A Pre-Phase III Efficacy Trial of the Spermicide/Contraceptive Effect of the Invisible Condom, a Non-Hormonal Vaginal Gel, in Women from Canada.

OBJECTIVES: To evaluate the spermicidal efficacy of non-hormonal vaginal gel in vitro and in a post-coital test, and to evaluate its contraceptive efficacy in Canadian women of childbearing age. METHODS: We conducted single-centre trial to assess spermicidal and contraceptive efficacy of vaginal gel. Participants were healthy, sexually active women aged 18-49 years and their regular male sexual partners (30 couples). Measured outcomes included effect of vaginal gel on sperm motility in vitro, its effect on sperm in a post-coital test, and its effect on pregnancy prevention over 3 months. RESULTS: For in vitro spermicidal effect, 98% and 67% of sperm were immotile in the presence of the gel with sodium lauryl sulfate (gel-SLS) and gel alone, respectively. For the post-coital test, 99% and 93% of sperm were immotile in the presence of gel-SLS and gel alone, respectively. In the second part of trial, a total of 410 instances of vaginal intercourse in 95 menstrual cycles were protected (during 3-month period of gel-SLS use before each sexual intercourse with probability of 24 conceptions prevented according to Wilcox's table). Four women became pregnant during the study period; 2 during unprotected vaginal intercourse around the time of ovulation, and 2 attributed to user failure. CONCLUSION: Based on our results, the vaginal gel demonstrated important spermicidal and contraceptive effect. A larger phase III contraceptive efficacy trial is warranted. The vaginal gel may represent a non-hormonal spermicide/contraceptive option for women.

[A multicenter, randomized, open and positive parallel controlled clinical study of clotrimazole vaginal expansion suppository and vaginal tablet in the treatment of mild and moderate vulvovaginal candidiasis].

Objective: Using clotrimazole vaginal tablet as a positive control, to evaluate the results of clotrimazole vaginal expansion suppository in the treatment of mild and moderate vulvovaginal candidiasis in terms of efficacy, patient satisfaction, side effects, and recurrence rate. Methods: This study was jointly conducted by 5 hospitals from August 2017 to October 2018, patients with mild and moderate vulvovaginal candidiasis confirmed by fungal culture and symptoms scores were selected. They were randomized to experimental group and control group as 1∶1 ratio. In the experimental group (n=105), the subjects applied clotrimazole vaginal expansion suppository (150 mg) daily at night for 7 days. In the control group (n=106), the subjects used a single dose of clotrimazole vaginal tablet (500 mg). Follow-ups were performed at (8±3) and (30±5) days after the discontinuation of the drugs, respectively. The difference in clinical symptoms and signs scores was used to evaluate the improvement of clinical symptoms, and the patient's satisfaction and side effects were recorded. Results: At the first follow-up, the experimental group and control group were followed up by fungal culture on the cure rate [66.7% (70/105) versus 63.2% (67/106), P>0.05] and total effective rate [98.1% (103/105) versus 99.1% (105/106), P>0.05], the differences were not statistically significant. At the second follow-up, the recurrence rates of the experimental group and the control group were 5.7% (4/70) and 14.9% (10/67), respectively, with no significant difference (P>0.05). In the evaluation of patient satisfaction, the leakage of the drug in the experimental group was significantly better than that in the control group (P<0.01). The side effects mainly included vaginal stimulation, itching and burning sensation, and there was no statistical difference between the two groups (χ2=1.070, P=0.586). Conclusions: In the treatment of mild and moderate vulvovaginal candidiasis, clotrimazole vaginal expansion suppository is no less effective than clotrimazole vaginal tablet, and there is no significant difference in the recurrence rate between the two. In terms of patient satisfaction, clotrimazole vaginal expansion suppository is superior to clotrimazole vaginal tablet.

Guideline No. 398: Progesterone for Prevention of Spontaneous Preterm Birth.

OBJECTIVES: To assess the benefits and risks of progesterone therapy for women at increased risk of spontaneous preterm birth (SPB) and to make recommendations for the use of progesterone to reduce the risk of SPB and improve postnatal outcomes. OPTIONS: To administer or withhold progesterone therapy for women deemed to be at high risk of SPB. OUTCOMES: Preterm birth, neonatal morbidity and mortality, and postnatal outcomes including neurodevelopmental outcomes. INTENDED USERS: Maternity care providers, including midwives, family physicians, and obstetricians. TARGET POPULATION: Pregnant women at increased risk of SPB. EVIDENCE: Medline, PubMed, EMBASE, and the Cochrane Library were searched from inception to October 2018 for medical subject heading (MeSH) terms and keywords related to pregnancy, preterm birth, previous preterm birth, short cervix, uterine anomalies, cervical conization, neonatal morbidity and mortality, and postnatal outcomes. This document represents an abstraction of the evidence rather than a methodological review. VALIDATION METHODS: This guideline was reviewed by the Maternal-Fetal Medicine Committee of the Society of Obstetricians and Gynaecologists of Canada (SOGC) and approved by the SOGC Board of Directors. BENEFITS, HARMS, AND/OR COSTS: Therapy with progesterone significantly reduces the risk of SPB in a subpopulation of women at increased risk. Although this therapy entails a cost to the woman in addition to the discomfort associated with its use, no other adverse effects to the mother or the baby have been identified. SUMMARY STATEMENTS (GRADE RATINGS IN PARENTHESES): RECOMMENDATIONS (GRADE RATINGS IN PARENTHESES).

