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PubMed1990

Umbilical artery Doppler flow velocity waveforms and maternal prostaglandin E2 and F2 alpha metabolite concentrations during cervical ripening with prostaglandin E2.

In 20 women, the umbilical artery flow velocity waveform (FVW) was recorded immediately before and 30-40 min after administering vaginal or extraamniotic prostaglandin E2 to ripen the cervix. Maternal plasma concentrations of prostaglandin E2 (PGE2) and prostaglandin F2 alpha (PGF2 alpha) metabolites (bicyclo-PGEM and PGFM, respectively) were measured at the time of the Doppler recordings. The administration of prostaglandin E2 was associated with a significant rise in maternal plasma PGFM and bicyclo-PGEM concentrations, but there was no change in the umbilical artery FVW Pulsatility index (PI). These results suggest that cervical ripening with local prostaglandin E2 has no effect on the umbilical artery FVW.

Administration, Intravaginal↗
PubMed1990

Induction of labour: the effect of vaginal prostaglandin or i.v. oxytocin--a matter of time only?

Ninety-one pregnant women with unfavourable cervix (Bishop score no higher than 6) were randomly allocated to induction of labour with either prostaglandin E2 suppositories 2.5 mg 1-2 a day or i.v. oxytocin 4-32 mU/min. The induction procedure was carried on for 2 days. For statistical comparison of efficacy, life table analysis and the logrank test were used with vaginal delivery as the aimed 'event'. Prostaglandin suppositories were more efficient after 12 h (p less than 0.025) and 24 h (p less than 0.005), whereas no difference in efficacy was observed after 48 h. Vaginal delivery was obtained within 48 h in 74% of the women in the prostaglandin group and in 70% in the oxytocin group. No difference was observed in methods of delivery or neonatal Apgar scores, though, in neonates delivered vaginally within 2 days, lowered umbilical artery blood pH values were found after prostaglandin E2 suppositories (p less than 0.05). The patients attitude toward the method of induction was highly in favour of the prostaglandin suppositories. Prostaglandin E2 suppositories are considered excellent for induction of labour if delivery has to be within 24 h, whereas the two methods are equally effective after 48 h.

Administration, Intravaginal↗
PubMed1992

Low-dose 17 beta-estradiol vaginal tablets in the treatment of atrophic vaginitis: a double-blind placebo controlled study.

The aim of the study was to investigate the effect of 25 micrograms 17 beta-estradiol administered as a small vaginal tablet (Vagifem, Novo Nordisk A/S) on the symptoms of the vagina related to atrophy. The study was designed as a double-blind randomized placebo controlled study running for 12 weeks. The women were treated once daily for 2 weeks with the active or the placebo tablet. During the subsequent 10 weeks the women were treated twice a week. One hundred and sixty-four women were included. Ten dropped out for minor reasons, most of these due to lack of effect in the placebo group. In the Vagifem group 78.8% were suffering from moderate to severe atrophy of the vagina, compared with 81.9% in the placebo group. After 2 weeks the percentages were 14.3 and 35.3, respectively. After 12 weeks of treatment, 10.7% in the Vagifem group compared with 29.9% in the placebo group had moderate to severe atrophy (P less than 0.0001). A substantial part of the women complained about subjective symptoms such as vaginal dryness and dyspareunia. After 12 weeks of treatment, a significant improvement was found in the Vagifem group (P less than 0.002). Before treatment 53.1% in the treatment group and 41.0% in the placebo group were suffering from urological symptoms. After 2 weeks, 60.5% of the women in the Vagifem group underwent a change for the better compared to 35.3% in the placebo group. After 12 weeks of treatment the percentages in the two groups feeling an improvement were 62.8% and 32.4%. In this study local low-dose treatment with 25 micrograms 17 beta-estradiol was found to have a significant effect on the postmenopausal urogenital symptoms related to atrophy.

