Missouri's Abortion law: Access to care for Patients with Lethal Fetal Anomalies at a Midwest Tertiary care Center.

OBJECTIVES: Missouri passed an 8-week gestational age abortion in August 2019. The objective of this study was to compare distance and time from referral to evaluation between patients who continued their pregnancy and those who terminated in patients with severe and lethal fetal anomalies and estimate the impact of the Missouri gestational age abortion ban on distance to abortion care in this patient population. METHODS: This is a retrospective cohort study of patients seen at the Washington University in St. Louis (WUSTL) Fetal Care Center (FCC) with a severe or lethal fetal anomaly between July 2018 and June 2019. Patient characteristics including gestational age at referral and distance traveled to the FCC were compared between patients who underwent abortion and who continued their pregnancies. RESULTS: From July 2018 to June 2019, 463 patients were seen in the Fetal Care Center and 13% (60/463) were diagnosed with severe or lethal fetal anomalies comprising the study population for this analysis. Of these, 21 (35%) patients underwent an abortion, and 39 (65%) patients continued their pregnancy. Patients who underwent abortion were referred at a significantly earlier gestational age (median 19 weeks [IQR 17, 20 weeks] v. 20 weeks [IQR 18, 24 weeks]), p = 0.04. There was a statistically significant difference between the median latency time between patients who underwent an abortion and who continued their pregnancy (median 8 days [IQR 4,13 days] v. 14 days [IQR 9, 22 days], p < 0.01). CONCLUSION: Patients with severe or lethal fetal anomalies are often evaluated at later gestational ages, which may preclude their access to abortion services.

The Impact of Group Prenatal Care on Interpregnancy Interval.

OBJECTIVE: To evaluate whether participation in CenteringPregnancy group prenatal care is associated with decreased risk of an interpregnancy interval (IPI) ≤6 months. STUDY DESIGN: We conducted a retrospective cohort study of women enrolled in Missouri Medicaid from 2007 to 2014 using maternal Medicaid data linked to infant birth certificate records. Inclusion criteria were women ≥11 years old, ≥1 viable singleton delivery during the study period, residency in St. Louis city or county, and ≥2 prenatal visits. The primary outcome was an IPI ≤6 months. Secondary outcomes included IPI ≤12 months, IPI ≤18 months, postpartum long-acting reversible contraception (LARC) uptake, and postpartum LARC or depot medroxyprogesterone acetate (DMPA) uptake. Data were analyzed using descriptive statistics and logistic regression. Backward stepwise logistic regression was used to adjust for potential confounders including maternal age, race, obesity, nulliparity, marital status, diabetes, hypertension, prior preterm birth, and maternal education. RESULTS: Of the 54,968 pregnancies meeting inclusion criteria, 1,550 (3%) participated in CenteringPregnancy. CenteringPregnancy participants were less likely to have an IPI ≤6 months (adjusted odds ratio [aOR]: 0.61; 95% confidence interval [CI]: 0.47-0.79) and an IPI ≤12 months (aOR: 0.74; 95% CI: 0.62-0.87). However, there was no difference for an IPI ≤18 months (aOR: 0.89; 95% CI: 0.77-1.13). Women in CenteringPregnancy were more likely to use LARC for postpartum contraception (aOR: 1.37; 95% CI: 1.20-1.57). CONCLUSION: Participation in CenteringPregnancy is associated with a significant decrease in an IPI ≤6 and ≤12 months and a significant increase in postpartum LARC uptake among women enrolled in Missouri Medicaid compared with women in traditional prenatal care. KEY POINTS: · CenteringPregnancy is associated with a significant decrease in interpregnancy intervals ≤6 and ≤12 months.. · LARC uptake is significantly higher among patients participating in CenteringPregnancy.. · CenteringPregnancy participation enhances self-efficacy in making contraception decisions and promotes healthy pregnancy spacing..

The Value of Assessing Self-Reported and Biological Indicators of Outcomes in Evaluating HIV Programs.

