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PubMed1998

A masked randomized comparison of oral and vaginal administration of misoprostol for labor induction.

OBJECTIVE: To test the null hypothesis that administering misoprostol orally or vaginally will result in no difference in time to vaginal birth, and to determine whether different frequencies of tachysystole and hyperstimulation are associated with route of administration. METHODS: Two hundred six women after 37 completed weeks' gestation who presented with an indication for induction were randomly assigned to receive misoprostol (50 microg) either orally or vaginally every 4 hours as needed to induce labor. Placebo use and allocation concealment accomplished blinding until data analysis was completed. Sample size was calculated to allow a two-tailed alpha of .05 and power (1-beta) of 80%. All fetal heart rate and uterine activity graphs were classified according to Curtis' criteria before induction groups were unmasked. RESULTS: Analysis involved 104 women in the oral group and 102 in the vaginal group. The mean time (+/-standard deviation) to vaginal birth with oral misoprostol was 1072 (+/-593) minutes compared with 846 (+/-385) minutes with the vaginal protocol (P=.004). There were no significant differences in cesarean rate, epidural use, or neonatal outcomes. More frequent tachysystole for 20 minutes (P < .01) and hyperstimulation (P < .04) were observed with vaginal misoprostol. No neonatal asphyxia occurred in either group. CONCLUSION: Misoprostol effectively induces labor, given orally or vaginally. There is a shorter interval to vaginal birth with vaginal application; however, the more frequent occurrence of fetal heart rate graph abnormalities in this group suggests that, until the optimal dosing interval for vaginal use is determined, the preferred route of misoprostol administration might be oral.

Abortifacient Agents, Nonsteroidal↗
PubMed1999

Comparison between oral and vaginal administration of misoprostol on uterine contractility.

OBJECTIVE: To compare the degree of absorption and the effect on uterine contractility of the prostaglandin E1 analogue misoprostol after vaginal and oral administration. METHODS: Thirty women with a normal intrauterine pregnancy between 8 and 11 weeks' gestation who requested termination of pregnancy were given either 0.2 mg (orally n = 5; vaginally n = 6) or 0.4 mg (orally n = 10; vaginally n = 9) of misoprostol. Intrauterine pressure was recorded using a Grass polygraph connected to a pressure transducer 30 minutes before misoprostol was given and for 4 hours thereafter. At the end of the recording, suction curettage was performed. Blood samples were obtained at 0, 0.5, 1, 2, 4, and 6 hours for measurement of misoprostol, which was assayed by high-pressure liquid chromatography-mass spectrometry. RESULTS: In all patients, the first effect was an increase in uterine tonus. After 0.4 mg of misoprostol administered orally, uterine tonus started to increase after a mean (+/- standard deviation) time of 7.8+/-3.0 minutes and reached its maximum after 25.5+/-5.0 minutes. The corresponding times after vaginal administration were 20.9+/-5.3 minutes and 46.3+/-20.7 minutes, respectively. The initial increase in tonus was also more pronounced after oral than after vaginal administration. After vaginal administration, all patients developed uterine contractions; the activity, measured in Montevideo units, increased continuously during the observation period. This was not the case after oral administration. Plasma levels of misoprostol were measured in 18 patients. The highest levels were found 30 minutes after oral treatment and 1-2 hours after vaginal administration. CONCLUSION: The long-lasting and continuously increasing uterine contractility after vaginal administration can be explained only in part by a direct effect of misoprostol. The longer period of elevated plasma levels of misoprostol may also have initiated the prolonged events leading to increased uterine contractility.

Abortifacient Agents, Nonsteroidal↗
PubMed1999

A randomized controlled trial of laminaria, oral misoprostol, and vaginal misoprostol before abortion.

