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The development of fistulas between the bladder and right ovary in a 27-year-old woman is reported. This exceedingly rare form of an internal vesical fistula occurred as a consequence of dextrolateral adnexitis with suppurative ovarian inflammation after placement of an intrauterine pessary. Therapy consisted of removal of the right adnexa, excision of the fistulous duct and suturing of the bladder.
This study from a community hospital documents the relatively frequent occurrence of Actinomyces in 36 women diagnosed by Papanicolaou stained cervicovaginal smears. Actinomyces was identified exclusively in patients wearing an intrauterine or vaginal foreign body (intrauterine devices and pessaries). By using fluorescein isothiocyanate labeled antiserum, the organisms were shown to be Actinomyces israelii in eight randomly selected smears. In five cases Actinomyces was demonstrated in tissues obtained by endocervical and endometrial curettage. Anaerobic microbiologic studies performed in 11 of the 36 cases showed a relatively high rate of recovery of Actinomyces (36.3 per cent) with a yield of four positive cultures. In two cases the isolated organisms were shown to be Actinomyces israelii. In the remaining two cases the exact species of Actinomyces has remained uncertain. Of the 36 patients with smear evidence of Actinomyces, nine (25 per cent) had pelvic inflammatory disease, a rate that appears to be much higher than the already high rate among all intrauterine device users. This observation underscores the importance and clinical significance of the finding of Actinomyces in the vaginal smears of intrauterine device users. Papanicolaou stained cervicovaginal smears provide a relatively easy, inexpensive, fast, and highly specific method for the morphologic diagnosis of Actinomyces and allows us to recognize at a relatively early stage a group of patients who are potentially at risk for the development of pelvic inflammatory disease and its associated more severe complications. The hope is that prompt identification of Actinomyces in cervicovaginal smears can help to prevent the more serious infectious complications in intrauterine device users.
OBJECTIVES: To determine the perioperative morbidity of performing a concurrent pubovaginal sling with prolapse repair in women with occult (or potential) stress incontinence, particularly on voiding dysfunction and emptying. METHODS: We reviewed the charts of 38 women with grade 3-4 pelvic prolapse and occult stress incontinence. All patients underwent video urodynamic testing with the prolapse unreduced and again with the prolapse reduced with a pessary or packing. The abdominal leak point pressure was determined. Appropriate surgical repair of all components of the prolapse was performed concurrently with pubovaginal sling placement. The outcomes were measured with respect to the time to spontaneous voiding, permanent urinary retention, development of stress incontinence or de novo urge incontinence, resolution of urge incontinence, and perioperative complications. RESULTS: The mean age was 72 years, and the mean follow-up was 15 months (range 6 to 39). The mean time required before spontaneous voiding resumed without the need for catheterization was 11.8 days (range 2 to 46). No patient developed permanent urinary retention. Two (9.5%) of 21 women without preoperative urge incontinence developed de novo urge incontinence. However, existing urge incontinence resolved in 45%. One woman developed a suprapubic wound infection, which resolved with conservative management. Stress incontinence occurred in 2 women (7%) at 4 and 19 months postoperatively. Clinically significant prolapse (uterine) developed in 1 patient 2 years after surgery. CONCLUSIONS: Simultaneous pubovaginal sling placement for women with occult stress incontinence undergoing repair of a large pelvic prolapse is effective in preventing postoperative stress incontinence and has little negative effect on postoperative bladder emptying. It should be considered in all women with occult stress incontinence undergoing prolapse repair.
Acute urinary retention during pregnancy is rare. Retention secondary to an impacted, gravid uterus is an emergency. Retroversion of the uterus, a history of pelvic inflammatory disease, and large fibroids are predisposing factors. The enlarging gravid uterus and uterine fibroids may trap the uterus inside the pelvic ring, preventing it from ascending into the abdominal cavity; furthermore, a history of inflammatory disease may trap the fundus of the uterus within scar tissue that also may prevent the enlarging, gravid uterus from ascending into the abdominal cavity. The impacted uterus should be manually replaced in the anterior position. Clean intermittent catheterization and placement of a vaginal pessary are temporizing measures. A knowledge of the causes of urinary retention during pregnancy can help prevent spontaneous abortion and other devastating consequences that can arise as a result of a delay in the diagnosis.