Administration, Intravaginal↗
PubMed1992

Pre-induction intracervical application of a highly viscous prostaglandin E2 gel in pregnant women with an unripe uterine cervix: a double-blind placebo-controlled trial.

Intracervical application of prostaglandin E2 (PGE2) gel has shown to be an effective method for pre-induction cervical ripening in pregnant women with an unripe uterine cervix. Side effects are minimal, provided that the instillation is carefully restricted to the cervical canal. This requires--apart from a proper technique--an optimal gel formulation. For this reason a newly developed highly viscous PGE2 gel was evaluated in a randomized, double-blind, placebo-controlled multicentre trial. Within a 9-h study period, successful cervical ripening (increase in Bishop score to 6 or more) was achieved in 39 (56%) of the 70 patients in the PGE2 groups and in 23 (34%) of the 68% patients in the placebo group (P = 0.04). During the first 12 h after gel application, 25 (35%) of the women in the PGE2 group and 2 (3%) in the placebo group had a spontaneous delivery. No serious adverse reactions were observed. The data suggest that the use of this highly viscous PGE2 gel may be advantageous if strictly intracervical application is the primary objective.

Administration, Intravaginal↗
PubMed1992

Vaginal progesterone as luteal phase support in an IVF/GIFT programme.

To determine whether luteal phase support with vaginal progesterone could improve pregnancy rates in our IVF/GIFT programme, we performed a prospective randomised controlled study. After stimulation with clomiphene citrate/human menopausal gonadotrophin, 123 women received no luteal support and 122 received progesterone pessaries 100 mg b.d. from 48 hours prior to embryo transfer and continued throughout the luteal phase. There was no difference in the pregnancy rate following IVF/ET (6/58 and 10/58 for the pessary and control group respectively), but a significantly higher rate was noted for GIFT (13/34 and 5/42 for the pessary and control group respectively; P less than 0.05). Of interest, only one of the 19 pregnancies using luteal support was extra-uterine, compared with 6/15 in the control group.

Administration, Intravaginal↗
PubMed1993

Preliminary report of unexpected local reactions to a progestogen-releasing contraceptive vaginal ring.

This is the first report of vaginal erythematous areas associated with the use of a levonorgestrel-releasing contraceptive ring. Of 139 female subjects, 48 developed lesions of varying size and degrees of redness. Sixteen of these have undergone serial colposcopy and thirteen have also had biopsy examinations, which revealed acetowhite areas and, histologically, chronic inflammation with widely dilated vessels and frequently with thinning of the epithelium. The cause remains uncertain but hormonal, chemical and physical effects might all have a role.

Administration, Intravaginal↗
PubMed1994

Induction of labour by balloon catheter with extra-amniotic saline infusion (BCEAS): a randomised comparison with PGE2 vaginal pessaries.

OBJECTIVE: A new method for induction of labour--balloon catheter with extra-amniotic saline infusion (BCEAS)--is evaluated in randomised comparison with prostaglandin E2 (PGE2) in vaginal pessaries. STUDY GROUP: One-hundred and nine pregnant women with unfavourable cervices. MAJOR OUTCOME MEASURES: The efficiency of inducing vaginal delivery and the level of 'disadvantages following induction of labour' (DisFIL scorings). RESULTS: Overall, BCEAS was less efficient inducing vaginal delivery than vaginal PGE2 (P < 0.01) because of a significant difference among parous women (P < 0.01). In the (larger) primiparous women group, and particularly in the subgroup of these having very low pelvic scores (Lange score, < or = 3), the efficiencies of the two methods were equal (P = 0.06) and P = 0.55, respectively). The levels of DisFIL scorings were not significantly different. However, higher rates of caesarean section followed BCEAS than PGE2 (29% and 10%, respectively; P < 0.05). Serious infectious complications were not recorded following BCEAS. No difference was apparent in the status of the neonates (judging from Apgar scores and umbilical artery pH and SBE). The women, delivering vaginally, commented the two methods equally favourably. CONCLUSION: BCEAS was less efficacious than vaginal PGE2 pessaries, though among primiparous women, especially those with very unfavourable cervices, the difference was not significant. Further refinements of the method are suggested.