OBJECTIVE: To compare the efficacy and acceptability of oral misoprostol, vaginal misoprostol, and laminaria tents for cervical dilation before surgical abortion. METHODS: We conducted a randomized, double-blind, placebo-controlled trial comparing oral misoprostol 400 microg, vaginal misoprostol 400 microg, and one medium laminaria for dilating the cervix over 4 hours before surgical abortion. The study sample consisted of 106 women at 7-14 weeks' gestation who presented to San Francisco General Hospital requesting abortion. The primary outcome was the amount of cervical dilation measured by Pratt dilators. Secondary outcomes were the proportion of subjects needing further manual dilation, difficulty of dilation, duration of the procedure, blood loss, and side effects. RESULTS: The vaginal-misoprostol group had a significantly greater mean dilation (28.0 mm) than the oral misoprostol group (24.2 mm; P < .05) and a greater mean dilation than the laminaria group (25.9 mm), although this difference did not reach significance. Women who received laminaria reported significantly more pain at the time of placement (85.7% reported at least "a little" pain) compared with women who received misoprostol by either route (28.9% of oral-misoprostol and 34.0% of vaginal-misoprostol subjects reported "a little" pain; P < .01). The proportion of subjects who required further manual dilation, ease of dilation, duration of the procedure, and blood loss were not significantly different among the groups. There was no difference in side effects during the 4-hour waiting period among the three groups, and gastrointestinal side effects were rare in all groups. CONCLUSION: Vaginal misoprostol is superior to oral misoprostol and is an acceptable alternative to laminaria tents for cervical dilation before surgical abortion in pregnancies of 7-14 weeks' gestation. It is inexpensive and easy to administer, and achieves equal or greater dilation with less pain on insertion and no increase in side effects compared with laminaria.

Abortifacient Agents, Nonsteroidal↗
PubMed2003

Effectiveness of vaginally administered oxybutynin on rabbit bladder function.

OBJECTIVES: To demonstrate the effectiveness of vaginally delivered oxybutynin on bladder function. Oxybutynin has been used for treatment of urge urinary incontinence for more than 20 years. METHODS: Thirty female New Zealand White rabbits were used for this experiment. Each rabbit was anesthetized, and the carotid artery was cannulated for blood pressure monitoring. The bladder dome was catheterized for both monitoring of bladder pressure and cystometry. After initial cystometry, acetylcholine (ACh) was injected into the vesical artery at 15-minute intervals for 4 hours. Cystometry was performed at the 2-hour mark and at the end of each experiment (4 hours). After the third ACh administration, vaginal or oral oxybutynin was given and the effect on the response to ACh, blood pressure, and cystometry was observed. RESULTS: The high dose of oxybutynin completely inhibited the response to ACh and significantly inhibited the micturition reflex. A 45% inhibition of micturition pressure occurred at the intermediate dose. Little effect on compliance after the low dose and a significant increase in compliance after the mid-dose occurred. Both the low and intermediate doses of oxybutynin reduced the response to ACh to approximately 50% of control. No blood pressure effects of vaginal oxybutynin were noted for any concentration. Oral oxybutynin showed very similar effects to that of the intermediate vaginal dose. CONCLUSIONS: Vaginally delivered oxybutynin was effective in decreasing bladder compliance and inhibiting intra-arterial ACh-stimulated bladder contractions with little or no effect on the vascular effect of ACh.

Acetylcholine↗
PubMed1999

Effect of treatment with recombinant bovine somatotropin on responses to superovulatory treatment in swamp buffalo (Bubalus bubalis).

The objective of this study was to determine the effect of treatment with recombinant bovine somatotropin (rBST) on the response to superovulatory treatment in swamp buffalo. Estrous cycles of 16 buffalo cows were synchronized by intravaginal administration of progesterone and estradiol benzoate, and the cows were then randomly divided into 2 groups. The rBST-treated group received 250 mg of a sustained-release formula of rBST on Day 4 after progesterone implantation, whereas the control group did not receive rBST. Both groups were then given a superovulatory regimen of twice daily injections of FSH for 3.5 d (total dose of 260 mg, i.m.), between Days 9 and 11 after administration of progesterone. The cows were bred naturally 1 d after the last FSH injection, then 6 d after breeding they were slaughtered, and their reproductive tracts were removed. The numbers of corpora lutea (CL) and follicles were recorded, and embryos were flushed out of the uterine horns. There were no significant differences between the rBST-treated and control cows for the mean numbers (+/- SEM) of CL (6.0 +/- 2.2 vs 4.3 +/- 1.1), follicles (15.9 +/- 4.1 vs 19.8 +/- 2.9), or total embryos recovered per collection (4.5 +/- 1.6 vs 2.3 +/- 1.0). However, there were significant differences between rBST-treated and control cows for the numbers of transferable embryos per collection (3.0 +/- 1.0 vs 0.8 +/- 0.3; P < or = 0.05) and the overall proportion of transferable embryos (75 vs 33%; P < or = 0.01). The results of this study show that pretreatment of swamp buffalo with rBST significantly increases the production of transferable embryos in response to superovulation.

