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Placebo-controlled trial of intravaginal clindamycin 2% cream for the treatment of bacterial vaginosis.

OBJECTIVE: To compare the safety and efficacy of intravaginal clindamycin 2% cream with placebo in nonpregnant women with bacterial vaginosis. DESIGN: A randomized, double-blind, placebo-controlled clinical trial. SETTING: Ambulatory patients in the general community. PATIENTS: Two hundred fifteen nonpregnant outpatients with a diagnosis of bacterial vaginosis were entered into this study. Of the 134 evaluable patients, 65 received clindamycin and 69 placebo. Demographic parameters were comparable between the two treatment groups. INTERVENTION: Study subjects were equally randomized to receive either 5 g of clindamycin 2% vaginal cream or placebo cream for seven nights. MAIN OUTCOME MEASURES: Clinical and microbiologic follow-up evaluations were scheduled for 5-10 days and 25-39 days posttreatment. Patients were interviewed about signs and symptoms, adverse events, and compliance. Diagnostic examinations were performed. RESULTS: Clinical success rates (cure and improvement) occurred in 50 of 65 patients who received clindamycin (77 percent) and 17 of 69 patients who received placebo (25 percent) by the first posttreatment visit (p < 0.001). Microbiologic cures or improvement were observed in 59 of the 65 patients treated with clindamycin (91 percent) compared with 20 of 69 placebo-treated patients (29 percent) (p < 0.001). At the end of the study, clinical and microbiologic cures or improvement were evident in 45 of 57 (79 percent) and 37 of 57 clindamycin-treated patients (65 percent), respectively, and 18 of 51 (35 percent) and 14 of 51 (28 percent) of the placebo-treated patients, respectively. The success rates with clindamycin 2% cream were statistically higher than those with placebo. The adverse-effect profiles in the two groups were similar and no serious adverse effects were reported. Patients who received clindamycin had a statistically higher incidence of nonbacterial vaginitis/cervicitis (18.5 vs. 7.5 percent, p = 0.003). CONCLUSIONS: Intravaginal clindamycin 2% cream appears to be an effective and safe treatment of symptomatic bacterial vaginosis in nonpregnant women.

Administration, Intravaginal↗

Preinduction cervical ripening techniques compared.

OBJECTIVE: To assess the clinical efficacy of pharmacologic, mechanical and combination techniques of cervical ripening. STUDY DESIGN: From March 1997 to August 1998, all cervical-ripening patients at Lehigh Valley Hospital were randomly assigned to three groups: intravaginal misoprostol, intracervical Foley catheter, or combination prostaglandin E2 (PGE2) gel and Foley catheter. Inclusion criteria included Bishop score < or = 5 and no contraindication to labor. The remaining delivery process was actively managed according to established guidelines. Multiple variables in perinatal outcome were analyzed, with the cesarean section rate and time from ripening to delivery as the main outcome variables. RESULTS: Of the 205 patients, 65 were randomized to the misoprostol group, 71 to the Foley group and 69 to the catheter-and-gel group. There were no differences between groups in delivery indications, maternal demographics, ultrasound findings, labor interventions, intrapartum times, mode of delivery, postpartum complications or neonatal outcomes. The misoprostol group demonstrated a higher rate of uterine tachysystole and required oxytocin less when compared to the two catheter groups. CONCLUSION: The higher rate of uterine tachysystole with misoprostol did not increase the cesarean section rate. The higher rate of oxytocin required by the two catheter groups did not increase the delivery time intervals. There appears to be no benefit to adding intracervical or intravaginal PGE2 gel to the intracervical Foley balloon. The misoprostol and catheter ripening techniques have similar safety and efficacy.

Administration, Intravaginal↗

Labor induction with intravaginal misoprostol versus intracervical prostaglandin E2 gel (Prepidil gel): randomized comparison.