PURPOSE OF REVIEW: In this manuscript, we present recent findings concerning concordance and discrepancy between biological measures and self-reports of these three outcomes of HIV programs: HIV status, adherence to antiretroviral medications (ARVs) and use of and adherence to pre-exposure prophylaxis medication (PrEP), and condom use/unprotected sex. RECENT FINDINGS: Recent studies suggest that three successive rapid HIV tests (for those whose first test in positive) might be reasonably inexpensive and valid biological data to collect to combine with self-reports of HIV status, dried blood spots sufficiently affordable to combine with self-reports of adherence to ARVs and use of or adherence to PrEP, and that the discrepancy between self-reports of condom use and biomarkers of unprotected sex may be relatively small in high-income countries. Additional work on assessment of incorrect condom usage and breakage, standardized self-report measures of condom use, and more private data collection methodologies in low-income settings might reduce the recent observed discrepancies even further. Concordance between self-reports of HIV and biomarkers indicating HIV positive status has varied considerably, with much lower rates in low-income countries, where the stigma of HIV is still very high. Recommendation is for combining self-report data with the results of three successive rapid tests for those testing positive. For adherence, again agreement between self-reports and a variety of more objective and/or biological measures is only moderate. Dried blood spots (DBS) may be sufficiently inexpensive in low-resource settings that this may be the best biological method to combine with self-reports. In publications over the last 8 years, the discrepancy between self-reports of condom use and biomarkers for unprotected sex may be even lower than 20% after controlling for other features of the study, particularly in high-income countries. Our results suggest that more careful assessment of incorrect condom use and breakage as reasons other than intentional misreporting should be investigated more carefully and that more private data collection methods such as audio, computer-assisted self-interviewing (ACASI) might be employed more often in low-resource settings to reduce this discrepancy in those settings further. In addition, further analysis of the discrepancy between self-reports of condom use and biomarkers should be conducted of published studies using the correct calculation methods to be more certain of these findings.

Familiarity and acceptability of long-acting reversible contraception and contraceptive choice.

BACKGROUND: Contraceptive choice is a preference-sensitive decision that is affected by contraceptive attributes, patient experience, and reproductive history. Familiarity with and acceptability of specific contraceptive methods may influence patient decisions. OBJECTIVE: The purpose of this study was to describe the acceptability of and previsit familiarity with long-acting reversible contraception (intrauterine devices and contraceptive implants) compared with depo-medroxyprogesterone acetate and oral contraceptive pills in women seeking contraceptive care and to investigate the relationship between acceptability and contraceptive choice. STUDY DESIGN: This was a secondary analysis of a study that was designed to compare 2 contraceptive care programs conducted at 3 Midwest federally qualified health centers. After contraceptive counseling, participants completed a baseline interviewer-administered survey before the healthcare provider visit. We asked participants questions about previsit familiarity with and acceptability of the intrauterine device, implant, depo-medroxyprogesterone acetate, and oral contraceptive pills. We assessed familiarity using 2 questions: (1) Before today have you ever heard of the [method]? (2) Do you know any woman who has/has used the [method]? Acceptability was assessed for each method on a 0-10 scale, with 0 being "strongly dislike" and 10 being "strongly like." We dichotomized the scores into high acceptability (7-10) and low/moderate acceptability (0-6) for analysis. We examined differences in demographic and reproductive characteristics between women with high and low long-acting reversible contraception acceptability using the chi-square test. We used univariate and multivariable Poisson regressions to examine the relationship among participants' characteristics, method acceptability, and method choice. We adjusted for any covariate that changed the effect size of acceptability by >10%. RESULTS: There were 1007 women included in the analysis: 900 women (89%) reported that they had heard of the intrauterine device, and 592 women (59%) knew someone who had used the intrauterine device. Eight hundred sixty-five (86%) women had heard of the implant, and 636 women (63%) knew someone who had used it. Knowledge of depo-medroxyprogesterone acetate and oral contraceptive pills was high (>98% for both). Five hundred seventy-six women (57%) found 1 or both long-acting reversible contraception methods highly acceptable. Women with high long-acting reversible contraception acceptability were more likely to be adolescents or aged 30-45 years, white, Hispanic, married/cohabitating, and uninsured and were less likely to desire a child in the next 1-3 years. They were more likely to desire a hormonal intrauterine device (90.5% vs 9.5%), copper intrauterine device (81.1% vs 18.9%), or implant (89.8% vs 10.2%) compared with women with low acceptability (P<.001). In adjusted analyses, women with high acceptability of an intrauterine device were more likely to desire an intrauterine device (adjusted relative risk, 9.62; 95% confidence interval, 6.42-14.42). Women with high acceptability of an implant were also more likely to desire one (adjusted relative risk, 8.74; 95% confidence interval, 6.17-12.38). Women were more likely to desire an intrauterine device or an implant if they knew someone who used the method. Previous use of the method and demographic factors were not associated with method choice. CONCLUSION: Previsit familiarity with intrauterine devices and implants was high in our federally qualified health centers population, although not as high as depo-medroxyprogesterone acetate and oral contraceptive pills. In adjusted analyses, women who found an intrauterine device or implant highly acceptable and who knew someone who had used the method were more likely to choose those respective methods at the end of their visit.