The absorption rates of PGE2 released from tablets, gel and pessary bases inserted into the vagina for the induction of labour in a total of 27 patients have been measured by means of serial plasma 15-keto-PGE2 levels. The results are discussed with a view to obtaining both the optimum dose of PGE2 and vehicle of release.
The objective was to investigate the effects of dietary energy and urea supplementation on oocyte and embryo quality in sheep using in vivo and in vitro experimental models. Sixty-three ewes were fed grass meal at 0.5 or 2.0 times maintenance energy requirements (MER). The diet was supplemented with feed grade urea (U) for half of the ewes on each energy treatment. Ewes were stimulated with 1000 IU eCG and either slaughtered on the day of pessary withdrawal, for in vitro embryo production, or mated and slaughtered on Day 5 for embryo recovery. Urea decreased cleavage rate (48.3 vs 39.7%) and consequently blastocyst rate (41.6 vs 36.8%) but the differences were not significant. Oocytes from animals on 2.0 MER had a lower cleavage rate (54.9 vs 36.0%) and blastocyst yield (49.3 vs 31.4%) than those on 0.5 MER. However, there was an interaction between urea and energy for cleavage (P = 0.04) and blastocyst yield (P = 0.03) indicating a variable response to urea in the presence of high energy. This was manifested by a decrease in cleavage rate in the presence of urea and high energy (22%, 8 of 36), and a reduction in blastocyst development (19%, 7 of 36). When blastocyst development rate was expressed as a proportion of cleaved oocytes there was no difference between groups; in addition, there was no difference between groups in terms of blastocyst hatching rate (overall mean 66.1%) or blastocyst cell number on Day 8 (overall mean +/- SEM, 138.4 +/- 9.0, n=61). The effect of urea on cleavage rate in vivo was more severe. Urea supplementation reduced (P<0.001) the cleavage rate (93 vs 62%). Despite this, the yield of blastocysts was unaffected. Oocytes from ewes on 0.5 MER exhibited a lower (P<0.05) cleavage rate than those on 2.0 MER (66 vs 87%). This effect was also apparent at the blastocyst stage (40.0 vs 50.9%), although the difference was no longer significant. There were no differences in hatching rate (overall mean 70.7%) or blastocyst cell numbers (overall mean +/- SEM, 166.3 +/- 15.6, n=40). Collectively, these results suggest that both high dietary energy and urea content influence subsequent embryo development in vitro, and the deleterious effects of urea are likely influenced by concomitant energy intake.
The effect of exogenous melatonin on prostaglandin secretion was measured on Rasa Aragonesa ewes. Fourteen ewes received an 18 mg melatonin implant (M+) on 10 April and were compared with 13 control animals (without implants M-). Twenty days later, intravaginal pessaries were inserted in all animals to induce a synchronized oestrus (day 0). On day 14, ewes were injected, i.v., with 0.5 IU oxytocin. Plasma 15-ketodihydro-PGF(2alpha) (PGFM) concentrations were measured to assess uterine secretory responsiveness to oxytocin. After euthanasia, pieces of endometrium were collected to determine progesterone content and PGE(2) and PGF(2alpha) secretion in vitro, in the presence or absence of either 20 microg/ml recombinant ovine interferon-tau (roIFNt) or 1 nmol/l oxytocin in the medium. Endometrial progesterone content was similar in the two treatments (M+: 50.25+/-17.34 ng/mg tissue, M-: 43.08+/-11.21 ng/mg tissue). M+ ewes that responded to oxytocin had significantly higher plasma PGFM concentrations between 10 and 80 min after oxytocin administration, a higher mean PGFM peak (P<0.001), higher plasma PGFM levels after the challenge (P<0.05) and higher plasma progesterone concentrations (P<0.01) than control ewes. In the in vitro experiment, M+ and M- control samples secreted similar amounts of PGE(2). The presence of roIFNtau and oxytocin only stimulated PGE(2) production (P<0.05) in M- tissues. Control M+ tissues secreted higher amounts of PGF(2alpha) (P=0.07) and PGF(2alpha) secretion was significantly (P<0.01) stimulated by roIFNtau. Oxytocin produced this effect only in M- samples (P<0.01). In conclusion, although previous studies have demonstrated a positive effect of melatonin on lamb production, PGF(2alpha) secretion is higher in vitro and the PGE(2):PGF(2alpha) ratio is unfavourable in response to IFNtau, which could affect embryo survival. Whether or not these mechanisms are similar in pregnant ewes remains to be elucidated.
