Carolyn Westhoff

Columbia University, New York, New York, United States

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Publications (238)1013.7 Total impact

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    ABSTRACT: Evaluate the levonorgestrel pharmacokinetics in nonobese and obese women after placement of LNG20 intrauterine contraceptive at 3 years of use. In a clinical trial to evaluate the LNG20 intrauterine contraceptive for contraception, levonorgestrel plasma concentrations were determined in 279 participants at the 36-month visit. Blood samples were collected from 166 nonobese LNG20, 77 obese LNG20, 23 nonobese Mirena, and 13 obese Mirena participants. Levonorgestrel plasma levels between nonobese and obese participants were compared using a Wilcoxon Mann-Whitney test. The mean plasma levonorgestrel concentrations at month 36 was 135±51 pg/mL for LNG20 overall; 145.8 ±47.7 pg/mL and 111.3±50.4 pg/mL for LNG20 nonobese and obese participants and 132.1±62.6 pg/mL for Mirena overall; 148.5±71.5 pg/mL and 103.2±27.5 pg/mL for Mirena nonobese and obese participants, respectively. Obese participants using LNG20 and Mirena had lower plasma levels than nonobese participants (P<.5). No difference in efficacy in obese and nonobese LNG20 participants was observed for the first 3 years of clinical use. Levonorgestrel plasma concentration at month 36 did not differ between LNG20 and Mirena nonobese and between LNG20 and Mirena obese participants. Obese women demonstrate significantly lower levonorgestrel concentrations than nonobese women in LNG20 with comparable efficacy in both groups, highlighting the predominantly local mechanism of action of the intrauterine contraceptive.
    Obstetrics and Gynecology 05/2015; 125 Suppl 1:84S-85S. DOI:10.1097/01.AOG.0000463238.63321.bd · 4.37 Impact Factor
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    ABSTRACT: The pelvic examination is under scrutiny given revised cervical cancer screening guidelines. Recent studies have examined physician attitudes and practices, but data are scarce on women's preferences. General mistrust of medical care is higher among Hispanics and blacks, but we know little about attitudes toward the pelvic examination by race and ethnicity. We examined variation in pelvic examination attitudes with baseline data from a cluster randomized trial on contraception. Women ages 18-25 years (n=1,500) were enrolled at 40 Planned Parenthood clinics across the United States. This secondary analysis used multivariable logistic regression with generalized estimating equations for clustering to examine variation in pelvic examination attitudes by race and ethnicity, controlling for individual variables (age, parity, prior contraceptive use, health insurance), site characteristics, and intervention. Hispanic women (67%) were less likely than black (84%) and white (85%) women to have had a pelvic examination (P=.001). However, Hispanic (61%) and black (69%) women were more likely than white women (43%) to report they would want a pelvic examination even if not required for contraception (Hispanic: adjusted odds ratio [OR] 2.2, 95% confidence interval [CI] 1.8-2.7; black: adjusted OR 3.2, 95% CI 2.3-4.4). Hispanic (8%) and black (10%) women were less likely than white women (17%) to have delayed going to a clinic for contraception to avoid a pelvic examination (Hispanic: adjusted OR 0.5, 95% CI 0.4-0.7; black: adjusted OR 0.6, 95% CI 0.4-0.9). The majority of young women in this contraceptive study had a pelvic examination, and perspectives on the examination varied by race and ethnicity. Women should be given the opportunity to avoid the examination when not medically necessary, as in provision of contraceptives.
    Obstetrics and gynecology; 05/2015
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    ABSTRACT: To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use. Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The primary outcome was pregnancy rate for women aged 16-35 years calculated as the Pearl Index. Women aged 36-45 years received LNG20 for safety evaluation only. All participants had in-person or phone follow-up approximately every 3 months during the study. A total of 1600 women aged 16-35 years and 151 women aged 36-45 years agreed to LNG20 placement, including 1011 (57.7%) nulliparous and 438 (25.1%) obese women. Successful placement occurred in 1714 (97.9%) women. Six pregnancies occurred, four of which were ectopic. The Pearl Index for LNG20 was 0.15 (95% CI 0.02-0.55) through Year 1, 0.26 (95% CI 0.10-0.57) through Year 2, and 0.22 (95% CI 0.08-0.49) through Year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24-1.23) through 3 years. Expulsion was reported in 62 (3.5%) participants, most (50 [80.6%]) during the first year of use. Of women who discontinued LNG20 and desired pregnancy, 86.8% conceived spontaneously within 12 months. Pelvic infection was diagnosed in 10 (0.6%) women. Only 26 (1.5%) LNG20 users discontinued due to bleeding complaints. The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women. A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years. Copyright © 2015. Published by Elsevier Inc.
