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Weight change in users of three progestin-only contraception methods
Abstracts / Contraception 84 (2011) 302–336 regard to contraceptive steroid hormones. This study was designed to determine whether phenotypic variability of cytochrome P450 3A4 (CYP3A4) enzyme activity (estimated by midazolam clearance) is a predictor of the pharmacokinetics (PK) of levonorgestrel (LNG) in obese women taking combined oral contraceptives (COC). Methods: Seven healthy obese women, ages 20 to 35 years and BMI 32 to 47 kg/m2, used a COC daily containing 20 mcg ethinyl estradiol/100 mcg LNG. After 21 days, participants were admitted and given midazolam 2 mg to estimate CYP3A4 activity. Serial blood sampling was performed to obtain PK parameters of LNG at 0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 and 24 h, and midazolam at 0.5, 1, 2, 4, 5, 6, 12 and 24 h. Samples were analyzed via radioimmunoassay for LNG and liquid chromatography tandem mass spectrometry for midazolam. PK parameters were analyzed using Pearson product-moment correlation. Results: LNG clearance (r=0.70, p=.08), half-life (r=0.69, p=.08) and maximum plasma concentration (r=0.84, p=.02) all demonstrated positive correlations with midazolam. However, volume of distribution (r=0.07, p=.88) and area under the curve (r=0.45, p=.31) did not. Conclusions: Cytochrome P450 activity, as predicted by midazolam clearance, correlates with LNG metabolism. CYP3A4 activity may be a potential marker to identify those COC users at risk for adverse events or failures.
P40
PAIN CONTROL FOR INTRAUTERINE DEVICE INSERTION: A RANDOMIZED TRIAL OF 1% LIDOCAINE PARACERVICAL BLOCK Krishnan S Northwestern University, Chicago, IL, USA
319
Objectives: Opportunities for medical students to place intrauterine contraception (IUC) in patients are uncommon in most teaching situations. This study was designed to determine if participation in a simulation exercise will increase medical students' knowledge, comfort level and willingness to recommend IUC. Methods: A prospective cohort study was undertaken which included all Harvard Medical School students completing the obstetrics and gynecology clerkship at one institution throughout one academic year. The intervention consisted of a lecture and a 30-min, hands-on, practicum in IUC placement and removal using medical instruments and realistic pelvic models. Both levonorgestrel and copper IUC devices were taught. Participants completed a pre- and post-simulation survey, designed to examine students' IUCspecific knowledge, attitudes and comfort. Pre- and post-simulation responses were compared by signed rank test. Results: Twenty-nine paired pre- and post-simulation surveys were analyzed (74% completion rate). Compared to before the simulation, median knowledge scores doubled following the intervention (pb.001). Students' willingness to recommend IUC to patients also doubled (pb.001), and 52% were more likely to recommend IUC to a family member after the simulation. Eighty-three percent reported improved confidence in their ability to place an IUC following the simulation. Seventy-two percent of students reported increased interest in women's health and 79% reported an increased interest in contraceptive management after this intervention. Conclusions: A hands-on simulation during the obstetrics and gynecology clerkship increased medical students' knowledge about IUC and resulted in more favorable attitudes toward the method. Including IUC simulation in medical curricula may help expand utilization of this effective contraceptive method.
P42 Kiley J, Rademaker A, Gawron L, Stika C, Hammond C Objectives: To study the effects of a 1% lidocaine paracervical block on perceived pain with intrauterine device (IUD) insertion. Methods: Fifty women undergoing IUD insertion were randomized to receive either a 10-mL 1% lidocaine paracervical block (n=26) or no local anesthetic (n=24). Randomization was stratified by parity (nulliparous or multiparous). Women marked their perceived pain on 100-mm visual analogue scales at various points of the procedure (speculum insertion, single-toothed tenaculum placement, paracervical block administration, IUD insertion and 5 min after the procedure). Results: The groups were similar in age, ethnicity and education. There was a significant difference in body mass index (BMI) between the groups (paracervical block: mean 30.8±8.0 kg/m2; no local anesthetic: mean 26.4± 7.0 kg/m2, p=.04). Pain on the visual analogue scale was not significantly different between the groups at any point during the procedure. In particular, although there was less perceived pain with IUD insertion in the paracervical block group, it was not statistically significant (paracervical block: mean 37.3±35.0 mm; no local anesthetic: mean 52.5±27.5 mm, p=.10). Adjusting for BMI did not change these results. Conclusions: Compared with no local anesthetic, a 1% lidocaine paracervical block did not result in decreased perceived pain with IUD insertion.