Medicaid savings from the Contraceptive CHOICE Project: a cost-savings analysis.

BACKGROUND: Forty-five percent of births in the United States are unintended, and the costs of unintended pregnancy and birth are substantial. Clinical and policy interventions that increase access to the most effective reversible contraceptive methods (intrauterine devices and contraceptive implants) have potential to generate significant cost savings. Evidence of cost savings for these interventions is needed. OBJECTIVE: The purpose of this study was to conduct a cost-savings analysis of the Contraceptive CHOICE Project, which provided counseling and no-cost contraception, to demonstrate the value of investment in enhanced contraceptive care to the Missouri Medicaid program. STUDY DESIGN: The Contraceptive CHOICE Project was a prospective cohort study of 9256 reproductive-age women who were enrolled between 2007 and 2011. Study follow-up was completed October 2013. This analysis includes 5061 Contraceptive CHOICE Project participants who were current Missouri Medicaid beneficiaries or were uninsured and reported household incomes <201% of the federal poverty line. We created a simulated comparison group of women who were receiving care through the Missouri Title X program and modeled the contraception and pregnancy outcomes that would have occurred in the absence of the Contraceptive CHOICE Project. Data about contraceptive use for the comparison group (N=5061) were obtained from the Missouri Title X program and adjusted based on age, race, ethnicity, and income. To make an accurate comparison that would account for the difference in the 2 populations, we used our simulation model to estimate total Contraceptive CHOICE Project costs and total comparison group costs. We reported all costs in 2013 dollars to account for inflation. RESULTS: Among the Contraceptive CHOICE Project participants who were included, the uptake of intrauterine devices and implants was 76.1% compared with 4.8% among the comparison group. The estimated contraceptive cost for the simulated Contraceptive CHOICE Project group was $4.0 million vs $2.3 million for the comparison group. The estimated numbers of unintended pregnancies and births averted among the simulated Contraceptive CHOICE Project group compared with the comparison group were 927 and 483, respectively, which represented a savings in pregnancy and maternity care of $6.7 million. We estimated that the total cost savings for the state of Missouri attributable to the Contraceptive CHOICE Project was $5.0 million (40.7%) over the project duration. CONCLUSION: A program providing counseling and no-cost contraception yields substantial cost savings because of the increased uptake of highly effective contraception and consequent averted unintended pregnancy and birth.

Provision of no-cost, long-acting contraception and teenage pregnancy.

