined gel, eldexomer, and applying it directly in the fornix of the vagina. The women were given the first vaccination on day 10 of the menstrual cycle. Sampling of peripheral blood and of cervical mucus (CM) using an Aspiglaire syringe was performed immediately prior to the first dose and at 8-10 days following the last immunization. The study showed that while only three of the seven orally immunized women responded with detectable IgA and IgG anti-CTB antibodies in the genital tract, six out of the seven women in the locally vaccinated group responded with genital tract antibodies. The responses were also generally stronger and CM contained higher specific IgA and secretory component containing anti-CTB titres in the locally vaccinated group. Of the orally vaccinated individuals all responded with increases in serum anti-CTB IgG and 4,7 also exhibited specific IgA serum titres. By contrast, only 3/7 in the intravaginal group responded with increases in serum IgG and IgA anti-CTB titers following immunization. The authors conclude that local intravaginal vaccination using a well-defined gel appears to be the route of choice to stimulate immunity in the female genital tract.

Administration, Intravaginal↗