Administration, Intravaginal↗
PubMed1995

A randomized trial of management of pre-labor rupture of membranes at term in multiparous women using vaginal prostaglandin gel.

OBJECTIVE: To compare conservative management of pre-labor spontaneous rupture of membranes (SROM) with the use of prostaglandin (PG) E2 in healthy parous women at term (gestational age at least 37 weeks). METHODS: An open randomized study was conducted with 100 parous women; 50 were treated conservatively for 24 hours, and 50 were managed actively using PGE2 gel (1 mg), administered at admission and repeated 6 hours later if labor was not established. Both groups received intravenous oxytocin if labor did not start within 24 hours after admission. RESULTS: The use of PGE2 gel led to a significant reduction in the mean interval (+/- standard error of the mean) from SROM to onset of labor: 17.26 +/- 1.51 hours in the conservative group versus 6.50 +/- 1.23 in the PGE2 group. A significantly smaller proportion of subjects required oxytocin in the PGE2 group (12 versus 38%, P < .02). The two groups were comparable with respect to analgesic requirements. Within 24 hours of SROM, 80% of the women in the PG group and 56% in the conservative group had delivered (P < .02). Most women delivered vaginally, 96% of those managed conservatively and 100% of those managed actively with PGE2. CONCLUSION: Active management using PGE2 gel in parous women with pre-labor SROM significantly improves the time to delivery without influencing the cesarean rate or fetal-maternal infective morbidity.

Administration, Intravaginal↗
PubMed1995

Pre-induction cervical ripening: a randomized comparison of two methods.

OBJECTIVES: To compare two methods of pre-induction cervical ripening in a randomized clinical trial. METHODS: A single intracervical prostaglandin E2 (PGE2) gel application was compared with a single insertion of hygroscopic dilators in 441 women at term with unfavorable cervical scores. Induction success was defined as entry into active labor within 6 hours of oxytocin infusion. RESULTS: There was no statistical difference in pre- or post-ripening cervical scores. In the group receiving hygroscopic dilators, only 28% entered the active phase of labor within 6 hours of oxytocin infusion compared with 45% (P < .001) in the PGE2 group. Thus, in this study, a change in cervical score did not directly predict induction success. There was a higher rate of postpartum endometritis (24 versus 14%; P = .007) and suspected neonatal infection (10 versus 5%; P = .03) in the dilator group. CONCLUSIONS: Pre-induction ripening by hygroscopic dilators and intracervical PGE2 was equivalent as measured by changes in the cervical score. The change in cervical score, however, was not predictive of successful induction, and PGE2 was more frequently associated with induction success. Hygroscopic dilators were associated with a higher incidence of postpartum maternal and neonatal infection because of a longer duration of labor. Hospital charges for intracervical PGE2 gel totaled $522 compared with $91 for the insertion of three dilators.

Administration, Intravaginal↗
PubMed1995

Randomized controlled trial of vaginal misoprostol and intracervical prostaglandin E2 gel for induction of labor at term.

OBJECTIVE: To compare misoprostol 25 micrograms administered at 2-hour intervals with intracervical prostaglandin (PG) E2 in women with Bishop scores of 5 or less. METHODS: Subjects were randomly assigned to receive either misoprostol 25 micrograms every 2 hours or a commercially available intracervical preparation containing 0.5 mg of PGE2 gel administered at 6-hour intervals for a maximum of two doses. RESULTS: Women who received misoprostol experienced a significantly reduced mean time (+/- standard deviation) from drug administration to onset of three contractions in 10 minutes, 6.7 +/- 5.8 versus 12.4 +/- 9.6 hours (P = .007). Mean time to rupture of membranes was also shorter in the misoprostol group, 9.7 +/- 5.5 versus 13.6 +/- 6.8 hours (P = .01), as was the mean time to delivery, 16.0 +/- 7.7 versus 22.4 +/- 10.9 hours (P = .006). Three patients in the misoprostol group experienced uterine hypertonus but not related fetal morbidity. CONCLUSION: Misoprostol is more effective than intracervical PGE2 in bringing about labor and delivery, but further work is needed to determine the ideal dosing regimen.

