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PubMed1996

A randomised study of two doses of gemeprost in combination with mifepristone for induction of abortion in the second trimester of pregnancy.

Two regimens of the prostaglandin E1 analogue, gemeprost, in combination with mifepristone were compared in a randomised trial for termination of pregnancy between 12-19 weeks. Thirty-six hours after treatment with 200 mg mifepristone, women were allocated at random to receive either 4 x 1 mg (Group I) or 4 x 0.5 mg (Group II) gemeprost by vaginal pessary every 6 hours (n = 50 in each group). If abortion had not occurred after 24 h, 5 x 1 mg of gemeprost was administered every 3 h to both groups of women. Although the median abortion interval was slightly shorter in the 1 mg group (7.8 h vs. 8.4 h, p = 0.5), the cumulative abortion rates at 24 h were similar (98% vs. 96%). Women in Group I required significantly more gemeprost to induce abortion than Group II (p < 0.0001). Parous women in both groups required significantly less of the prostaglandin to induce abortion. In Group II, the median abortion interval was significantly longer in primigravidae than multigravidae (9.5 h vs. 6.1 h; p < 0.02). There were no significant differences between the groups in the incidence of vomiting, diarrhoea or the request for analgesia. The results suggest that in parous women, the dose of gemeprost can be reduced to 0.5 mg every 6 h within the first 24 h without loss of clinical efficacy.

Abortifacient Agents, Nonsteroidal↗
PubMed1986

Continuous extraovular prostaglandin F2 alpha instillation for late pregnancy termination in patients with previous cesarean section delivery.

Late pregnancy termination by continuous extraovular instillation of prostaglandin F2 alpha (PGF2 alpha) was successfully performed in 13 patients with previous cesarean section (CS) delivery. The indications for pregnancy termination were intrauterine fetal demise in nine patients, social indications in two patients. Down's Syndrome in one patient and quadruplets pregnancy in one patient. One patient had a previous classical vertical cesarean section, two had two previous and one three previous low segment transverse (LST) cesarean sections. The other nine patients had one previous low segment transverse cesarean section. The instillation of prostaglandin solution was obtained by using a new double balloon catheter designed for extraovular pregnancy terminations. All patients aborted following the procedure with no complications. The instillation abortion time ranged from 5 1/2 to 20 h (mean 13.3 h).

Abortion, Therapeutic↗
PubMed1986

Yugoslavian experience with the contraceptive sponge.

A trial of the contraceptive sponge was conducted at two clinics (403 subjects) in Yugoslavia. Women were periodically followed up for 1 year. The 1-year method pregnancy rate (life-table) was 5.6 per 100 women. Rates of other events leading to discontinuation of sponge use were similarly low. There were no serious complications. The results of the study show that the contraceptive sponge may be successfully used by a population of women with limited experience with the use of vaginal contraceptive methods.

Administration, Intravaginal↗
PubMed1988

Effect of human menopausal gonadotrophin on the non-pregnant uterine response to intrauterine administration of prostaglandin E2.

The effect of intrauterine instillation of 50 micrograms of prostaglandin E2 (PGE2) on the non-pregnant human uterus was evaluated in 10 volunteers, before and after systemic administration of human menopausal gonadotrophin (HMG). The cases were either in the early proliferative (n = 5) or late secretory (n = 5) phases of the cycle. Before HMG administration, the uterus responded to local PGE2 by stimulation in all the cases. After HMG treatment, no response to PGE2 was detected in eight cases and a decrease in uterine tonus was observed in two cases. The implications of these findings in certain physiological and pathological conditions relating to reproduction are discussed.

Administration, Intravaginal↗
PubMed1990

A scoring system for induction of labor using prostaglandin E2 vaginal tablets.

A randomized controlled trial was carried out in order to establish the efficacy of a scoring system for calculating the dose of vaginal prostaglandin E2 tablets for the induction of labor. One hundred ten women were included in the study. The patients received a dose of prostaglandin E2 calculated according to a scoring system based on the Bishop's score, or the standard dose of 3 mg repeated 6 h later if labor did not start. The percentage of inductions achieved was the same with both regimens (92.7%). The mean total dose used in the scoring system-group (2.7 mg) was significantly lower than that used in the 3-mg group (3.5 mg, P less than 0.025). Thirty-seven of 55 women receiving the scoring dose delivered with amounts of 2.5 mg prostaglandin E2 or less. Three cases of uterine hyperstimulation were observed in the 3-mg group whereas no cases were observed in the scoring group. The scoring system is proposed as a method for calculating the dose of vaginal prostaglandin E2 for induction of labor and minimizing the risk of overdosage.