BACKGROUND: The rate of teenage pregnancy in the United States is higher than in other developed nations. Teenage births result in substantial costs, including public assistance, health care costs, and income losses due to lower educational attainment and reduced earning potential. METHODS: The Contraceptive CHOICE Project was a large prospective cohort study designed to promote the use of long-acting, reversible contraceptive (LARC) methods to reduce unintended pregnancy in the St. Louis region. Participants were educated about reversible contraception, with an emphasis on the benefits of LARC methods, were provided with their choice of reversible contraception at no cost, and were followed for 2 to 3 years. We analyzed pregnancy, birth, and induced-abortion rates among teenage girls and women 15 to 19 years of age in this cohort and compared them with those observed nationally among U.S. teens in the same age group. RESULTS: Of the 1404 teenage girls and women enrolled in CHOICE, 72% chose an intrauterine device or implant (LARC methods); the remaining 28% chose another method. During the 2008-2013 period, the mean annual rates of pregnancy, birth, and abortion among CHOICE participants were 34.0, 19.4, and 9.7 per 1000 teens, respectively. In comparison, rates of pregnancy, birth, and abortion among sexually experienced U.S. teens in 2008 were 158.5, 94.0, and 41.5 per 1000, respectively. CONCLUSIONS: Teenage girls and women who were provided contraception at no cost and educated about reversible contraception and the benefits of LARC methods had rates of pregnancy, birth, and abortion that were much lower than the national rates for sexually experienced teens. (Funded by the Susan Thompson Buffett Foundation and others.).

Meeting the Contraceptive Needs of a Community: Increasing Access to Long-Acting Reversible Contraception.

To control their reproductive lives, women must have access to all contraceptive methods including the most effective reversible methods, intrauterine devices, and implants. The Contraceptive CHOICE Project, a study of 9,256 women in St. Louis, showed that when barriers to contraception are removed, many women choose intrauterine devices and implants, substantially reducing rates of unintended pregnancy and abortion. This article discusses strategies we learned from the CHOICE Project to improve uptake of the most effective contraceptive methods.

Accuracy of information about the intrauterine device on the Internet.

BACKGROUND: Intrauterine devices (IUDs) are highly effective methods of contraception, but use continues to lag behind less effective methods such as oral contraceptive pills and condoms. Women who are aware of the actual effectiveness of various contraceptive methods are more likely to choose the IUD. Conversely, women who are misinformed about the safety of IUDs may be less likely to use this method. Individuals increasingly use the Internet for health information. Information about IUDs obtained through the Internet may influence attitudes about IUD use among patients. OBJECTIVE: Our objective was to evaluate the quality of information about IUDs among World Wide Web sites providing contraceptive information to the public. STUDY DESIGN: We developed a 56-item structured questionnaire to evaluate the quality of information about IUDs available through the Internet. We then conducted an online search to identify web sites containing information about contraception and IUDs using common search engines. The search was performed in August 2013 and web sites were reviewed again in October 2015 to ensure there were no substantial changes. RESULTS: Our search identified >2000 web sites, of which 108 were eligible for review; 105 (97.2%) of these sites contained information about IUDs. Of sites, 86% provided at least 1 mechanism of the IUD. Most web sites accurately reported advantages of the IUD including that it is long acting (91%), highly effective (82%), and reversible (68%). However, only 30% of sites explicitly indicated that IUDs are safe. Fifty percent (n = 53) of sites contained inaccurate information about the IUD such as an increased risk of pelvic inflammatory disease beyond the insertion month (27%) or that women in nonmonogamous relationships (30%) and nulliparous women (20%) are not appropriate candidates. Among sites, 44% stated that a mechanism of IUDs is prevention of implantation of a fertilized egg. Only 3% of web sites incorrectly stated that IUDs are an abortifacient. More than a quarter of sites listed an inaccurate contraindication to the IUD such as nulliparity, history of pelvic inflammatory disease, or history of an ectopic pregnancy. CONCLUSION: The quality of information about IUDs available on the Internet is variable. Accurate information was mixed with inaccurate or outdated information that could perpetuate myths about IUDs. Clinicians need knowledge about accurate, evidence-based Internet resources to provide to women given the inconsistent quality of information available through online sources.

Effectiveness of long-acting reversible contraception.