OBJECTIVE: Our purpose was to compare the safety and efficacy of intravaginal prostaglandin E1, misoprostol, with that of intracervical prostaglandin E2 (Prepidil gel) for labor induction. STUDY DESIGN: One hundred three patients with an indication for induction of labor were randomly assigned to induction with prostaglandin E1, 50 micrograms intravaginally, or with Prepidil gel, 0.5 mg intracervically, every 4 hours until active labor. RESULTS: Four patients were excluded, leaving 49 patients who received prostaglandin E1 and 50 who received prostaglandin E2. The time from start of induction to vaginal delivery was significantly shorter in the prostaglandin E1 group (11.4 vs 18.9 hours, p < 0.001), and fewer patients in the prostaglandin E1 group required oxytocin augmentation (23% vs 55%, p < 0.005). No significant differences were noted in mode of delivery or in adverse maternal, fetal, or neonatal effects. CONCLUSION: Intravaginal prostaglandin E1 is a more effective, lower-cost agent for induction of labor than is intracervical prostaglandin E2 gel and is comparable in safety.

Administration, Intravaginal↗

Induction of labor in toxemia with misoprostol.

BACKGROUND: To compare the efficacy and complications of intravaginal misoprostol application with oxytocin infusion for induction of labor in toxemia of pregnancy with a modified Bishop score of < or =4. METHODS: A hundred preeclamptic women with a modified Bishop score of < or =4 were randomized into two groups of 50 patients one group receiving 50 microg intravaginal misoprostol 4 times at 4 hour intervals, the second group receiving oxytocin infusion for induction of labor starting from 1 mIU/per minute, increasing it every 30 minutes with 2 mIU/per minute increments up to maximum of 30 mIU/per minute. Modified Bishop scores 12 hours after induction, the time from induction to delivery, the route of delivery, fetal outcome and maternal complications were recorded. Statistical analyses were performed using Mann Whitney-U, Chi-Square and hypothesis tests about differences for two proportions (t test) to determine differences between the two groups. p< or =0.05 was considered significant. RESULTS: Misoprostol was significantly superior for induction of labor in toxemia of pregnancy with modified Bishop score of < or =4. After 12 hours median modified Bishop scores of misoprostol administered group and oxytocin administered group were 7 and 4 respectively. Misoprostol administered group 1 was significantly better than oxytocin administered group 2 (p=0.027). The rate of patients who were in labor after 12 hours were 94% and 80% in group 1 and 2 respectively and the difference showed significant difference (p<0.05). The median time from induction to delivery was 14 hours and 16 hours in the misoprostol and oxytocin administered group respectively with significant difference between the groups (p=0.003). The rate of vaginal delivery was significantly higher in the misoprostol administered group 1 (82%) when compared with the oxytocin administered group 2 (66%) (p<0.05). The 1 and 5 minutes median Apgar scores were 5-7 and 6-7.5 in group 1 and 2, respectively with no significant differences between the groups (p=0.96, p=0.64). The rate of admission to neonatal intensive care unit was similar in both groups. The complication rates were similar in all groups and no significant detrimental effects were noted. CONCLUSIONS: Intravaginal misoprostol is an efficacious, cheap and safe method of induction of labor in toxemia of pregnancy with modified Bishop score of < or =4.

Administration, Intravaginal↗

The optimization of intravaginal misoprostol dosing schedules in second-trimester pregnancy termination.

