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Intrauterine lidocaine infusion for pain management during outpatient transcervical tubal sterilization
Abstracts / Contraception 82 (2010) 183–216 pregnancy status at each visit. We described reported methods at initial inquiry and compared demographic and clinical factors according to contraceptive use status. AmongthosewithN1visit,wedeterminedmodificationsincontraceptionovertime. Results: Six hundred ninety-five women enrolled in the program. Four hundred forty-nine were evaluated in the contraception assessment. Mean number of visits was 4.3. Mean time from delivery to initial contraceptive inquiry was 364 days. At baseline, one woman was pregnant, and 361 (80%) reported using contraception, with 61% using injectables. Women reporting no method were younger (26.7 vs. 29.1,p=.0526) and hadlowerparity (2.7 vs.3.5, pb.05),but there wasnodifference in their ART status or time from delivery; 408 (91%) women had N1 visit (mean follow-up=113 days). Two became pregnant during follow-up. Of those reporting no method initially, 21 (30%) initiated contraception at a subsequent visit; 2% (5/256) using injectables, 17% (3/18) using pills and 28% (8/29) using condoms discontinued their methods. Conclusions: Reported use of contraception among these HIV+ women was extremely high and the pregnancy rate was low. Consistent exposure to health care providers and contraceptive counselling messages during the postnatal period is a successful means to obtain high contraceptive rates among HIV+ women. P90
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Method: Cross-sectional study of data from the Pregnancy Risk Assessment Monitoring System (PRAMS) survey linked to Utah birth certificates. Complex survey design and weighting methods were used to analyze data from 190,948 mothers delivering a singleton, live birth ≥20 weeks gestation, from 2004 to 2007. Results: DataincludedUSBL(4.5%),FBL(11.4%),andWhite(84.1%)womenand their infants. Unintended pregnancy (UIP) was more commonly reported by USBLs (50%)thaneitherFBLs(38%)orwhites(30%),pb.001.USBLswereleastlikelytouse any method of birth control (36.9% vs. 55.2% and 50.5%, pb.001). In all three populations, UIP was more commonly reported by unmarried and teenage mothers. AmongUSBLsand whites, smokers andlow-income womenalsohad increasedrates of UIP. Among FBLs and whites, women with UIP were significantly more likely to have a low birth weight (LBW) infant than those with intended pregnancies. After adjusting for maternal age, parity, education, poverty, marital status, maternal conditions, pregnancy complications, smoking/alcohol use and pre-pregnancy body mass index, FBLs with UIP remained significantly more likely to have a LBW infant (adjusted OR=1.62, 95%CI=1.08, 2.44) than FBLs with intended pregnancies. Conclusions: In Utah, USBLs are more likely to have UIP and less likely to use an effective method ofcontraceptionthanFBLs or Whites.FBLs who experience UIP are more likely to have LBW infants than those with intended pregnancies. P92
INTRAUTERINE LIDOCAINE INFUSION FOR PAIN MANAGEMENT DURING OUTPATIENT TRANSCERVICAL TUBAL STERILIZATION Isley M Ohio State University, Columbus, OH, USA Jensen J, Nichols M, Bednarek PH, Lehman A, Edelman A
COMPARISON OF LNG20, A NEW LEVONORGESTREL INTRAUTERINE SYSTEM, AND MIRENA FOR TREATMENT FOR MENORRHAGIA Gordenne V Uteron Pharma Holding, Inc., Liege, Belgium
Objectives: To study the effects of a 4% intrauterine lidocaine infusion prior to hysteroscopy on patient perceived pain during transcervical sterilization (Essure®). Method: A randomized, double-blind, placebo-controlled trial in which all subjects received standard premedication with 800 mg of ibuprofen, a 10-ml 1% lidocaine paracervical block, and transcervical instillation of 5 ml of either 4% lidocaine or saline 5 minutes prior to insertion of the hysteroscope. Subjects completed a series of 100-mm visual analogue scales (anchors, 0 mm=none, 100 mm=worst imaginable) to measure their perceived pain at a variety of time points during and after the procedure. Serum lidocaine levels were obtained. The study was designed to detect a minimum difference of 20 mm in the VAS score between groups with 80% power. Results: There were no significant differences in the baseline characteristics, procedure times, or requests for additional pain medication between subjects in the lidocaine (n=29) and placebo (n=29) groups. Mean pain scores were not significantly different between groups with tubal cannulization (saline 35.5±23 mm, lidocaine 30.1±23 mm, p=0.4) or at any other time point. No subject demonstrated symptoms of lidocaine toxicity, and mean lidocaine levels did not differbetweengroups.Thehighest serumlidocainelevel recordedwas4022ng/ml. Overall satisfaction scores were high and similar between groups. In multivariate analysis, only level of dysmenorrhea was significantly associated with pain. Conclusions: The addition of intrauterine lidocaine prior to outpatient transcervical sterilization does not appear to significantly decrease patient self-reported pain.