Administration, Intravaginal↗
PubMed1991

Endometrial responses to various hormone replacement regimens in ovarian failure patients preparing for embryo donation.

Various regimens are recommended for replacing sex steroids in ovarian failure patients attempting donor embryo transfer. We histologically assessed endometrial biopsies obtained on simulated cycle day 26 from functionally agonadal patients (n = 19) receiving hormone replacement according to three different regimens: Regimen 1, oral micronized estradiol (E2) 2 mg days 1-5, 4 mg days 6-9, 6 mg days 10-13, 4 mg days 14-28, with progesterone vaginal suppositories, 100 mg day 15 followed by 200 mg days 16-28; Regimen 2, oral micronized E2 1 mg days 1-5, 2 mg days 6-9, 6 mg days 10-13, 2 mg days 14-28, with progesterone vaginal suppositories, 100 mg day 15 followed by 200 mg days 16-28; Regimen 3: oral micronized E2 1 mg days 1-5, 2 mg days 6-9, 6 mg days 10-13, 2 mg days 14-28, progesterone 50 mg intramuscularly delivered day 15 followed by 100 mg intramuscularly days 16-28. Biopsies were interpreted according to Noyes criteria. While all regimens resulted in variable degrees of stromal pseudodecidualization, Regimen 1 biopsies uniformly demonstrated glandular abnormalities consistent with excessive estrogen stimulation. This included aberrant maturation, intraluminal papillary excrescences and variations in epithelium size and stratification. Regimen 2 biopsies were morphologically normal in most patients, yet many manifested minor variations in gland maturity. Only Regimen 3 biopsies were consistently normal on day 26 or slightly advanced in maturation. We conclude that endometrial morphology differs according to the hormone replacement preparation and route of administration.(ABSTRACT TRUNCATED AT 250 WORDS)

Administration, Intravaginal↗
PubMed1991

A comparison of single prostaglandin E2 vaginal tablet with prostaglandin E2 vaginal pessaries for induction of labor at term.

This study represents the first of its kind in Kuwait. Two preparations of prostaglandin E2 (PGE2) have been compared as agents for induction of labor. In a randomized controlled study of 200 women of low parity and unfavorable cervical induction features induction of labor by means of a single vaginal tablets of PGE2 was compared with locally prepared PGE2 vaginal pessaries. The gradual increase of uterine contractions and the establishment of labor in a similar way to that observed during spontaneous labor was more apparent after PGE2 tablets. Labor induction was successful in 80% of patients in PGE2 tablet group compared with 59% in PGE2 pessaries group. The incidence of cesarean section was equal in both groups (4%), but none was performed due to uterine hyperactivity. The data presented indicate that the PGE2 vaginal tablet is safe and effective in induction of labor in healthy women at term.

Administration, Intravaginal↗
PubMed1991

The use of 16,16-dimethyl-trans-delta 2 prostaglandin E1 methyl ester vaginal suppositories for management of missed abortion and fetal death.

The effect of vaginal administration of a PgE1 analogue to terminate missed abortion and fetal death in utero was evaluated in 62 women with gestation ranging from the 13th to the 37th week. Abortion occurred in 85.4% of women with missed abortion and in 86% of women with fetal death. In both groups, the mean induction time was less than 12 h. The incidence of side effects, primarily gastrointestinal symptoms, was infrequent.

Abortion, Missed↗
PubMed1995

Induction of labor utilizing vaginal vs. intracervical prostaglandin E2.

OBJECTIVE: To compare the efficacy of intracervical vs. vaginal prostaglandin E2 (PGE2) gel for induction of labor. METHOD: Sixty-eight women scheduled for elective induction of labor at term were randomized to receive either 0.5 mg intracervical PGE2 (I/C group, n = 37) or 2 mg vaginal PGE2 gel (Vag group, n = 31) on a 6-hourly basis for a maximum of three doses. RESULTS: Three participants who delivered by cesarean section soon after gel administration were excluded from further analysis. Twenty-nine of 30 (97%) in the Vag group were successfully induced compared with 23 of 35 (66%) in the I/C group (P < 0.01). The induction-active labor intervals were 8.0 +/- 5.4 h for the Vag group and 23.1 +/- 27.6 h for the I/C group (P = 0.002). The induction-delivery intervals were 12.4 +/- 6.3 h for the Vag group and 29.8 +/- 29.1 h for the I/C group (P = 0.001). Uterine hyperstimulation and perinatal outcome were similar in both groups. CONCLUSION: Vaginal PGE2 was more efficacious than intracervical PGE2 in inducing labor.

Administration, Intravaginal↗
PubMed1994

Vaginal prostaglandins for the ripe cervix.

