Factors associated with abortion at 12 or more weeks gestation after implementation of a restrictive Texas law.

OBJECTIVE: To examine factors associated with obtaining abortion at 12 or more weeks gestation in Texas after implementation of a restrictive law. STUDY DESIGN: In this retrospective cohort study, we collected data from eight Texas abortion clinics that provided services at 12 or more weeks gestation from April 1, 2015 to March 30, 2016, after a restrictive abortion law enacted in November 2013 shuttered many of the state's clinics. We examined factors associated with obtaining in-clinic abortion services between 3-11 versus 12-24 weeks gestation including patient race-ethnicity, income level, and driving distance to the clinic using chi-square tests and calculating odds ratios. We further subcategorized abortion between 15-24 weeks to determine who may be most affected by a Texas law banning dilation and evacuation (D&E). RESULTS: Among 24,555 in-clinic abortions, 19.2% (n = 4,714) occurred at 12 or more weeks gestation. Compared to patients who obtained care between 3-11 weeks, those who obtained care at 12 or more weeks were more likely to be Black than White (OR 1.18; 95% CI 1.05-1.31), live ≤110% of the federal poverty level than have higher income (OR 2.09; 95% CI 1.94-2.26), and drive 50+ miles than 1-24 miles to obtain care (OR 1.25; 95% CI 1.15-1.38). These associations remained for those obtaining care between 15-24 weeks. Even after adjusting for race-ethnicity and driving distance, low-income patients had greater odds of obtaining care in between 15-24 weeks (aOR 1.52; 95% CI 1.21-1.91). CONCLUSIONS: Patients obtaining abortion at 12 or more weeks gestation in Texas are more likely to be Black, low-income, and travel far distances to obtain in-clinic care. IMPLICATIONS: In Texas, patients who are Black, low-income, and travel the farthest are more likely to obtain in-clinic abortion between 15-24 weeks gestation, commonly performed via D&E. If Texas Senate Bill 8 (SB8) banning D&E goes into effect, these patients may be prevented from obtaining care.

Medication abortion use among low-income and rural Texans before and during state-imposed restrictions and after FDA-updated labeling.

BACKGROUND: In 2013, the Texas legislature passed House Bill 2, restricting use of medication abortion to comply with Food and Drug Administration labeling from 2000. The Food and Drug Administration updated its labeling for medication abortion in 2016, alleviating some of the burdens imposed by House Bill 2. OBJECTIVE: Our objective was to identify the impact of House Bill 2 on medication abortion use by patient travel distance to an open clinic and income status. MATERIALS AND METHODS: In this retrospective study, we collected patient zip code, county of residence, type of abortion, family size, and income data on all patients who received an abortion (medication or aspiration) from 7 Texas abortion clinics in 3 time periods: pre-House Bill 2 (July 1, 2012-June 30, 2013), during House Bill 2 (April 1, 2015-March 30, 2016), and post-Food and Drug Administration labeling update (April 1, 2016-March 30, 2017). Patient driving distance to the clinic where care was obtained was categorized as 1-24, 25-49, 50-99, or 100+ miles. Patient county of residence was categorized by availability of a clinic during House Bill 2 (open clinic), county with a House Bill 2-related clinic closure (closed clinic), or no clinic any time period. Patient income was categorized as ≤110% federal poverty level (low-income) and >110% federal poverty level. Change in medication abortion use in the 3 time periods by patient driving distance, residence in a county with an open clinic, and income status were evaluated using χ2 tests and logistic regression. We used geospatial mapping to depict the spatial distribution of patients who obtained a medication abortion in each time period. RESULTS: Among 70,578 abortion procedures, medication abortion comprised 26%, 7%, and 29% of cases pre-House Bill 2, during House Bill 2, and post-Food and Drug Administration labeling update, respectively. During House Bill 2, patients traveling 100+ miles compared to 1- 24 miles were less likely to use medication abortion (odds ratio, 0.21; 95% confidence interval, 0.15, 0.30), as were low-income compared to higher-income patients (odds ratio, 0.76; 95% confidence interval, 0.68, 0.85), and low-income, distant patients (adjusted odds ratio, 0.14; 95% confidence interval, 0.08, 0.25). Similarly, post-Food and Drug Administration labeling update, rebound in medication abortion use was less pronounced for patients traveling 100+ miles compared to 1-24 miles (odds ratio, 0.82; 95% confidence interval, 0.74, 0.91), low-income compared to higher-income patients (odds ratio, 0.77; 95% confidence interval, 0.72, 0.81), and low-income, distant patients (adjusted odds ratio, 0.80; 95% confidence interval, 0.68, 0.94). Post-Food and Drug Administration labeling update, patients residing in counties with House Bill 2-related clinic closures were less likely to receive medication abortion as driving distance increased (52% traveling 25-49 miles, 41% traveling 50-99 miles, and 26% traveling 100+ miles, P < .05). Geospatial mapping demonstrated that patients traveled from all over the state to receive medication abortion pre-House Bill 2 and post-Food and Drug Administration labeling update, whereas during House Bill 2, only those living in or near a county with an open clinic obtained medication abortion. CONCLUSION: Texas state law drastically restricted access to medication abortion and had a disproportionate impact on low-income patients and those living farther from an open clinic. After the Food and Drug Administration labeling update, medication abortion use rebounded, but disparities in use remained.

