Hormone-related side effects in new users of a levonorgestrel 52 mg intrauterine device.

BACKGROUND: Although the levonorgestrel 52 mg intrauterine device is locally active and has low systemic hormone exposure, hormonal intrauterine device users sometimes report hormone-related side effects. OBJECTIVE: Evaluate hormone-related adverse event rates among all participants and compare these among those who used combined hormonal or no hormonal contraception in the month before enrollment. STUDY DESIGN: A total of 1714 women aged 16-45 years old received a levonorgestrel 52 mg intrauterine device in a multicenter phase 3 trial to evaluate contraceptive efficacy and safety for up to 10 years. This analysis evaluated a subset of participants who used combined hormonal or no hormonal contraception in the month prior to device placement. We assessed all non-expulsion, non-bleeding-related events with ≥1% incidence at 180 days with a plan to include weight increase regardless of incidence; we excluded events considered non-hormonal. We computed 180-day side effect frequency rates based on the number of days a side effect was reported during the study period. We created a multivariable model for side effect incidence at 180 days based on age, race, ethnicity, body mass index at enrollment, parity, and contraception use in the month before enrollment. For those side effects with a p-value <0.2 on univariate comparison between combined-hormonal and no-hormonal contraception users, we secondarily evaluated 360-day event rates. RESULTS: Overall, 644 participants used combined hormonal contraception (primarily oral [n=499, 77.5%]) and 855 used no hormonal method before IUD placement. Individual side effect rates over the first 180 days did not differ between prior combined-hormonal and no-hormonal contraception users except for acne (84 [13.0%] versus 73 [8.5%], respectively), p=0.006, OR 1.61 (95% CI 1.15-2.24). However, this association was weaker after adjustment for age, race, ethnicity, obesity status, and parity (aOR 1.40, 95% CI 0.99-1.98) At 360 days, prior combined hormonal contraception users were more likely to report acne (101 [15.7%] vs. 91 [10.6%], respectively, p=0.005) and orgasm/libido problems (20 [3.1%] vs. 12 [1.4%], respectively, p=0.03). Over the first 180 days, all side effects other than acne were reported in less than 3% of days; acne was reported an average of 13 days (7.4%) per prior combined hormonal contraception user and 9 days (5.0%) per prior non-hormonal contraception user (p<0.0001). Discontinuation for evaluated side effects occurred in 83 (5.5%) participants with no difference between those who used combined hormonal (36 [5.6%]) or no hormonal contraception (47 [5.5%]), p=1.0) before study entry. CONCLUSIONS: Using combined hormonal contraception prior to levonorgestrel 52 mg intrauterine device placement is only weakly associated with reporting hormonally related side effects like acne. Only a small percentage of levonorgestrel 52 mg intrauterine device users experienced potentially hormone-related side effects during the initial 6 months of use that resulted in discontinuation.

Abortion Access in Ohio's Changing Legislative Context, 2010-2018.

Objectives. To examine abortion utilization in Ohio from 2010 to 2018, a period when more than 15 abortion-related laws became effective.Methods. We evaluated changes in abortion rates and ratios examining gestation, geographic distribution, and abortion method in Ohio from 2010 to 2018. We used data from Ohio's Office of Vital Statistics, the Centers for Disease Control and Prevention's Abortion Surveillance Reports, the American Community Survey, and Ohio's Public Health Data Warehouse.Results. During 2010 through 2018, abortion rates declined similarly in Ohio, the Midwest, and the United States. In Ohio, the proportion of early first trimester abortions decreased; the proportion of abortions increased in nearly every later gestation category. Abortion ratios decreased sharply in most rural counties. When clinics closed, abortion ratios dropped in nearby counties.Conclusions. More Ohioans had abortions later in the first trimester, compared with national patterns, suggesting delays to care. Steeper decreases in abortion ratios in rural versus urban counties suggest geographic inequity in abortion access.Public Health Implications. Policies restricting abortion access in Ohio co-occur with delays to care and increasing geographic inequities. Restrictive policies do not improve reproductive health.

Bleeding patterns for the Liletta® levonorgestrel 52 mg intrauterine system.