    Contraception 04/2015; DOI:10.1016/j.contraception.2015.04.006 · 2.93 Impact Factor
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    ABSTRACT: Female adolescents at high pregnancy risk frequently visit the emergency department (ED) and lack primary providers. It is unclear if current methods of ED referral are successful. The objective of this pilot study was to assess the potential effect and feasibility of a standardized, enhanced method of referral of sexually active females from an ED for family planning (FP). We conducted an ED-based intervention study using an enhanced referral process, which included a wallet card advertising a walk-in, adolescent-friendly FP clinic and a standardized ED physician monologue. ED physicians were instructed to disseminate the enhanced process to sexually active females ages 12-19 years (intervention group). Patients receiving the intervention were prospectively enrolled. The control group consisted of patients who, on retrospective review, came to the ED during the enrollment period and were eligible but were not enrolled. We used the electronic medical record (EMR) to identify and randomly select missed eligible patients (control group) and accumulated one control for each case. The primary outcome was FP follow-up within 2 months, measured by EMR review. The intervention (n=101) and control groups (n=101) were similar in age, prior ED visits (54% versus 56%), and previous FP visits (28% versus 28%). The absolute difference in follow-up to a FP clinic between the enhanced referral group (7%; 7/101) compared with the nonenhanced referral group (5%; 5/101) was only 2% (95% confidence interval -5% to 9%). Feasibility of the intervention was modest, with a best-case scenario of 59/160 (37%) of eligible patients captured. An enhanced referral initiative relying on physician participation did not substantially increase follow-up rates to a FP clinic and showed modest feasibility. More research is required to identify effective means of ED-based referral for preventive reproductive care.
    Journal of Women's Health 04/2015; 24(4):324-328. DOI:10.1089/jwh.2014.4994 · 1.90 Impact Factor
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    ABSTRACT: This study was conducted to compare single-dose pharmacokinetics of ethinyl estradiol in an oral contraceptive to steady-state values, and to assess whether any simpler measures could provide an adequate proxy of the 'gold standard' 24-hour steady-state area-under-the-curve. Identifying a simple, less expensive, measure of systemic ethinyl estradiol exposure would be useful for larger studies designed to assess the relationship between an individual's ethinyl estradiol exposure and her side effects. We conducted a 13 samples over 24 hours pharmacokinetic analysis on day 1 and day 21 of the first cycle of a monophasic oral contraceptive containing 30 mcg ethinyl estradiol and 150 mcg levonorgestrel in 17 non-obese healthy white women. We also conducted an abbreviated single dose 9-sample pharmacokinetic analysis after a month washout. Ethinyl estradiol was measured by liquid chromatography-tandem mass spectrometry. We compared results of full 13-sample steady-state pharmacokinetic analysis with results calculated using fewer samples (9 or 5) and following the single doses. We calculated Pearson correlation coefficients to evaluate the relationships between these estimates of systemic ethinyl estradiol exposure. The area-under-the-curve, maximum (Cmax), and 24-hour (C24) values were similar following the two single oral contraceptive doses (area-under-the-curve, r = 0.92). The steady-state 13-sample 24-hour area-under-the-curve was highly correlated with the average 9-sample area-under-the-curve after the two single doses (r = 0.81, p = 0.0002). This correlation remained the same if the number of samples was reduced to 4, taken at time 1, 2.5, 4 and 24 hours. The C24 at steady-state was highly correlated with the 24-hour steady-state area-under-the-curve (r = 0.92, p < 0.0001). The average of the C24 values following the two single doses was also quite highly correlated with the steady-state area-under-the-curve (r = 0.72, p = 0.0026). Limited blood sampling, including results from two single doses, gave highly correlated estimates of an oral contraceptive user's steady-state ethinyl estradiol exposure. Copyright © 2014 Elsevier Inc. All rights reserved.