Animals↗
PubMed1999

Low-potency oestrogen and risk of endometrial cancer: a case-control study.

BACKGROUND: Urogenital symptoms are common among postmenopausal women. Such symptoms may be alleviated by low-potency oestrogen formulations administered orally or vaginally. Although low-potency oestrogen formulations are assumed to have few, if any, adverse effects on the endometrium, risk of endometrial neoplasia has not been quantified. METHODS: In a nationwide population-based case-control study in Sweden of endometrial cancer among postmenopausal women, we obtained detailed information on hormone replacement from 789 cases of endometrial cancer and 3368 population controls. In a histopathological review, 80 cases were reclassified as having endometrial atypical hyperplasia. Odds ratios and 95% CI were calculated with unconditional logistic regression. FINDINGS: After multivariate adjustment, oral use of oestriol 1-2 mg daily increased the relative risk of endometrial cancer and endometrial atypical hyperplasia: the odds ratios for at least 5 years of use compared with never use were 3.0 (95% CI 2.0-4.4) and 8.3 (4.0-17.4), respectively. The association was stronger for well-differentiated cancers and those with limited invasion. The excess relative risk was lost rapidly after cessation of treatment. Only weak associations were observed between vaginal application of low-potency oestrogen formulations and relative risk of endometrial neoplasia. INTERPRETATION: Oral, but not vaginal, treatment with low-potency oestrogen formulations increases the relative risk of endometrial neoplasia. Thus close surveillance of patients is needed, and addition of a progestagen should be considered.

Administration, Intravaginal↗
PubMed2000

Transmucosal delivery systems for calcitonin: a review.

The commercial availability of peptides and proteins and their advantages as therapeutic agents have been the basis for tremendous efforts in designing delivery systems for such agents. The protection of these agents from biological fluids and physiological interactions is crucial for the treatment efficacy. One such agent is salmon calcitonin, a 32 amino-acid polypeptide hormone used in the treatment of bone diseases such as Paget's disease, hypercalcemia and osteoporosis. Researchers have studied different routes to deliver salmon calcitonin more effectively, including nasal, oral, vaginal and rectal delivery. These systems are designed to protect the polypeptide from the biological barriers that each delivery route imposes. Oil-based and polymer-based delivery systems are discussed.

Acrylic Resins↗
PubMed1998

Vaginal immunization of Cynomolgus monkeys with Streptococcus gordonii expressing HIV-1 and HPV 16 antigens.

Cynomolgus monkeys (Macaca fascicularis) were immunized by intravaginal administration of live recombinant Streptococcus gordonii. The vaccine strains of S. gordonii expressed the V3 domain of the gpl20 of human immunodeficiency virus type 1 (HIV-1), and the E7 protein of human papillomavirus type 16 (HPV 16). Multiple inocula of recombinant bacteria were used, since S. gordonii could persist for no longer than 3 days in the monkey vagina. Vaginal immunization was found to induce a local and systemic immune response specific for the heterologous antigen expressed by the bacteria. This antigen-specific immune response consisted of vaginal IgA, serum IgG, and a T-cell proliferative response measured on PBMCs. Vaginal IgG and serum IgA were not detected.

Animals↗
PubMed2000

Rectal and vaginal immunization with a macromolecular multicomponent peptide vaccine candidate for HIV-1 infection induces HIV-specific protective immune responses.

An effective vaccine for human immunodeficiency virus (HIV) is needed to stimulate the immune response of the genital mucus to prevent mucosal transmission of the virus. We have developed a macromolecular multicomponent peptide vaccine candidate, VC1. Both rectal and vaginal immunization of VC1 mixed with cholera toxin (CT) induced HIV-1-specific IgA antibody in mouse fecal extract solution and vaginal wash. These antibody productions were enhanced by the combination with IL-4 or GM-CSF expressing plasmids. Either fecal extract or vaginal wash solution from immunized mice inhibited production of HIV-1IIIB p24 protein. The mononuclear cells from spleen, intestinal lymph nodes, or Peyer's patches from VC1- and CT-immunized mice released IFN-gamma or IL-4, when these cells were co-cultured with VC1 antigen. In addition, the regional lymphoid cells from rectal and vaginal region of mice immunized with VC1 and CT also elicited a substantial level of HIV-1-specific cytotoxic T cell (CTL) response. This CTL response was enhanced by the addition of IL-12 expressing plasmid. Our results clearly demonstrated that both rectal and vaginal immunization could induce systemic and mucosal immunities specific for HIV-1.

