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PubMed1985

[Use of a new vaginal suppository: prostaglandin E1 analog Gemeprost for cervix maturation prior to abortion in the 1st trimester].

This double-blind study is concerned with the efficacy and safety of a new prostaglandin E1-analogue (16,16'-dimethyl-trans-delta 2PGE1-methylester) (Gemeprost) (ONO-802), which was administered as a single 1 mg vaginal pessary three hours prior to legal abortion. The efficacy of the prostaglandin was assessed by the largest size of the dilator meeting no resistance when inserted in the cervical channel. Furthermore, the quality of the cervix and the effort needed for further dilatation was evaluated. The average size of the cervix prior to dilatation was found to be 10 mm, in comparison to only 7 mm in the placebo-group (p less than 0.001). 80% of the patients of the Gemeprost group did not need any further dilatation, i.e. the dilatation procedure of the cervix was easier than in the group without treatment (19%). The incidence of uterine pain was more frequent in the Gemeprost group (40%) than in the Placebo group (7%). Analgesics were not required. The frequency of gastrointestinal side effects was rare in the Gemeprost group (13%) and in the Placebo group (11%) compared with other prostaglandins. By the preoperative application of a new prostaglandin E1-analogue (1 mg) prior to vacuum aspiration in the first trimenon of pregnancy sufficient softening of the cervix and a dilatation of the cervix was achieved. It significantly reduces the need for further mechanical dilatation of the cervix as well as the force needed to perform this dilatation. These effects reduce the trauma associated with mechanical dilatation and therefore diminish the risk of subsequent complications.

Abortifacient Agents↗
PubMed1989

[Clinical relevance and pathognomonic significance of Actinomycetes colonization of intra-uterine devices].

Microbiological investigations were carried out on 524 intrauterine pessaries (IUP) from 488 patients. All patients underwent a gynecological examination on the occasion of IUP extraction. An actinomycete colonization of the extracted IUPs could be detected by culture in 8% of the cases. Actinomyces israelii was cultured most frequently. The raised detection of anaerobic bacteria in the endocervix of patients with actinomycin detection constitutes a potential danger for these women with regard to the development of genital actinomycosis. In addition, the clinical parameters document a higher susceptibility of these patients to ascending genital infections. The infectious morbidity is significantly raised.

Actinomyces↗
PubMed1980

[Long-term experience in intrauterine contraception a comparison between Lippes' loop, Dalcon-shield and copper-t (author's transl)].

Three different models of intrauterine pessaries are compared with each other in respect of tolerance and safety. They were worn for different lengths of time, partly for up to ten years. The comparison shows that the Pearl index in its conventional form is not a suitable indicator. It does provide a pointer if the individual collectives are reduced to the same wearing period. The Life-Table method yields better results. It relates the events for a total of 100 women in each case to the same interval periods. This shows that the most favourable rate of complications and quota of failures is obtained with Cu-T 200. During the first three years this quota decreases steadily. Hence it is recommended to effect intrauterine contraception according to this model wherever suitable and to allow Cu-T to be retained in position for at least three years if it is well tolerated.

Adult↗
PubMed1993

[Abdominal actinomycosis].

Twelve years after adnexectomy, performed for actinomycosis of the left ovary, a 32-year-old woman developed abdominal and back pain. A solid tumour was palpated in the left lower abdomen. Colon contrast examination revealed a subtotal stenosis in the sigmoid colon, while sonography showed a complete stenosis of the left ureter with left hydronephrosis. Relaparotomy demonstrated a stone-hard tumour at the rectosigmoid junction, which involved the right ovary and ureter, as well as having infiltrated the retroperitoneum, predominantly on the left. After resection of the sigmoid colon, uterus and right ovary, as well as of the ureteric stenosis with reanastomosis, the further course was without complication. Histological examination confirmed actinomycosis of the left ovary, sigmoid colon and pelvic mesocolon. Therapy with amoxycillin, 500 mg three times daily, was started. As the patient had worn an intrauterine pessary for several years, primary infection of the uterus with spread into the abdominal cavity via tube and ovaries is likely to have been the course of events. The recurrence was probably caused by reactivation of residual actinomycetes in the retroperitoneum and pelvic mesocolon.

Abdomen↗
PubMed2002

Production of lambs of predetermined sex after the insemination of ewes with low numbers of frozen-thawed sorted X- or Y-chromosome-bearing spermatozoa.