    American Journal of Obstetrics and Gynecology 12/2014; 212(5). DOI:10.1016/j.ajog.2014.12.007 · 3.97 Impact Factor
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    ABSTRACT: To evaluate skin irritation and patch adhesiveness of a new weekly low-dose levonorgestrel (LNG) and ethinyl estradiol (EE) contraceptive patch (LNG/EE patch). This analysis was part of an open-label, parallel-group, multicenter, phase 3 study that randomized healthy women to the LNG/EE patch (one patch weekly for three consecutive weeks, followed by a patch-free week for 13 cycles) or to an oral contraceptive for six cycles followed by seven LNG/EE patch cycles. Participants selected patch application sites of abdomen, buttock or upper torso. Investigators rated patch adhesiveness and skin irritation using standardized scales. Participants rated skin irritation and itching daily using standardized scales and recorded patch fall-off on daily diary cards. A total of 32,508 patches were applied (n=1273). At the five clinic visits in which investigators rated the patches, they rated adhesiveness=0 (no lift) for ≥84% of participants and skin irritation=absent/mild for 97% of patches. Participants reported that 2-3.7% of patches fell off and rated skin irritation as absent or mild for 92- 95% of patches, according to site. Investigator- and participant-rated assessments of LNG/EE patch adhesiveness and irritation demonstrated a low incidence of patch detachment, skin irritation and pruritus. This secondary analysis of a phase 3 clinical trial of a new weekly low-dose LNG and EE contraceptive patch, which used assessment by both investigators and participants, observed a low incidence of skin irritation, pruritus and patch detachment. Copyright © 2014 Elsevier Inc. All rights reserved.
    Contraception 11/2014; 91(3). DOI:10.1016/j.contraception.2014.11.013 · 2.93 Impact Factor
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    ABSTRACT: Pregnancy rates in US contraceptive clinical trials are increasing due to decreased treatment compliance. This study compared compliance with a new low-dose levonorgestrel (LNG) and ethinyl estradiol (EE) contraceptive patch (CP, Twirla™) with that of a low-dose combination oral contraceptive (COC) in a demographically diverse population. This analysis was part of an open-label, parallel-group, multicenter phase 3 study that randomized healthy sexually active women (17-40years) to 13cycles of LNG/EE CP or 6cycles of COC, then 7cycles of LNG/EE CP. We defined self-reported compliance as cycles that, according to diaries, show 21days of patch wear without missed days or any patch worn >7days or 21days of pill-taking without missed pill days. We verified compliance by detectable plasma presence of LNG and EE at cycles 2, 6, and 13. Of the intention-to-treat population with diary information (N=1328, mean age 26.4years, 46% minorities, 33% obese), 10.0% of the CP (n=998) versus 21.2% of the COC group (n=330) self-reported noncompliance after 6cycles (p<.001). Laboratory assessments verified 10-14% of participants in both groups as noncompliant. Self-reported perfect use did not vary between obese [body mass index (BMI) ≥30kg/m(2)] versus nonobese (BMI <30kg/m(2)) participants in both groups or when stratified by age, education, or race/ethnicity in the CP group. Self-reported compliance was significantly greater in the CP than COC group and did not vary by obesity status. Discrepancies between self-reported and verified compliance question reliability of patient diaries. This paper, based on an analysis of a phase 3 trial, shows that compliance was significantly greater with a new weekly transdermal CP than with a once-daily COC in obese as well as nonobese participants. Discrepancies between self-reported compliance and laboratory-verified compliance raise questions regarding the reliability of patient diaries. Copyright © 2014 Elsevier Inc. All rights reserved.