PURPOSE: Evaluate bleeding patterns for the Liletta® levonorgestrel 52 mg intrauterine system (IUS) using the World Health Organization Belsey definitions. MATERIAL AND METHODS: This prospective multicenter trial evaluates the efficacy and safety of Liletta® (Clinicaltrials.gov NCT00995150). We evaluated bleeding patterns for 1700 nulliparous and multiparous women using a daily diary completed by participants for the first 2 years and by questionnaire every 3 months thereafter. We assessed amenorrhea rates over 3 years and the proportion of subjects with infrequent, frequent, prolonged and irregular bleeding per 90-day reference period over 2 years for the entire study population as well as comparing nulliparous and parous women and obese and non-obese women. RESULTS: Amenorrhea rates at 1 and 3 years in levonorgestrel 52 mg IUS users were 19 and 37%, respectively. The infrequent bleeding rate increased from 14% in the first 90 days to 30% at the end of Year 1, and was maintained at the same rate through Year 2. Frequent, prolonged and irregular bleeding declined to low levels by the end of the first year. Discontinuation for bleeding-related complaints occurred in 35 (2.1%, 95% CI 1.3-2.7%) women during the first 36 months; only one subject discontinued for amenorrhea (in Year 2). Outcomes did not vary for nulliparous versus parous or obese versus non-obese women. CONCLUSIONS: Among Liletta users, amenorrhea and infrequent bleeding become more prevalent over time and amenorrhea rates continue to increase after the first year of use. Bleeding patterns do not differ significantly by parity or by obesity-status. Discontinuation for bleeding concerns is uncommon with this product.

Postpartum intentions on contraception use and method choice among breastfeeding women attending a university hospital in Ohio: a cross-sectional study.

BACKGROUND: Few postpartum women use effective contraception and those who use less effective methods have increased rates of unintended pregnancy. Little is known about postpartum contraception intentions among breastfeeding women. Our objectives were to measure the extent of prenatal contraceptive counseling, to assess contraceptive intentions, and to identify correlates of both among postpartum women who were planning to breastfeed. METHODS: We conducted a cross-sectional study using a convenience sample of 100 breastfeeding women before their discharge following delivery at a large university hospital in 2015. We used logistic regression to assess three outcomes of interest: not intending to use contraception before 6 months postpartum, reporting receiving counseling on postpartum contraception during prenatal care, and considering the effects of contraception methods on the breastfeeding mother-infant dyad when choosing a postpartum contraception method. RESULTS: Most women (91%) intended to use contraception. Prior history of no contraception use was the sole factor related to not intending to use contraception. The most commonly cited reason for the intended choice of contraceptive method was convenience (35%). Few women (21%) reported considering the effects of contraception methods on the breastfeeding dyad when choosing a postpartum contraception method. Nearly half of women reported never discussing postpartum contraception options with their healthcare provider during prenatal care. In the multivariate analysis, receiving public assistance was the only factor that remained statistically significantly associated with reporting having received contraception counseling during prenatal care. CONCLUSIONS: Although most women intended to use contraception, they did not appear to have received adequate prenatal counseling on postpartum contraception.

Comparison of Outcomes before and after Ohio's Law Mandating Use of the FDA-Approved Protocol for Medication Abortion: A Retrospective Cohort Study.

