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Preloaded inserter for levonorgestrel implants
THURSDAY,
SEPTEMBER
7
P4.04.05 IUD PERFORMANCE AFTER ENDOMETRIAL BIOPSY. A.C.Cunha. C.R.Miranda, M.S.Wanderley, C.N. Resende, University of Brasilia, SQN 114 Bloco A Ap. 201, Brasilia, DF, Brazil, 70764010. Introduction: Several reports evaluate endometrial lining before and after IUD placement. Therefore, there are no reports on if Endometrial Biopsy (EB) changes or not positioning or misplaces IUD into the uterine cavity. Objective: We evaluate the endometrial cavity handling (EB) alters the method performance. Patients and Methods: During three years we followed 71 outpatients submitted to BE (rectal probe # 10) before and after IUD placement. They were followed up by clinical exam every six months, and tram vaginal sonogram (TVS) once, a month after IUD insertion. The criteria we used assessing the IUD performance were: pregnancy rate, IUD expulsion, pain and bleeding, decision to get pregnant, personal reasons, compliance. Results: Unwanted pregnancy rate during the three years study was 1.4%, expulsion rate was 5.6%, pain and bleeding was observed in 4.2%, and 4.2% wanted to get pregnant and eventually withdraw the device. Personal reasons were the motif for quitting the method for just one patient. We observed an significant increasing in compliance from the first to the last year of study. At the end of the study, 84% of the patients complied to the method, very much similar to those reports were EB was not performed. Conclusions: We conclude EB is safe and do not harm the will to couple the method or the IUD performance rate.
P4.04.06 ORAL CONTRACEPTIVES (OC) PRESCRIBING PRACTICES IN URBAN AREAS OF POLAND M.M. School of Public Health, Postgraduate Center of Medical Education, Warszawa, Poland. Objective: In the more than 2 decades since OC have become available in Poland, a wide spectrum of formulations has been introduced. However, little is known about the rationale behind OC prescribing. The aim of the study was to recognize rationale behind OC prescribing in urban areas of Poland. Study Method: The survey contained a variety of questions about OC prescribing practices. The survey in a first instance was mailed to all gynecologists practicing in the Warsaw area of Poland. In a second instance, all gynecologists who had not answered before were interviewed by phone. Results: 42 of the 430 gynecologists surveyed returned questionnaires by post. More than half the respondents were available by phone and answered survey questions. Altogether, more than 65% of gynecologists from the Warsaw area were interviewed. The majority of gynecologists preferred modern, low-dose OCs. Specifically, monophasic pills containing 20 to 35 pg of ethinyl estradiol and low doses of desogestrel, gestoden, levonorgestrel or norgestimate. Over 80% of respondents said they prescribe OC primarily because of its tolerability and good hormonal contents. Less than 50% of gynecologists now prescribe OC to women over 40 years. Conclusions: The study, although not covering all parts of Poland, revealed that OC prescribing practice is not uninformed and gynecologists’ opinion in that matter is not homogenous.
P4.04.07 PRELOADED INSERTER FOR LEVONORGESTREL IMPLANTS P. Holma (l), M. Haukkamaa (2), A. Kuukankorpi (3), M. Siljander (4), A-L Simpanen (5), I. Rauramo (6) (1) Dept. OBIGYN, Middle Finland Central Hospital, JyvaskylP, Finland. (2) Dept. OBIGYN, Helsinki City Maternity Hospital, Helsinki, Finland. (3) Dept. OBIGYN, Tampere Health Care Center, Tampere, Finland (4) Dept. OBIGYN, Oulu Health Care Center, Oulu, Finland. (5) Dept. OBIGYN, Laboratorio Simpanen, Kuopio, Finland. (6) Dept. OBIGYN, Leiras Oy Clinical Research, Helsinki, Finland.
97
Objectives: The study evaluated the feasibility and performance of an investigational preloaded inserter in the insertion of the levonorgestrel (LNG) implants. Study Methods: This was an open, non-comparative, multi-center study in 204 women seeking for long-lasting reversible contraception. Investigators and subjects assessed the performance and feasibility of the inserter by filling in relevant questionnaires and the background, efficacy and safety were assessed by using standard medical procedures. Results: All insertions were successful and totally 204 subjects received implants. Only in three insertions a second set of implants was needed. Both implants were easily released in 85.6% of all insertions (95% confidence interval from 80.2 to 90.3%) and the usefulness of the preloaded inserter, scalpel and the cut-off blade were assessed in over 94% of the insertions as good. The median time taken by the insertion was 35 seconds. The general assessment of the insertion by the investigators was easy in 75.5% and slightly difficult in 21.6% of the insertions. All subjects assessed the insertions as easy and the pain perception during the insertion was not common. Bleeding during the procedure and bruising at the insertion site occurred rarely. 13% of the adverse events were localized skin reaction, which were mainly caused by the bandage used to cover the wound after insertion. Conclusion: The results suggest that the preloaded inserter is a safe and efficient method for the insertion of LNG implants and the insertion technique was easy to adapt. The method was also well tolerated and accepted by the subjects.