OBJECTIVE: The purpose of this study was to compare the clinical efficacy and side effects of 3 doses of intravaginal misoprostol for second-trimester pregnancy termination. STUDY DESIGN: This was a prospective randomized, double-blind controlled clinical trial of 150 women who underwent pregnancy termination between 14 and 30 weeks of gestation. Three intravaginal misoprostol regimens were compared: 200 microg misoprostol at 6-hour intervals (group 1), 400 microg misoprostol at 6-hour intervals (group 2), and a loading dose of 600 microg misoprostol followed by 200 microg at 6-hour intervals (group 3). RESULTS: There was a significant difference in the median time to achieve delivery among the 3 groups: group 1 (18.2 hours [IQ, 13.3-32.5 hours]) vs group 2 (15.1 hours [IQ, 10.9-23.7 hours]) vs group 3 (13.2 hours [IQ, 11.2-21.7 hours]; P =.035). Fifty-nine percent of the women in group 1, 76% of the women in group 2, and 80% of the women in group 3 delivered within 24 hours (P =.013). There were 7.8% of the women in group 1, 0% of the women in group 2, and 2% of the women in group 3 who were undelivered at 48 hours (P =.02). There was an increase in the incidence of fever in the first 12 hours (P =.038) and in the incidence of vomiting within 3 hours of the initial dose (P =.048) in group 3 compared with the other groups. CONCLUSION: Intravaginal misoprostol 400 microg at 6-hour intervals appears to be the preferred regimen for second-trimester pregnancy termination, with a shorter commencement to delivery interval than the 200 microg regimen and fewer maternal side-effects than the 600 microg loading dose regimen.

Abortifacient Agents, Nonsteroidal↗

Misoprostol in labor induction.

The efficacy of a new dosing regimen of misoprostol, a recently introduced labor-inducing agent, was studied. Fifty-eight patients received 50 microg of misoprostol intravaginally and the dose was repeated every 3 hours until uterine contractions begin. Those who had an adequate contraction pattern, defined as three contractions in 10 minutes, were not given the repeat dose. Oxytocin augmentation, but not further misoprostol doses, was used in patients with an inadequate contraction pattern. The maximum total daily dose was 200 microg. The patients had the mean age of 28.9 +/- 5.4, the mean gestational age of 211.8 +/- 46.6 days, the mean gravidity of 2.5 +/- 1.2, the mean parity of 0.9 +/- 0.9 and the mean initial Bishop score of 1.6 +/- 1.8. The mean required dose of misoprostol was 120.5 +/- 54.7 microg and 10 of 58 patients required oxytocin augmentation. The mean induction of labor to delivery time was 701.5 +/- 404.0 minutes. When 3 cases who gave birth with caesarean section were excluded, the interval was 708.4 +/- 407.2 minutes. The mean 5th minute Apgar score of the newborns was 8.2 +/- 2.5. Two patients developed tachysystole after the second dose of misoprostol and were managed with vaginal irrigation and O2 supplementation successfully. Slight nausea and vomiting in 2 patients were the other adverse reactions. Our findings revealed that, 50 microg intravaginal misoprostol, combined with oxytocin augmentation when necessary, appears to be an effective and safe method of labor induction.

Administration, Intravaginal↗

Vaginal misoprostol for abortion at 10-13 weeks' gestation.

OBJECTIVE: The effectiveness and safety of misoprostol have been reported for abortion up to 22 weeks' gestation. The objective of this study was to demonstrate the effectiveness and safety of self-administration of misoprostol every 12 h, without the need of postexpulsion systematic curettage, in late first-trimester abortions (10-13 weeks' gestation). METHODS: A group of 180 women with gestations from 64 to 91 days, self-administered 800 micrograms of vaginal misoprostol every 12 h for a maximum of three doses without performing postexpulsion systematic preventive curettage. Outcome measures included successful abortion (complete and incomplete abortion without requiring a surgical procedure), side-effects, mean expulsion time and vaginal bleeding. RESULTS: Successful abortion occurred in 153/180 (85%) subjects (95% confidence interval (CI) 79-90). The decrease of hemoglobin was statistically significant (p = 0.0001) but clinically unimportant: 12.1 mg/dl (SD 1.1) before treatment and 11.7 mg/dl (SD 1.1) afterwards. The mean expulsion time for patients who aborted after the first dose was 8.3 +/- 3.6 h (median 8 h, range 2-12 h). Vaginal bleeding lasted 6 +/- 3 days, spotting 7 +/- 3 days and total bleeding 13 +/- 4 days. The median dose of misoprostol administered was 1780 micrograms (range 1400-3000 micrograms). CONCLUSIONS: The high degree of acceptability, its efficacy and the fact that postabortion systematic curettage was not needed make misoprostol a suitable alternative to the currently available methods for termination of pregnancy at 10-13 weeks' gestation.