P41
MEDICAL STUDENT SIMULATION TRAINING IN INTRAUTERINE CONTRACEPTION INSERTION AND REMOVAL: AN INTERVENTION TO IMPROVE KNOWLEDGE, SKILL AND INTEREST Paris A Brigham and Women's Hospital, Boston, MA, USA Maurer R, Gardner R, Bartz D
WEIGHT CHANGE IN USERS OF THREE PROGESTIN-ONLY CONTRACEPTION METHODS Vickery Z Washington University, St. Louis, MO, USA Madden T, Secura G, Allsworth J, Zhao Q, Nash L, Peipert J Objectives: The aim of this study was to compare the change in weight over the first 12 months of use between users of etonogestrel subdermal implant (ENG implant), depot medroxyprogesterone acetate (DMPA) or levonorgestrel intrauterine contraception (LNG-IUC), and the copper intrauterine device (copper-IUC). Our hypothesis was that weight gain will be greater in DMPA, LNG-IUC and ENG implant users compared to copper-IUC users after the first 12 months of use. Methods: Women were recruited from participants of the Contraceptive CHOICE Project, an on-going prospective cohort study designed to remove the financial barriers to contraception and promote the uptake of long-acting reversible contraception. The study provides all reversible methods at no cost to women for 2–3 years. Women who had been using the ENG implant, DMPA, LNG-IUC or copper-IUC for more than 11 months continuously were eligible for participation. We obtained body weight at enrolment and at 12 months and calculated the median weight change for each method. Results: A total of 239 participants were enrolled and using one of these methods for 12 months. The mean weight change for copper-IUC users (n=33) was 1.4±12.3 lb, DMPA users (n=32) was 5.7±9.5 lb, ENG implant users (n=44) was 6.6±17.0 lb and LNG-IUC users (n=130) was 2.3±11.8 lb. Conclusions: Participants both gained and lost weight with all three progestin-only methods. The mean weight change for the group represented an increase; however, the range in weight change was very broad. Copper-IUC users' mean weight change was typical of gains expected in the general population of reproductive aged women over 1 year.
P40
PAIN CONTROL FOR INTRAUTERINE DEVICE INSERTION: A RANDOMIZED TRIAL OF 1% LIDOCAINE PARACERVICAL BLOCK Krishnan S Northwestern University, Chicago, IL, USA
319
Objectives: Opportunities for medical students to place intrauterine contraception (IUC) in patients are uncommon in most teaching situations. This study was designed to determine if participation in a simulation exercise will increase medical students' knowledge, comfort level and willingness to recommend IUC. Methods: A prospective cohort study was undertaken which included all Harvard Medical School students completing the obstetrics and gynecology clerkship at one institution throughout one academic year. The intervention consisted of a lecture and a 30-min, hands-on, practicum in IUC placement and removal using medical instruments and realistic pelvic models. Both levonorgestrel and copper IUC devices were taught. Participants completed a pre- and post-simulation survey, designed to examine students' IUCspecific knowledge, attitudes and comfort. Pre- and post-simulation responses were compared by signed rank test. Results: Twenty-nine paired pre- and post-simulation surveys were analyzed (74% completion rate). Compared to before the simulation, median knowledge scores doubled following the intervention (pb.001). Students' willingness to recommend IUC to patients also doubled (pb.001), and 52% were more likely to recommend IUC to a family member after the simulation. Eighty-three percent reported improved confidence in their ability to place an IUC following the simulation. Seventy-two percent of students reported increased interest in women's health and 79% reported an increased interest in contraceptive management after this intervention. Conclusions: A hands-on simulation during the obstetrics and gynecology clerkship increased medical students' knowledge about IUC and resulted in more favorable attitudes toward the method. Including IUC simulation in medical curricula may help expand utilization of this effective contraceptive method.