The fertilizing ability of sex-sorted frozen-thawed ram spermatozoa was assessed after insemination of mature Merino ewes at a synchronized oestrus. Ewes were inseminated into the uterus or utero-tubal junction (UTJ) with a total of 140 x 10(6) unsorted (control) or 2-4 x 10(6) sorted (X or Y) frozen-thawed ram spermatozoa 54 to 57 hours after removal of progestagen-impregnated pessaries and an injection of 400 IU of pregnant mare serum gonadotrophin (Folligon, Intervet). The spermatozoa were separated into X- and Y-chromosome-bearing spermatozoa after analysis with a modified high-speed cell sorter (SX MoFlo). The number of ewes pregnant after insemination with unsorted frozen-thawed spermatozoa was significantly higher (26/48; 54.3%) than for ewes inseminated with either X- (12/48; 25.0%) or Y-sorted spermatozoa (7/48; 14.6%) (P<0.05). Seventeen of the eighteen lambs produced by ewes inseminated with X-sorted spermatozoa were female (94.4%) and 8/8 lambs from ewes inseminated with Y-sorted spermatozoa were male (100%). The sex ratio of the lambs born to ewes inseminated with sex-sorted spermatozoa was significantly skewed from the 51.3% male and 48.7% female ratio in the control group (P<0.05). This study showed, for the first time, that lambs of predicted sex can be produced after insemination with low numbers of sex-sorted cryopreserved ram spermatozoa.

Abortion, Veterinary↗
PubMed2001

Mid-trimester termination of pregnancy by dilatation and evacuation.

The object of this study was to evaluate the feasibility and safety of Dilatation and Evacuation (D&E) as a method of termination of pregnancy in the second trimester. We conducted a retrospective analysis of 61 cases. The mean age of women was 25.6 years (range 1545) and the majority of terminations were performed for social reasons. Twelve women (20%) had at least one previous termination of pregnancy. The median gestational age was 16 weeks (range 1322). Except for three multiparous women, they all had Cervagem vaginal pessaries preoperatively and the mean operative time was 26.6 minutes. Most of the operations were performed under ultrasound guidance, but there was no increased risk of complications in the rest of the group. One multiparous woman suffered uterine perforation and severe haemorrhage, for which she underwent hysterectomy. One in four women tested positive for chlamydia infection. Evacuation of retained products of conception (ERPC) was required in four cases. No postoperative analgesia was required in 43% of women and most of the rest required only mild non-opiate analgesia. Except for two women, all were discharged from the hospital either on the same or the day after the operation. This retrospective study shows that surgical evacuation in the second trimester of pregnancy is a quick and well tolerated method of termination, although there is a risk of perforation and hysterectomy.

Journal Article↗
PubMed2001

Three decades of acquired gynaetresia in Ibadan: clinical presentation and management.

A retrospective analysis of acquired gynaetresia (Vaginal Stenosis) managed at the University College Hospital Ibadan, Nigeria between 1967 and 1996 was conducted in terms of clinical presentation and management. The prevalence rate was 7/1000. The peak age incidence was 20-30 years. Chemical vaginitis resulting from insertion of caustic vaginal pessaries for various reasons was the major cause of acquired gynaetresia. Dyspareunia/apyreunia and vaginal stenosis/occlusion were the most common symptoms and clinical findings respectively. The various surgical treatment of acquired gynaetresia included one stage vaginoplasty, McIndole-Read's two stage vaginplasty, separation of labial agglutination, Williams's operation, and simple dilatation of the vagina. Successful correction was recorded in 68% of the patients while 28% had residual partial stenosis, 4% had complete stenosis and 6% were lost to follow-up. It was concluded that acquired gynaetresia is preventable. Efforts should be made by authorities to address this issue and create designated centres in the country for the management of these cases and training of junior gynaecologists.

Journal Article↗
PubMed2002

Medical termination of pregnancy at 9-12 weeks of gestation.

Current RCOG guidelines advise that surgical termination should be offered to those within the 9-12 weeks gestation band. While auditing the quality of services offered for termination of pregnancy in our unit, it became apparent that many women presenting at this gestation were requesting a medical method. There has been little clinical research into medical method of abortion at this gestation. The aim of the study was to assess the efficacy of medical methods of termination at 9-12 weeks gestation. A retrospective analysis of 25 cases who underwent medical termination using a regime of mifepristone followed 48 hours later by a course of vaginal gemeprost was undertaken. Complete abortion was achieved in 96% of cases; 92% of women required no more than two pessaries to achieve complete abortion. All but one patient was suitable for discharge on the same day. One woman underwent surgical evacuation in view of heavy bleeding. We conclude that medical TOP is a safe alternative to surgical method at 9-12 weeks' gestation.

Abortifacient Agents, Steroidal↗
PubMed2006

Self-administration of vaginal misoprostol after mifepristone for termination of pregnancy: patient acceptability.

