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The effect on contraceptive use and pregnancy rates (postpartum) of giving expert contraceptive counseling in the antenatal clinic
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FC1.22.02 A NEW APPROACH TO TRANSCERVICAL TUBAL STERILIZATION WITH THE STOP DEVICE .I. M. Coouer (l), .I. Kerin (2), B. Van Herendael(3), T. Price (4) (1) University of Arizona School of Medicine, Tuscan, Arizona, USA. (2) University of Adelaide, Adelaide, Australia. (3) Jan Palfjin General Hospital, Antwerp, Belgium. (4) Greenville Hospital System, Greenville, South Carolina, USA. Objectives: A Phase II study is ongoing to evaluate the ability of STOP device to safely and effectively prevent pregnancy in women who are seeking permanent contraception. The STOP procedure obviates the need for incisional surgery and general anesthesia. Study Methods: 88 women have been enrolled for transcervical tubal placement of the STOP device. The STOP device (Conceptus, Inc.) is a dynamic, micro-coil that is hysteroscopically inserted into the fallopian tube at a reduced diameter and expands upon deployment to the fallopian tube lemen. The mechanism of action is a combination of the space filling design of the STOP device and a local, benign tissue response to polyester fibers. Results: Bilateral device placement was achieved in 76188 patients (86%). Average procedure time was 22 minutes. Patient tolerance of the device placement procedure was rated as good to excellent in 91% of cases. Patient tolerance to wearing the devices has been rated as very good to excellent in 100% of cases. HSG performed at the three-month follow-up visit demonstrated occlusion in 100% of patients with devices placed in tubes. Device-related adverse events have been reported in 6% of cases with no clinical sequelae reported to date. There are 302 woman months of wearing and 97 woman months of effectiveness with no reports of pregnancies to date. Conclusions: Preliminary date indicate that the STOP device may be a safe and effective alternative for permanent contraception. A pivotal trial is planned to commence in the first half of 2000.
FC1.22.03 THE EFFECT ON CONTRACEPTIVE USE AND PREGNANCY RATES (POSTPARTUM) OF GIVING EXPERT CONTRACEPTIVE COUNSELING IN THE ANTENATAL CLINIC L. Cheng (l), X. Ho (l), Z. Van der Spuy (2), M. Heap (2), A. Mayo (3), A. Glasier (3) (1) Shanghai Institute of Family Planning Technical Instruction, Shanghai, China. (2) Dept. OBIGYN, University of Cape Town, Cape Town, South Africa. (3) University of Edinburgh, Edinburgh, Scotland. Objectives: To determine whether expert contraceptive counseling given during the antenatal period affects contraceptive prevalence, patterns of contraceptive use and pregnancy rates during one year after childbirth. Study Methods Over 500 women attending antenatal clinics in each of three centers (Shanghai, PRC, Edinburgh, Scotland, Cape Town, South Africa) were randomized either to receive expert contraceptive advice (subjects n=771) or the standard advice routinely given in that setting (controls n=866). Follow-up was by a questionnaire at 16 and 52 weeks after childbirth. Results: There were no significant differences in the prevalence of contraceptive use at one year (over 79% in all centers) between subjects and controls. In Edinburgh, subjects were more likely to undergo sterilization (p
MONDAY,
SEPTEMBER
FC1.22.04 A COMPARATIVE STUDY OF THE USE OF AN IMPLANON IMPLANT AND MULTILOAD 375 IUD ON LACTATING WOMEN D. Reinuravoon (l), S. Taneepanichskul (l), S. Bunyavejchevin (l), P. Thaithumyanon (2), S. Punnahitananda (2), P. Tosukhowong (3), Chulalongkom University, Bangkok, Thailand. (1) Dept. OB/GYN (2) Dept. of Pediatrics (3) Dept. of Biochemisty Objectives: The aim of this project is to study the effects of Implanon implant on the volume and quantity of breast milk compared to an IUD and to determine in the implant users the concentration of etonogestrel in breast milk and compare these to the concentrations in the maternal serum. Study Methods: 80 healthy subjects, aged 18 - 40 years, fully lactating for 4-month period, having BMI 18 - 29, 42 in the Implanon group and 38 in the IUD group were enrolled in this open, non-randomized comparative study. The 24.hr. volume of breast milk was to be determined by weighing of infant and breast pump. The composition of breast milk was to be assessed by the determination of total fat, total protein and lactose concentrations in the breast milk. Milk analysis was to be performed prior to the start of treatment and after one, two and four month of treatment. Serum etonogestrel concentrations were to be assessed by means of radioimmunoassay with sample purification using solid phase extraction. Results: Determination of 24.hour volume of breast milk for Implanon group vs the IUD group at baseline month 1, month 2, month 4 and last measurement were 637 f vs 659 f 162 ml, 655 f 154 vs 617 f 173 ml, 648~211vs600~195ml,599~195vs667~196mland589~192vs 560 f 189 ml, respectively. These differences were not statistically significant. The total protein, total fat and lactose content of breast milk were not statistically significant differences. The mean transfer of etonogestrel (ENG) to the infant for up to 4 months were highest at month 1 and amounted to 19.86 @kg/day. Concentration decreased with time. Conclusions: In lactating women, treatment with Implanon or an IUD up to 4 months did not differ with regard to the effect on the 24.hours volume of breast milk and on the composition of breast milk. The mean transfer of ENG to infant for up to 4 months was highest at month 1. Concentrations decreased with time.