P4.04.08 RELIABILITY OF MODERN TECHNOLOGY AS AID TO NATURAL FAMILY PLANNING FOR SPACING PREGNANCY. A. Sauorosi, E. Giacchi, M.C. Squintani, E. Menini’, A. Cappella and J.B. Brown”. Center for Study and Research on Natural Fertility Regulation, * Hormonal Biochemistry Laboratory Catholic University of the Sacred Hearth, Rome, “Department of Obstetrics and Gynaecology, University of Melbourne. Objectives: Today natural family planning (nfp) can be supported by modern technologies. We will compare the hormonal data provided by the brown’s ovarian monitor (om) and by unipath persona system with the information provided by the cervical mucus symptoms according to billings ovulation method (born). Study Methods: We studied 6 women, 26-45 aged, BOM users with regular cycles for 31 menstrual cycles. All combined the Persona system (Unipath Ltd, Bedford, MK443UP, UK) with the hormone assay by Ovarian Monitor (St. Michael NFP Services Pty, Ltd, Melbourne). The OM measures the urinary oestrogen glucuronide (ElG) or pregnandiol glucuronide (PdG) by “homogeneous enzyme immunoassay”. Results: The hormone assay by the OM correlated well with the BOM symptoms. The first rise from ElG baseline agreed with the first mucus change (87,1% cycles) to identify the beginning of fertile phase, the day of maximum fertility (“Peak day”) by BOM correlated with the ovulation day by OM within 24 hrs (83,9% cycles). The “PdG cutoff’=7 umoV24 hrs measured by OM identified the late infertile phase al least one day earlier than the other two systems (80,6% cycles). The Persona showed a good correlation with the BOM symptoms in the regular cycles. When Persona did not provide sufficient data to time ovulation (19,3% cycles), this could be timed only by the BOM symptoms. Conclusions: The subjects integrated BOM rules and the “PdG cut-off rule by OM for spacing pregnancy. The OM accurately identified the first estrogen rise, the timing of ovulation and the adequancy of the luteal phase also in unpredictable irregular cycles. Fewer days of abstinence are required for pregnancy avoidance, but it is more complicated and time consuming then the two others. It does not replace NFP methods but can support them in some difficult cases.
SEPTEMBER
7
P4.04.05 IUD PERFORMANCE AFTER ENDOMETRIAL BIOPSY. A.C.Cunha. C.R.Miranda, M.S.Wanderley, C.N. Resende, University of Brasilia, SQN 114 Bloco A Ap. 201, Brasilia, DF, Brazil, 70764010. Introduction: Several reports evaluate endometrial lining before and after IUD placement. Therefore, there are no reports on if Endometrial Biopsy (EB) changes or not positioning or misplaces IUD into the uterine cavity. Objective: We evaluate the endometrial cavity handling (EB) alters the method performance. Patients and Methods: During three years we followed 71 outpatients submitted to BE (rectal probe # 10) before and after IUD placement. They were followed up by clinical exam every six months, and tram vaginal sonogram (TVS) once, a month after IUD insertion. The criteria we used assessing the IUD performance were: pregnancy rate, IUD expulsion, pain and bleeding, decision to get pregnant, personal reasons, compliance. Results: Unwanted pregnancy rate during the three years study was 1.4%, expulsion rate was 5.6%, pain and bleeding was observed in 4.2%, and 4.2% wanted to get pregnant and eventually withdraw the device. Personal reasons were the motif for quitting the method for just one patient. We observed an significant increasing in compliance from the first to the last year of study. At the end of the study, 84% of the patients complied to the method, very much similar to those reports were EB was not performed. Conclusions: We conclude EB is safe and do not harm the will to couple the method or the IUD performance rate.
P4.04.06 ORAL CONTRACEPTIVES (OC) PRESCRIBING PRACTICES IN URBAN AREAS OF POLAND M.M. School of Public Health, Postgraduate Center of Medical Education, Warszawa, Poland. Objective: In the more than 2 decades since OC have become available in Poland, a wide spectrum of formulations has been introduced. However, little is known about the rationale behind OC prescribing. The aim of the study was to recognize rationale behind OC prescribing in urban areas of Poland. Study Method: The survey contained a variety of questions about OC prescribing practices. The survey in a first instance was mailed to all gynecologists practicing in the Warsaw area of Poland. In a second instance, all gynecologists who had not answered before were interviewed by phone. Results: 42 of the 430 gynecologists surveyed returned questionnaires by post. More than half the respondents were available by phone and answered survey questions. Altogether, more than 65% of gynecologists from the Warsaw area were interviewed. The majority of gynecologists preferred modern, low-dose OCs. Specifically, monophasic pills containing 20 to 35 pg of ethinyl estradiol and low doses of desogestrel, gestoden, levonorgestrel or norgestimate. Over 80% of respondents said they prescribe OC primarily because of its tolerability and good hormonal contents. Less than 50% of gynecologists now prescribe OC to women over 40 years. Conclusions: The study, although not covering all parts of Poland, revealed that OC prescribing practice is not uninformed and gynecologists’ opinion in that matter is not homogenous.