    Contraception 11/2014; 91(3). DOI:10.1016/j.contraception.2014.11.011 · 2.93 Impact Factor
  • Carolyn L. Westhoff, Beverly Winikoff
    Contraception 10/2014; 90(4):353. DOI:10.1016/j.contraception.2014.08.008 · 2.93 Impact Factor
  • Contraception 09/2014; 90(3):349. DOI:10.1016/j.contraception.2014.05.194 · 2.93 Impact Factor
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    ABSTRACT: Background Body mass index (BMI) may influence ovulation inhibition resulting from transdermal hormone delivery. Investigation of this effect is important given the high prevalence of obesity in the US. Study Design This open-label, uncontrolled, Phase 2b trial stratified 173 women (18–35 years) according to three BMI groups (Group 1, n = 56, ≤ 30 kg/m2; Group 2, n = 55, > 30 kg/m2 and ≤ 35 kg/m2; and Group 3, n = 47, > 35 kg/m2). Women used a contraceptive patch containing 0.55 mg ethinyl estradiol (EE) and 2.1 mg gestodene (GSD). The EE/GSD patch was used weekly for three 28-day cycles (one patch per week for 3 consecutive weeks followed by a 7-day, patch-free interval) and its effect on ovulation was assessed by the Hoogland score, a composite score that comprises transvaginal ultrasound and estradiol (E2) and progesterone levels every 3 days in Cycles 2 and 3. Evaluation of PK parameters was a secondary aim of the study, and blood samples for analytic determination of EE, GSD and SHBG were taken during the pre-treatment cycle, Cycle 2 and Cycle 3. Compliance was assessed using diary information and serum drug levels. Results In the per-protocol set, there were only six ovulations during the study, and no participant ovulated in both study cycles. One ovulation occurred in Group 1, three in Group 2, and two in Group 3. Ovulation inhibition was unaffected by BMI; in all groups, most participants had Hoogland scores of 1 or 2 (i.e. follicle-like structures < 13 mm (Group 1, ≤ 30 kg/m2, 80.0% in Cycle 2, 85.7% in Cycle 3; Group 2, > 30 kg/m2 and ≤ 35 kg/m2, 61.4% in Cycle 2, 75.0% in Cycle 3; Group 3, > 35 kg/m2, 78.0% in Cycle 2, 72.5% in Cycle 3). Serum levels of follicle-stimulating hormone, luteinizing hormone, E2 and progesterone were similar between groups. Body weight had a limited effect on EE clearance that was unlikely to be clinically relevant. Conclusion The EE/GSD patch provided effective ovulation inhibition, even in women with higher BMI. Implications This is the largest-to-date study of physiologic endpoints and found no clinically important differences in ovarian suppression among obese and normal-weight users of the EE/GSD contraceptive patch, thus providing reassurance that obese women can achieve the same high level of contraceptive protection as normal-weight users.
    Contraception 09/2014; 90(3). DOI:10.1016/j.contraception.2014.04.018 · 2.93 Impact Factor
  • Contraception 09/2014; 90(3):292–293. DOI:10.1016/j.contraception.2014.05.204 · 2.93 Impact Factor
  • Contraception 09/2014; 90(3):331-332. DOI:10.1016/j.contraception.2014.05.135 · 2.93 Impact Factor
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    ABSTRACT: PurposeTo describe women’s condom use and assess predictors of consistent condom use and dual method use in the 6 months after the initiation of oral contraception (OC).MethodsWe conducted a planned secondary cohort analysis among women less than 25 years of age initiating oral contraceptives at public family planning clinics in Atlanta, Dallas and New York City, USA, as part of a randomized trial. These clinics provide care to predominantly African American or Hispanic women of low socioeconomic status. Participants completed interviews at enrollment and at 6 months after OC start. We used multivariate logistic regression to assess factors associated with consistent condom and dual method use at 6 months.Results1281 participants met the inclusion criteria for this analysis. At enrollment prior to OC start, 28% were consistent condom users. In the six months after initiation of oral contraception, only 14% always used a condom and 4% always used dual methods. In multivariate analysis, receiving basic advice to always use a condom after OC initiation from a provider during the baseline clinic consultation was associated with a 50% increase in the odds of using condoms consistently. Only 28% of participants were given this condom use advice.ConclusionsThis study documents a decline in women’s condom consistent use subsequent to initiation of the oral contraceptive and suggests that opportunities for positive intervention around condom use among women starting hormonal methods are being missed. Basic condom use advice, which is neither time consuming nor resource dependent, was associated with increased consistent use and should be immediately implemented in all family planning services.
