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Facilitation of sexual behavior in French-Alpine goats treated with intravaginal progesterone-releasing devices and estradiol during the breeding and nonbreeding seasons.

The effectiveness of administering progesterone (P4) using controlled intravaginal drug release (CIDR) devices on estradiol (E2)-induced sexual behaviors was examined in ovariectomized (ovx) French-Alpine goats during the fall and spring. Estradiol-induced attractivity and receptivity were facilitated during the spring when P4-filled CIDR devices were removed 24 or 48 h before injection of 30 microg of E2. During the fall, attractivity was also facilitated by CIDR removal 24 h prior to E2 injection, whereas E2-induced receptivity was unaffected by removal of the CIDR at this interval. Concentrations of P4 in circulation during the 3 d of treatment with a CIDR were similar to those during the late luteal phase of the estrous cycle in intact goats. Treatment with P4-filled CIDR for 3 d, followed by injection with 30 microg of E2 24 h after removal, was determined to be a useful model for inducing sexual behavior in a physiologically relevant manner, and it may also be an effective means for facilitating estrus detection due to the high frequency of display of sexual behavior during a predictable time period following steroid treatment.

Administration, Intravaginal↗

Stag exposure advances the LH surge and behavioral estrus in Eld's deer hinds after CIDR device synchronization of estrus.

The impact of male presence or absence on the timing of the preovulatory LH surge and estrus was studied in 3 experimental groups (n = 6/group) of Eld's deer hinds pretreated with intravaginal progesterone-releasing devices (CIDR-type G) as follows: Group 1 = indirect male contact barn; Group 2 = direct male contact barn; and Group 3 = male isolation barn. For all hinds, the duration of the preovulatory LH surge averaged 2.5+/-0.5 h, whereas mean peak preovulatory and basal LH concentrations were 2.9+/-0.2 ng mL(-1) and 0.27+/-0.03 ng mL(-1), respectively. Nine of 12 male-exposed hinds exhibited a preovulatory LH surge within 24 to 32 h postCIDR device withdrawal, whereas 0 of 6 male-isolated hinds exhibited a preovulatory LH surge during the same time period. Onset of behavioral estrus (45.2+/-2.3, 52.7+/-5.7 and 66.3+/-1.8 h, respectively) was significantly advanced (P<0.05) after CIDR device withdrawal in male exposed hinds (Groups 1 and 2) compared with male isolated hinds (Group 3). These data suggest that stag exposure is important for modulating the timing of the preovulatory LH surge and behavioral estrus after synchronization of estrus with exogenous progestagens.

Administration, Intravaginal↗

Seasonal variation in preovulatory events associated with synchronization of estrus in dwarf goats.

This experiment was conducted to define the temporal relationships among estrus, the LH surge and ovulation after estrus synchronization in dwarf goats and to assess the effect of season on these parameters. In November (breeding season), March (transition period) and July (non-breeding season), estrus was synchronized in 12 dwarf goats by means of intravaginal sponges containing 60 mg medroxyprogesterone acetate (MAP) for 10 d, coupled with 125 microg cloprostenol i.m. 48 h before sponge removal and 300 IU eCG i.m. at sponge removal. A different group of animals was used during each time period. Onset of estrus was monitored using two males, and blood samples for the measurement of plasma LH were collected at 2-h intervals from 24 to 60 h after sponge removal. Ovulation was confirmed by laparoscopy at 54 and 72 h after sponge removal. A seasonal shift was detected in the intervals to onset of estrus, LH surge, and ovulation after sponge removal (P<0.05), with sponge removal to onset of estrus being shorter (P<0.05) in November (25.0 +/- 1.56 h) and July (28.9 +/- 2.43 h) than in March (40.9 +/- 3.27 h). The intervals between onset of estrus and the LH surge and between the LH surge and ovulation were found to be constant throughout the different seasons. An optimal time for breeding, artificial insemination, oocyte and embryo recovery, and embryo transfer may be predicted using information gained from these studies.

