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A pilot study of the effect of methotrexate or combined oral contraceptive on bleeding patterns after induction of abortion with mifepristone and a prostaglandin pessary.

Although a combination of mifepristone and a prostaglandin is a safe, acceptable alternative to vacuum aspiration for inducing abortion in early pregnancy, the longer period of vaginal bleeding after medical abortion is a disadvantage. The present study investigated whether administration of the combined oral contraceptive pill (COC) or the injection of methotrexate at the time of abortion would shorten the period of vaginal bleeding after medical abortion. After having a medical abortion induced with mifepristone (200 mg) and 0.5 mg gemeprost pessary, 80 women were randomized to four groups of 20 women each; Group A, COC; Group B, control; Group C, 50 mg/m2 methotrexate; and Group D, placebo injection. There was no significant difference in the duration of bleeding between Groups A and B (median 14 and 17 days) or between Groups C and D (18 and 15 days), or in the amount of bleeding (4 days of heavy bleeding in each group). The first period occurred sooner in Group A who took the COC (median/range: 25/15-54 control group versus 32/16-46 days, p < 0.04). The administration of methotrexate was associated with a temporary elevation in liver enzyme concentration in one woman. It is concluded that women who wish to use COC can start immediately after medical abortion. Addition of methotrexate after abortion has no significant beneficial effect on patterns of bleeding and cannot be recommended.

Abortifacient Agents↗

Induction of therapeutic abortion in early pregnancy with mifepristone in combination with prostaglandin pessary.

Therapeutic abortion was induced in 100 women in early pregnancy (less than 56 days' amenorrhoea) with a combination of the antigestagen mifepristone (RU 486) and a synthetic prostaglandin analogue, gemeprost. Mifepristone in oral doses of 400-600 mg was followed 48 h later by a gemeprost vaginal pessary (0.5-1.0 mg). Bleeding was induced in all women 22-70 h after the mifepristone dose and although bleeding continued for 4-43 days (median 12) the total measured blood-loss was only a median of 72.5 ml (range 15-398). Complete abortion occurred in 95 women. Surgical evacuation of the uterus for minimum debris was required in the remaining 5. Only 10 women had diarrhoea or pain that required opioid analgesia. The combination of mifepristone and gemeprost provides a safe and effective alternative to surgical evacuation of the uterus for therapeutic abortion in early pregnancy.

Abortifacient Agents↗

Preoperative cervical dilatation by vaginal pessaries containing prostaglandin E1 analogue.

A double-blind trial comparing use of placebo with use of a single intravaginal pessary of 1 mg 16,16-dimethyl-trans-delta 2-prostaglandin E1 methyl ester, inserted approximately three hours before first-trimester surgical abortion, was carried out. There were 54 women each in the study and control groups. A spring gauge was used to record the force required to dilate the cervix. With the use of the prostaglandin analogue, operative time, blood loss, and the need for additional mechanical dilatation of the cervix were significantly reduced compared with the control group (P less than .0001). This reduction greatly facilitates the operation and should reduce the incidence of cervical trauma.

Abortifacient Agents↗

Plasma metronidazole concentrations after single and repeated vaginal pessary administration.

Metronidazole concentrations in plasma were measured by h.p.l.c. in 12 healthy female volunteers after single and repeated vaginal administration of 500 mg metronidazole pessaries. The area under the plasma concentration-time curve (AUC(0,12 h) was 8.4 +/- 3.9 micrograms ml-1 h (mean +/- s.d.) on day 1 and 20.6 +/- 7.1 micrograms ml-1 h (mean +/- s.d.) on day 5. The peak plasma drug concentration on day 1 was 1.2 +/- 0.6 micrograms ml-1 (mean +/- s.d.) and on day 5 it was 2.0 +/- 0.7 micrograms ml-1 (mean +/- s.d.). The plasma concentration of metronidazole at steady state was above the minimum inhibitory concentration (MIC) for anaerobic Streptococci and Clostridium tetani. These results demonstrate much lower systemic exposure than after oral administration.

Adult↗

Induction of labour with vaginal prostaglandin E2 pessaries.

Wax-based pessaries, each containing 3 mg of prostaglandin E2 (PGE2), were administered intravaginally for the induction of labour. The induction to delivery intervals were shorter than those in a control group induced by amniotomy and intravenous oxytocin. There was a remarkable reduction in the Caesarean section rate from 12 per cent in the control group to 2.4 per cent in the study group in primiparae, and from 8 per cent to 1.6 per cent in multiparae. Side effects associated with the PGE2 were rare, as were complications.

Adult↗

Lipoprotein levels during hormone replacement therapy by vaginal ring pessaries.

Nineteen women who had had a surgical menopause had a vaginal ring pessary containing levonorgestrel and oestradiol in situ for a period of 3 months. Fasting lipoprotein levels were measured before, and after 1 and 3 months on therapy. After 3 months total triglyceride levels were significantly lower than baseline values (P less than 0.01) as were very-low-density-lipoprotein cholesterol (P less than 0.01), low-density-lipoprotein cholesterol (P less than 0.05) and high-density-lipoprotein cholesterol (P less than 0.001) levels. These changes suggest that in this preparation the effects of the progestogen component are dominant.

Adult↗

Interruption of first trimester human pregnancy following Epostane therapy. Effect of prostaglandin E2 pessaries.