Based on our previous work, we found that exogenous oxytocin induces uterine tetany and cervical dilation, and permits transcervical access to the uterus. However, the oxytocin does not reduce sustained sperm transport from the uterus to the oviducts. Thus, we hypothesized that exogenous oxytocin may be a useful adjunct to transcervical intrauterine AI procedures for sheep: two experiments were conducted to test our hypothesis. In Experiment 1, purebred ewes (n = 75/group) were artificially inseminated intrauterine with either laparoscopic or oxytocin-transcervical (i.e., 200 USP units of oxytocin 30 min before AI) procedures. At 54 h after progestogenated pessaries were removed, ewes were inseminated with 200 x 10(6) sperm/0.25 ml of fresh, extended semen, which was collected from a purebred ram of the corresponding breed. Pregnancy rate was greater (P < 0.05) after laparoscopic (37.5%) than after transcervical AI (0%). Because of the disappointing results of Experiment 1, Experiment 2 was conducted to determine whether oxytocin or the AI procedure per se reduced ovum fertilization rate. Treatments were designed in a 2 x 2 factorial arrangement. At 60 h after norgestomet implant removal and 10 min before either laparoscopic or transcervical (cervical in a saline group) AI with 100 x 10(6) sperm/0.25 ml, ewes (n = 10/group) received an intravenous injection of either isotonic saline or 200 USP units of oxytocin. Fertilization rate, which was determined 72 h after AI, was greater (P < 0.05) after laparoscopic than after transcervical/cervical AI (92.5 vs 28%), but oxytocin treatment did not affect fertilization rate. The results indicate that exogenous oxytocin did not reduce ovum fertilization rate, but the transcervical AI procedure per se seemed to reduce fertilization rate.
We investigated the effect of GnRH given after gonadotropin stimulation on follicle growth and oocyte quality in young calves in a transvaginal oocyte recovery program. A 60 mg MPA pessary was inserted into each of nineteen 5-mo-old Friesian calves for 7 d; on Day 5 they received 140 mg, s.c. FSH (Folltropin) and 200 IU, i.m. PMSG and on Day 8 ten of the calves received 40 micrograms, i.m. GnRH (Fertagyl). Follicles were measured and aspirated on Day 9 using an ultrasound unit with a 6 MHz transvaginal probe (Toshiba). Oocytes from individual calves were recovered, graded and cultured in maturation media for 2 h (+GnRH group) or 22 h (-GnRH group), then fertilized and cultured for 6 d in SOF containing 0.8% BSA and amino acids. Oocyte viability (Class A,B or C) and embryo morphology were recorded. This procedure was repeated on the 19 calves plus 5 others 1 m.o. later, after random allocation to their respective groups. Approximately 70% of the calves responded to gonadotropin stimulation (> 2 follicles over 5 mm in diameter). Calves receiving GnRH tended to have both a higher number of follicles > 2 mm in diameter (27.1 vs 18.7) and of aspirated follicles (22.0 vs 14.1); however, there was a large variability between individuals (0 to 83 follicles and 0 to 73 aspirated). The total number of oocytes collected (10.8 vs 10.9) was not affected by GnRH treatment, probably due to the poor recovery rates in the highly stimulated calves from the +GnRH group, but GnRH did improve the proportion of viable oocytes (6.5 vs 4.1) due to a lower number of Class E oocytes (1.4 vs 4.5; P < 0.05). In the GnRH group, 40% of the viable oocytes had matured at the time of collection versus 0% in the group not treated with GnRH. The necessity of different culture runs between times and treatments prevented any meaningful comparison between groups for embryo development. Following the transfer of 19 morula/blastocyst-stage embryos to recipients, 3 pregnancies were detected by ultrasound examination on Day 60, with 1 oocyte originating from the +GnRH group and 2 from the -GnRH group.
