Jessica N. Sanders

Preference for and efficacy of oral levonorgestrel for emergency contraception with concomitant placement of a levonorgestrel IUD: a prospective cohort study

OBJECTIVES We assessed intrauterine device (IUD) preference among women presenting for emergency contraception (EC) and the probability of pregnancy among concurrent oral levonorgestrel (LNG) plus LNG 52 mg IUD EC users. METHODS We offered women presenting for EC at a single family planning clinic the CuT380A IUD (copper IUD) or oral LNG 1.5 mg plus the LNG 52 mg IUD. Two weeks after IUD insertion, participants reported the results of a self-administered home urine pregnancy test. The primary outcome, EC failure, was defined as pregnancies resulting from intercourse occurring within five days prior to IUD insertion. RESULTS One hundred eighty-eight women enrolled and provided information regarding their current menstrual cycle and recent unprotected intercourse. Sixty-seven (36%) chose the copper IUD and 121 (64%) chose oral LNG plus the LNG IUD. The probability of pregnancy two weeks after oral LNG plus LNG IUD EC use was 0.9% (95% CI 0.0-5.1%). The only positive pregnancy test after treatment occurred in a woman who received oral LNG plus the LNG IUD and who had reported multiple episodes of unprotected intercourse including an episode more than 5 days prior to treatment. CONCLUSIONS Study participants seeking EC who desired an IUD preferentially chose oral LNG 1.5 mg with the LNG 52 mg IUD over the copper IUD. Neither group had EC treatment failures. Including the option of oral LNG 1.5 mg with concomitant insertion of the LNG 52 mg IUD in EC counseling may increase the number of EC users who opt to initiate highly effective reversible contraception. IMPLICATIONS Consideration should be given to LNG IUD insertion with concomitant use of oral LNG 1.5 mg for EC. Use of this combination may increase the number of women initiating highly effective contraception at the time of their EC visit.

Immediate postpartum intrauterine device and implant program outcomes: a prospective analysis.

BACKGROUND: In‐hospital placement of intrauterine devices and contraceptive implants following vaginal and cesarean delivery is increasingly popular and responds to maternal motivation for highly effective postpartum contraception. Immediate postpartum intrauterine device insertion is associated with higher expulsion than interval placement, but emerging evidence suggests that the levonorgestrel intrauterine device may have a higher expulsion rate than the copper intrauterine device. OBJECTIVE: This study evaluated in‐hospital provision, expulsion, and 6‐month continuation of immediate postpartum copper T380 intrauterine devices, levonorgestrel intrauterine devices, and contraceptive implants. STUDY DESIGN: We offered enrollment in this prospective observational trial to women presenting to the University of Utah labor and delivery unit from October 2013 through February 2016 who requested an intrauterine device or implant for postpartum contraception during prenatal care or hospitalization at the time of delivery. Following informed consent, participants completed questionnaires prior to hospital discharge and at 3 and 6 months postpartum. Data on expulsions at 6 months were validated by chart abstraction. RESULTS: During the study period, 639 patients requested a postpartum intrauterine device or implant and 350 patients enrolled in prospective follow‐up prior to discharge from the hospital. Among enrollees, 325 (93%) received their preferred contraceptive device prior to hospital discharge: 88 (27%) copper intrauterine device users, 123 (38%) levonorgestrel intrauterine device users, and 114 (35%) implant users. Participants predominantly were Hispanic (90%), were multiparous (87%), reported a household income <

The intimate link: a systematic review of highly effective reversible contraception and women's sexual experience.

24,000 per year (87%), and underwent a vaginal delivery (77%). At 6 months postpartum, 289 of 325 device recipients (89%) completed follow‐up. Among levonorgestrel intrauterine device users 17% reported expulsions relative to 4% of copper intrauterine device users. The adjusted hazard ratio for expulsion was 5.8 (confidence interval, 1.3–26.4). There was no statistically significant difference in expulsions by delivery type or continuation by device type. Among the 21 women who experienced intrauterine device expulsions, 14 (67%) requested a replacement long‐acting reversible contraception device for contraception. The 6‐month device continuation was ≥80% for all device types. CONCLUSION: An immediate postpartum long‐acting reversible contraception program effectively provides women who desire highly effective reversible contraceptive devices with their method of choice prior to hospital discharge. Immediate postplacental levonorgestrel intrauterine device users have higher expulsion rates than copper intrauterine device users, but >8 of 10 women initiating an intrauterine device or implant continue use at 6 months postpartum.