We should really keep in touch: predictors of the ability to maintain contact with contraception clinical trial participants over 12 months.

OBJECTIVES: This study assesses the ability to maintain contact with participants enrolled in an emergency contraception (EC) trial with 12 months of follow-up based on the modes of contact they provided at enrollment. STUDY DESIGN: Data came from a clinical trial offering women the copper intrauterine device or oral levonorgestrel for EC. A modified Poisson regression was used to assess predictors associated with the ability to contact study participants 12 months after enrollment. RESULTS: Data were available for 542 participants; 443 (82%) could be contacted at 12 months. Contact at 12 months was greatest for those whose preferred the method of contact was text messaging, e-mail or any (62/68; 91% contacted) and worst for the 18 who had a landline phone (only 7 contacted; 39%). After controlling for age, having an e-mail address, text messaging, language preference, type of EC chosen and insurance, preferred contact other than phone increased the likelihood of follow-up by 10% [risk ratio (RR) 1.1 95% confidence interval (CI) 1.0-1.2], while having a landline reduced a woman's likelihood of being contacted at 12 months by 50% compared to women with a contract cell (RR 0.5, 95% CI 0.3-1.0). CONCLUSION: The few women with a landline for contact had poor follow-up at 1 year, while women who preferred e-mail or text had the highest rate of follow-up. IMPLICATIONS: Understanding how best to reduce loss to follow-up is an essential component of conducting a contraceptive clinical trial. Improved participant retention maximizes internal validity and allows for important clinical outcomes, such as pregnancy, to be assessed.

Vaginal microbiome changes with levonorgestrel intrauterine system placement.

OBJECTIVE: To investigate changes in female genital tract bacterial ecology associated with levonorgestrel intrauterine system (LNG IUS) use. STUDY DESIGN: Study participants were regularly cycling Caucasian women without recent history of pregnancy or exogenous hormone use. Vaginal, cervical and uterine samples were obtained at nine time intervals, from 1 week before to 12 weeks after LNG IUS placement. Replicate paired vaginal and cervical specimens were collected to determine the consistency of specimen collection and processing. RESULTS: A total of 406 samples from 11 women were available for analysis after DNA extraction, amplification and species identification. Of the 355 bacterial species or genera detected, Lactobacillus crispatus was most prevalent representing 48.9% of over 6 million total reads. L. crispatus reads of replicate vaginal samples were not significantly different [odds ratio (OR) 0.79, 0.36-1.73]. In addition, L. crispatus reads of vaginal and cervical samples from the same visit were not significantly different (OR 0.69, 0.31-1.51). Compared to sampling visits prior to LNG IUS placement, sampling visits after LNG IUS insertion were more likely to have L. crispatus reads greater than 50% of total reads (OR 2.13, 1.01-4.48). Of the 63 uterine samples demonstrating bacteria, Burkholderia genus proteobacteria, a common environmental contaminant, were most prevalent both before and after LNG IUS insertion accounting for 48.0% of all uterine sample reads. CONCLUSION: The vaginal microbiome changes very little in response to LNG IUS placement. Further study is needed to place this finding in context with clinical outcomes. IMPLICATIONS: There do not appear to be any clinically important differences in the vaginal microbiome in response to insertion of the LNG IUS.