This was a questionnaire survey involving women who self-administered vaginal misoprostol in the hospital setting following oral mifepristone for medical termination of pregnancy. The sample number was 89 with a median gestational age of 9 weeks; median dose of misoprostol used was 1600 mug and median induction abortion interval was 5.3 h. The success rate was 100% with the majority finding it easy to self-administer vaginal misoprostol and two-thirds did not mind doing this. Only one-third experienced adverse effects of the medication and 83% were satisfied with the procedure. Only one-third was willing to try it at home in future if necessary. Self-administration of vaginal misoprostol for termination of pregnancy in the hospital is safe and effective. Although women were comfortable in self administering the pessaries in the hospital, they do not appear to be keen to do it at home without any supervision. However, as this is the first study in the UK involving women expressing their views regarding this issue, added research in this area is required.

Abortifacient Agents↗
PubMed2003

Development pharmaceutics of microbicide formulations. Part I: preformulation considerations and challenges.

Microbicides, the compounds and formulations that can prevent transmission of sexually transmitted diseases (STDs)/HIV are being pursued actively as a promising AIDS intervention. The drug development chain for a topical microbicide differs significantly from that of any systemic or topical compound/formulation regarding to time line, cost, activities, and milestones. This is in part because of the lack of standard in vitro models to assess efficacy, and complex ethical issues in clinical trials of microbicides. Several factors, including changes in the physiology of the cervix and vagina with age and menstrual cycle, intercourse, as well as leakage of the formulation from the vagina may affect their design, development, and performance. Selection and development of optimal microbicide delivery systems (gel/cream, pessary, film, tablet, foam, etc.), their inactive ingredients, manufacturing details, and packaging system are dependent on the properties of active drug, or their preformulation parameters (PP). The PP of the active drug substance needs to be evaluated in initial stages of drug discovery and development so that the most suitable delivery system can be selected. Some PP of microbicide agents include physical state, organoleptic properties (color, odor, appearance, taste, etc.), molecular weight, aqueous solubility, hygroscopicity, acidity/alkalinity, permeability and absorption characteristics, stability in solid/solution state, and inherent bioadhesiveness. Thus, a well-coordinated, planned, and implemented preformulation program can help in not only accelerating microbicide formulation development, but also to minimize unforeseen failures in subsequent stages of the development. The objective of this review is to highlight the significance of PP, suggesting a systematic preformulation program.

Administration, Intravaginal↗
PubMed2004

Pituitary suppression in ultrasound-monitored frozen embryo replacement cycles. A randomised study.

BACKGROUND: This study was designed to assess the value of using a gonadotrophin-releasing hormone (GnRH) agonist prior to exogenous steroid supplementation for endometrial preparation in frozen-thawed embryo replacement (FER) cycles. METHODS: A prospective randomized trial of 234 patients undergoing FER cycles was conducted. The study population was randomly divided into two groups according to a computer-generated list. In group A (n = 117), a daily dose of 6 mg of oral estradiol valerate was initiated on menstrual day 1 following pituitary suppression using 400 mcg buserelin acetate daily. In group B (n = 117), the same dose of estradiol valerate was initiated on day 1 of bleeding without prior GnRH agonist therapy. In both groups, ovulation monitoring was not undertaken and progesterone pessaries (800 mg daily) were administrated when the endometrial thickness had reached 8 mm or more with embryo transfer taking place 2 days later. RESULTS: The two groups were comparable with respect to cause of infertility, age at stimulation (32.8 +/- 4 vs 33.2 +/- 3.9 years, P = 0.4), basal FSH level (6.3 +/- 1.7 vs 6.4 +/- 2 IU/l, P = 0.5), number of oocytes collected (16.9 +/- 7.3 vs 16.5 +/- 7.4, P = 0.7) and fertilized normally in the retrieval cycle (11.5 +/- 4.9 vs 11 +/- 4.9, P = 0.4) and number of embryos cryopreserved (6.6 +/- 3.6 vs 6.2 +/- 3.6, P = 0.3). There was no significant difference between the two groups in age at frozen replacement (33.6 +/- 4.2 vs 34 +/- 3.9 years, P = 0.4), duration of the proliferative phase (20.7 +/- 8.6 vs 21 +/- 9.2 days, P = 0.7) and number of thawed embryos replaced (2.3 +/- 0.6 vs 2.2 +/- 0.6, P = 0.2). However, compared with group B, group A achieved significantly higher pregnancy (37.6% vs 24%, OR 1.8, 95%CI 1.1-3.4), clinical pregnancy (24% vs 11.3%, OR 2.5, 95%CI 1.2-5.5) and live birth rates (20% vs 8.5%, OR 2.9, 95%CI 1.2-8). CONCLUSION: Medicated frozen embryo replacement cycles timed by endometrial thickness measurement alone without monitoring or suppression of ovarian activity are associated with reduced outcome.