Administration, Intravaginal↗

Results of postoperative radiation therapy for patients with carcinoma of the uterine cervix: evaluation of intravaginal cone boost with an electron beam.

Retrospective analysis was carried out from the records of 108 patients with carcinoma of the uterine cervix treated with postoperative external whole pelvic irradiation (EWPI) followed by intravaginal cone boost with an electron beam to the vaginal cuff (IVCB) to evaluate the efficacy of this method. The 5-year cause-specific survival rates were 89% for 89 patients undergoing prophylactic radiation therapy and 56% for 19 patients undergoing salvage radiation therapy (P < 0.001). The 5-year survival rates were 62% for 11 patients with macroscopic residual tumors and 41% for 8 patients with microscopic residual tumors. Of the patients with pelvic lymph node (PLN) involvement, incidences of intrapelvic recurrence, extrapelvic recurrence, and distant metastases were 12, 9, and 3%, respectively. The prognosis for patients without PLN metastasis was significantly better than that for patients with PLN metastasis in the prophylactic radiation therapy group (P < 0.001). Recurrent tumors at the vaginal cuff were observed in only 2 patients in the prophylactic radiation therapy group. Vesicovaginal fistula was observed in 4 patients. Only 1 patient developed Grade 2 rectal complications. No other severe complications were observed. IVCB following EWPI is a safe and effective postoperative radiation therapy technique for patients with cervical cancer.

Adenocarcinoma↗

A randomized study comparing Crinone 8% and intramuscular progesterone supplementation in in vitro fertilization-embryo transfer cycles.

OBJECTIVE: To compare the efficacy of Crinone 8% intravaginal progesterone gel vs. IM progesterone for luteal phase and early pregnancy support after IVF-ET. DESIGN: Randomized, open-label study. SETTING: Academic medical center. PATIENT(S): Two hundred and one women undergoing IVF-ET. INTERVENTION(S): Women were randomized to supplementation with Crinone 8% (90 mg once daily) or IM progesterone (50 mg once daily) beginning the day after oocyte retrieval. MAIN OUTCOME MEASURE(S): Pregnancy, embryo implantation, and live birth rates. RESULT(S): The women randomized to luteal phase supplementation with IM progesterone had significantly higher clinical pregnancy (48.5% vs. 30.4%; odds ratio [OR], 2.16; 95% confidence interval [CI], 1.21, 3.87), embryo implantation (24.1% vs. 17.5%; OR, 1.89; 95% CI, 1.08, 3.30), and live birth rates (39.4% vs. 24.5%; OR, 2.00; 95% CI, 1.10, 3.70) than women randomized to Crinone 8%. CONCLUSION(S): In women undergoing IVF-ET, once-a-day progesterone supplementation with Crinone 8%, beginning the day after oocyte retrieval, resulted in significantly lower embryo implantation, clinical pregnancy, and live birth rates compared with women supplemented with IM progesterone.

Administration, Intravaginal↗

Estrus and luteal function in suckled beef cows that were anestrous when treated with an intravaginal device containing progesterone with or without a subsequent injection of estradiol benzoate.

The objectives in this study were to determine whether treatment with progesterone (P4) via an intravaginal device would induce estrus and development of corpora lutea (CL) with typical life spans and whether treatment with estradiol benzoate (EB) following device removal would enhance the responses. At treatment initiation (d 0), suckled beef cows (n = 362) that were anestrous received one of the following: 1) an intravaginal device containing P4 for 7 d plus an injection of 1 mg of EB 24 to 30 h after device removal (P4+EB), 2) an intravaginal device containing P4 for 7 d (P4), 3) a sham device for 7 d plus an injection of 1 mg of EB 24 to 30 h after device removal (EB), or 4) a sham device for 7 d (control). Progesterone treatment increased the proportion of cows that formed CL with a typical lifespan (P < .001) and exhibited behavioral estrus (P < .05). Treatment with EB in combination with P4 increased (P < .001) the proportion of cows that exhibited estrus. Treatment with P4 alone had no effect, but the combination of P4 and EB increased (P < .01) the proportion of cows that formed short-lived or typical lifespan CL by the end of the experiment compared with untreated cows. In summary, treatment with P4 increased the incidence of estrus and the proportion of cows that formed CL with a typical lifespan. Treatment with P4 resulted in resumption of luteal function in suckled beef cows that were anestrous, with most cows developing CL with a typical lifespan, whereas EB enhanced the expression of estrus.