Two-year continuation of intrauterine devices and contraceptive implants in a mixed-payer setting: A retrospective review.

Contraception is expressly designed for nonprocreative sexual activity, but we know little about how methods shape women’s sexual experience. To systematically review the literature on highly effective reversible contraception (HERC) and sexual experiences. MEDLINE, SCOPUS, and Google Scholar were searched for relevant literature. Eleven studies met the inclusion criteria; all were conducted outside of the United States. All studies reviewed found either improvements or no change in sexual experience and function outcomes with HERC use. A need exists for more prospective studies with a wider range of measures to assess HERC methods’ impact on women’s sexual experiences.

Evaluation of an intervention designed to improve the management of difficult IUD insertions by advanced practice clinicians

BACKGROUND: As the popularity of long‐acting reversible contraception increases, so does the need for accurate data on method continuation in diverse clinical settings. We determined 2‐year continuation rates for the levonorgestrel 52‐mg intrauterine device, the copper T380A intrauterine device, and the 68‐mg etonogestrel contraceptive implant in an academic healthcare system with mixed‐payer reimbursement. OBJECTIVE: The purpose of this study was to examine the proportion and characteristics of women who continue intrauterine device and implant use to 2 years and to relate continuation to device type when controlling for patient characteristics. STUDY DESIGN: This retrospective chart review assessed University of Utah Healthcare System patients who had an intrauterine device or contraceptive implant inserted between January 1, 2004, and December 31, 2012. We identified users and dates of insertions and removals by querying billing, medication, and procedural data in the Electronic Data Warehouse. Multivariable Poisson regression was conducted to estimate incidence risk ratios and to relate the probability of 2‐year continuous use to device type. RESULTS: Data on 8603 device insertions were obtained with the following distribution: levonorgestrel 52‐mg intrauterine devices (6459; 75.1%), copper T380A intrauterine devices (1136; 13.2%), and 68‐mg etonogestrel implant (1008; 11.7%). Two‐year continuation rates were 77.8%, 73.1%, and 75.9%, respectively. There was no statistical difference in 2‐year continuation between levonorgestrel 52‐mg intrauterine device users (adjusted risk ratio, 1.1; 95% confidence interval, 1.0–1.1) and 68‐mg etonogestrel implant users (adjusted risk ratio, 1.1; 95% confidence interval, 1.0–1.1) compared with copper device users, after we controlled for age, Hispanic ethnicity, payer type, and year of insertion. Older‐age, self‐pay, or public payer insurance (reference commercial payer) and Hispanic ethnicity were associated with 2‐year continuation. CONCLUSION: Three‐quarters of women with an intrauterine device or implant continue using it for 2 years. In this cohort, the 2‐year continuation rates were 77.8%, 73.1%, and 75.9% for the levonorgestrel 52‐mg intrauterine device, copper T380A intrauterine device, and 68‐mg etonogestrel implant, respectively.

Removal of the LNG IUD when strings are not visible: a case series ☆ ☆☆

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 womens 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.

One-year continuation of copper or levonorgestrel intrauterine devices initiated at the time of emergency contraception

OBJECTIVES To report length of intrauterine device (IUD) and strings as well as technique for extraction when IUD removal occurs without visible strings. STUDY DESIGN A prospective case series of 29 women who had IUDs removed in-office when strings were not visible at the external cervical os. RESULTS One third (n=11) were found to have a total length of IUD and strings <7.5 cm. All IUD removals were successfully performed as outpatient procedures. CONCLUSION Removal of IUDs without visible strings can be successfully done as an in-office procedure. IMPLICATIONS In-office removal of IUDs without visible strings is effective, safe and economically sound.

Immediate postpartum levonorgestrel intrauterine device insertion and breast-feeding outcomes: a noninferiority randomized controlled trial