BACKGROUND: In February 2011, an Ohio law took effect mandating use of the United States Food and Drug Administration (FDA)-approved protocol for mifepristone, which is used with misoprostol for medication abortion. Other state legislatures have passed or enacted similar laws requiring use of the FDA-approved protocol for medication abortion. The objective of this study is to examine the association of this legal change with medication abortion outcomes and utilization. METHODS AND FINDINGS: We used a retrospective cohort design, comparing outcomes of medication abortion patients in the prelaw period to those in the postlaw period. Sociodemographic and clinical chart data were abstracted from all medication abortion patients from 1 y prior to the law's implementation (January 2010-January 2011) to 3 y post implementation (February 2011-October 2014) at four abortion-providing health care facilities in Ohio. Outcome data were analyzed for all women undergoing abortion at ≤49 d gestation during the study period. The main outcomes were as follows: need for additional intervention following medication abortion (such as aspiration, repeat misoprostol, and blood transfusion), frequency of continuing pregnancy, reports of side effects, and the proportion of abortions that were medication abortions (versus other abortion procedures). Among the 2,783 medication abortions ≤49 d gestation, 4.9% (95% CI: 3.7%-6.2%) in the prelaw and 14.3% (95% CI: 12.6%-16.0%) in the postlaw period required one or more additional interventions. Women obtaining a medication abortion in the postlaw period had three times the odds of requiring an additional intervention as women in the prelaw period (adjusted odds ratio [AOR] = 3.11, 95% CI: 2.27-4.27). In a mixed effects multivariable model that uses facility-months as the unit of analysis to account for lack of independence by site, we found that the law change was associated with a 9.4% (95% CI: 4.0%-18.4%) absolute increase in the rate of requiring an additional intervention. The most common subsequent intervention in both periods was an additional misoprostol dose and was most commonly administered to treat incomplete abortion. The percentage of women requiring two or more follow-up visits increased from 4.2% (95% CI: 3.0%-5.3%) in the prelaw period to 6.2% (95% CI: 5.5%-8.0%) in the postlaw period (p = 0.003). Continuing pregnancy was rare (0.3%). Overall, 12.6% of women reported at least one side effect during their medication abortion: 8.4% (95% CI: 6.8%-10.0%) in the prelaw period and 15.6% (95% CI: 13.8%-17.3%) in the postlaw period (p < 0.001). Medication abortions fell from 22% (95% CI: 20.8%-22.3%) of all abortions the year before the law went into effect (2010) to 5% (95% CI: 4.8%-5.6%) 3 y after (2014) (p < 0.001). The average patient charge increased from US$426 in 2010 to US$551 in 2014, representing a 16% increase after adjusting for inflation in medical prices. The primary limitation to the study is that it was a pre/post-observational study with no control group that was not exposed to the law. CONCLUSIONS: Ohio law required use of a medication abortion protocol that is associated with a greater need for additional intervention, more visits, more side effects, and higher costs for women relative to the evidence-based protocol. There is no evidence that the change in law led to improved abortion outcomes. Indeed, our findings suggest the opposite. In March 2016, the FDA-protocol was updated, so Ohio providers may now legally provide current evidence-based protocols. However, this law is still in place and bans physicians from using mifepristone based on any new developments in clinical research as best practices continue to be updated.

A prospective assessment of pelvic infection risk following same-day sexually transmitted infection testing and levonorgestrel intrauterine system placement.

BACKGROUND: Misperceptions persist that intrauterine device placement is related to pelvic infections and Chlamydia and gonorrhea testing results are needed prior to placement. OBJECTIVE: We sought to evaluate the relationship of Chlamydia and gonorrhea screening to pelvic infection for up to 2 years following placement of the levonorgestrel 52-mg intrauterine system. STUDY DESIGN: A total of 1751 nulliparous and multiparous females 16 to 45 years old enrolled in a multicenter trial designed to evaluate the efficacy and safety of a new levonorgestrel intrauterine system for up to 7 years. Participants had Chlamydia screening at study entry and yearly if they were age ≤25 years. Women also had baseline gonorrhea screening if testing had not been performed since starting their current sexual relationship. Those who changed sexual partners during the trial had repeated Chlamydia and gonorrhea testing. Intrauterine system insertion could occur on the same day as screening. Participants did not receive prophylactic antibiotics for intrauterine system placement. Investigators performed pelvic examinations after 12 and 24 months and when clinically indicated during visits at 3, 6, and 18 months after placement and unscheduled visits. Pelvic infection included any clinical diagnosis of pelvic inflammatory disease or endometritis. RESULTS: Most participants (n = 1364, 79.6%) did not have sexually transmitted infection test results available prior to intrauterine system placement. In all, 29 (1.7%) participants had positive baseline testing for a sexually transmitted infection (Chlamydia, n = 25; gonorrhea, n = 3; both, n = 1); 6 of these participants had known results (all with Chlamydia infection) prior to intrauterine system placement and received treatment before enrollment. The 23 participants whose results were not known at the time of intrauterine system placement received treatment without intrauterine system removal and none developed pelvic infection. The incidence of positive Chlamydia testing was similar among those with and without known test results at the time of intrauterine system placement (1.9% vs 1.5%, respectively, P = .6). Nine (0.5%) participants had a diagnosis of pelvic infection over 2 years after placement, all of whom had negative Chlamydia screening on the day of or within 1 month after intrauterine system placement. Infections were diagnosed in 3 participants within 7 days, 1 at 39 days, and 5 at ≥6 months. Seven participants received outpatient antibiotic treatment and 2 (diagnoses between 6-12 months after placement) received inpatient treatment. Two (0.1%) participants had intrauterine system removal related to infection (at 6 days and at 7 months after placement), both of whom only required outpatient treatment. CONCLUSION: Conducting Chlamydia and gonorrhea testing on the same day as intrauterine system placement is associated with a low risk of pelvic infection (0.2%). Over the first 2 years of intrauterine system use, infections are infrequent and not temporally related to intrauterine system placement. Pelvic infection can be successfully treated in most women with outpatient antibiotics and typically does not require intrauterine system removal. Women without clinical evidence of active infection can have intrauterine system placement and sexually transmitted infection screening, if indicated, on the same day.