AIDS Vaccines↗
PubMed2001

Second trimester termination of pregnancy for fetal anomaly or death: comparing mifepristone/misoprostol to gemeprost.

OBJECTIVE: To assess the effect of changing the regimen for second trimester induction of labour from gemeprost to mifepristone/misoprostol. DESIGN AND SETTING: A retrospective study at a university teaching hospital over the 5-year period 1993-1997. SUBJECTS, METHODS and REGIMENS: 68 patients, 34 in the gemeprost group and 34 in the mifepristone/misoprostol group. The gemeprost group received 1mg vaginally every 3h to a maximum of five doses. The mifepristone/misoprostol group were pre-treated with 600 mg mifepristone orally followed by 800 microg misoprostol vaginally and then 400 microg orally every 3h to a maximum of four oral doses. MAIN OUTCOME MEASURES: Induction to abortion interval; delivery within 24h. RESULTS: The mifepristone/misoprostol group had a lower induction to abortion interval compared to the gemeprost group (median 8.9h versus 19.8h, respectively, p<0.01). The mifepristone/misoprostol regimen was more successful than the gemeprost regimen; 94% versus 68%, respectively, aborted without extra medical or surgical intervention, p=0.02. There were no significant differences in side effects, analgesia requirements or complications between the two groups. Three patients with previous Caesarean sections had a ruptured uterus; two from the gemeprost group and one from the mifepristone/misoprostol group. CONCLUSIONS: The new mifepristone/misoprostol regimen was more effective in second trimester induction of labour. Induction of labour with misoprostol or gemeprost should be used with care in patients with a previous Caesarean section.

Abnormalities, Multiple↗
PubMed2004

[Medical termination of pregnancy at 9-14 weeks gestation. Prospective study of 105 cases in Saint-Laurent-du-Maroni (French Guyana)].

OBJECTIVES: To demonstrate the effectiveness and safety of mifepristone 600mg with misoprostol 800 mg, for termination of pregnancy at 9-14 weeks gestation. PATIENTS AND METHODS: This prospective study included 105 women at 9 to 14 weeks gestation given 800 mg of vaginal misoprostol, 2 or 3 days after a single dose of 600 mg of mifepristone for pregnancy termination. Outcomes measures included mean expulsion time, the interval between fotal and placental expulsion, adverse effects, vaginal bleeding, requirement for analgesia, and hospital stay, analyzed by parity and gestational age. RESULTS: Pregnancy termination was successful in 92.4% of the patients without requirement for surgery. The mean time to expulsion was 6 hours. The fetus and placenta were expelled together in 79% of the cases. In 15% the conception products were retained in the cervical canal, and removed with a ring forceps. Additional misoprostol doses were necessary in 33% and analgesia (nalbuphine sublingually, mean dose was 10mg) in 56%. Significant bleeding was observed in 7.5%, leading to curettage in 2 patients. No statistically significant differences were found between the rate of success and term (9-12 versus 12-14) or parity. CONCLUSION: Combining oral mifepristone and vaginal misoprostol is a successful alternative to surgical termination of pregnancy, even after 9 weeks' gestation. The use of nalbuphine for analgesia improves acceptability; sublingual administration helps avoid invasive procedures. Before 14 weeks gestation, the legal limit for termination of pregnancy in France, the choice between the surgical and medical alternatives should be left to the patient.

Abortifacient Agents, Nonsteroidal↗
PubMed2006

Use of mifepristone and sublingual misoprostol for early medical abortion.

OBJECTIVE: Existing drug-induced abortion techniques involve oral administration of 200 mg of mifepristone, followed by oral administration of 600 microg of misoprostol 48 hours later, but the effects are variable. As revealed by recent research, sublingual and oral administrations of misoprostol are equally efficacious in terms of rapid absorption, but the former lasts longer in serum. Hence, in the near future, sublingual administration of misoprostol may become the most effective way to induce abortion. MATERIALS AND METHODS: Women with intrauterine pregnancy up to 49 gestational days received vaginal ultrasonography, followed by oral administration of mifepristone 200 mg and sublingual administration of misoprostol 600 microg 48 hours later. They returned for follow-up consultations 3 and 14 days after. The definition of a successfully induced complete medical abortion was that the abortion occurred without surgery or evacuating the uterus. RESULTS: A total of 356 women underwent medical abortion; the complete abortion rate was 98.3% (350 women). Medical abortion was unsuccessful in five (1.7%) women, who eventually had to undergo dilation and curettage. Patients found the side effects to be bearable; the reported satisfaction rate was 89.9% (325 women). CONCLUSION: Medical abortion for early termination of pregnancy should be achieved by oral administration of mifepristone, followed by sublingual administration of misoprostol.