OBJECTIVE(S) This study compares 1-year intrauterine device (IUD) continuation among women presenting for emergency contraception (EC) and initiating the copper (Cu T380A) IUD or the levonorgestrel (LNG) 52 mg IUD plus 1.5 mg oral LNG. STUDY DESIGN This cohort study enrolled 188 women who presented at a single family planning clinic in Utah between June 2013 and September 2014 and selected either the Cu T380A IUD or LNG 52 mg IUD plus oral LNG for EC. Trained personnel followed participants by phone, text or e-mail for 12 months or until discontinuation occurred. We assessed reasons for discontinuation and used Cox proportional hazard models, Kaplan-Meier estimates and log-rank tests to assess differences in continuation rates between IUDs. RESULTS One hundred seventy-six women received IUDs; 66 (37%) chose the Cu T380A IUD and 110 (63%) chose the LNG 52 mg IUD plus oral LNG. At 1 year, we accounted for 147 (84%) participants, 33 (22%) had requested removals, 13 (9%) had an expulsion and declined reinsertion, 3 (2%) had a pregnancy with their IUD in place and 98 (67%) were still using their device. Continuation rates did not differ by IUD type; 60% of Cu T380A IUD users and 70% of LNG 52 mg IUD plus oral LNG users were still using their device at 12 months (adjusted hazard ratio 0.72, 95% confidence interval 0.40-1.3). CONCLUSION(S) Two-thirds of women who chose IUD placement at the EC clinical encounter continued use at 1 year. Women initiating Cu T380A IUD and LNG 52 mg IUD had similar 1-year continuation rates. These findings support same-day insertion of IUDs for women who are seeking EC and would like to use a highly effective reversible method going forward. IMPLICATIONS Providing IUD options for EC users presents an opportunity to increase availability of highly effective contraception.

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

Background Immediate postpartum levonorgestrel intrauterine device insertion is increasing in frequency in the United States, but few studies have investigated the effect of early placement on breast‐feeding outcomes. Objective This study examined the effect of immediate vs delayed postpartum levonorgestrel intrauterine device insertion on breast‐feeding outcomes. Study Design We conducted this noninferiority randomized controlled trial at the University of Utah and the University of New Mexico Health Sciences Centers from February 2014 through March 2016. Eligible women were pregnant and planned to breast‐feed, spoke English or Spanish, were aged 18‐40 years, and desired a levonorgestrel intrauterine device. Enrolled women were randomized 1:1 to immediate postpartum insertion or delayed insertion at 4‐12 weeks’ postpartum. Prespecified exclusion criteria included delivery <37.0 weeks’ gestational age, chorioamnionitis, postpartum hemorrhage, contraindications to levonorgestrel intrauterine device insertion, and medical complications of pregnancy that could affect breast‐feeding. We conducted per‐protocol analysis as the primary approach, as it is considered the standard for noninferiority studies; we also report the alternative intent‐to‐treat analysis. We powered the study for the primary outcome, breast‐feeding continuation at 8 weeks, to detect a 15% noninferiority margin between groups, requiring 132 participants in each arm. The secondary study outcome, time to lactogenesis, used a validated measure, and was analyzed by survival analysis and log rank test. We followed up participants for ongoing data collection for 6 months. Only the data analysis team was blinded to the intervention. Results We met the enrollment target with 319 participants, but lost 34 prior to randomization and excluded an additional 26 for medical complications prior to delivery. The final analytic sample included 132 in the immediate group and 127 in the delayed group. Report of any breast‐feeding at 8 weeks in the immediate group (79%; 95% confidence interval, 70–86%) was noninferior to that of the delayed group (84%; 95% confidence interval, 76–91%). The 5% difference in breast‐feeding continuation at 8 weeks between the groups fell within the noninferiority margin (95% confidence interval, –5.6 to 15%). Time to lactogenesis (mean ± SD) in the immediate group, 65.3 ± 25.7 hours, was noninferior to that of the delayed group, 63.6 ± 21.6 hours. The mean difference between groups was 1.7 hours (95% confidence interval, –4.8 to 8.2 hours), noninferior by log‐rank test. A total of 24 intrauterine device expulsions occurred in the immediate group compared to 2 in the delayed group (19% vs 2%, P < .001), consistent with the known higher expulsion rate with immediate vs delayed postpartum intrauterine device insertion. No intrauterine device perforations occurred in either group. Conclusion Our results of noninferior breast‐feeding outcomes between women with immediate and delayed postpartum levonorgestrel intrauterine device insertion suggest that immediate postpartum intrauterine device insertion is an acceptable option for women planning to breast‐feed and use the levonorgestrel intrauterine device. Expulsion rates are higher with immediate postpartum levonorgestrel intrauterine device insertion compared to delayed insertion, but this disadvantage may be outweighed by the advantages of immediate initiation of contraception. Providers should offer immediate postpartum intrauterine device insertion to breast‐feeding women planning to use the levonorgestrel intrauterine device.

Contraceptive method use during the community-wide HER salt lake contraceptive initiative

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 womans 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.