OBJECTIVES: To assess the efficacy of vaginal prostaglandin (PGE2) tablets for induction of labor in the presence of a ripe cervix. METHODS: A randomized controlled trial was performed. Two hundred and nine consecutive women undergoing induction of labor with a Bishop Score > or = 5 were randomly assigned to (a). Study group receiving PGE2 tablets (n = 106) and (b). Control group having artificial rupture of membranes only (n = 103). The duration of labor, oxytocin and analgesia requirements, the mode of delivery, complications and duration of confinement were recorded. RESULTS: Mean duration of first stage of labor was shorter in parous patients in the study group (194 min v. 319 min), as was the mean induction delivery interval in primigravidas. Oxytocin was used in 75% of primiparas and 40% multiparas in the study group compared with 100% and 80%, respectively, in the controls. Epidural analgesics and instrumental delivery rates were also reduced. CONCLUSIONS: The use of vaginal PGE2 tablets for induction of labor with a ripe cervix is associated with a shorter first stage of labor and with reduced requirements for oxytocin, analgesia and instrumental delivery.

Administration, Intravaginal↗
PubMed1987

The place of progesterone in human contraception.

Progesterone, the natural hormone produced by the corpus luteum and other steroid-secreting glands, is endowed with antiestrogenic action and has a fundamental role in the initiation and maintenance of pregnancy and in the regulation of gonadotropin secretion. Although it was discovered half a century ago, it has found little clinical use as a therapeutic agent due to its low potency and extensive degradation following oral administration in comparison with a variety of highly potent synthetic analogs that became available in the last three decades. When delivered systemically, a large proportion of the dose bypasses degradation in the gut and liver, and progesterone can achieve effective levels in target tissues for clinical use. Sustained administration via compressed pellets implanted subdermally or silicone rubber rings placed in the vagina produced circulating levels of progesterone within the lower third of those found in the luteal phase of the human menstrual cycle. Those levels were shown to delay the recovery of fertility in nursing women without adverse effects to the mother or the infant. Progesterone transferred to the babies via the breast milk did not change their rate of pregnandiol-3-alpha glucuronide excretion. It is concluded that sustained administration of the natural hormone progesterone may be an effective and safe contraceptive method for nursing women.

Administration, Intravaginal↗
PubMed1989

Oestrogen concentrations in plasma, endometrium, myometrium and vagina of postmenopausal women, and effects of vaginal oestriol (E3) and oestradiol (E2) applications.

Oestradiol (E2), oestriol (E3) and oestrone (E1) levels were measured in plasma and endometrium, myometrium and vagina of 29 postmenopausal women who underwent hysterectomy. The influence of vaginal E3, compared to vaginal E2 therapy at a dose one-tenth that of E3 on the basal steroid levels was examined. We found (1) no correlation between basal tissue and plasma concentrations of the oestrogens in untreated postmenopausal women, however, after vaginal E3 therapy we did find a positive correlation between them, (2) E2 to be the oestrogen in the highest basal concentration in endometrium and myometrium as well as in the vagina, (3) higher basal concentrations of all three oestrogens in endometrium compared to myometrium and vagina, (4) a long term (at least 12 h) elevation of the plasma and tissue E3 concentrations after vaginal E3 therapy (0.5 mg per day), (5) no significant changes of the plasma and tissue E2 concentrations after 0.05 mg per day vaginal E2 therapy, measured 12 h after the last application and (6) no signs of a difference between vagina and uterus in uptake and retention of E3 or E2. In conclusion, there was no difference on this level of mechanism of action in vagina and uterus which can account for the supposed vaginotrophicity and non-uterotrophicity observed with E3 but not E2.

Administration, Intravaginal↗
PubMed1987

A prostaglandin analogue (ONO-802) in treatment of missed abortion, intrauterine fetal death and hydatiform mole: a dose-finding trial.

Forty-eight patients affected with missed abortion, intrauterine fetal death and hydatiform mole were treated with vaginal suppositories containing 1 mg of 16,16-dimethyl-trans-delta 2-PGE1 methyl ester (ONO-802). The patients were divided into two treatment groups. The first, Group A, was given one vaginal suppository every 3 h to a maximum of five suppositories. The product of conception was expelled in 95.8% of patients. In Group B the maximum number of suppositories was reduced to three. The product of conception was expelled in 100% of cases and the average duration of treatment was similar to that for the first group. Although side-effects were mild in both groups, they were reduced in the patients of Group B.

Abortifacient Agents↗
PubMed1987

Chlorhexidine for prevention of neonatal colonization with group B streptococci. IV. Depressed puerperal carriage following vaginal washing with chlorhexidine during labour.