P42 Kiley J, Rademaker A, Gawron L, Stika C, Hammond C Objectives: To study the effects of a 1% lidocaine paracervical block on perceived pain with intrauterine device (IUD) insertion. Methods: Fifty women undergoing IUD insertion were randomized to receive either a 10-mL 1% lidocaine paracervical block (n=26) or no local anesthetic (n=24). Randomization was stratified by parity (nulliparous or multiparous). Women marked their perceived pain on 100-mm visual analogue scales at various points of the procedure (speculum insertion, single-toothed tenaculum placement, paracervical block administration, IUD insertion and 5 min after the procedure). Results: The groups were similar in age, ethnicity and education. There was a significant difference in body mass index (BMI) between the groups (paracervical block: mean 30.8±8.0 kg/m2; no local anesthetic: mean 26.4± 7.0 kg/m2, p=.04). Pain on the visual analogue scale was not significantly different between the groups at any point during the procedure. In particular, although there was less perceived pain with IUD insertion in the paracervical block group, it was not statistically significant (paracervical block: mean 37.3±35.0 mm; no local anesthetic: mean 52.5±27.5 mm, p=.10). Adjusting for BMI did not change these results. Conclusions: Compared with no local anesthetic, a 1% lidocaine paracervical block did not result in decreased perceived pain with IUD insertion.
P41
MEDICAL STUDENT SIMULATION TRAINING IN INTRAUTERINE CONTRACEPTION INSERTION AND REMOVAL: AN INTERVENTION TO IMPROVE KNOWLEDGE, SKILL AND INTEREST Paris A Brigham and Women's Hospital, Boston, MA, USA Maurer R, Gardner R, Bartz D
WEIGHT CHANGE IN USERS OF THREE PROGESTIN-ONLY CONTRACEPTION METHODS Vickery Z Washington University, St. Louis, MO, USA Madden T, Secura G, Allsworth J, Zhao Q, Nash L, Peipert J Objectives: The aim of this study was to compare the change in weight over the first 12 months of use between users of etonogestrel subdermal implant (ENG implant), depot medroxyprogesterone acetate (DMPA) or levonorgestrel intrauterine contraception (LNG-IUC), and the copper intrauterine device (copper-IUC). Our hypothesis was that weight gain will be greater in DMPA, LNG-IUC and ENG implant users compared to copper-IUC users after the first 12 months of use. Methods: Women were recruited from participants of the Contraceptive CHOICE Project, an on-going prospective cohort study designed to remove the financial barriers to contraception and promote the uptake of long-acting reversible contraception. The study provides all reversible methods at no cost to women for 2–3 years. Women who had been using the ENG implant, DMPA, LNG-IUC or copper-IUC for more than 11 months continuously were eligible for participation. We obtained body weight at enrolment and at 12 months and calculated the median weight change for each method. Results: A total of 239 participants were enrolled and using one of these methods for 12 months. The mean weight change for copper-IUC users (n=33) was 1.4±12.3 lb, DMPA users (n=32) was 5.7±9.5 lb, ENG implant users (n=44) was 6.6±17.0 lb and LNG-IUC users (n=130) was 2.3±11.8 lb. Conclusions: Participants both gained and lost weight with all three progestin-only methods. The mean weight change for the group represented an increase; however, the range in weight change was very broad. Copper-IUC users' mean weight change was typical of gains expected in the general population of reproductive aged women over 1 year.