Objectives: To compare the safety and efficacy of LNG20, a new levonorgestrel intrauterine system (LNG-IUS), and a marketed LNG-IUS, Mirena®, over 12 months for treatment of menorrhagia. Method: A total of 280 women with menorrhagia were recruited at 15 sites in 3 European countries. Women with a mean blood loss per cycle of at least 80 ml over three baseline cycles were randomized in a 1:1 ratio to LNG20 or Mirena. Subjects were seen at weeks 1, 2, 4, 13, 24, 38 and 52. Blood loss was assessed using a validated modified Wyatt pictogram. Women who completed ≥ 360 days of IUS use without protocol violations were included in this analysis. Noninferiority, using a one-sided ratio test procedure, was defined as a ratio of mean changes in blood loss (LNG20/Mirena) N0.75. Results: The mean change in blood loss for each individual from baseline was 150 ±85mlforLNG20users(n=108)and152±105mlforMirenausers(n=100),foraratio of 0.99. Continuation rates were 88.7% (125/141) for LNG20 and 87.1% (121/139) for Mirena (p=.7). Expulsion rates were 4.3% (6/141) and 3.6% (5/139), respectively (p=.8). One pregnancy, after IUS expulsion, occurred in the LNG20 group, and no pregnancies occurred in the Mirena group. The incidence of adverse events was similar between groups. Only one reported serious adverse event (bilateral ovarian cysts), reported in a LNG20 subject, was considered possibly related to IUS use. Conclusions: LNG20 and Mirena have similar safety and efficacy profiles when used for treatment of menorrhagia.
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RISK FACTORS FOR AND CONSEQUENCES OF UNINTENDED PREGNANCY AMONG LATINA AND WHITE POPULATIONS IN UTAH, 2004-2007
PRESUMPTIVE TREATMENT OF ABNORMAL EARLY PREGNANCY OF UNKNOWN LOCATION
Flores M University of Utah, Salt Lake City, UT, USA Schwarz EB, Manuck TA, Jacobson J, Simonsen SE, Turok DK Objectives: To examine differences in pregnancy intentions and perinatal outcomes among US-born Latinas (USBLs), foreign-born Latinas (FBLs), and non-Latina whites.
Wijzen F, Foidart J-M, Marmon T, Creinin MD, Frankenne F
Cooksey C University of North Carolina, Chapel Hill, NC, USA Objectives: Early pregnancies with inappropriately increasing serum hCG may be intrauterine or ectopic. When ultrasound is unable to localize the gestation, suction curettage can exclude an intrauterine gestation before methotrexate administration. Whether suction curettage is necessary in this setting is unclear. We performed a decision analysis to evaluate whether
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Method: Cross-sectional study of data from the Pregnancy Risk Assessment Monitoring System (PRAMS) survey linked to Utah birth certificates. Complex survey design and weighting methods were used to analyze data from 190,948 mothers delivering a singleton, live birth ≥20 weeks gestation, from 2004 to 2007. Results: DataincludedUSBL(4.5%),FBL(11.4%),andWhite(84.1%)womenand their infants. Unintended pregnancy (UIP) was more commonly reported by USBLs (50%)thaneitherFBLs(38%)orwhites(30%),pb.001.USBLswereleastlikelytouse any method of birth control (36.9% vs. 55.2% and 50.5%, pb.001). In all three populations, UIP was more commonly reported by unmarried and teenage mothers. AmongUSBLsand whites, smokers andlow-income womenalsohad increasedrates of UIP. Among FBLs and whites, women with UIP were significantly more likely to have a low birth weight (LBW) infant than those with intended pregnancies. After adjusting for maternal age, parity, education, poverty, marital status, maternal conditions, pregnancy complications, smoking/alcohol use and pre-pregnancy body mass index, FBLs with UIP remained significantly more likely to have a LBW infant (adjusted OR=1.62, 95%CI=1.08, 2.44) than FBLs with intended pregnancies. Conclusions: In Utah, USBLs are more likely to have UIP and less likely to use an effective method ofcontraceptionthanFBLs or Whites.FBLs who experience UIP are more likely to have LBW infants than those with intended pregnancies. P92
INTRAUTERINE LIDOCAINE INFUSION FOR PAIN MANAGEMENT DURING OUTPATIENT TRANSCERVICAL TUBAL STERILIZATION Isley M Ohio State University, Columbus, OH, USA Jensen J, Nichols M, Bednarek PH, Lehman A, Edelman A