BACKGROUND: The rate of unintended pregnancy in the United States is much higher than in other developed nations. Approximately half of unintended pregnancies are due to contraceptive failure, largely owing to inconsistent or incorrect use. METHODS: We designed a large prospective cohort study to promote the use of long-acting reversible contraceptive methods as a means of reducing unintended pregnancies in our region. Participants were provided with reversible contraception of their choice at no cost. We compared the rate of failure of long-acting reversible contraception (intrauterine devices [IUDs] and implants) with other commonly prescribed contraceptive methods (oral contraceptive pills, transdermal patch, contraceptive vaginal ring, and depot medroxyprogesterone acetate [DMPA] injection) in the overall cohort and in groups stratified according to age (less than 21 years of age vs. 21 years or older). RESULTS: Among the 7486 participants included in this analysis, we identified 334 unintended pregnancies. The contraceptive failure rate among participants using pills, patch, or ring was 4.55 per 100 participant-years, as compared with 0.27 among participants using long-acting reversible contraception (hazard ratio after adjustment for age, educational level, and history with respect to unintended pregnancy, 21.8; 95% confidence interval, 13.7 to 34.9). Among participants who used pills, patch, or ring, those who were less than 21 years of age had a risk of unintended pregnancy that was almost twice as high as the risk among older participants. Rates of unintended pregnancy were similarly low among participants using DMPA injection and those using an IUD or implant, regardless of age. CONCLUSIONS: The effectiveness of long-acting reversible contraception is superior to that of contraceptive pills, patch, or ring and is not altered in adolescents and young women. (Funded by the Susan Thompson Buffet Foundation.).

Long-term utilization and continuation of intrauterine devices.

OBJECTIVE: We compared the 48 and 60 month continuation rates of levonorgestrel (LNG) and copper (Cu) intrauterine devices (IUDs) among women enrolled in the Contraceptive CHOICE Project (CHOICE). Our primary outcome was continuation at 48 months. STUDY DESIGN: This is a prospective cohort study of women who received an IUD through CHOICE. We randomly selected women who had either LNG or Cu IUDs inserted between January 2008 and June 2009 and contacted them by telephone. Once contacted and consented, they were asked whether they were still using their IUD. Women who reported discontinuation of the IUD were asked for the reasons and subsequent contraceptive use. Survival analysis using Cox proportional hazards was performed to assess for factors associated with discontinuation and to calculate hazard ratios. RESULTS: Of the 460 women we attempted to contact, 321 (70%) were reached for interviews. Continuation data on the remaining 139 women were available from CHOICE and its substudies. Continuations at 48 and 60 months were 62.3% and 51.7% for LNG IUD and 64.2% and 55.9% for the Cu IUD, respectively. Continuation at 48 months was highest among women older than 29 years of age at insertion (LNG IUD, 72.5%; Cu IUD, 77.1%). Women younger than 24 years of age had the lowest 48 month continuation (LNG IUD, 55.4%, and Cu IUD, 53.2%). In univariable and multivariable analysis, demographic characteristics, menstrual profile, and pregnancy history were not associated with discontinuation. Age older than 29 years was associated with less discontinuation than those 24-29 years of age (hazard ratio, 0.67, 95% confidence interval, 0.47-0.96). CONCLUSION: IUD continuation remains high (> 60%) at 48 months with no difference between Cu and LNG IUDs.

Three-year continuation of reversible contraception.

OBJECTIVE: The objective of this analysis was to estimate the 3-year continuation rates of long-acting reversible contraceptive (LARC) methods and to compare these rates to non-LARC methods. STUDY DESIGN: The Contraceptive CHOICE Project (CHOICE) was a prospective cohort study that followed 9256 participants with telephone surveys at 3 and 6 months, then every 6 months for 2-3 years. We estimated 3-year continuation rates of baseline methods that were chosen at enrollment. The LARC methods include the 52-mg levonorgestrel intrauterine device; the copper intrauterine device, and the subdermal implant). These were then compared to rates to non-LARC hormonal methods (depot medroxyprogesterone acetate, oral contraceptive pills, contraceptive patch, and vaginal ring). Eligibility criteria for this analysis included participants who started their baseline chosen method by the 3-month survey. Participants who discontinued their method to attempt conception were censored. We used a Cox proportional hazard model to adjust for confounding and to estimate the hazard ratio for risk of discontinuation. RESULTS: Our analytic sample consisted of 4708 CHOICE participants who met inclusion criteria. Three-year continuation rates were 69.8% for users of the levonorgestrel intrauterine device, 69.7% for copper intrauterine device users, and 56.2% for implant users. At 3 years, continuation was 67.2% among LARC users and 31.0% among non-LARC users (P < .001). After adjustment for age, race, education, socioeconomic status, parity, and history of sexually transmitted infection, the hazard ratio for risk of discontinuation was 3-fold higher among non-LARC method users than LARC users (adjusted hazard ratio, 3.08; 95% confidence interval, 2.80-3.39). CONCLUSION: Three-year continuation of the 2 intrauterine devices approached 70%. Continuation of LARC methods was significantly higher than non-LARC methods.