P4.04.07 PRELOADED INSERTER FOR LEVONORGESTREL IMPLANTS P. Holma (l), M. Haukkamaa (2), A. Kuukankorpi (3), M. Siljander (4), A-L Simpanen (5), I. Rauramo (6) (1) Dept. OBIGYN, Middle Finland Central Hospital, JyvaskylP, Finland. (2) Dept. OBIGYN, Helsinki City Maternity Hospital, Helsinki, Finland. (3) Dept. OBIGYN, Tampere Health Care Center, Tampere, Finland (4) Dept. OBIGYN, Oulu Health Care Center, Oulu, Finland. (5) Dept. OBIGYN, Laboratorio Simpanen, Kuopio, Finland. (6) Dept. OBIGYN, Leiras Oy Clinical Research, Helsinki, Finland.
97
Objectives: The study evaluated the feasibility and performance of an investigational preloaded inserter in the insertion of the levonorgestrel (LNG) implants. Study Methods: This was an open, non-comparative, multi-center study in 204 women seeking for long-lasting reversible contraception. Investigators and subjects assessed the performance and feasibility of the inserter by filling in relevant questionnaires and the background, efficacy and safety were assessed by using standard medical procedures. Results: All insertions were successful and totally 204 subjects received implants. Only in three insertions a second set of implants was needed. Both implants were easily released in 85.6% of all insertions (95% confidence interval from 80.2 to 90.3%) and the usefulness of the preloaded inserter, scalpel and the cut-off blade were assessed in over 94% of the insertions as good. The median time taken by the insertion was 35 seconds. The general assessment of the insertion by the investigators was easy in 75.5% and slightly difficult in 21.6% of the insertions. All subjects assessed the insertions as easy and the pain perception during the insertion was not common. Bleeding during the procedure and bruising at the insertion site occurred rarely. 13% of the adverse events were localized skin reaction, which were mainly caused by the bandage used to cover the wound after insertion. Conclusion: The results suggest that the preloaded inserter is a safe and efficient method for the insertion of LNG implants and the insertion technique was easy to adapt. The method was also well tolerated and accepted by the subjects.
P4.04.08 RELIABILITY OF MODERN TECHNOLOGY AS AID TO NATURAL FAMILY PLANNING FOR SPACING PREGNANCY. A. Sauorosi, E. Giacchi, M.C. Squintani, E. Menini’, A. Cappella and J.B. Brown”. Center for Study and Research on Natural Fertility Regulation, * Hormonal Biochemistry Laboratory Catholic University of the Sacred Hearth, Rome, “Department of Obstetrics and Gynaecology, University of Melbourne. Objectives: Today natural family planning (nfp) can be supported by modern technologies. We will compare the hormonal data provided by the brown’s ovarian monitor (om) and by unipath persona system with the information provided by the cervical mucus symptoms according to billings ovulation method (born). Study Methods: We studied 6 women, 26-45 aged, BOM users with regular cycles for 31 menstrual cycles. All combined the Persona system (Unipath Ltd, Bedford, MK443UP, UK) with the hormone assay by Ovarian Monitor (St. Michael NFP Services Pty, Ltd, Melbourne). The OM measures the urinary oestrogen glucuronide (ElG) or pregnandiol glucuronide (PdG) by “homogeneous enzyme immunoassay”. Results: The hormone assay by the OM correlated well with the BOM symptoms. The first rise from ElG baseline agreed with the first mucus change (87,1% cycles) to identify the beginning of fertile phase, the day of maximum fertility (“Peak day”) by BOM correlated with the ovulation day by OM within 24 hrs (83,9% cycles). The “PdG cutoff’=7 umoV24 hrs measured by OM identified the late infertile phase al least one day earlier than the other two systems (80,6% cycles). The Persona showed a good correlation with the BOM symptoms in the regular cycles. When Persona did not provide sufficient data to time ovulation (19,3% cycles), this could be timed only by the BOM symptoms. Conclusions: The subjects integrated BOM rules and the “PdG cut-off rule by OM for spacing pregnancy. The OM accurately identified the first estrogen rise, the timing of ovulation and the adequancy of the luteal phase also in unpredictable irregular cycles. Fewer days of abstinence are required for pregnancy avoidance, but it is more complicated and time consuming then the two others. It does not replace NFP methods but can support them in some difficult cases.