Abortifacient Agents, Nonsteroidal↗

[Randomized comparative study of induced labor with oxytocin and misoprostol in prolonged pregnancies].

UNLABELLED: The efficacy of oxytocin for induction of labor at 41 to 42 weeks of gestational age, was compared with misoprostol (a PGE1 analog) in 100 pregnant women. Half a tablet containing 100 mcg of misoprostol was placed intravaginally in 50 women and the remaining 50 received iv oxytocin (2-32 mU/min). The obstetric features were similar in both groups. Delivery within 24 hours was achieved in 88% of the patients induced with misoprostol and in 72% with oxytocin (p < 0.05). The mean time from induction to delivery was similar, 10.3-10.9 hrs (p NS) and no differences in obstetric and perinatal outcomes were found. Polisystoly with misoprostol, was the only side effect observed in the study (11.4%), and was without neonatal consequences. CONCLUSION: intravaginal misoprostol (100 mcg), is more effective, cheaper and less stressful than IVI oxytocin in post term inductions. The safety profiles of both were similar.

Abortifacient Agents, Nonsteroidal↗

A pilot clinical trial comparing an acid-buffering formulation (ACIDFORM gel) with metronidazole gel for the treatment of symptomatic bacterial vaginosis.

AIM: To compare the effectiveness of an acid-buffering formulation gel (ACIDFORM) with metronidazole gel in the treatment of symptomatic bacterial vaginosis (BV). METHODS: After a confirmed diagnosis of BV according to the criteria established by Nugent and Amsel, 30 nonpregnant women were enrolled in a randomized, double-blind clinical study. The women were randomly assigned to receive either 5 g ACIDFORM gel (n = 13) or 10% metronidazole gel (n = 17) intravaginally once daily for five consecutive days. Participants were evaluated in two follow-up visits (7-12 days and 28-35 days after treatment). Therapeutic success was defined as the presence of less than three of Amsel's criteria. If three or more criteria were present at first or second follow-up visit, the woman was excluded from the study and treated orally with metronidazole. Nugent scores were recorded at each visit but these were not used to define cure. RESULTS: At the first follow-up visit, 15 (88%) of the women in the metronidazole group were cured compared with only three (23%) in the ACIDFORM group (P < 0.001). The remaining 12 women (10 of the ACIDFORM group and two of the metronidazole group) were considered as failure and were treated orally with metronidazole. At the second follow-up visit, two of the ACIDFORM-treated women and six of the metronidazole-treated women presented recurrent BV. Four women in the ACIDFORM group and one in the metronidazole group reported occasional burning and itching during product use. CONCLUSION: ACIDFORM gel was significantly less effective than high-dose metronidazole gel for the treatment of symptomatic BV.

Administration, Intravaginal↗

A randomized, double-blind, placebo-controlled trial of 5-fluorouracil for the treatment of cervicovaginal human papillomavirus.

OBJECTIVE: To compare intravaginal 5-fluorouracil (5-FU) and placebo for the treatment of cervical and/or vaginal human papillomavirus (HPV). METHODS: A randomized, placebo-controlled trial was performed. Women with HPV detected visually or by Papanicolaou (Pap) test and confirmed by colposcopic biopsy were randomized to receive either intravaginal 5-FU cream or an intravaginal placebo cream. Women with cervical or vaginal intraepithelial neoplasia were excluded. The primary outcome measure was cytologic regression of HPV as determined by Pap test screening 4 to 6 months after treatment. The secondary outcome was cytologic evidence of disease progression at both the 4-6-month and 12-month follow-up evaluations. Data were analyzed using the Chi square test with significance established at P < 0.05. RESULTS: A total of forty patients were randomized, and thirty patients had a follow-up Pap test 4 to 6 months after treatment. Of those patients treated with 5-FU, 28% demonstrated regression of HPV on cytologic evaluation, compared with 69% of those treated with placebo (P < 0.05). Twelve-month follow-up cytology was available from 18 of the study participants. There were no significant differences in the frequency of cytologic progression or regression between groups at 12 months. CONCLUSION: Four to six months post treatment, the use of intravaginal 5-FU for the treatment of cervical or vaginal HPV is associated with a lower rate of regression than the use of placebo.