Association of short-term bleeding and cramping patterns with long-acting reversible contraceptive method satisfaction.

OBJECTIVE: We sought to examine the short-term (3- and 6-month), self-reported bleeding and cramping patterns with intrauterine devices (IUDs) and the contraceptive implant, and the association of these symptoms with method satisfaction. STUDY DESIGN: We analyzed 3- and 6-month survey data from IUD and implant users in the Contraceptive CHOICE Project, a prospective cohort study. Participants who received a long-acting reversible contraceptive (LARC) method (levonorgestrel-releasing intrauterine system [LNG-IUS], copper IUD, or the etonogestrel implant) and completed their 3- and 6-month surveys were included. Univariable and multivariable analyses were performed to examine the association of bleeding and cramping patterns with short-term satisfaction. RESULTS: Our analytic sample included 5011 Contraceptive CHOICE Project participants: 3001 LNG-IUS users, 826 copper IUD users, and 1184 implant users. At 3 months, >65% of LNG-IUS and implant users reported no change or decreased cramping, while 63% of copper IUD users reported increased menstrual cramping. Lighter bleeding was reported by 67% of LNG-IUS users, 58% of implant users, and 8% of copper IUD users. Satisfaction of all LARC methods was high (≥90%). LARC users with increased menstrual cramping (relative risk adjusted [RRadj], 0.78; 95% confidence interval [CI], 0.72-0.85), heavier bleeding (RRadj, 0.83; 95% CI, 0.76-0.92), and increased bleeding frequency (RRadj, 0.73; 95% CI, 0.67-0.80) were less likely to report being very satisfied at 6 months. CONCLUSION: Regardless of the LARC method, satisfaction at 3 and 6 months is very high. Changes in self-reported bleeding and cramping are associated with short-term LARC satisfaction.

The role of contraceptive attributes in women's contraceptive decision making.

OBJECTIVE: Contraceptive methods have differing attributes. Women's preferences for these attributes may influence contraceptive decision making. Our objective was to identify women's contraceptive preferences among women initiating a new contraceptive method. STUDY DESIGN: We conducted a cross-sectional, self-administered survey of women's contraceptive preferences at the time of enrollment into the Contraceptive CHOICE Project. Participants were asked to rank the importance of 15 contraceptive attributes on a 3-point scale (1 = not at all important, 2 = somewhat important, and 3 = very important) and then to rank the 3 attributes that were the most important when choosing a contraceptive method. The survey also contained questions about prior contraceptive experience and barriers to contraceptive use. Information about demographic and reproductive characteristics was collected through the CHOICE Project baseline survey. RESULTS: There were 2590 women who completed the survey. Our sample was racially and socioeconomically diverse. Method attributes with the highest importance score (mean score [SD]) were effectiveness (2.97 [0.18]), safety (2.96 [0.22]), affordability (2.61 [0.61]), whether the method is long lasting (2.58 [0.61]), and whether the method is "forgettable" (2.54 [0.66]). The attributes most likely to be ranked by respondents among the top 3 attributes included effectiveness (84.2%), safety (67.8%), and side effects of the method (44.6%). CONCLUSION: Multiple contraceptive attributes influence decision making and no single attribute drives most women's decisions. Tailoring communication and helping women make complex tradeoffs between attributes can better support their contraceptive decisions and may assist them in making value-consistent choices. This process could improve continuation and satisfaction.