Administration, Intravaginal↗

Reproductive performance of ewes after 5-day treatment with intravaginal inserts containing progesterone in combination with injection of prostaglandin f2alpha.

Three experiments were conducted with a total of 1579 ewes to examine reproductive performance in response to synchronization of oestrus during the breeding season, using controlled internal drug releasing (CIDR-G) inserts in regimens designed to provide high concentrations of circulating progesterone. In experiment 1, treatment with two CIDR-G inserts for 12 days produced conception rate (79%) and prolificacy (1.9) to first service equivalent to breeding at natural oestrus (56% and 2.0, respectively). Pregnancy rates to two service periods were 90 and 79%, respectively. In experiments 2 and 3, progesterone was delivered by a single CIDR-G insert for 5 days in combination with prostaglandin F2alpha (PGF2alpha; 5 mg i.m., twice, 3 h apart) the day before (experiment 2), or at insert removal (experiment 3). The combined treatments improved rates of synchronization of oestrus (p<0.01) by 23 and 20% points, respectively, and pregnancy rates to the first service period by 19 (p<0.05) and 13 (p<0.01) percentage points, respectively, compared to treatment with PGF2alpha alone. It is concluded that the combination of treatment for 5 days with a CIDR-G insert and two injections of 5 mg PGF2alpha, the day before, or the day of insert removal, were effective treatments to obtain high fertility at synchronized oestrus in ewes during the breeding season.

Administration, Intravaginal↗

Suppression of ovarian progesterone production in dairy cows using an implant of GnRH-agonist (deslorelin) for the purpose of evaluating progesterone metabolism [corrected].

OBJECTIVE: To evaluate the potential of an implant of a GnRH-agonist (deslorelin) to create a progesterone free animal suitable for studying progesterone (P4) metabolism in intact cows by measuring blood P4 and faecal P4 metabolites. METHODS: Experiment 1: Eighteen non-lactating cycling Holstein-Friesian cows, 4 to 7 years old, were allocated to one of three groups to study plasma P4 concentrations preceding an intravaginal insert. These groups comprised: i) a deslorelin group (GnRH-agonist implanted); ii) a PGF group receiving two injections of prostaglandin (PGF2alpha) 12 days apart; and, iii) an ovariectomised (OVX) group. An intravaginal device (CIDR) was inserted into the vagina of each animal and left in place for 11 days. Plasma P4 concentrations were measured during the study period. Experiment 2: Twelve non-lactating cycling Holstein-Friesian cows, 4 to 7 years old, were allocated to two groups: i) a deslorelin group (GnRH-agonist implanted); and ii) an ovariectomised group. Plasma P4 and faecal P4 metabolites (20-oxo-pregnanes, 20alpha-OH and 20beta-OH) were monitored for a period of 5 weeks. RESULTS: Experiment 1: Average plasma P4 concentration did not differ between the three groups (1.28, 1.43 and 1.55 ng/mL for deslorelin, OVX and PGF cows, respectively, P = 0.8) during the period of supplementation. Experiment 2: There was no difference in plasma P4 (mean plasma P4 < 0.02 ng/mL, P = 0.9) and faecal P4 metabolites between deslorelin and OVX cows 2 weeks after the implantation (P = 0.7). CONCLUSIONS: These data showed that a GnRH-agonist (deslorelin) implant may be used as an alternative to ovariectomy to create a progesterone free animal suitable for studying the metabolism of administered P4.