Administration, Intravaginal↗

Response of guinea pigs to intravaginal inoculation with guinea pig cytomegalovirus.

Female guinea pigs were inoculated intravaginally with guinea pig cytomegalovirus (GPCMV) propagated either in guinea pig embryo fibroblast cultures (GPEF) or salivary glands. The incidence of infection was higher with GPEF virus. Rare instances of isolation of GPCMV from cervical swabs 9-48 hr after inoculation was attributed to survival of inoculum in the genital tract. Neither immunofluorescence microscopy nor histopathologic examination showed evidence for active infection of genital tract tissue examined up to day 5 after inoculation. At necropsy on days 30-49, GPCMV was isolated from salivary glands and occasionally from pancreas and lymph nodes. Seroconversion following intravaginal inoculation was demonstrated by an enzyme-linked immunosorbent assay (ELISA) test, and titers were comparable to those after intraperitoneal or subcutaneous inoculation. However, titers of neutralizing antibody, determined by plaque-reduction assay, were significantly lower in the group inoculated intravaginally. These findings are relevant to consideration of cytomegalovirus as a sexually transmitted agent in humans.

Administration, Intravaginal↗

Eradication of methicillin-resistant Staphylococcus aureus vaginitis with mupirocin.

We report the case of a 54-year-old, quadriplegic woman with a methicillin-resistant Staphylococcus aureus (MRSA) vaginal infection. After failing a five-day course of intravenous vancomycin therapy, the patient was treated for ten days with mupirocin ointment applied intravaginally twice daily, which resulted in eradication of the infection. This report details a novel approach in treating MRSA vaginal infections.

Administration, Intravaginal↗

Vaginal sildenafil (Viagra): a preliminary report of a novel method to improve uterine artery blood flow and endometrial development in patients undergoing IVF.

Endometrial growth is thought to depend on uterine artery blood flow and the importance of endometrial development on in-vitro fertilization (IVF) outcome has been previously reported. Nitric oxide (NO) relaxes vascular smooth muscle through a cGMP-mediated pathway and NO synthase isoforms have been identified in the uterus. Sildenafil citrate (Viagra), a type 5-specific phosphodiesterase inhibitor, augments the vasodilatory effects of NO by preventing the degradation of cGMP. In this preliminary report we describe the use of vaginal sildenafil to improve uterine artery blood flow and sonographic endometrial appearance in four patients with prior failed assisted reproductive cycles due to poor endometrial response. The uterine artery pulsatility index (PI) was measured in a mock cycle after pituitary down-regulation with Lupron. The PI was decreased after 7 days of sildenafil (indicating increased blood flow) and returned to baseline following treatment with placebo. The combination of sildenafil and oestradiol valerate improved blood flow and endometrial thickness in all patients. These findings were reproduced in an ensuing gonadotrophin-stimulated cycle. Three of the four patients conceived. Although greater numbers of patients and randomized evaluation are needed to validate this treatment, vaginal sildenafil may be effective for improving uterine artery blood flow and endometrial development in IVF patients with prior poor endometrial response.

Administration, Intravaginal↗

The effect of timing of administration of oestradiol benzoate on characteristics of oestrus, timing of ovulation and fertility in Bos indicus heifers synchronised with a progesterone releasing intravaginal insert.