Maternal age and risk of labor and delivery complications.

We utilized an updated nationally representative database to examine associations between maternal age and prevalence of maternal morbidity during complications of labor and delivery. We used hospital inpatient billing data from the 2009 United States Nationwide Inpatient Sample, part of the Healthcare Cost and Utilization Project. To determine whether the likelihood that maternal morbidity during complications of labor and delivery differed among age groups, separate logistic regression models were run for each complication. Age was the main independent variable of interest. In analyses that controlled for demographics and clinical confounders, we found that complications with the highest odds among women, 11-18 years of age, compared to 25-29 year old women, included preterm delivery, chorioamnionitis, endometritis, and mild preeclampsia. Pregnant women who were 15-19 years old had greater odds for severe preeclampsia, eclampsia, postpartum hemorrhage, poor fetal growth, and fetal distress. Pregnant women who were ≥35 years old had greater odds for preterm delivery, hypertension, superimposed preeclampsia, severe preeclampsia, and decreased risk for chorioamnionitis. Older women (≥40 years old) had increased odds for mild preeclampsia, fetal distress, and poor fetal growth. Our findings underscore the need for pregnant women to be aware of the risks associated with extremes of age so that they can watch for signs and symptoms of such complications.

Fertility after intrauterine device removal: a pilot study.

BACKGROUND: Despite high efficacy, only 7.7% of women in the United States currently using contraception use an IUD. There is little published contemporary data about fertility rates after IUD use, especially in nulliparous women and women using the hormonal IUD. STUDY DESIGN: We recruited sexually active women 18 to 35 years of age enrolled in the Contraceptive CHOICE Project who had discontinued a contraceptive method and desired pregnancy. RESULTS: In this pilot project, we enrolled 69 former IUD users (19 copper and 50 levonorgestrel) and 42 former non-IUD users. Pregnancy rates at 12 months were similar between the two groups; 81% of IUD users became pregnant compared to 70% of non-IUD users (p = 0.18). In the Cox model, there was no difference in the time to pregnancy in IUD users compared to non-IUD users (HRadj 1.19, 95% CI 0.74-1.92). African American race was the only variable associated with reduced fertility (HRadj 0.40, 95% CI 0.24-0.67). CONCLUSIONS: We found no difference in 12-month pregnancy rates or time to pregnancy between former IUD users and users of other contraceptive methods. However, there was a clinically and statistically significant reduction in fertility in African American women.

The Human Microbiome Project strategy for comprehensive sampling of the human microbiome and why it matters.

The Human Microbiome Project used rigorous good clinical practice standards to complete comprehensive body site sampling in healthy 18- to 40-yr-old adults, creating an unparalleled reference set of microbiome specimens. To ensure that specimens represented minimally perturbed microbiomes, we first screened potential participants using exclusion criteria based on health history, including the presence of systemic diseases (e.g., hypertension, cancer, or immunodeficiency or autoimmune disorders), use of potential immunomodulators, and recent use of antibiotics or probiotics. Subsequent physical examinations excluded individuals based on body mass index (BMI), cutaneous lesions, and oral health. We screened 554 individuals to enroll 300 (149 men and 151 women, mean age 26 yr, mean BMI 24 kg/m, 20.0% racial minority, and 10.7% Hispanic). We obtained specimens from the oral cavity, nares, skin, gastrointestinal tract, and vagina (15 specimens from men and 18 from women). The study evaluated longitudinal changes in an individual's microbiome by sampling 279 participants twice (mean 212 d after the first sampling; range 30-359 d) and 100 individuals 3 times (mean 72 d after the second sampling; range 30-224 d). This sampling strategy yielded 11,174 primary specimens, from which 12,479 DNA samples were submitted to 4 centers for metagenomic sequencing. Our clinical design and well-defined reference cohort has laid a foundation for microbiome research.

Medical contraindications in women seeking combined hormonal contraception.