The effect of vaginal washing with chlorhexidine acetate, 2 g/l at delivery, on the colonization of the urogenital tract with group B streptococci (GBS) 4 days later was investigated. Patients who were culture-positive for GBS in urethra and/or cervix in pregnancy weeks 32 and 36 as well as at delivery were included in a prospective study. The washing procedure was performed in 31 parturients, and 10 (32%) were culture-negative at day 4 after delivery. In contrast, only 7/47 (15%) non-washed controls were negative at day 4 (p = 0.044). The results demonstrate a prolonged suppressive effect of vaginal washing with chlorhexidine on the recovery of GBS from the urogenital tract in this highly selected patient group.

Administration, Intravaginal↗
PubMed1988

The efficiency of prostaglandin E2 vaginal suppositories versus intracervical prostaglandin gel for induction of labor in patients with unfavorable inducibility prospects.

Two different applications of prostaglandin E2 for induction of labor were randomly used in 113 women with an unripe cervix; 57 women were given prostaglandin suppositories each containing 2.5 mg PGE2 in a basis of Witepsol S55 (Dynamit Nobel), another 56 women were treated with intracervical gel containing 1 mg PGE2 in 5 g hydroxypropylmethyl cellulose. The treatment was repeated after 4 h if the cervix was still unripe, and the procedure was repeated the following day if the cervix was still unfavorable. Cesarean sections was performed within 48 h after the start of induction and before the second stage of labor in 8 women in the suppository group and 7 women in the intracervical gel group. Of the remaining 98 women, 73% (34/48 women) in the suppository group and 36% (18/50 women) in the cervical gel group had delivered within 24 h (p less than 0.01). After 48 h, 88% (42/48 women) in the suppository group and 74% of the women (37/50 women) in the cervical gel group had delivered (p greater than 0.05). The induction-delivery interval in the suppository group was half that found in the cervical gel group. There was no significant difference between the two groups in the use of instrumental vaginal deliveries and cesarean sections nor was there any difference with regard to fetal distress. The post-delivery condition of the newborn was similar in the two groups. No side-effects were reported in either of the two groups.

Administration, Intravaginal↗
PubMed1989

Prevention of group B streptococci transmission during delivery by vaginal application of chlorhexidine gel.

In a prospective study in 227 parturients, carriership of group B streptococci was established to be 25%. In carriers, transmission of streptococci to the newborn occurred in 50%. 10 ml of a chlorhexidine gel containing hydroxypropylmethylcellulose was introduced into the vagina during labor in 17 parturients, who were known to be carriers of group B streptococci from the first trimester of pregnancy. In none of the newborns from these mothers colonization by group B streptococci did occur. Vaginal application of chlorhexidine may prevent transmission of group B streptococci, and serve as an alternative to intrapartum prophylaxis using antibiotics. A large multicenter randomized controlled study should be performed to confirm this hypothesis.

Administration, Intravaginal↗
PubMed1989

Chlorhexidine for prevention of neonatal colonization with group B streptococci. V. Chlorhexidine concentrations in blood following vaginal washing during delivery.

Chlorhexidine 2 g/l was applied to the vagina of 96 women during delivery, whereas 28 served as controls. Both groups were given a shower using a chlorhexidine soap, and outer washing of the outer anogenital tract was also performed in all patients using chlorhexidine 2 g/l. Using a gas chromatographic method with a detection limit of 10 ng chlorhexidine per ml blood, 10-83 ng/ml was demonstrated in 34 (35%) of the study group patients, whereas the remaining study group patients and controls showed no detectable chlorhexidine. Performing the washing a second time after 6 hours in 14 patients and a third time in 3 patients after a further 6 hours did not result in increased serum levels. It was concluded that small amounts of chlorhexidine are absorbed through the vaginal mucosa and that chlorhexidine is not accumulated in the blood on repeated usage with 6 hour intervals during delivery.

Administration, Intravaginal↗
PubMed1989

A prospective comparative study on the use of prostaglandin E2 gel (2 mg) and prostaglandin E2 tablet (3 mg) for the induction of labour in primigravid women with unfavorable cervices.

Eighty primigravid patients with singleton pregnancies, cephalic presentation and unfavourable cervices (score less than 5) between 37 and 43 weeks gestation were studied prospectively to compare the ripening effect of vaginal PGE2 (3 mg) tablet with that of PGE2 gel (2 mg). Following the use of gel, the final mean cervical score was considerably improved and half of the patients went into spontaneous labour. The requirement for oxytocin augmentation was also reduced. The priming-to-induction and induction-to-delivery intervals were also considerably shortened in gel-treated patients. The proportion of patients delivered by Caesarean section in the gel group was lower than that in the tablet group (30 vs. 15%).

Administration, Intravaginal↗