Administration, Intravaginal↗

Estrus synchronization and conception rate after a progesterone releasing intravaginal device (PRID) treatment from the early luteal phase in heifers.

The objective of the present study was to evaluate estrus synchronization and conception rate after progesterone releasing intravaginal device (PRID) treatment from the early luteal phase in the presence or absence of estradiol benzoate (EB) in heifers. Heifers (n=11) were assigned randomly to two treatments; insertion of a PRID containing 1.55 g progesterone with a capsule attached including 10 mg EB (P+EB; n=6) and the PRID withdrawn the EB capsule (P-EB; n=5). The PRID was inserted into the vagina on Day 2 of the estrous cycle (Day 0 was the day of ovulation) and was left for 12 days. The proportion of heifers exhibiting standing estrus within 3 days after PRID removal was 83.3% (5/6) for the P+EB group, and 80.0% (4/5) for the P-EB group, respectively. Conception rate by artificial insemination on synchronized estrus was 80.0% (4/5) in the P+EB group, and 100% (4/4) in the P-EB treatment group, respectively. These results suggest that a PRID treatment from 2 days after ovulation for 12 days in the presence or absence of EB has an effect on the synchronization of estrus and produces a beneficial conception rate in heifers.

Administration, Intravaginal↗

Use of estradiol cypionate as a substitute for GnRH in protocols for synchronizing ovulation in dairy cattle.

Our purpose was to determine whether estradiol cypionate (ECP) could be substituted for the second GnRH injection of the standard Ovsynch protocol (injection of GnRH given 7 d before and 48 h after PGF(2alpha), with timed AI [TAI] 12 to 20 h after the second GnRH injection). Lactating dairy cows ranging from 61 to 82 d in milk at TAI were studied in 14 replicates. Main effects were hormone (ECP vs. GnRH) to induce ovulation and exposure to progesterone (P4) or not during the week preceding PGF(2alpha)-induced luteolysis. Four treatments were: 1) 100 microg of GnRH at 48 h after PGF(2alpha) (Ovsynch; n = 27); 2) same as Ovsynch, plus a P4-releasing intravaginal insert (CIDR) placed for 7 d beginning at the first GnRH injection (Ovsynch + CIDR, n = 20); 3) same as Ovsynch, but substituting 1 mg of ECP for GnRH, and injecting ECP at 24 h after PGF(2alpha) (Heatsynch; n = 33); or 4) Heatsynch + CIDR (n = 26). The largest follicle was identified by ultrasonography 24 h after PGF(2alpha) and was monitored every 6 h until ovulation. Incidence of estrus was less after GnRH (54%) than after ECP (87%), but more GnRH-treated cows had LH surges detected (95 vs. 65%) and ovulated (100 vs. 86%). Duration of LH surges, but not peak concentrations, was less after GnRH than after ECP (6.1 +/- 0.7 vs. 12.2 +/- 0.9 h). Pre-treatment with P4 reduced the incidence of LH surges but had no effects on incidence of estrus or ovulation. Intervals to the LH surge and ovulation were less after GnRH than after ECP, but intervals between onset of the LH surge and ovulation did not differ (26 +/- 2 vs. 30 +/- 3 h). We concluded that substituting ECP for GnRH resulted in more cows in estrus and slightly fewer ovulating.

Administration, Intravaginal↗

Induction of HIV immunity in the genital tract after intranasal delivery of a MVA vector: enhanced immunogenicity after DNA prime-modified vaccinia virus Ankara boost immunization schedule.