Intravaginal Application of Topical Black Salve for High-Grade Cervical Intraepithelial Neoplasia.

Background: Black salve, or sanguinarine, is a topical escharotic agent that has been used by patients for homeopathic ablation of epithelial dysplasia, including cervical intraepithelial neoplasia. Case Report: A 33-year-old female presented to the obstetric and gynecologic clinic for management of a missed abortion. At the time of presentation, she admitted to the use of topical black salve for treatment of cervical intraepithelial neoplasia 2 years prior. Speculum examination revealed a stenotic cervix that appeared flush against the vaginal cuff. Hysteroscopy performed 4 months later after the patient developed new oligomenorrhea revealed significant vaginal scarring with formation of a blind pouch that concealed the true cervix. Conclusion: Health care providers should be aware of homeopathic remedies trialed by patients on their own or as an alternative to recommended treatment. Such self-treatment may cause significant patient harm, such as scarring or deformity.

Effect of Sophora flavescens alkaloid on aerobic vaginitis in gel form for local treatment.

OBJECTIVE: To investigate the effect of Sophora flavescens alkaloid (SFA) in gel form on aerobic vaginitis (AV) and the possible mechanism underlying the effects. METHODS: AV rat models were prepared by intravaginal inoculation of Escherichia coli and Staphylococcus aureus. SFA gel and placebo gel were intravaginally administered. In vivo antibacterial effects, vaginal microenvironment, vaginal smears, pathological tissues of vaginas, and retention of gel in the vaginal cavity were investigated. RESULTS: SFA gel had much higher antibacterial effect than placebo gel. SFA gel protected the vaginal mucosa from erosion of bacteria. At the same time, they inhibited the inflammatory responses, exhibiting little leukocytes and parabasal cells. Furthermore, the number of vaginal Lactobacilli remarkably increased following administration of SFA gel. However, the vaginal pH did not recover to the healthy acidic levels after treatment due to the buffering effect of gel. The gel of a fluorescent agent, Cyanine 7, showed very long retention time in the vaginal cavity, up to more than 24 h, much longer than the solutions. CONCLUSION: The SFA gel is a promising medicine for local treatment of AV with the advantages of anti-bacteria, protection of vaginal mucosa, increase of Lactobacilli, and long retention time in the vaginal cavity.

Intravaginal prostaglandin-E2 for cervical priming and induction of labour

A prospective study examined the safety, efficacy and labour outcome in 436 women undergoing labour induction using intravaginal prostaglandin E2. Women with singleton pregnancies [235 nulliparas and 201 multiparas] were recruited if they had a clinically unfavourable cervix, and indications for induction. The mean [standard deviation] interval from initiation to delivery was statistically significantly shorter in multiparas than nulliparas: 13.5 hours [SD 1.8] versus 15.5 hours [SD 2.4]. No more than 2 x 3 mg tablets were needed to achieve a clinically feasible cervix for amniotomy. The overall need for oxytocin augmentation of labour was 42%, significantly higher in nulliparas [47%] than multiparas [35%]. Intrapartum complications, caesarean section and perinatal deaths showed no statistically significant differences between the groups

Termination of second trimester, complicated gestation

To assess the effectiveness of intravaginal misoprostol for second trimester uterine evacuation, we studied 70 women with singleton pregnancies complicated by fetal malformation or dead fetuses. Participants received 200 microgram misoprostol administered at 4-hour intervals. Gestations with dead fetuses had a shorter induction-abortion interval [14.2 hours, st and ard deviation [SD] 4.3] than those with live, malformed fetuses [20.2 hours, SD 7.3] [P< 0.001]. The abortion rate was significantly higher for gestations with dead fetuses [92.1%] than those with live, malformed fetuses [68.8%] [P< 0.05]. There were no major complications and no significant difference in the incidence of side-effects. All women aborted within 38 hours. Administration of misoprostol is an effective clinical method to terminate second trimester, complicated pregnancy

Comparison of prostaglandin E2 tablets or Foley catheter for labour induction in grand multiparas

The efficacy, safety and outcome of prostagl and in [PG]E2 was compared with Foley catheter for labour induction in gr and multiparous women. At a hospital in Jordan, 147 women with Bishop score </= 5 were r and omized to receive 3 mg PGE2 vaginal tablets [n = 75] or 50 mL intracervical Foley catheter [n = 72]. The change in Bishop score was significantly higher in the PGE2 group than the catheter group, and time from induction to delivery was significantly shorter in the PGE2 group. Significantly more women needed oxytocin for labour augmentation in the catheter than the PGE2 group and fetal distress was significantly more frequent. For gr and multiparas, PGE2 vaginal tablets may be preferable for ripening the cervix as well as for labour induction

Vaginal misoprostol in managing premature rupture of membranes

We compared the efficacy of misoprostol with that of prostaglandin E2 in cervical ripening and labour induction. Thus 238 women with rupture of membranes beyond 36 weeks gestation without labour were randomized to receive 50 microg misoprostol vaginal gel or 5 mg of prostaglandin E2 gel. Bishop score was evaluated before drug application and 6 hours later. Clinical data and perinatal outcome were recorded. Mean time from induction to delivery and the need for oxytocin were significantly less in the misoprostol group. There were no significant differences in spontaneous labour rate, type of delivery and perinatal outcome. It is concluded that intravaginal misoprostol is safe and more effective than prostaglandin E2 for preinduction cervical ripening in premature rupture of membranes beyond 36 weeks gestation