309 women whose menstruation was delayed by 3-35 days were treated with intrauterine or vaginal prostaglandins. Of 275 confirmed pregnancies, 229 were successfully terminated without further abortifacient therapy. A successful outcome was often associated with episodes of vomiting, diarrhoea, and uterine cramps in the 24 hours after prostaglandin administration, but the incidence was related to prostaglandin dosage and gastrointestinal side-effects were more common after vaginal administration. The best results were achieved by the analogue 16:16 dimethyl P.G.E2 as a vaginal pessary. 14 patients (6.1%) required uterine curettage for escessive or prolonged bleeding, while 2 patients required blood transfusion. One patient, who had an intrauterine contraceptive device left in situ during treatment, developed acute pelvic sepsis. No deleterious side-effects occurred in 34 patients who were subsequently proven not to be pregnant at the time of treatment. Treatment by intrauterine or vaginal prostaglandins offers promise as a method of pregnancy termination which avoids much of the physical and emotional trauma associated with surgical termination, and has the advantage of not requiring hospital admission in the majority of cases. The present study shows the safety of the method, and its potential as a self-administration technique.
Twenty-seven randomized patients with biopsy proven carcinoma of the uterine cervix were treated with human natural leucocytic interferon (HNLI) and followed up, while 30 randomized patients were followed up in the control group and were not treated with HNLI. International Federation of Gynecology and Obstetrics (FIGO) classification of HNLI-treated patients was IA: 8, IB: 9, IIA and IIB: 10. FIGO classification of control non-treated patients was IA: 9, IB: 10, IIA and IIB: 12. HNLI was applied locally at 2x10(6) U daily in pessaries for 21 days before surgery. Survival analysis of the HNLI-treated patients after 240 months of observation showed that 20 patients (74.07%) out of 27 survived, and in the control group 14 patients (46.67%) out of 30 survived. Statistical difference between the HNLI-treated group and control group of patients is significant P<0.05.
Nonlactating Leccese ewes (n = 61) were used during seasonal anestrus to investigate the effects on ovarian response and embryo production of adding defined amounts of p-LH to purified p-FSH as well as decreasing the FSH/LH ratio during treatment. The ewes were synchronized with FGA-impregnated intravaginal pessaries for 9 days and prostaglandin F2 alpha (Cloprostenol) injected on the seventh day. They were divided into six treatment groups in a 3 x 2 factorial design: three amounts of purified p-LH (100, 50 or 25% equivalent to 525, 262 or 131 IU p-LH) x 2 regimen of p-FSH and p-LH administration (constant or decreasing FSH/LH ratio). Each ewe received a total of 525 IU p-FSH at a decreasing dose, twice daily over a 3-day period. Group I (n = 11), Group II (n = 10) and Group III (n = 10) were treated with p-FSH supplemented with p-LH at 100%, 50% and 25%, respectively, of p-FSH dose and a constant FSH/LH ratio throughout the treatment period. Group IV (n = 10), Group V (n = 10) and Group VI (n = 10) were treated with p-FSH supplemented with p-LH at 100%, 50% and 25%, respectively, of p-FSH dose but with a decreasing FSH/LH ratio over the 3 days of the treatment: 1.7-0.86-0.43 for Group IV; 3.4-1.7-0.86 for Group V; 6-3-1.5 for Group VI. Embryos were flushed surgically on Day 6 after estrus. The ovulation rate did not differ among the groups (8-12.8). Superovulation with 100% p-LH and decreasing the FSH/LH ratio (Group IV) resulted in: (i) the highest ova recovery (9.8 +/- 1.7), and this was significantly different (P < 0.05) from the 25% p-LH treated group (Group VI; 5.0 +/- 1.7), (ii) the highest fertilization rate (90.6 +/- 9.2%), with a significant (P < 0.01) difference compared with the constant ratio regimen (Group I; 62.6 +/- 8.3%); (iii) the highest transferable embryo yield (6.4 +/- 1.1), differing significantly (P < 0.01) from Group VI (2.2 +/- 1.1) and Group I (2.7 +/- 1.0). It is concluded that decreasing the amount of p-LH added to purified p-FSH did not improve the superovulatory response of ewes during the anestrous period. Transferable embryo production was significantly improved when ewes were treated with p-LH equivalent to 100% p-FSH, with the FSH/LH ratio decreasing during treatment.