OBJECTIVE: The objective of the study was to evaluate the prevalence of medical contraindications in a large group of women seeking combined hormonal contraception (CHC). STUDY DESIGN: The Contraceptive CHOICE Project is a prospective cohort study designed to promote the use of long-acting reversible contraceptive methods to reduce unintended pregnancies in the St Louis region. During baseline enrollment, participants were asked about their desired methods of contraception and medical history. Potential medical contraindications were defined as self-reported history of hypertension, myocardial infarction, cerebral vascular accidents, migraines with aura, any migraine and age 35 years or older, smoking in women older than 35 years, venous thromboembolism, or liver disease. We reviewed all research charts of women with self-reported medical contraindications to verify all conditions. Binomial 95% confidence intervals (CIs) were calculated around percentages. RESULTS: Between August 2007 and December 2009, 5087 women who enrolled in the CHOICE Project provided information about their medical history and 1010 women (19.9%) desired CHC at baseline. Seventy women (6.93%; 95% CI, 5.44-8.68%) were defined as having a potential medical contraindication to CHC at baseline. After chart review, only 24 of 1010 participants desiring CHC (2.38%; 95% CI, 1.53-3.52%) were found to have true medical contraindications to CHC including 17 with hypertension, 2 with migraines with aura, 2 with a history of venous thromboembolism, and 3 smokers aged 35 years or older. CONCLUSION: The prevalence of medical contraindications to CHC was very low in this large sample of reproductive-aged women. This low prevalence supports provision of CHC without a prescription.

The contraceptive CHOICE project round up: what we did and what we learned.

The Contraceptive CHOICE Project was a prospective cohort study of 9256 women in the St Louis area. The project provided no-cost reversible contraception to participants for 2 to 3 years with the goal of increasing uptake of long-acting reversible contraception and decreasing unintended pregnancy in the area. This manuscript will provide a brief summation of the major findings to date including the dramatic effect the project had on unintended pregnancy and abortion rates.

Does the shape of the copper intrauterine device play a role in expulsion? Results from the ongoing European Active Surveillance Study on LCS12.

OBJECTIVE: To compare the incidence of expulsion for different copper intrauterine device (IUD) shapes. STUDY DESIGN: We conducted a secondary analysis of the ongoing, prospective, non-interventional European Active Surveillance Study on LCS12 (EURAS-LCS12). Users of newly inserted IUDs were recruited in 10 European countries via a network of approximately 1200 clinicians. We restricted the analysis to copper IUD users. In the main analysis, we classified copper IUDs by shape [Nova-T frame, Tatum-T frame, Multiload frame, frameless IUDs and intrauterine balls], without differentiation of size. We calculated the cumulative incidence, crude, and adjusted hazard ratios for expulsion. Covariates included in the adjusted analyses were age, BMI, parity, education, income, IUD user status, marital status, length of device, heavy menstrual bleeding, and clinician's experience. RESULTS: We included 26,381 copper IUD users from the EURAS-LCS12 dataset for this study. The most frequently used IUD shape was the Nova-T frame (14,724 [55.8%]) followed by the Tatum-T frame (4276 [16.2%]), frameless IUDs (3374 [12.8%]), Multiload frame (2962 [11.2%]), and intrauterine balls (IUBs) (1045 [4.0%]). Cox regression analysis regarding expulsions yielded an adjusted hazard ratio of 0.8 (95% CI, 0.7-1.0), 1.3 (95% CI, 1.0-1.8), 1.6 (95% CI, 1.2-2.1) and 3.6 (95% CI, 2.7-4.9) for Nova-T frame IUD, frameless IUDs, Multiload frame IUDs and IUBs versus Tatum-T frame IUD, respectively. CONCLUSION: The risk of expulsion following placement of a copper IUD is related to IUD shape, with Nova-T frame and Tatum-T frame IUDs demonstrating the lowest risk. IMPLICATIONS: Our finding of a higher risk of expulsion observed with Multiload frame, frameless, and intrauterine ball copper IUDs compared to Tatum-T frame and Nova-T frame devices during real world use has clinical importance. Clinicians may choose to use these data when counseling patients.