    PLoS ONE 07/2014; 9(7):e101804. DOI:10.1371/journal.pone.0101804 · 3.53 Impact Factor
  • Margo S Harrison, Marianne N DiNapoli, Carolyn L Westhoff
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    ABSTRACT: OBJECTIVE:To assess the effectiveness of using local anesthesia during interval laparoscopic tubal ligation to control postoperative pain.DATA SOURCES:We searched MEDLINE, PubMed, and Cochrane databases and found additional articles from bibliographies of relevant studies.METHODS OF STUDY SELECTION:We included only randomized, double-blind, placebo-controlled trials reporting postoperative pain after interval laparoscopic tubal ligation under general anesthesia (n=20). The trials compared the application of topical or injectable local anesthetic with placebo and used a visual analog scale (VAS) (scores 0-100) or the Modified McGill Pain Intensity Scale (subsequently converted to a VAS) to assess pain.TABULATION, INTEGRATION, AND RESULTS:Pain scores were evaluated at the following times after extubation: 30 minutes, 1 hour, 2 hours, 4 hours, 8 hours, and 24 hours. The meta-analysis was based on random-effects methods for pooled data using RevMan. Postoperative pain decreased with the use of local anesthetic compared with placebo as follows (mean VAS decrease in millimeters, 95% confidence interval): 30 minutes 18.6 (11.7-25.5); 1 hour 16.6 (9.3-24.0); 2 hours 17.4 (9.6-25.2); 4 hours 12.5 (5.1-19.9); 8 hours 11.9 (6.7-17.1); and 24 hours 3.9 (-1.4 to 9.2). There was moderate heterogeneity in the data across studies (I-2 statistic ranging from 55% to 75%). The effect size was similar for the following subgroups: pain scores reported as means or medians and use of McGill compared with VAS pain scales. A stratified analysis of trials including ring tubal ligation compared with clip tubal ligation showed the use of local anesthetic decreased pain substantially for both. No eligible studies assessed tubal ligation with cautery.CONCLUSION:Use of local anesthetic during laparoscopic tubal ligation substantially reduces postoperative pain up to 8 hours after surgery.
    Obstetrics and Gynecology 06/2014; 124(1). DOI:10.1097/AOG.0000000000000342 · 4.37 Impact Factor
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    ABSTRACT: Short-term bleeding patterns after intrauterine device (IUD) insertion are poorly characterized. Most young women text message daily. We aimed to assess success of collecting 90 days bleeding data after IUD insertion by method of data collection (text message compared with traditional paper diaries). We enrolled women with cell phones initiating the copper T380A IUD or levonorgestrel intrauterine system and randomized participants (one-to-one) to record bleeding through daily text messages or monthly paper calendars. Women in the text group received automated daily prompts. The groups received equal compensation for completing the diaries. We enrolled 230 participants. The groups were similar in baseline characteristics, including age, parity, ethnicity, and education. Twenty percent of participants provided no bleeding data; of these, 76% were in the paper group; only 20% in each group provided complete 90-day data. The median diary completion was 82 days for the text group (interquartile range 40-89) and 36 days in the paper group (interquartile range 0-88). Those with 30 or fewer responses were less educated and more likely to self-identify as Hispanic than those providing more than 60 responses. Women providing bleeding data electronically by daily text message gave more complete data than women using traditional paper diaries; however, bleeding data were incomplete in both groups. For future studies of contraception and bleeding patterns, use of text may be superior to paper diaries.