Administration, Intravaginal↗
PubMed1996

Postmenopausal hormone therapy and breast cancer.

Given the magnitude of the older female population, the possibility that postmenopausal hormone therapy is associated with an increased risk of breast cancer is an issue of great public and individual importance. Epidemiologic evidence indicates the possibility of a slightly increased risk of breast cancer associated with long durations of postmenopausal estrogen use. However, in a review of the literature, it is apparent that the epidemiologic data are contradictory and do not yield uniform and consistent results. It is further apparent that adding a progestin to a postmenopausal hormone program does not alter the findings compared with the use of estrogen alone. Reasons for this disagreement and lack of definitive evidence are detailed, and it is suggested that any impact of postmenopausal hormone therapy on the risk of breast cancer is unlikely to be great. Finally, the question of whether a woman who has had breast cancer should use postmenopausal hormones is addressed.

Administration, Intravaginal↗
PubMed1996

Concentrated oxytocin plus low-dose prostaglandin E2 compared with prostaglandin E2 vaginal suppositories for second-trimester pregnancy termination.

OBJECTIVE: To examine the efficacy and side effects of concentrated oxytocin plus low-dose prostaglandin (PG) E2 compared with a standard dose of vaginal PGE2 for second-trimester pregnancy termination. METHODS: Patients with obstetric or fetal complications were randomly assigned to receive either a 20-mg PGE2 vaginal suppository every 4 hours (n = 81) or a concentrated oxytocin infusion plus a 10-mg PGE2 vaginal suppository every 6 hours (n = 73). Treatment success was defined as delivery (or imminent delivery) within 24 hours of therapy. Women who failed their assigned regimen were crossed to the alternate method. RESULTS: Indications for delivery were similar in the two groups. The success rate with oxytocin was 89%, compared with 81% with vaginal PGE2 (relative risk 0.92, 95% confidence interval 0.8-1.04; P = .2). Maternal fever (P < .001), nausea (P = .02), and vomiting (P = .003) occurred significantly more often in women who received a 20-mg PGE2 vaginal suppository every 4 hours. CONCLUSION: Concentrated oxytocin plus low-dose PGE2 should be considered as an alternative to vaginal PGE2 for indicated second-trimester pregnancy termination.

Abortion, Induced↗
PubMed1996

Vaginal misoprostol for induction of labor: a randomized controlled trial.

OBJECTIVE: To evaluate the effectiveness and safety of the vaginal application of misoprostol for induction of labor at term, with the interval duration from labor induction to vaginal birth as the primary outcome measure. METHODS: Two hundred twenty-two women with indications for induction of labor at term were randomized to receive either misoprostol 50 micrograms per vagina every 4 hours as needed or our standard approach (physician-chosen combinations of intracervical or vaginal dinoprostone every 6 hours, artificial rupture of membranes, and oxytocin infusion). RESULTS: Mean (+/-standard deviation) time to vaginal delivery was 753 +/- 588 minutes for misoprostol versus 941 +/- 506 minutes for the physician-chosen combination (P = .018). Oxytocin infusion was used less frequently (relative risk [RR] 0.48, 95% confidence interval [CI] 0.31-0.74). There was no significant difference in cesarean rate or maternal morbidity. Neonatal outcomes, including cord-blood acid-base analysis, were not significantly different. The estimated cost per patient in Canadian dollars for prostaglandins was $0.22 with misoprostol and $70.00 with standard therapy. CONCLUSION: Vaginal misoprostol is a cost-effective alternative to current labor-induction protocols. We found no evidence of harm to mother or newborn in substantive outcomes.

