Search

Objectives To assess whether clinical skills training in cervical dilation and paracervical anesthesia, as well as the introduction of a clinical protocol for difficult insertions, increased intrauterine device (IUD) insertion success rates among advanced practice clinicians (APCs) including women's health and family practice nurse practitioners, physician assistants and certified nurse midwives. Study design This prospective study assessed an intervention to improve IUD insertions among APCs at six family planning clinics in Utah. We collected data on IUD insertions performed by participating clinicians during two observation phases: preintervention (Phase 1) and postintervention (Phase 2). Using electronic medical records, we tracked patient characteristics, IUD insertion success, difficulties and failures. We constructed a mixed-effects logistic regression model to control for provider and patient demographics influencing insertion success rates. Results Nine clinicians participated in both preintervention and postintervention phases. The analysis included 428 IUD insertion procedures (242 preintervention and 186 postintervention). During Phase 1, 31/242 (12.8%) insertions failed. Insertion rates in Phase 2 improved with only 8/186 (4.3%) failures. Using mixed-effects logistic regression, the odds of a successful insertion postintervention was 4.8 times greater than preintervention (aOR = 4.8.95% CI 1.8–12.7) when controlling for provider and patient characteristics. Increased risk of insertion failure was associated with nulliparity and younger age during Phase 1, but not during Phase 2. Conclusions A brief training for APCs and the use of a clinical protocol for difficult insertions may be able to improve IUD insertion rates. Implications Clinics with high rates of IUD insertion failure can improve care with a simple intervention, which may yield significant benefits in IUD service delivery.

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.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.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) and110% 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 χAmong 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.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.

To compare preference for long-acting contraception (LARC) and subsequent use, year-long continuation, and pregnancy among women after induced abortion who were and were not eligible to participate in a specialized funding program that provided LARC at no cost. Between October 2014 and March 2016, we conducted a prospective study of abortion patients at Planned Parenthood in Austin, Texas (located in Travis County). We compared our primary outcome of interest, postabortion LARC use, among women who were eligible for the specialized funding program (low-income, uninsured, Travis County residents) and two groups who were ineligible (low-income, uninsured, non–Travis County residents, and higher income or insured women). Secondary outcomes of interest included preabortion preference for LARC and 1-year continuation and pregnancy rates among the three groups. Among 518 women, preabortion preference for LARC was high among all three groups (low-income eligible: 64% [91/143]; low-income ineligible: 44% [49/112]; and higher income 55% [146/263]). However, low-income eligible participants were more likely to receive LARC (65% [93/143] compared with 5% [6/112] and 24% [62/263], respectively, P

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.

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.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.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).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.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.

Study question Does the efficacy of placing a copper intrauterine device (IUD) for emergency contraception (EC) to prevent pregnancy depend on menstrual cycle timing and timing of unprotected intercourse (UPI)? Summary answer If the urine pregnancy test is negative prior to IUD placement, the copper IUD is highly effective for EC at any point in the menstrual cycle. What is known already The use of the Copper T380A for EC has been encouraged by the failure of oral EC methods to decrease rates of unintended pregnancy and the documented success of the IUD in reducing unintended pregnancies. However scant data exist regarding the efficacy and safety of IUD insertion for EC when accounting for menstrual cycle timing and time since UPI. Study design, size, duration This is a secondary analysis of data obtained from a previously published prospective cohort study of women who received the Copper T380A IUD for EC between July 1997 and January 2000. We included 1840 participants according to the study inclusion criteria of a known last menstrual period (LMP) and cycle lengths of 25-35 days. Participants/materials, setting, methods The original study included women aged between 18 and 44 years who presented for EC at 18 sites throughout China and who had regular menstrual cycles between 24 and 42 days, a known LMP, UPI within 120 h (5 days) and a negative urine pregnancy test (cutoff Main results and the role of chance Among the 1840 participants with usual cycle lengths of 25-35 days, 850 (46.2%) had their IUD inserted following UPI in the expected fertile window and 84 (4.6%) had the insertion >5 days after the predicted ovulation day and 52 (2.8%) had the insertion >5 days after UPI. There were no pregnancies in the first month among the 1771 women who had information available regarding their 1-month follow-up pregnancy test. Limitations, reasons for caution This was a secondary analysis of an observational study, and thus participants were not randomized to an alternative postcoital method. There were a small number of women who had UPI >5 days after their predicted ovulation day thus limiting the confidence of assuring a low risk of pregnancy in this situation. The ovulation day was calculated based on the LMP prior to IUD insertion and not on the subsequent first day of menses following IUD insertion. Wider implications of the findings If the urine pregnancy test is negative prior to IUD placement, the copper IUD is likely to be effective for EC at almost any point in the menstrual cycle. Study funding/competing interest(s) The original study was funded by the UNDP/UNPFA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. The donors and sponsors of the study had no role in the study design, data collection, data analysis, data interpretation, writing of the report or the decision to submit the paper for publication.

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.

OBJECTIVES: To estimate the effects of self-administered misoprostol compared with placebo before intrauterine device (IUD) insertion in nulliparous women. METHOD: Nulliparous women requesting either the copper T380A or levonorgestrel IUD were randomized to self-administer either 400 mug of misoprostol or placebo (vaginally or buccally) 3-4 hours before the IUD insertion appointment. The primary outcome was health care provider-perceived ease of insertion recorded on a visual analog scale (anchors: 0 extremely easy 100 impossible). Patients completed questionnaires addressing pain using a validated visual analog scale (anchors: 0 none 100 worst imaginable) before insertion immediately postinsertion and before clinic discharge. RESULTS: Of the 108 women enrolled in the study 54 received misoprostol and 54 received placebo. There was no significant difference in perceived ease of insertion between the two groups (25.0 mm [standard error 3.5] compared with 27.4 mm [standard error 3.5] P=.64). Patients who received misoprostol before IUD insertion had significantly higher pain scores before placement (17.1 mm [standard error 3.5] compared with 4.7 mm [standard error 2.0] P=.003). Groups did not differ in perception of pain during IUD insertion (58.4 mm [standard error 3.3] compared with 56.9 mm [standard error 3.0] P=.74). There were two expulsions in the misoprostol group and none in the placebo group. Failed insertions need for adjuvant pain medication and need for cervical dilation or ultrasonographic guidance did not differ between the two groups. CONCLUSION: Self-administered misoprostol before IUD insertion does not ease IUD insertion or reduce patient-perceived pain in nulliparous women. These data do not support the routine use of misoprostol before IUD insertion in nulliparous women. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov www.clinicaltrials.gov NCT00886834. LEVEL OF EVIDENCE: I.