    Obstetrics and Gynecology 05/2014; 123 Suppl 1:12S-3S. DOI:10.1097/01.AOG.0000447260.94490.27 · 4.37 Impact Factor
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    ABSTRACT: Objectives To evaluate feasibility, acceptability, continuation, and trough serum levels following self-administration of subcutaneous (SC) depot medroxyprogesterone acetate (DMPA). Study Design Women presenting to a family planning clinic to initiate, restart, or continue DMPA were offered study entry. Participants were randomized in a 2:1 ratio to self or clinician administered SC DMPA 104mg. Those randomized to self-administration were taught to self-inject and were supervised in performing the initial injection; they received printed instructions and a supply of contraceptive injections for home use. Participants randomized to clinician administration received usual care. Continued DMPA use was assessed by self-report and trough MPA levels at six and twelve months. Results 250 women were invited to participate and 137 (55%) enrolled. Of these, 91 were allocated to self-administration, and 90/91 were able to correctly self-administer SC DMPA. Eighty-seven percent completed follow-up. DMPA use at one year was 71% for the self-administration group and 63% for the clinic group (p=0.47). Uninterrupted DMPA use was 47% and 48% for the self and clinic administration groups at one year (p = 0.70), respectively. Serum analyses confirmed similar mean DMPA levels in both groups and therapeutic trough levels in all participants. Conclusions Sixty-three percent of women approached were interested in trying self-administration of DMPA, even in the context of a randomized trial, and nearly all eligible for enrollment were successful at doing so. Self-administration and clinic administration resulted in similar continuation rates and similar DMPA serum levels. Self-administration of SC-DMPA is feasible, and may be an attractive alternative for many women. Implications Self-administration of SC DMPA is a feasible and attractive option for many women. Benefits include increased control over contraceptive measures and less time spent on contracepting behaviors. Globally, self-administration has the potential to revolutionize contraceptive uptake by increasing the number of women with access to DMPA.
    Contraception 05/2014; 89(5). DOI:10.1016/j.contraception.2014.01.026 · 2.93 Impact Factor
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    ABSTRACT: Unintended pregnancy remains persistently high in the United States. Few randomized interventions have effectively reduced pregnancy. We conducted a cluster randomized trial in 40 Planned Parenthood sites, including family planning and abortion, to assess the effect of a clinic-wide training in long-acting reversible contraceptives (LARCs) on patient outcomes. A cohort of 1,500 patients, 18-25 years, who received contraceptive counseling and did not want to become pregnant in the next 12 months, were recruited from intervention and control clinics. Pregnancy was measured over 12 months with questionnaires, pregnancy tests, and medical record review. In blinded intent-to-treat analyses, we used survival analysis with shared frailty for clustered data to measure the intervention effect compared with standard care. The trial was registered with ClinicalTrials.gov and followed CONSORT (Consolidated Standards of Reporting Trials) guidelines. Participants were similar in baseline characteristics by arm. At enrollment, after counseling, participants in arm 1 were twice as likely to choose a LARC method as those in arm 2 using generalized estimating equation models for clustered data and robust standard errors (odds ratio 2.0, 95% confidence interval [CI] 1.3-2.9). In family planning settings, pregnancy during the study was lower in arm 1 (7.5%) than in arm 2 (13.8%). Analyses of the intervention effect in a model with an interaction for setting type showed a highly significant effect on reduced pregnancy in family planning settings (hazard ratio 0.5, 95% CI 0.3-0.8). However, there were no significant differences in pregnancy by arm in the abortion setting. A half-day replicable LARC intervention effectively reduced pregnancy in family planning clinics.
    Obstetrics and gynecology; 05/2014
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    ABSTRACT: Health care providers may restrict intrauterine device (IUD) insertion until menstruation occurs secondary to device labeling. We describe pregnancy and bleeding patterns when IUD insertions occur at any time in the menstrual cycle. We enrolled women initiating the copper T380A or levonorgestrel intrauterine system after pregnancy test regardless of cycle day. Participants recorded bleeding and cramping with paper calendars or text message for 90 days. We enrolled 230 participants; 131 (57%) provided adequate data for analyses. Intrauterine devices were inserted through cycle day 7 (n=34), later (n=76), or when a cycle day could not be determined (eg, recently pregnant) (n=21). Copper IUD users (n=67) reported a median of 26 days of bleeding overall. Median bleeding days reported were 22 when the device was inserted during cycle week 1, 28 when inserted at any other time, and 24 when cycle day could not be determined (P=.1). Levonorgestrel intrauterine system users (n=64) overall had a median of 38 bleeding days and 37 bleeding days for insertion during cycle week 1, 39 at any other time, and 35 if indeterminate cycle day (P=.6). Sixty-seven percent of copper IUD insertions and 80% of levonorgestrel intrauterine system insertions occurred beyond cycle week 1. No pregnancies occurred in the month of IUD insertion. Bleeding was reported more frequently by levonorgestrel intrauterine system users. Reported bleeding days did not differ by timing of IUD insertion. Intrauterine devices can, thus, be inserted any time during the menstrual cycle.