Vaccines intended to prevent mucosal transmission of HIV should be able to induce multiple immune effectors in the host including Abs and cell-mediated immune responses at mucosal sites. The aim of this study was to characterize and to enhance the immunogenicity of a recombinant modified vaccinia virus Ankara (MVA) expressing HIV-1 Env IIIB Ag (MVAenv) inoculated in BALB/c mice by mucosal routes. Intravaginal inoculation of MVAenv was not immunogenic, whereas intranasally it induced a significant immune response to the HIV Ag. Intranasal codelivery of MVAenv plus cholera toxin (CT) significantly enhanced the cellular and humoral immune response against Env in the spleen and genitorectal draining lymph nodes, respectively. Heterologous DNAenv prime-MVAenv boost by intranasal immunization, together with CT, produced a cellular immune response in the spleen 10-fold superior to that in the absence of CT. A key finding of these studies was that both MVAenv/MVAenv and DNAenv/MVAenv schemes, plus CT, induced a specific mucosal CD8(+) T cell response in genital tissue and draining lymph nodes. In addition, both immunizations also generated systemic Abs, and more importantly, mucosal IgA and IgG Abs in vaginal washings. Specific secretion of beta-chemokines was also generated by both immunizations, with a stronger response in mice immunized by the DNA-CT/MVA-CT regimen. Our findings are of relevance in the area of vaccine development and support the optimization of protocols of immunization based on MVA as vaccine vectors to induce mucosal immune responses against HIV.

AIDS Vaccines↗

Comparing ovulation synchronization protocols for artificial insemination in the scimitar-horned oryx (Oryx dammah).

Ovarian response and pregnancy success in scimitar-horned oryx (n=28) were compared, following treatment with two synchronization protocols and fixed-time artificial insemination (AI) with frozen-thawed semen. Each oryx received two injections of 500 microg of prostaglandin-F(2alpha) analogue (PGF(2alpha)-only) 11 days apart, and half received PGF(2alpha) in combination with an intravaginal progesterone-releasing device (CIDR11+PGF(2alpha)). Semen was collected by electroejaculation from anaesthetised adult oryx and cryopreserved. Anaesthetised females were transcervically inseminated 56.0+/-1.1 h (+/-S.E.M.) after PGF(2alpha) injection and/or device withdrawal using 28.0+/-1.5x10(6) motile thawed sperm. Ovarian endocrine response was monitored in 20 females by analysing faecal oestrogen and progesterone metabolites. Periovulatory oestrogen peaks were detected in 19/20 (95%) females after synchronization. There were no between-treatment differences in oestrogen concentrations or peak characteristics (P0.05). Luteal development after synchronization was delayed in half the progesterone treated (CIDR11+PGF(2alpha)) females, and faecal progestin excretion profiles indicated that the ovulatory follicle associated with synchronization either failed to ovulate or to fully lutenise. Pregnancy was diagnosed by ultrasonography and/or rectal palpation and was monitored by faecal progestin excretion. More (P=0. 013) pregnancies resulted from the PGF(2alpha)-only treatment (37.5%, 5/14) than from the CIDR11+PGF(2alpha) treatment (0/14), and four healthy scimitar-horned oryx calves were born, three after gestation intervals of 247 days and one after 249 days.

Administration, Intravaginal↗

Perspectives related to the potential use of vaginal microbicides among drug-involved women: focus groups in three cities in the United States and Puerto Rico.

HIV transmission through heterosexual contact remains the greatest risk factor for women globally. Topical microbicides applied intravaginally may offer a female-initiated HIV prevention option for many who are unable or unwilling to use male condoms or who would want additional protection. This article presents results of focus groups in Bridgeport, Connecticut, Providence, Rhode Island, and San Juan, Puerto Rico, with women who use crack or heroin or have male partners who inject illegal drugs. Participants revealed motivation for and openness to using microbicides effective against HIV should they become available. Additional lubrication during intercourse was one of several expected positive features of microbicides; women saw lubrication as a means of enhancing pleasure and reducing condom irritation and breakage while also protecting them from infection. Conversely, some women feared that their male partners would interpret excessive lubrication as an indication of infection, improper hygiene, or evidence of sex with another man. Focus groups also provided insight into how aspects of different women's sexual lives, including partner type, might influence the issues that would concern them if and when they tried out new microbicidal products in the future.