Administration, Intravaginal↗
PubMed1988

Disposition of [14C]nonoxynol-9 after intravenous or vaginal administration to female Sprague-Dawley rats.

The disposition of nonoxynol-9 labeled with carbon-14 at the ethylene oxide units was studied following an iv or vaginal administration to female Sprague-Dawley rats. The results from the vaginal administration studies indicate 12.8% absorption of 14C radioactivity in 6.0 hr and 37.7% in 24.0 hr. Tissue distribution studies showed that the small and large intestines, including their contents, had the highest 14C activity by either route of administration. Radiomonitored HPLC of bile collected at 6.0 hr and urine at 6.0, 24.0, and 48.0 hr following an iv injection of [14C]nonoxynol-9 showed that the compound was completely metabolized in the body of the rat. The metabolites were primarily excreted in the feces and secondarily in the urine. Analysis of urinary metabolites containing the carbon-14 label, 6.0 hr following an iv dose, indicated the presence of highly polar neutral (53.27%) and acidic (39.23%) species.

Administration, Intravaginal↗
PubMed1987

Vaginal treatment with a prostaglandin F2 alpha derivative (alfaprostol) for inducing labor in pregnancy at term.

The effectiveness and acceptability of Alfaprostol (an analog of PGF2 alpha) in inducing labor were assessed in 20 pregnant women at term. All subjects had no spontaneous uterine activity before treatment and the mean (M +/- SE) Bishop score was 2.45 +/- 0.21. The drug was administered by vaginal route at the dose of 10 mg every 3 hours. Regular uterine contractions appeared in all patients and delivery occurred in 85% of the patients after a mean time of 9h50min +/- 0h55min following the start of treatment. The mean dose of Alfaprostol utilized to achieve delivery was 29.4 +/- 2.0 mg. No major side effects were noted in the mothers and their fetuses at any time during treatment. Two patients exhibited vomiting. The Apgar score of all newborns at birth was 8 or more. These results suggest the usefulness of Alfaprostol to induce labor in pregnant women at term, as it has oxytocic activity without adverse effects on either the mother or the fetus.

Administration, Intravaginal↗
PubMed1987

Prostaglandin release from preparations used vaginally for the induction of labour.

The release and absorption profiles from the vagina of PGE2 in different vehicles used for cervical ripening and labour induction have been studied observing changes in concentrations of PGE metabolite (PGEM) and PGF metabolite (PGFM). In all groups a rise in PGEM concentration occurred over the 6 hour observation time but with wide variation. The profiles obtained differed markedly between the preparations under investigation correlating with the uterine contractions generated. PGFM generally showed little change. The model used could be explored further to enable modification of the vehicles used for PGE2 incorporation to achieve improved clinical results.

Abortion, Therapeutic↗
PubMed1991

Prostaglandin metabolite levels during cervical ripening with a controlled-release hydrogel polymer prostaglandin E2 pessary.

Prostaglandin E and F metabolite (PGEM and PGFM) concentrations in peripheral plasma were assayed following the vaginal administration of a controlled release hydrogel polymer pessary designed to release 0.6 mg PGE2 per hour in vivo. A linear relationship between calculated PGE2 release from the pessary and PGEM levels was observed with a correlation coefficient of 0.78. A significant rise in PGEM levels occurred two hours following pessary administration, with significantly higher PGEM levels in patients delivering within the eight hour observation period compared with those delivering later. PGFM levels increased more slowly. The results suggest that PGE2 released by the pessary crosses the vaginal epithelium and may stimulate endogenous prostaglandin production. The controlled rise of metabolites in association with the polymer pessary suggest that it should provide greater control in labour induction than other vehicles we have studied, but this should be confirmed by clinical trials.

Administration, Intravaginal↗