    Obstetrics and Gynecology 05/2014; 123 Suppl 1:12S. DOI:10.1097/01.AOG.0000447259.56373.c2 · 4.37 Impact Factor
  • Noa’a Shimoni, Anne Davis, Carolyn Westhoff
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    ABSTRACT: Objectives Our randomized trial compared early and delayed IUD insertion following medical abortion. In this planned sub-study, we explore if endometrial thickness and initial IUD position were associated with IUD expulsion. We also describe IUD movement within the uterus during the six months after insertion. Study Design We recruited women undergoing medical abortion and choosing the copper IUD for contraception (n = 156). Participants were randomly assigned to early insertion one week after mifepristone or delayed insertion 4–6 weeks later. We measured endometrial thickness by transvaginal sonogram one week after abortion, and IUD distance from the fundal aspect of the endometrial cavity three times: at insertion, 6–8 weeks later, and at 6 months. Results We analyzed endometrial thickness in 113 women, baseline IUD position in 114 women, and IUD movement in 65 women. Women who expelled IUDs (n = 15) had slightly thicker endometria (p = .007) and slightly lower baseline IUD positions (p = .03) than those who retained IUDs, but no clear cutoffs emerged in the ROC analysis. Retained IUDs commonly moved up and down throughout the six months (from 14 mm towards the fundus to 32 mm towards the cervix ). Overall, retained IUDs moved a median of 2 mm towards the cervix between insertion and exit (p < .0001). Conclusions After medical abortion, the risk of IUD expulsion increases with thicker endometria and lower baseline position. Since no clear cutoffs emerged in the analysis and expulsion remained uncommon even with thicker endometria, we do not recommend restricting IUD insertion based on ultrasound data. Implication Copper T IUDs often move within the uterus without expelling. Expulsion is uncommon and we do not recommend restricting IUD insertion based on ultrasound data.
    Contraception 05/2014; 89(5). DOI:10.1016/j.contraception.2014.01.006 · 2.93 Impact Factor
  • Article: In Reply.
    Obstetrics and Gynecology 05/2014; 123(5):1107-1108. DOI:10.1097/AOG.0000000000000248 · 4.37 Impact Factor

Publication Stats

3k Citations
1,013.70 Total Impact Points

Institutions

  • 1995–2015
    • Columbia University
      • • Department of Obstetrics and Gynecology
      • • Department of Epidemiology
      • • College of Physicians and Surgeons
      New York, New York, United States
  • 2002–2013
    • New York Presbyterian Hospital
      • • Department of Obstetrics and Gynecology
      • • Department of Urology
      New York, New York, United States
  • 2011
    • Princeton University
      • Office of Population Research
      Princeton, New Jersey, United States
  • 2009
    • Washington University in St. Louis
      • Department of Obstetrics and Gynecology
      San Luis, Missouri, United States
  • 1999–2009
    • CUNY Graduate Center
      New York, New York, United States
  • 2008
    • Boston University
      Boston, Massachusetts, United States
  • 2004
    • National Cancer Institute (USA)
      • Division of Cancer Epidemiology and Genetics
      Bethesda, MD, United States
    • National Institute of Child Health and Human Development
      베서스다, Maryland, United States
  • 2000
    • Oregon Health and Science University
      Portland, Oregon, United States
  • 1996
    • Icahn School of Medicine at Mount Sinai
      Borough of Manhattan, New York, United States