FC1.22.05 CONTRACEPTIVE POTENTIAL OF ORAL DESOGESTREL WITH DEPOT TESTOSTERONE IN MEN D. Kinniburnh (l), R.A. Anderson(l), L. Cheng (2), H. Zhu (l), D.T. Baird (l), (1) Contraceptive Development Network, Centre for Reproductive Biology, University of Edinburgh, UK. (2) Institute of Family Planning Technical Instruction, Shanghai, PRC. Objectives: To determine the degree of suppression of spermatogenesis resulting form daily oral desogestrel with depot prepartain of testosterone in two populations of men. Study Methods: Normal men were recruited in Edingburgh (n=30) and Shanghai (n=36) and randomized to take either 15Opg or 3OOpg desogestrel (dsg) p.o. daily for 24 weeks. All men additionally received 2x200mg testosterone pellets S.C. at start of treatment and 12 weeks later. In an ‘extension phase’ of the study, men who became azoospermic during treatment could continue treatment for a further 24 weeks. Such subjects continued oral desogestrel daily at the original dose with further testosterone administration at 12 week intervals. No other methods of contraception were used during the extension phase. Results: Spermatogenensis was profoundly suppressed in all men. In the Edinburgh cohort sperm concentration fell from 76.2e12.8 to 0.7eO.7 M/ml after 24 weeks in the dsgl50 group with 11113 men (85%) becoming azoospermic. Pretreatment sperm concentration in the dsg300 group was 60.4*10.4 million/ml: all men became azoospermic (14114) by 16 weeks treatment. Similar results were obtained in Shanghai: pretreatment sperm concentrations were 75.6e9.9 and 98.9e11.3 M/ml in the 2 groups, and fell to 11.5e5.8 M/m (11118, 61% azoospermic) in the dsgl50 group with azoospermia in all men (12/12) in the dsg300 group. 11 men (6 and 5 in dsgl50 and dsg300 groups respectively) completed the extension phase: all remained azoospermic and there were no pregnancies in their partners. Sperm concentrations recovered to retreatment values in all men on discontinuing dsg. Testosterone levels remained in the normal range in all groups throughout the study.
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FC1.22.02 A NEW APPROACH TO TRANSCERVICAL TUBAL STERILIZATION WITH THE STOP DEVICE .I. M. Coouer (l), .I. Kerin (2), B. Van Herendael(3), T. Price (4) (1) University of Arizona School of Medicine, Tuscan, Arizona, USA. (2) University of Adelaide, Adelaide, Australia. (3) Jan Palfjin General Hospital, Antwerp, Belgium. (4) Greenville Hospital System, Greenville, South Carolina, USA. Objectives: A Phase II study is ongoing to evaluate the ability of STOP device to safely and effectively prevent pregnancy in women who are seeking permanent contraception. The STOP procedure obviates the need for incisional surgery and general anesthesia. Study Methods: 88 women have been enrolled for transcervical tubal placement of the STOP device. The STOP device (Conceptus, Inc.) is a dynamic, micro-coil that is hysteroscopically inserted into the fallopian tube at a reduced diameter and expands upon deployment to the fallopian tube lemen. The mechanism of action is a combination of the space filling design of the STOP device and a local, benign tissue response to polyester fibers. Results: Bilateral device placement was achieved in 76188 patients (86%). Average procedure time was 22 minutes. Patient tolerance of the device placement procedure was rated as good to excellent in 91% of cases. Patient tolerance to wearing the devices has been rated as very good to excellent in 100% of cases. HSG performed at the three-month follow-up visit demonstrated occlusion in 100% of patients with devices placed in tubes. Device-related adverse events have been reported in 6% of cases with no clinical sequelae reported to date. There are 302 woman months of wearing and 97 woman months of effectiveness with no reports of pregnancies to date. Conclusions: Preliminary date indicate that the STOP device may be a safe and effective alternative for permanent contraception. A pivotal trial is planned to commence in the first half of 2000.