A new estradiol-dienogest oral contraceptive marks "The Pill's" 50th anniversary.

Oral contraceptive pills were first approved by the Food and Drug Administration 50 years ago. Discovery of the physiology of reproduction and demonstration of the ability to inhibit ovulation with ovarian extracts laid the early groundwork for the development of contraceptives. Later, characterization of the hormones controlling ovulation and synthesis of progestins allowed production of oral contraceptives. Modern estrogen and progestin pills have undergone significant changes since their initial introduction. New formulations have been developed, doses have been lowered, and extended use introduced. The Food and Drug Administration has recently approved a new oral contraceptive containing estradiol valerate and dienogest. This pill contains an orally active estradiol in combination with a progestin with strong endometrial activity. The decreasing estrogen dose combined with an increasing progestin dose decreases the risk of break through bleeding when compared to previous estradiol valerate formulations. The contraceptive efficacy and a tolerability of this new pill are similar to currently marketed low dose combined estrogen-progestin oral contraceptives.

Who attends a crisis pregnancy center in Ohio?

OBJECTIVES: We sought to quantify the prevalence of ever attendance at a crisis pregnancy center (CPC) among adult, reproductive-age women in Ohio and identify demographic factors associated with ever attendance. STUDY DESIGN: We analyzed data from the Ohio Survey of Women, a survey of adult, reproductive-age women (N = 2529) conducted in 2018 to 2019. We calculated unadjusted and adjusted prevalence ratios (PRs) to evaluate the possible associations between demographic factors and ever CPC attendance. Analyses used statistical weights to be population-representative. RESULTS: Analyses are based on women reporting ever (n = 291) or never CPC attendance (n = 2151). Prevalence of ever CPC attendance was 13.5%. Ever CPC attendance was higher among women of Black, non-Hispanic race/ethnicity (adjusted PR, 2.1; 95% confidence interval [CI], 1.4-3.2) and currently in the lowest socioeconomic status (SES) stratum (defined as less than a college degree and annual household income less than $75,000) (aPR, 1.6; 95% CI, 1.1-2.3) compared to those of other race/ethnicity and in the highest SES stratum. CONCLUSIONS: Disparities exist among adult women in Ohio regarding their ever use of CPCs. Because CPCs typically are not medical facilities and may provide inaccurate information, future studies should evaluate a wider range of correlates of recent CPC attendance. IMPLICATIONS: Findings from a population-based survey of adult, reproductive-age women in Ohio indicate that ever attendance to a CPC for pregnancy-related care is not rare, and this attendance is higher among Black/non-Hispanic women and those of low SES compared to other women.

Six-year contraceptive efficacy and continued safety of a levonorgestrel 52 mg intrauterine system.

OBJECTIVE: To assess 6-year contraceptive efficacy and safety of a levonorgestrel 52 mg intrauterine system (IUS). STUDY DESIGN: We assessed pregnancy rates through 72 months in women aged 16-35 years at enrollment and safety in all participants (aged 16-45 years, n = 1751) in an ongoing 10-year phase-3 trial. RESULTS: Over six years, nine pregnancies occurred (none in year 6) for a life-table pregnancy rate of 0.87 (95% CI 0.44-1.70). Adverse event rates remain low through 6 or more years of use. Two expulsions occurred in year 6. CONCLUSION: This levonorgestrel 52 mg IUS is a highly effective and safe contraceptive over 6 years of use. IMPLICATIONS: The levonorgestrel 52 mg IUS shows high 6-year contraceptive efficacy and a low rate of adverse events through 6 or more years of use.