Emergency contraception with a copper IUD or oral levonorgestrel: an observational study of 1-year pregnancy rates.

OBJECTIVE: We investigated the 1-year pregnancy rates for emergency contraception (EC) users who selected the copper T380 intrauterine device (IUD) or oral levonorgestrel (LNG) for EC. STUDY DESIGN: This prospective study followed women for 1 year after choosing either the copper T380 IUD or oral LNG for EC. The study was powered to detect a 6% difference in pregnancy rates within the year after presenting for EC. RESULTS: Of the 542 women who presented for EC, agreed to participate in the trial and met the inclusion criteria, 215 (40%) chose the copper IUD and 327 (60%) chose oral LNG. In the IUD group, 127 (59%) were nulligravid. IUD insertion failed in 42 women (19%). The 1-year follow-up rate was 443/542 (82%); 64% of IUD users contacted at 1 year still had their IUDs in place. The 1-year cumulative pregnancy rate in women choosing the IUD was 6.5% vs. 12.2% in those choosing oral LNG [hazard ratio (HR) 0.53, 95% confidence interval (CI): 0.29-0.97, p=.041]. By type of EC method actually received, corresponding values were 5.2% for copper IUD users vs. 12.3% for oral LNG users (HR 0.42, 95% CI: 0.20-0.85, p=.017). A multivariable logistic regression model controlling for demographic variables demonstrates that women who chose the IUD for EC had fewer pregnancies in the following year than those who chose oral LNG (HR 0.50, 95% CI: 0.26-0.96, p=.037). CONCLUSION: One year after presenting for EC, women choosing the copper IUD for EC were half as likely to have a pregnancy compared to those choosing oral LNG. IMPLICATIONS: Compared to EC users who choose oral levonorgestrel, those who select the copper IUD have lower rates of pregnancy in the next year. Greater use of the copper IUD for EC may lower rates of unintended pregnancy in high-risk women.

The copper intrauterine device for emergency contraception: an opportunity to provide the optimal emergency contraception method and transition to highly effective contraception.

Worldwide, 40% of all pregnancies are unintended. Widespread, over-the-counter availability of oral emergency contraception (EC) has not reduced unintended pregnancy rates. The EC visit presents an opportunity to initiate a highly effective method of contraception in a population at high risk of unintended pregnancy who are actively seeking to avoid pregnancy. The copper intrauterine device (IUD), the most effective method of EC, continues to provide contraception as effective as sterilization for up to 12 years, and it should be offered as the first-line method of EC wherever possible. Increased demand for and supply of the copper IUD for EC may have an important role in reducing rates of unintended pregnancy. The EC visit should include access to the copper IUD as optimal care but should ideally include access to all highly effective methods of contraception.

Failed IUD insertions in community practice: an under-recognized problem?

BACKGROUND: The data analysis was conducted to describe the rate of unsuccessful copper T380A intrauterine device (IUD) insertions among women using the IUD for emergency contraception (EC) at community family planning clinics in Utah. METHODS: These data were obtained from a prospective observational trial of women choosing the copper T380A IUD for EC. Insertions were performed by nurse practitioners at two family planning clinics in order to generalize findings to the type of service setting most likely to employ this intervention. Adjuvant measures to facilitate difficult IUD insertions (cervical anesthesia, dilation, pain medication, and use of ultrasound guidance) were not utilized. The effect of parity on IUD insertion success was determined using exact logistic regression models adjusted for individual practitioner failure rates. RESULTS: Six providers performed 197 IUD insertion attempts. These providers had a mean of 14.1 years of experience (range 1-27, S.D. ±12.5). Among nulliparous women, 27 of 138 (19.6%) IUD insertions were unsuccessful. In parous women, 8 of 59 IUD insertions were unsuccessful (13.6%). The adjusted odds ratio (aOR) showed that IUD insertion failure was more likely in nulliparous women compared to parous women (aOR=2.31, 95% CI 0.90-6.52, p=.09). CONCLUSION: The high rate of unsuccessful IUD insertions reported here, particularly for nulliparous women, suggests that the true insertion failure rate of providers who are not employing additional tools for difficult insertions may be much higher than reported in clinical trials. Further investigation is necessary to determine if this is a common problem and, if so, to assess if the use of adjuvant measures will reduce the number of unsuccessful IUD insertions.