During the ovine estrous cycles, three waves of follicular growth, closely associated with the FSH secretion pattern, were observed. The parameters of these follicular waves and the ability of follicles to produce steroids in vitro were studied in various conditions. In vivo, the follicular events were similar between the breeding season and the anestrus, except for the lack of ovulation; but at the end of the breeding season and in anestrus, the follicles lose a big part of their aromatization ability. In ewes carrying the Booroola fecundity gene or Cambridge fecundity gene, the reduction in follicular atresia seems to be one of the main follicular features implicated in the control of high ovulation rate. In vitro, the most relevant difference is an early acquisition of estrogen production ability of small follicles in Booroola fecundity gene barring ewes. Fluoro-gestone-acetate (FGA) pessaries reduced the number of growing follicles; despite this effect disappearing after the sponge withdrawal, the ovulation rate is significantly reduced. But an equine chorionic gonadotrophin (eCG) treatment restores the ovulation rate (OR) by reducing the atresia rate of pre-ovulatory follicles. In similar conditions, a pretreatment of the ewes with melatonin again reduced the atresia rate of large follicles and resulted in an increased ovulation rate. In vitro, FGA blocked aromatization ability, and melatonin inhibited both androstenedione and estradiol production, but a further treatment with eCG partly restores the steroid secretion. Immunization against androstenedione leads to a higher OR, owning to a reduced atresia of large follicles. Daily growth hormone injections for a hole cycle resulted in an increased follicular population and ovulation rate, while FSH plasma levels decreased and the follicle sensitivity to gonadotrophins was reduced.
OBJECTIVES: to examine the effectiveness and safety of controlled-release prostaglandin for cervical ripening. DATA SOURCES: we conducted a computerized search of Medline using the keywords "Cervidil"; or "Propess"; or "prostaglandin/dinoprostone" and "pessary"; or "prostaglandin/dinoprostone" and "controlled" and "release"; or "prostaglandin/dinoprostone" and "vaginal" and "insert"; identifying studies in the English literature published between January 1980 and December 1999. STUDY SELECTION: we included all randomized trials that compared controlled-release vaginal prostaglandin with a retrieval string with any other method of cervical ripening or with a placebo. Nine studies were identified.TABULATION, INTERACTION, AND RESULTS: the two coauthors independently abstracted the data and evaluated the studies for methodologic quality, blinded to each other's results. Homogeneity of results was evaluated, and if present, the summary odds ratio and 95 percent confidence intervals were determined. Compared with placebo, controlled-release prostaglandin resulted in cervical change (summary odds ratio [OR] = 3.99, 95% confidence interval [CI] = 2.71-5.86), a higher rate of vaginal delivery in 12 hours (OR = 29.01, 95% CI = 7.08-118.87), less need for oxytocin (OR = 0.14, 95% CI = 0.06-0.32), but a higher incidence of excessive uterine activity (P<0.0001) and hyperstimulation (P = 0.004). When compared with Prepidil, there was a higher rate of excessive uterine activity with controlled-release prostaglandin (P = 0.03), but less need for oxytocin (OR = 0.09, 95% CI = 0.01-0.53). When compared with Prepidil/immediate oxytocin, there was a lower rate of active labour in 12 hours with controlled-release prostaglandin (OR = 0.27, 95% CI = 0.10-0.72). There was a lower rate of vaginal delivery in 12 hours and higher incidence of oxytocin use with controlled-release prostaglandin as compared with misoprostol (OR = 0.53, 95% CI = 0.34-0.83 and OR = 1.58, 95% CI = 1.08-2.32 respectively). The induction to delivery interval was shorter with controlled-release prostaglandin than with placebo or Prepidil, but longer than with Prepidil/immediate oxytocin, or misoprostol. Although no differences were seen with maternal morbidity (such as Caesarean delivery) or neonatal outcomes, the sample size was not adequate to evaluate these outcomes. CONCLUSION: controlled-release prostaglandin appears to be an effective cervical ripening agent as compared with Prepidil, but may result in an increased incidence of excessive uterine activity. Controlled-release prostaglandin may not be as effective as misoprostol or Prepidil/immediate oxytocin. Further randomized trials with larger sample sizes are needed to evaluate maternal morbidity and neonatal outcomes.