OBJECTIVE: To compare the timing of onset of oestrus and ovulation, characteristics of oestrus, and fertility in Bos indicus heifers synchronised with a progesterone releasing intravaginal insert (IVP4) and administration of oestradiol benzoate (ODB) either at the time of removal of the insert or 24 h later. DESIGN: Cohort study. PROCEDURE: Bos indicus and Bos indicus cross heifers were treated on two farms (Farm A, n = 273; Farm B, n = 47) with an IVP4 for 8 days with 1.0 mg of ODB administered at the time of device insertion and 250 mg of cloprostenol at the time of device removal. Heifers in the ODB-0 group were administered 0.75 mg of ODB at the time of device removal while heifers in the ODB-24 group were administered the same dose of ODB 24 h after device removal. Heifers were inseminated once daily after detection of oestrus. Heifers not detected in oestrus by 72 h after removal of inserts were inseminated at that time. Oestrus was detected in heifers on Farm A using heatmount detectors while on Farm B oestrus in heifers was monitored using radiotelemetry of mounting pressure. Ovarian follicular development was monitored daily in 30 heifers on Farm B from the time of administration of inserts until ovulation to a maximum of 96 h after removal of inserts, and again 11 days after removal of inserts (Day 19). A blood sample was collected from all heifers on Farm B on Day 19 and analysed for plasma concentration of progesterone. Pregnancy was diagnosed 6 to 8 weeks after insemination. RESULTS: Administration of ODB at the time of removal of inserts shortened the time interval to oestrus and ovulation (P < 0.001), increased the number of mounts recorded during oestrus (P = 0.04) and reduced the odds of pregnancy (P = 0.03). The proportion of heifers ovulating on Farm B was 67% and was not affected by treatment group (P = 0.61). The mean diameter of the largest follicle measured in ovaries was greater at the time of removal of inserts (9.1 +/- 0.6 vs 10.7 +/- 0.4; P = 0.03) and at the expected time of the LH surge (8.1 +/- 0.4 vs 11.5 +/- 0.3 mm; P < 0.001) in heifers that ovulated compared to heifers that failed to ovulate, respectively. Emergence of a new follicular wave was not detected during the synchronisation treatment in heifers that failed to ovulate. Concentrations of progesterone in plasma on Day 19 were less in non-pregnant heifers (P = 0.05) compared to heifers subsequently diagnosed as pregnant to insemination and were affected by the diameter of the ovulatory follicle (P = 0.01). CONCLUSION: Administration of ODB at the time of removal of inserts can shorten the time interval to oestrus and ovulation and can reduce fertility when insemination is carried out once daily. Further work is needed to determine if prolonged suppression of follicular development, anovulatory oestrus and premature ovulation occuring in some heifers is associated with administration of ODB.

Administration, Intravaginal↗

A study of intravaginal misoprostol for induction of labor in toxemia of pregnancy.

OBJECTIVE: To compare the efficacy and complications of intravaginal misoprostol for induction of labor in patients with and without toxemia of pregnancy. METHODS: Forty-two patients with toxemia of pregnancy (group 1) and 59 women at term without toxemia (group 2) with Bishop scores of < or = 6 were treated with 50 microg intravaginal misoprostol given four times at 4-h intervals. Labor and neonatal outcomes, and any complications, were recorded. Mann-Whitney U-, Student's t- and chi(2)-tests were used for statistical analyses. P < or = 0.05 was considered significant. RESULTS: The rates of vaginal delivery were 73.8% and 84.6%, oxytocin augmentation were 4.8% and 5.1% and the mean insertion to delivery times were 12.5 and 13.8 h in group 1 and 2, respectively, with no significant differences between the groups. Neonatal outcomes, rates of uterine contraction abnormalities and gastrointestinal symptoms were similar in both groups. CONCLUSIONS: Intravaginal misoprostol is an equally effective and safe method of induction of labor in patients with toxemia of pregnancy and in normal pregnant women.

Administration, Intravaginal↗

Recombinant human relaxin as a cervical ripening agent.