Adult↗
PubMed1995

Changes in the coelomic fluid composition following two different methods of cervical ripening.

We have evaluated the changes in maternal serum and coelomic fluid biochemical composition following two different methods of cervical ripening, i.e. mechanical and biochemical. Each study group included 20 women between 8 and 12 weeks of gestation who were requesting termination for psychosocial reasons. In the first group, a 3 mm hypan (synthetic hygroscopic dilator) was inserted into the cervix 12 h preoperatively. In the second group, two 1 mg pessaries of gemeprost (prostaglandin analogue) were inserted into the posterior fornix 6 and 2 h preoperatively. Coelomic fluid and maternal serum were obtained at the time of the surgical procedure and assayed for urea, total protein, potassium, sodium, human chorionic gonadotrophin (HCG) and alpha-fetoprotein (AFP). Significantly higher coelomic fluid sodium (t = 4.72; P = 0.029) and significantly higher maternal serum AFP (t = 13.21; P < 0.001) concentrations were observed after gemeprost than after hypan. There was no difference in the concentration of potassium, urea, total protein and HCG between the two groups. These findings indicate that prostaglandin analogues, when used for cervical ripening, provoke a breakdown of the placental barrier resulting in an increase in AFP molecules transferred from the fetal fluid compartments into the maternal circulation. The results also suggest that these drugs increase the placental permeability to sodium with a secondary accumulation of this ion in the coelomic fluid.

Abortion, Induced↗
PubMed1989

Circulating levels of placental protein 12 and chorionic gonadotrophin following RU 38486 and gemeprost for termination of first trimester pregnancy.

First trimester termination of pregnancy was successfully induced in ten patients with RU 38486 followed 2 days later by a prostaglandin (Gemeprost) pessary. Human chorionic gonadotrophin (HCG) values remained unaltered until after the abortion. The levels of placental protein 12 (PP12) showed an immediate and significant fall following RU 38486, then rose to values substantially higher than those at the initial visit after 2 days. These findings show that RU 38486 has a direct inhibitory effect on tissues producing PP12 and confirm the progesterone dependency of this protein.

Abortifacient Agents↗
PubMed1991

A morphometric study of the uterine glandular epithelium in women with premature ovarian failure undergoing hormone replacement therapy.

In this study we examined the fine structure of the human glandular epithelium in women with idiopathic ovarian failure in artificial cycles produced by two different types of hormone replacement therapy (oestradiol valerate orally and either intramuscular injection of progesterone or progesterone via vaginal pessary), both of which had been claimed to be capable of supporting successful implantation. Biopsies were performed on day 19 of the artificial cycle. A variety of sterological probes were used to quantify the structural characteristics of these cells and the results obtained were compared with those from normal fertile subjects biopsied on days 2 and 5 after the luteinizing hormone (LH) surge. The glandular epithelial cells from the vaginal group had a less elaborate secretory apparatus when compared with the intramuscular group or with LH + 5 controls. Many of the features of the vaginal group suggested a continued oestrogenic influence, while the intramuscular group seemed to be more advanced than LH + 5.

Cell Nucleus↗
PubMed1991

Lack of placental protein 14 production in pregnancy after frozen embryo transfer, down-regulation of anterior pituitary and administration of exogenous oestradiol and progesterone.

The circulating levels of placental protein 14 (PP14) and progesterone were measured in three pregnancies resulting from the transfer of cryopreserved embryos. Two of these women had suppressed ovarian activity as a result of pituitary down-regulation with the luteinizing hormone-releasing hormone agonist (buserelin) prior to treatment with exogenous oestradiol and progesterone. After 14 days of oral oestradiol treatment and if the endometrial thickness was greater than 7 mm, progesterone was given intramuscularly for a further 14 days with embryo transfer on the third day of this treatment. On confirmation of pregnancy by human chorionic gonadotrophin analysis, progesterone administration was altered to transvaginal pessaries for maintenance of adequate progesterone levels and endometrial support. In the two women with ovarian suppression, PP14 levels remained below the 2.5th centile of the normal range for pregnancy. In the third pregnancy, embryo transfer was performed 3 days after a spontaneous luteinizing hormone surge in a normal menstrual cycle. In this pregnancy, PP14 levels were within the normal range. Ultrasonic examination confirmed three normal ongoing singleton pregnancies. These results suggest that the majority of PP14 production in normal pregnancy is under ovarian or anterior pituitary control and that the influence of progesterone is of a secondary nature.