COMPARISON OF LNG20, A NEW LEVONORGESTREL INTRAUTERINE SYSTEM, AND MIRENA FOR TREATMENT FOR MENORRHAGIA Gordenne V Uteron Pharma Holding, Inc., Liege, Belgium
Objectives: To study the effects of a 4% intrauterine lidocaine infusion prior to hysteroscopy on patient perceived pain during transcervical sterilization (Essure®). Method: A randomized, double-blind, placebo-controlled trial in which all subjects received standard premedication with 800 mg of ibuprofen, a 10-ml 1% lidocaine paracervical block, and transcervical instillation of 5 ml of either 4% lidocaine or saline 5 minutes prior to insertion of the hysteroscope. Subjects completed a series of 100-mm visual analogue scales (anchors, 0 mm=none, 100 mm=worst imaginable) to measure their perceived pain at a variety of time points during and after the procedure. Serum lidocaine levels were obtained. The study was designed to detect a minimum difference of 20 mm in the VAS score between groups with 80% power. Results: There were no significant differences in the baseline characteristics, procedure times, or requests for additional pain medication between subjects in the lidocaine (n=29) and placebo (n=29) groups. Mean pain scores were not significantly different between groups with tubal cannulization (saline 35.5±23 mm, lidocaine 30.1±23 mm, p=0.4) or at any other time point. No subject demonstrated symptoms of lidocaine toxicity, and mean lidocaine levels did not differbetweengroups.Thehighest serumlidocainelevel recordedwas4022ng/ml. Overall satisfaction scores were high and similar between groups. In multivariate analysis, only level of dysmenorrhea was significantly associated with pain. Conclusions: The addition of intrauterine lidocaine prior to outpatient transcervical sterilization does not appear to significantly decrease patient self-reported pain.
Objectives: To compare the safety and efficacy of LNG20, a new levonorgestrel intrauterine system (LNG-IUS), and a marketed LNG-IUS, Mirena®, over 12 months for treatment of menorrhagia. Method: A total of 280 women with menorrhagia were recruited at 15 sites in 3 European countries. Women with a mean blood loss per cycle of at least 80 ml over three baseline cycles were randomized in a 1:1 ratio to LNG20 or Mirena. Subjects were seen at weeks 1, 2, 4, 13, 24, 38 and 52. Blood loss was assessed using a validated modified Wyatt pictogram. Women who completed ≥ 360 days of IUS use without protocol violations were included in this analysis. Noninferiority, using a one-sided ratio test procedure, was defined as a ratio of mean changes in blood loss (LNG20/Mirena) N0.75. Results: The mean change in blood loss for each individual from baseline was 150 ±85mlforLNG20users(n=108)and152±105mlforMirenausers(n=100),foraratio of 0.99. Continuation rates were 88.7% (125/141) for LNG20 and 87.1% (121/139) for Mirena (p=.7). Expulsion rates were 4.3% (6/141) and 3.6% (5/139), respectively (p=.8). One pregnancy, after IUS expulsion, occurred in the LNG20 group, and no pregnancies occurred in the Mirena group. The incidence of adverse events was similar between groups. Only one reported serious adverse event (bilateral ovarian cysts), reported in a LNG20 subject, was considered possibly related to IUS use. Conclusions: LNG20 and Mirena have similar safety and efficacy profiles when used for treatment of menorrhagia.
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P93
RISK FACTORS FOR AND CONSEQUENCES OF UNINTENDED PREGNANCY AMONG LATINA AND WHITE POPULATIONS IN UTAH, 2004-2007
PRESUMPTIVE TREATMENT OF ABNORMAL EARLY PREGNANCY OF UNKNOWN LOCATION
Flores M University of Utah, Salt Lake City, UT, USA Schwarz EB, Manuck TA, Jacobson J, Simonsen SE, Turok DK Objectives: To examine differences in pregnancy intentions and perinatal outcomes among US-born Latinas (USBLs), foreign-born Latinas (FBLs), and non-Latina whites.
Wijzen F, Foidart J-M, Marmon T, Creinin MD, Frankenne F
Cooksey C University of North Carolina, Chapel Hill, NC, USA Objectives: Early pregnancies with inappropriately increasing serum hCG may be intrauterine or ectopic. When ultrasound is unable to localize the gestation, suction curettage can exclude an intrauterine gestation before methotrexate administration. Whether suction curettage is necessary in this setting is unclear. We performed a decision analysis to evaluate whether