FC1.22.03 THE EFFECT ON CONTRACEPTIVE USE AND PREGNANCY RATES (POSTPARTUM) OF GIVING EXPERT CONTRACEPTIVE COUNSELING IN THE ANTENATAL CLINIC L. Cheng (l), X. Ho (l), Z. Van der Spuy (2), M. Heap (2), A. Mayo (3), A. Glasier (3) (1) Shanghai Institute of Family Planning Technical Instruction, Shanghai, China. (2) Dept. OBIGYN, University of Cape Town, Cape Town, South Africa. (3) University of Edinburgh, Edinburgh, Scotland. Objectives: To determine whether expert contraceptive counseling given during the antenatal period affects contraceptive prevalence, patterns of contraceptive use and pregnancy rates during one year after childbirth. Study Methods Over 500 women attending antenatal clinics in each of three centers (Shanghai, PRC, Edinburgh, Scotland, Cape Town, South Africa) were randomized either to receive expert contraceptive advice (subjects n=771) or the standard advice routinely given in that setting (controls n=866). Follow-up was by a questionnaire at 16 and 52 weeks after childbirth. Results: There were no significant differences in the prevalence of contraceptive use at one year (over 79% in all centers) between subjects and controls. In Edinburgh, subjects were more likely to undergo sterilization (p
MONDAY,
SEPTEMBER
FC1.22.04 A COMPARATIVE STUDY OF THE USE OF AN IMPLANON IMPLANT AND MULTILOAD 375 IUD ON LACTATING WOMEN D. Reinuravoon (l), S. Taneepanichskul (l), S. Bunyavejchevin (l), P. Thaithumyanon (2), S. Punnahitananda (2), P. Tosukhowong (3), Chulalongkom University, Bangkok, Thailand. (1) Dept. OB/GYN (2) Dept. of Pediatrics (3) Dept. of Biochemisty Objectives: The aim of this project is to study the effects of Implanon implant on the volume and quantity of breast milk compared to an IUD and to determine in the implant users the concentration of etonogestrel in breast milk and compare these to the concentrations in the maternal serum. Study Methods: 80 healthy subjects, aged 18 - 40 years, fully lactating for 4-month period, having BMI 18 - 29, 42 in the Implanon group and 38 in the IUD group were enrolled in this open, non-randomized comparative study. The 24.hr. volume of breast milk was to be determined by weighing of infant and breast pump. The composition of breast milk was to be assessed by the determination of total fat, total protein and lactose concentrations in the breast milk. Milk analysis was to be performed prior to the start of treatment and after one, two and four month of treatment. Serum etonogestrel concentrations were to be assessed by means of radioimmunoassay with sample purification using solid phase extraction. Results: Determination of 24.hour volume of breast milk for Implanon group vs the IUD group at baseline month 1, month 2, month 4 and last measurement were 637 f vs 659 f 162 ml, 655 f 154 vs 617 f 173 ml, 648~211vs600~195ml,599~195vs667~196mland589~192vs 560 f 189 ml, respectively. These differences were not statistically significant. The total protein, total fat and lactose content of breast milk were not statistically significant differences. The mean transfer of etonogestrel (ENG) to the infant for up to 4 months were highest at month 1 and amounted to 19.86 @kg/day. Concentration decreased with time. Conclusions: In lactating women, treatment with Implanon or an IUD up to 4 months did not differ with regard to the effect on the 24.hours volume of breast milk and on the composition of breast milk. The mean transfer of ENG to infant for up to 4 months was highest at month 1. Concentrations decreased with time.
FC1.22.05 CONTRACEPTIVE POTENTIAL OF ORAL DESOGESTREL WITH DEPOT TESTOSTERONE IN MEN D. Kinniburnh (l), R.A. Anderson(l), L. Cheng (2), H. Zhu (l), D.T. Baird (l), (1) Contraceptive Development Network, Centre for Reproductive Biology, University of Edinburgh, UK. (2) Institute of Family Planning Technical Instruction, Shanghai, PRC. Objectives: To determine the degree of suppression of spermatogenesis resulting form daily oral desogestrel with depot prepartain of testosterone in two populations of men. Study Methods: Normal men were recruited in Edingburgh (n=30) and Shanghai (n=36) and randomized to take either 15Opg or 3OOpg desogestrel (dsg) p.o. daily for 24 weeks. All men additionally received 2x200mg testosterone pellets S.C. at start of treatment and 12 weeks later. In an ‘extension phase’ of the study, men who became azoospermic during treatment could continue treatment for a further 24 weeks. Such subjects continued oral desogestrel daily at the original dose with further testosterone administration at 12 week intervals. No other methods of contraception were used during the extension phase. Results: Spermatogenensis was profoundly suppressed in all men. In the Edinburgh cohort sperm concentration fell from 76.2e12.8 to 0.7eO.7 M/ml after 24 weeks in the dsgl50 group with 11113 men (85%) becoming azoospermic. Pretreatment sperm concentration in the dsg300 group was 60.4*10.4 million/ml: all men became azoospermic (14114) by 16 weeks treatment. Similar results were obtained in Shanghai: pretreatment sperm concentrations were 75.6e9.9 and 98.9e11.3 M/ml in the 2 groups, and fell to 11.5e5.8 M/m (11118, 61% azoospermic) in the dsgl50 group with azoospermia in all men (12/12) in the dsg300 group. 11 men (6 and 5 in dsgl50 and dsg300 groups respectively) completed the extension phase: all remained azoospermic and there were no pregnancies in their partners. Sperm concentrations recovered to retreatment values in all men on discontinuing dsg. Testosterone levels remained in the normal range in all groups throughout the study.
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