Acquired Immunodeficiency Syndrome↗

Mouse model of cervicovaginal toxicity and inflammation for preclinical evaluation of topical vaginal microbicides.

Clinical trials evaluating the efficacy of nonoxynol-9 (N-9) as a topical microbicide concluded that N-9 offers no in vivo protection against human immunodeficiency virus type 1 (HIV-1) infection, despite demonstrated in vitro inactivation of HIV-1 by N-9. These trials emphasize the need for better model systems to determine candidate microbicide effectiveness and safety in a preclinical setting. To that end, time-dependent in vitro cytotoxicity, as well as in vivo toxicity and inflammation, associated with N-9 exposure were characterized with the goal of validating a mouse model of microbicide toxicity. In vitro studies using submerged cell cultures indicated that human cervical epithelial cells were inherently more sensitive to N-9-mediated damage than human vaginal epithelial cells. These results correlated with in vivo findings obtained by using Swiss Webster mice in which intravaginal inoculation of 1% N-9 or Conceptrol gel (containing 4% N-9) resulted in selective and acute disruption of the cervical columnar epithelial cells 2 h postapplication accompanied by intense inflammatory infiltrates within the lamina propria. Although damage to the cervical epithelium was apparent out to 8 h postapplication, these tissues resembled control tissue by 24 h postapplication. In contrast, minimal damage and infiltration were associated with both short- and long-term exposure of the vaginal mucosa to either N-9 or Conceptrol. These analyses were extended to examine the relative toxicity of polyethylene hexamethylene biguanide (PEHMB), a polybiguanide compound under evaluation as a candidate topical microbicide. In similar studies, in vivo exposure to 1% PEHMB caused minimal damage and inflammation of the genital mucosa, a finding consistent with the demonstration that PEHMB was >350-fold less cytotoxic than N-9 in vitro. Collectively, these studies highlight the murine model of toxicity as a valuable tool for the preclinical assessment of toxicity and inflammation associated with exposure to candidate topical microbicides.

Administration, Intravaginal↗

Applicability of a progesterone-based timed artificilal insemination protocol after follicular fluid aspiration using the ovum pick-up technique in suckled beef cows.

We conducted a progesterone-based timed AI protocol after follicular fluid aspiration using the ovum pick-up (OPU) technique to examine its applicability to the suckled beef cow. A total of 19 beef cows were randomly allocated to one of the following three groups based on the number of days postpartum: 13 to 60 days (Group A: suckled; early postpartum period, n=9), 61 to 150 days (Group B: suckled; mid postpartum period, n=6), or 151 to 281 days (Group C: non-suckled; prolonged open period, n=4) postpartum. These cows were treated with follicular fluid aspiration and insertion of a progesterone-releasing intravaginal device (PRID) on day 0. The PRID was removed and 500 microg of cloprostenol was intramuscularly administered on day 7. A dose (100 microg) of fertirelin acetate was injected intramuscularly 48 hours later, and this was followed by a timed AI (TAI) after another 18 hours (day 10). Serum samples were taken on days 0, 7, 9, 10, 12, 17, 24 and 31 for determination of the estradiol-17beta (E(2)) and progesterone concentrations. Pregnancy diagnosis was made by rectal palpation approximately 60 days after TAI. There was no significant difference in the peripheral E(2) concentrations among the three groups during the period of the hormonal treatment. The average progesterone concentrations in Group A on day 17 were significantly higher than those in Group B and exceeded 1.0 ng/ml on day 17 and thereafter. There was no significant difference in the numbers of collected immature oocytes among the three groups. The pregnancy rates in Groups A, B, and C were 77.8% (7/9), 83.3% (5/6) and 50.0% (2/4), respectively. In conclusion, this timed AI protocol is applicable to suckled beef cows within the period of 60 days postpartum.

Administration, Intravaginal↗

A randomized trial of saline solution-moistened misoprostol versus dry misoprostol for first-trimester pregnancy failure.