This chapter has reported the findings of acceptability of prostaglandin pessaries compared with vacuum aspiration as methods for inducing abortion in a very early stage of pregnancy. Acceptability has been defined by the WHO as the degree with which a treatment method has attributes that make it perceived by a user or potential user to be consonant with his or her own sense of well-being and therefore will be used or preferred. The acceptability of the medical and surgical procedures for inducing abortion was studied in Swedish abortion patients using a pre- and post-abortion design for obtaining observations. Methods used included interview schedules, questionnaires, rating scales and attitude measuring techniques. Patients consenting to take part in the acceptability study had agreed to be randomly assigned to prostaglandin treatment, given at the clinic or self-administered by the patient at home, or to vacuum aspiration. A high degree of acceptability for the prostaglandin treatment was obtained in this group of patients who had applied for an abortion very soon after one missed menstrual period. This was indicated from the finding that the very high preference for this procedure remained unchanged in the group randomly assigned to it. Other measures of attitudes to prostaglandin treatment also indicated the unchanged positive attitude. There was a significant change in the attitude to vacuum aspiration among those assigned to this treatment, indicating that post-abortion it was more acceptable to these patients. However, 30% of them would still prefer the prostaglandin treatment, especially self-administered, in the event of another abortion. There were consistent and significant relationships found between the degree of negative emotional arousal before and after abortion and preference for the medical or surgical procedure and also the amount of complaints after abortion. Those patients who pre-abortion had preferred the self-administered procedure were, regardless of which treatment they had been assigned to, those who were least emotionally upset both before and after the treatment and also complained the least. This chapter also reported on findings of how acceptable the medical and surgical procedures can be inferred to be from comparisons of preferences and attitude measures obtained from abortion patients before treatment and from women in the same age group (who would not exclude an abortion if pregnant) in samples from outside the clinical setting. In the non-patient groups about half the subjects would prefer the medical alternative.(ABSTRACT TRUNCATED AT 400 WORDS)
Reliable statistical data indicate that even today abortion is widely used in the regulation of human reproduction, irrespective of whether it is well or badly tolerated. Medical responsibility therefore dictates that abortions should be made as safe as possible in order to safeguard the health of women who cannot avoid abortion. The most advanced development in abortion technology is medical abortion. At present, the best available method is the combination of an antiprogesterone (RU-486) and a low dose of prostaglandin, either in an injection (sulprostone) or in a vaginal pessary (gemeprost). The currently employed treatment schedules are still not optimal. The treatment lasts for at least 48 or 72 hours and close follow-up is needed to assess whether the treatment has been successful or not. The side-effects, however, are negligible, and the medical method is free from the complications of the surgical methods and those of anaesthesia. The high efficacy (95% complete abortion rate at a gestational age up to eight weeks) restricts the risk of surgery and anaesthesia to the 5% failures. Further research is required to develop a more appropriate treatment schedule, preferably a single-shot treatment. At the same time, the prevention of misuse of the medical methods must be guaranteed to achieve a better acceptance of these safe abortion methods by society. For the time being, medical supervision and follow-up seems to be mandatory, and a 'do-it-yourself' home method providing complete privacy must be regarded as unsafe and medically unacceptable.