Early Breast Milk Pumping Intentions Among Postpartum Women.

INTRODUCTION: Milk expression has become common, but little is known about women's intentions and motivations for pumping. Our objectives were to measure, among newly postpartum women, intentions related to breast milk feeding and pumping, reasons for intending to pump, and timing of pumping initiation. METHODS: We conducted a cross-sectional study at a large university hospital in 2015 using a convenience sample of 100 women before their discharge following delivery, who intended to feed their infant breast milk for at least 6 months. RESULTS: All participants planned to feed their baby at the breast. Ninety-eight percent said that they would use a breast pump to express milk for their baby, with most of this subset (69%) intending to start within weeks of delivery. Over a quarter of participants (29%) had already initiated pumping or intended to initiate within the subsequent few days. Primiparae were more likely to report having already started pumping at the time of the interview. For all women, the most common reason for pumping was to keep up their milk supply. Women who started pumping while in the hospital also noted that they pumped to increase their milk supply and overcome latch difficulties. CONCLUSIONS: The common intention to use a breast pump so early after delivery indicates a need for increased lactation support to reduce concerns about having an insufficient milk supply immediately following delivery. Additionally, clinicians who help facilitate breastfeeding should be aware of how early women intend to use a breast pump.

Multicenter trial of the clinical activities tool to document the comparability of clinical experiences in obstetrics-gynecology clerkships.

PURPOSE: To assess the implementation of the Clinical Activities Tool (CAT) for facilitating Liaison Committee on Medical Education-required documentation of the comparability of obstetrics-gynecology (ob/gyn) clinical experiences and midclerkship feedback at multiple sites during one academic year. METHOD: Ob/gyn clerkship students at six U.S. medical schools were given CATs to guide and document clinical experiences from June 2006 to June 2007. Students used a paper CAT at five institutions and an electronic version at one. CATs listed procedures, skills, and topics recommended by the Association of Professors of Gynecology and Obstetrics and included a midclerkship feedback section. Resident/faculty signatures documented completion of items for paper CATs. Electronic CAT item completion was self-documented by students. Students completed a questionnaire on CAT use. RESULTS: At the six schools, 876 medical students rotated on ob/gyn clerkships; 808 (92%) submitted CATs. Mean item completion rate was 72%. Five of six schools achieved >/=70% completion rates. Midclerkship feedback signature rates ranged from 0% to 97.8% with four of six schools reporting >/=65% feedback. Comparability of clinical experiences and midclerkship feedback was successfully documented across sites for each institution (number of sites: range = 1-9; median = 5). Questionnaires on CAT use were submitted by 231 students (26%). Students using paper CATs reported that doing so clarified course objectives (93%), provided clerkship guidance/structure (93%), and facilitated interaction with faculty/residents (76%/74%). Students rated the electronic CAT significantly less favorably. CONCLUSIONS: CAT implementation at multiple institutions for documentation of student clinical experience comparability and midclerkship feedback was successful. Students evaluated the paper CAT positively.

Best practices in surgical abortion.

Surgical abortion in the first trimester comprises the majority of voluntary pregnancy interruptions performed in the United States. The majority of these procedures are done in outpatient settings with the patient under local anesthesia. Appropriate volume of and deep injection of local anesthetic can reduce pain associated with the procedure. Waiting between administration of the paracervical block and initiating the procedure does not affect pain. Intravenous administration of sedation and analgesia improves patient satisfaction but does not significantly affect pain ratings. Antibiotic prophylaxis is warranted. Vasopressin is useful for prevention of hematometra and hemorrhage. Less evidence supports the routine use of ergots. Preoperative cervical priming reduces the risk of cervical injury and uterine perforation. Attention to operative technique can reduce the risk of incomplete abortion. Routine postoperative care at 2 or 3 weeks is timed to identify complications and to reinforce pregnancy and sexually transmitted disease prevention.