OBJECTIVE: The purpose of this study was to estimate whether the efficacy of treatment with intravaginal misoprostol for first-trimester pregnancy failure is enhanced by the addition of saline solution. STUDY DESIGN: Eighty women with embryonic/fetal death or anembryonic pregnancy were assigned randomly to receive either 800 microg of misoprostol with saline solution (group I, 41 women) or without (group II, 39 women). Treatment was repeated on day 3 if the gestational sac remained. Curettage was performed if the gestational sac remained on day 8 or as necessary during at least 30 days of follow-up. Data were analyzed with the Student t test and the chi(2) or Fisher exact test. RESULTS: By the first follow-up visit, 73% (group I) and 64% (group II) of women passed the gestational sac (P=.38). By the second follow-up visit, expulsion rates were 83% and 87%, respectively (P=.59). Five subjects in each group underwent curettage. CONCLUSION: Misoprostol is effective for the treatment of failed first-trimester pregnancy. The expulsion rate is not improved by adding saline solution.

Abortifacient Agents, Nonsteroidal↗

Serial intravaginal prostaglandin E2 gel cervical ripening in preterm pregnancies.

OBJECTIVE: To determine if prostaglandin (PG) E2 cervical ripening is safe and effective in high-risk preterm pregnant women who do not have an indication for immediate delivery. METHODS: This was a retrospective case-control study of preterm pregnant women treated with sequential PGE2 gel between 3/1/92 and 3/1/95. Study subjects were between 24 and 36 weeks gestation, had intact membranes, and complications requiring inpatient monitoring but not immediate delivery. PGE2 gel was inserted serially until either maternal or fetal deterioration required intervention, fetal maturity was achieved, a Bishop > or = 7 was reached, or the patient improved and was discharged. Control subjects were matched for inclusion criteria and diagnoses on admission. RESULTS: A total of 22 study and 22 control patients were evaluated. The gestational age at admission was 32.3 +/- 2.8 versus 31.8 +/- 2.9 weeks. The mean number of PGE2 gel applications was 11.6 over a mean of 5.0 days. Intervention during ripening was required in 11 (50%). A Bishop score > or = 7 without labor was achieved in 11 (50%), and labor during the ripening process occurred in 2 (9%). The mean time from Bishop > or = 7 to delivery was 2.6 days. The total cesarean delivery rate was 10 (45%) versus 15 (68%), in the control group (P = NS). Neonatal outcomes were similar. CONCLUSIONS: Sequential PGE2 gel cervical ripening when used in preterm pregnant women improves the Bishop score, and has a low incidence of spontaneous preterm labor.

Administration, Intravaginal↗

Effectiveness and safety of a new vaginal misoprostol product specifically labeled for cervical ripening and labor induction.

OBJECTIVE: The purpose of this study was to evaluate the effectiveness and safety of misoprostol in two different formulations: vaginal tablets of 25 microg and one-eighth of a 200-microg oral tablet, also administered intravaginally, for cervical ripening and labor induction of term pregnancies with an indication for that. METHODS: A single-blind, randomized, controlled clinical trial was carried out in 120 pregnant women who randomly received one of the two formulations. The main dependent variables were mode of delivery, need for additional oxytocin, time between beginning of induction and delivery, perinatal results, complications, and maternal side effects. Student's t, Mann-Whitney, chi2, Fisher's Exact, Wilcoxon and Kolmogorov-Smirnoff tests, as well as survival analysis, were used in the data analysis. RESULTS: There were no significant differences between the groups in terms of general characteristics, uterine contractility, and fetal well-being during labor, cesarean section rates, perinatal outcomes, or maternal adverse events. The mean time between the beginning of cervical ripening and delivery was 31.3 h in the vaginal tablet group and 30.1 h in the oral tablet group, a difference that was not statistically significant. CONCLUSION: The results showed that the 25-microg vaginal tablets of misoprostol were as effective and safe for cervical ripening and labor induction as the dose-equivalent fraction of 200-microg oral tablets.

Administration, Intravaginal↗