Therapeutic abortion can be performed effectively and safely by vacuum aspiration of the uterus up to 12 weeks of amenorrhoea. Although the operative procedure could be regarded as simple, complications do occur and attempts have been made to develop non-surgical means of terminating pregnancy in the first 3-4 weeks following the first missed menstrual period. A variety of PG analogues have been developed which induce abortion in over 90% of women when given by vaginal pessary or intramuscular injections (see Bygdeman, 1984). In a large multicentre study (WHO, 1987) 0.5 mg sulprostone, administered three times with 3 h intervals, was recently found to be equally as effective as vacuum aspiration for termination of early pregnancy. The frequencies of complete abortion were 91 and 94%, respectively. However, the widespread acceptance of PG treatment is limited by a relatively high incidence of gastrointestinal side-effects and uterine pain. Treatment with antiprogesterones, both mifepristone and epostane, effectively induces abortion during early pregnancy, but the frequency of complete abortion is too low to be clinically acceptable. It remains to be demonstrated if other antiprogesterones such as ZK 98.734 and ZK 98.299, currently under development, may change this conclusion. Administration of mifepristone induces uterine contractions and increases the sensitivity of the myometrium to prostaglandins. These effects allowed the development of sequential treatment with a low dose of mifepristone and PG analogues administered vaginally or intramuscularly. The combined therapy has been shown to be highly effective (frequency of complete abortion between 95 and 100%) and is seemingly associated with a lower frequency of side-effects than if PG analogues are used alone. Whether this medical abortion method will be a realistic alternative to vacuum aspiration during the first 8 weeks of pregnancy depends on the outcome of further clinical trials, including randomized studies comparing the two procedures. It has been shown that mifepristone crosses the placenta (Frydman et al, 1985). An important factor which needs to be verified in future studies is therefore the possible embryotoxicity of this type of compound. The risk that pregnancy continues in spite of treatment can never be excluded.(ABSTRACT TRUNCATED AT 400 WORDS)
Objective: To compare the relative cost efficacy of three commercially available prostaglandin analogues, misoprostol (Cytotec(R), PGE(1)), dinoprostone gel (Prepidil(R), PGE(2)), and dinoprostone pessary (Cervidil(R), PGE(2)), as labor preinduction agents.Methods: The investigation was conducted as a prospective randomized, blinded phase III clinical trial. One hundred twelve gravid females undergoing induction of labor with an unfavorable cervix (Bishop score </=5) were enrolled and randomized to receive either Cytotec(R) 50 µg q6 hours x 2 doses, Prepidil(R) 0.5 mg q6 hours x 2 doses, or Cervidil(R) 10 mg x 1 intravaginally. Twelve hours after initial treatment, cervical Bishop score was reassigned by the same blinded initial examiner and oxytocin induction initiated per standardized protocol. Therapeutic efficacy and cost of the labor preinduction/induction with the study treatments were compared. Statistical comparisons between groups were made using ANOVA with Bonferroni post test, Wilcoxon rank sum test, and chi(2) test.Results: The three study groups did not differ significantly with respect to parity, gestational age, indication for induction, or initial cervical Bishop score. A significantly greater proportion of patients had a favorable cervix (Bishop score >/=6) after the initial preinduction interval in the Cytotec(R) (79.0%) and Cervidil(R) groups (60.5%) as compared to Prepidil(R) (40.0%) (P <.05). The average relative cost per patient for prostaglandin preinduction was significantly less with Cytotec(R) ($0.42) as compared to both Cervidil(R) ($168.00) and Prepidil(R) ($184.17) (P <.0001). A greater percentage of patients treated with Cytotec(R) (42.1%) achieved active labor and delivered without the use of oxytocin when compared to Cervidil(R) (15.8%) or Prepidil(R) treatment groups (2.9%) (P <.05). Additionally, time to delivery (+/-SD) was significantly shorter in the Cytotec(R) group (24.0 +/- 10.8 h) as compared to the Cervidil(R) (32.2 +/- 14.7 h) or Prepidil(R) groups (33.9 +/- 16.2 h) (P <.05). This reduction in time resulted in a significantly lower overall mean cost per patient incurred by labor induction in the Cytotec(R) group ($723.66) as compared to the Cervidil(R) ($1058.90) or Prepidil(R) treatment ($1124.84) (P <.01). No significant differences were noted with respect to rate of cesarean delivery.Conclusion: Misoprostol is more cost-effective than the comparable commercial dinoprostone prostaglandin preparations as an adjuvant to labor induction in patients with an unfavorable cervix.