Buserelin↗
PubMed1994

A comparison of medical abortion (using mifepristone and gemeprost) with surgical vacuum aspiration: efficacy and early medical sequelae.

A total of 363 women undergoing legal abortion at < 63 days of amenorrhoea were allocated by a patient-centered, partially randomized study design to undergo medical abortion (using mifepristone 600 mg followed 48 h later by gemeprost 1 mg vaginal pessary) or vacuum aspiration (performed under general anaesthesia). The aim of the study was to compare the efficacy and complications of the two procedures. Main outcome measures included efficacy rates, medical complications within 21 days of abortion and unplanned family doctor consultation rates within 8 weeks following abortion. Sequelae such as pain, vaginal bleeding and recovery time were assessed by the change in haemoglobin level, the time taken to return to work or normal activity and the analgesic use. Results were gestation-related; at 50 days of amenorrhoea there was little to choose between the two procedures. At 50-63 days of amenorrhoea medical abortion becomes more painful and less effective, whereas vacuum aspiration retains high tolerance and efficacy. Women who are unsure which method to use are likely to find vacuum aspiration more acceptable at longer gestations.

Abortion, Induced↗
PubMed1992

Active and passive immunoneutralization of inhibin increases follicle-stimulating hormone levels and ovulation rate in ewes.

Two experiments were conducted to determine effects of active and passive immunoneutralization of inhibin on FSH secretion and ovulation rate. A synthetic peptide (alpha-IF) matching the N-terminus of the alpha-subunit of ovine inhibin was coupled to human alpha-globulin (h alpha-G) and used as an immunogen. In experiment 1, estrus was synchronized in 10 sheep that had been actively immunized against alpha-IF-h alpha-G or h alpha-G. Plasma FSH levels were similar in the two groups of ewes at -52 and -48 h (0 h = onset of estrus). In alpha-IF-h alpha-G-immunized ewes, FSH increased from -48 to -44 h (18.8-22.1 ng/ml), and then fell to 16.2 ng/ml by 0 h. In h alpha-G-immunized ewes, FSH decreased from -48 to 0 h (17.6-7.2 ng/ml). Ovulation rate was higher in alpha-IF-h alpha-G- than h alpha-G-immunized ewes (9.4 vs. 2.4). In experiment 2, antibodies (Ab) were extracted from sera obtained from experiment 1 ewes and then were injected i.v. into 12 other ewes. Estrus was synchronized twice during the breeding season using progesterone-releasing pessaries (CIDR-G). One day before CIDR-G withdrawal, alpha-IF-h alpha-G and h alpha-G Ab were administered in a crossover design. After injection of Ab against alpha-IF-h alpha-G, plasma FSH increased from 0 to 24 h post-injection (10.9-21.5 ng/ml), after which levels fell to 14.2 ng/ml by onset of the preovulatory LH surge.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗
PubMed1995

Effects of passive immunization of ewes against an inhibin-peptide on gonadotropin levels, ovulation rate, and prolificacy.

The experimental objectives were to determine whether injection of semi-purified (sp; ammonium sulfate-precipitated) and highly purified (hp; immunoaffinity-purified) ovine antibody (Ab) against an inhibin-peptide fragment (alpha-IF) before the preovulatory period would 1) stimulate FSH secretion in a dose-response manner, 2) induce an increase in ovulation rate, and 3) affect pregnancy rate and prolificacy (lambs born alive per ewe lambing). During the early breeding season, estrus was synchronized in 30 2-yr-old crossbred ewes through use of progesterone-releasing pessaries (CIDR-G). Two doses (330 and 660 laboratory reference preparation [RP-2] kU) of sp- and hp-alpha-IF-Ab were injected i.m. 48 h before CIDR-G removal (6 ewes per group). Six other ewes received control solution. Plasma alpha-IF-Ab titers peaked at 12 h postinjection. Plasma FSH levels were higher (p < 0.02) in alpha-IF-Ab-treated ewes than in control ewes from 12 to 24 h postimmunization. Magnitudes of FSH increases were similar in ewes administered sp- and hp-alpha-IF-Ab and were greater (p < 0.05) in ewes receiving 660 than in those receiving 330 RP-2 kU. Compared to control values, the higher alpha-IF-Ab dose increased FSH levels by 44 +/- 5% and the lower dose increased the levels by 22 +/- 3%. Plasma LH levels were similar among passively immunized and control sheep. Ovulation rate was increased (p < 0.0005) by alpha-IF-Ab treatment.(ABSTRACT TRUNCATED AT 250 WORDS)

Animals↗