OBJECTIVE: The aim of this study was to investigate the efficacy and safety of recombinant human relaxin (rhRIx) as a cervical ripening agent in women with an unfavourable cervix before induction of labour at term. DESIGN: A multi-centre, double-blind, placebo-controlled trial performed in Edinburgh, Glasgow and Oxford. Women were treated with 0, 1, 2 or 4 mg of rhRIx in a gel vehicle administered intravaginally. Analysis of variance tests were performed on all continuous variables, and Cochran Mantel-Haenszel tests employed for all discrete variables. PARTICIPANTS: Ninety-six women at 37 to 42 weeks of gestation with a singleton pregnancy and a modified Bishop score of < or = 4 were recruited. RESULTS: There was no significant difference in the change in modified Bishop score between the four treatment groups. The lengths of the first and second stages of labour were similar in all 4 groups. PGE2 and oxytocin requirements were similar in all groups, as was the mode of delivery. There was no evidence that relaxin was absorbed systemically when given in this way. CONCLUSION: Recombinant human relaxin 1 to 4 mg, administered as an intravaginal gel, has no effect as a cervical ripening agent before induction of labour at term.

Administration, Intravaginal↗

Intravaginal immunization in sheep using a bioadhesive microsphere antigen delivery system.

An enzymatically cleaved glycoprotein fragment (amino acids 28-328: 40 kDa) from influenza virus haemagglutinin (TOPS) was used to assess an intravaginal antigen delivery system, comprising lysophosphatidylcholine (LPC) and degradable starch microspheres (DSM). Three groups of three sheep received intravaginal immunization with TOPS as follows: group 2, TOPS in solution; group 3, TOPS and DSM/LPC as a powder formulation and group 4, TOPS and LPC in solution. A fourth group, group 1, received intramuscular immunization with TOPS adsorbed to aluminium hydroxide gel (Alugel). Intravaginal immunizations were repeated on two consecutive days. Two weeks later, booster doses of the same formulations were administered on two consecutive days to each group. Group 1 sheep were boosted with a single injection, 2 weeks after the single primary immunization. The serum and vaginal wash IgA and IgG antibody responses were compared among the four groups of sheep at days 15, 30 and 45 after the booster immunizations. At day 45, the serum IgG and the vaginal wash IgA antibody responses induced by TOPS and DSM/LPC (group 3), were significantly greater than the responses induced by intravaginal immunization with TOPS (group 2). However, the highest levels of antibodies in serum and vaginal wash samples were induced by intramuscular immunization with TOPS and Alugel (group 1). Intravaginal immunization with TOPS and LPC (group 4) did not result in the induction of enhanced levels of antibodies in serum or vaginal wash samples.

Administration, Intravaginal↗

A randomized comparison of transcervical Foley catheter to intravaginal misoprostol for preinduction cervical ripening.

OBJECTIVE: To compare the efficacy of intravaginal misoprostol tablets with transcervical Foley catheter for preinduction cervical ripening. METHODS: Pregnant women who presented for induction of labor with unfavorable cervices (Bishop score less than 6) were assigned randomly to intravaginal misoprostol (50 microg tablet every 4 hours for a maximum of six doses) or 30-mL Foley catheter placed transcervically with maintenance of traction. RESULTS: Among 111 women, 53 were allocated to misoprostol and 58 to Foley bulb. Contractile abnormalities were more frequent in the misoprostol group (20.4%) than the Foley group (0%) (P <.001). No statistically significant differences were noted between groups in change in Bishop score, preinduction cervical ripening times, and total induction times. There were no statistically significant differences in mode of delivery or adverse neonatal outcomes. Uterine rupture occurred in one woman with two previous cesarean deliveries in the misoprostol group. CONCLUSION: Intravaginal misoprostol and transcervical Foley catheter are equivalent for cervical ripening. Uterine contractile abnormalities and meconium passage are more common with misoprostol.

Administration, Intravaginal↗