The effect of Epostane, a competitive inhibitor of the 3 beta hydroxy steroid dehydrogenase enzyme system in combination with prostaglandin E2 (PGE2) for induction of abortion in early first trimester pregnancy has been studied in a group of 20 women awaiting termination of pregnancy. The women were consecutively assigned to four treatment groups. The first group was treated with PGE2 alone, administered vaginally as a lipid based (Witepsol) pessary. The remaining three groups received Epostane at differing doses for 5 days, and were treated with PGE2 on the fourth day. Significant falls in serum progesterone and oestradiol occurred in the Epostane-treated patients. Abortion was induced in one of the five control patients and in three of 10 patients treated with low doses (300-400 mg) of Epostane. Intrauterine pressure monitoring showed an increased reactivity to PGE2 in the treated groups. At the highest dose (600 mg) of Epostane, serum progesterone and oestradiol showed the greatest decline to 8% and 21% of the pretreatment values, a prompt and sustained pressure response occurred to PGE2 and abortion was induced in all five patients. A critical degree of progesterone suppression appears to sensitize the myometrium to exogenous prostaglandin. This combined treatment is an effective method of early pregnancy termination and may have a role in the management of mid-trimester abortion.

3-Hydroxysteroid Dehydrogenases↗

Oral ketoconazole and miconazole vaginal pessary treatment for vaginal candidosis.

This prospective study was carried out on 250 patients having clinical and mycological evidence of vaginal candidosis. One hundred patients received ketoconazole orally (400 mg/day for 5 days), another 100 patients received miconazole vaginal pessary treatment (one 100 mg tablet locally for 14 days), while the other 50 patients received combination therapy of oral ketoconazole and miconazole vaginal tablets. Although all 3 regimens were significantly effective in relieving patients symptoms and physical signs, the combination therapy gave the best results. There was 98% symptomatic relief with the combination therapy in contrast to 82% and 78% in the oral ketocanozole and vaginal micronazole groups respectively (p less than 0.001). Mycological cure rates were also significantly higher in the combination therapy group (94% versus 80% and 76%). The relapse rate was least in the combination group 2% versus 8% and 12%. The combination therapy is recommended for the best results in vaginal candidosis.

Administration, Oral↗

A comparison of Syntocinon infusion with prostaglandin vaginal pessaries when spontaneous rupture of the membranes occurs without labour after 34 weeks gestation.

In a prospective randomized trial of 106 patients who had spontaneously ruptured their membranes greater than or equal to 4 hours in the absence of labour, vaginal prostaglandin E2 pessaries and intravenous Syntocinon were compared. There was no significant difference in the treatment to delivery times between the 2 groups. The number of operative deliveries in each group were comparable. No untoward side-effects were noted. The use of vaginal prostaglandin E2 tablets appears to be a safe alternative to Syntocinon for induction of labour when spontaneous rupture of membranes has occurred in the absence of uterine contractions.

Dinoprostone↗

Induction of labour with a sustained-release prostaglandin E2 vaginal pessary.

A new polymer vaginal pessary providing sustained constant release of prostaglandin E2 was administered to 66 patients before planned induction of labour. Effective ripening of the unfavourable cervix was achieved in each of 18 primigravidas, in eight of whom labour was initiated without further treatment. When the cervix was moderately favourable the need for orthodox induction of labour was obviated in 16 out of 23 primigravidas and 21 out of 23 multigravidas. This method of sustained release of prostaglandin E2 is simple and convenient and readily acceptable to the patient; it is an important step in the development of non-invasive methods of inducing labour.

Delayed-Action Preparations↗

Comparison of vaginal flora after treatment with a clotrimazole 500 mg vaginal pessary or a fluconazole 150 mg capsule for vaginal candidosis.

The effect of antifungal therapy on the vaginal microbial flora was studied in 23 patients suffering from culture-positive, symptomatic vaginal candidosis. They were randomly allocated to receive either a 500 mg clotrimazole vaginal pessary or a 150 mg fluconazole capsule. Quantitative microbiological examination was carried out on samples of vaginal secretions obtained prior, and at intervals up to 10 days after, treatment. No significant difference was found in the vaginal flora before or after therapy in individual patients or between the treatment groups. In patients with C glabrata or C krusei, the yeasts persisted longer in the vagina with poorer response to either of the medications.

Administration, Oral↗

A randomised, double-blind, placebo-controlled trial of gemeprost (Cervagem) pessaries for cervical dilatation in non-pregnant women.

In a randomised, double-blind trial, 75 women received either placebo or a 1-mg gemeprost (Cervagem) pessary for cervical dilatation prior to gynecological procedures which require mechanical dilatation of the cervix. No significant difference was seen between gemeprost and placebo with respect to preoperative cervical dilatation. The incidence of vaginal bleeding and adverse effects was similar in each group.

Alprostadil↗

[Therapy of cervix insufficiency--cerclage or support pessary?].

To evaluate the efficiency of cerclage or pessary a prospective random study has been done from 1982 to 1983. Pelvic score of Bishop and tocolysis index of Baumgarten were used to define the situation at the beginning. Success has been estimated with help of neonatal parameters (birth weight, Apgar score and RDS-morbidity) and final gestational week. Both methods are equal in their effects.

Adult↗

Treatment of vaginal candidiasis in pregnancy with a single clotrimazole 500 mg vaginal pessary.

A single vaginal pessary containing clotrimazole 500 mg (Canesten; Bayer-Miles) was used to treat candidiasis during a prospective, mycologically controlled trial among 46 patients in the second and third trimesters of pregnancy. Positive cultures were obtained from vaginal swabs before commencement of treatment. Swabs were taken 1 week and 1 month after treatment. Four patients were lost to follow-up. One week after treatment 83,3% of the patients were cured on microscopic and mycological examination, and all of the patients had relief of symptoms. The recurrence rate was 5,7% after 1 month. Of the 7 patients in whom treatment was unsuccessful, 3 were available for repeat treatment and all 3 responded successfully to a second course.

Candidiasis, Vulvovaginal↗