Abortifacient Agents, Nonsteroidal↗
PubMed2006

Concurrent use of mifepristone and misoprostol for early medical abortion.

OBJECTIVE: This study was designed to evaluate the efficacy of using mifepristone and misoprostol concurrently for early medical abortion. MATERIALS AND METHODS: A total of 90 women with undesired pregnancies <or= 49 days' gestation were enrolled. All women concurrently received oral mifepristone 200 mg and vaginal misoprostol 800 microg. Follow-up evaluation with transvaginal ultrasonography was performed 4 days and 2 weeks after treatment. RESULTS: The complete abortion rate was 97.8% (88/90 women). The mean induction to abortion interval was 5.5 hours. The mean bleeding duration was 11.8 days. Patients found the side effects acceptable and reported a 91.1% (82 patients) satisfaction rate. CONCLUSION: Concurrent administration of oral mifepristone and vaginal misoprostol is an efficacious regimen for medical abortion of pregnancies <or= 49 days of gestation.

Abortifacient Agents, Nonsteroidal↗
PubMed2003

Pharmacokinetics of prostaglandins.

Naturally occurring prostaglandins (PGs) are rapidly metabolized in the human circulation. For clinical use a number of PG analogues have therefore been developed which are resistant to rapid inactivation. Among these are carboprost, gemeprost and misoprostol. Following intramuscular injection of carboprost, plasma levels peaked after 20 minutes and declined slowly thereafter. In amniotic fluid the half-life was between 31 and 37 hours. Gemeprost is administered vaginally, and maximum plasma levels were reached after 2-3 hours, with detectable levels for at least 6-8 hours. Pharmacokinetic data on misoprostol are available following oral, vaginal and sublingual administration. Following oral treatment, plasma levels peaked at about 30 minutes, while after vaginal administration of the tablets the levels increased gradually and reached maximum levels after 70-80 minutes, but remained detectable for a significantly longer time. After sublingual administration the peak concentration was the same as for oral treatment but declined significantly more slowly. Endocervical administration of PGE(2) might be regarded as a local therapy, while following vaginal administration increased plasma levels of metabolites can generally be found. The plasma profile varies with the vehicle used.

Abortifacient Agents, Nonsteroidal↗
PubMed2003

Prostaglandins for first-trimester termination.

Since the 1980s, when mifepristone combined with a prostaglandin was found to be safe and effective for early abortion, many studies have refined the regimens and investigated alternatives such as methotrexate plus misoprostol, and misoprostol alone. Evidence now demonstrates that more than 200 mg of mifepristone provides no additional benefit, that vaginal misoprostol is superior to oral, especially between 7 and 9 weeks' gestation, and that misoprostol may be safely self-administered at home. Buccal and sublingual routes of administration of misoprostol also are promising. Absolute contraindications to medical abortion arise infrequently. Gastrointestinal and other side-effects occur in about one-third of women, primarily after administration of the prostaglandin. Careful assessment before and after medical abortion is essential and can be accomplished in various ways, depending on the skills of the clinician.

Abortifacient Agents, Nonsteroidal↗
PubMed2003

Prostaglandins in the prevention and management of postpartum haemorrhage.

Myometrial contractility is integral to the delivery of the placenta and the arrest of potential subsequent haemorrhage. The details of this physiological process are patchy but it is clear that there is an important hormonal contribution. Oxytocin, with or without ergometrine, has thus been widely used with a recognized beneficial treatment effect. This practice, however, was never universal. The injectable nature of these agents restricted their wider use, even in societies with average medical services. The availability of the prostaglandin analogue misoprostol has renewed interest in the third stage of labour, has taken its pharmacological management to new frontiers, and has expanded the therapeutic options for the management of postpartum haemorrhage.

Administration, Intravaginal↗