Not seeking yet trying long-acting reversible contraception: a 24-month randomized trial on continuation, unintended pregnancy and satisfaction.

OBJECTIVES: To measure the 24-month impact on continuation, unintended pregnancy and satisfaction of trying long-acting reversible contraception (LARC) in a population seeking short-acting reversible contraception (SARC). STUDY DESIGN: We enrolled 916 women aged 18-29 who were seeking pills or injectables in a partially randomized patient preference trial. Women with strong preferences for pills or injectables started on those products, while others opted for randomization to LARC or SARC and received their methods gratis. We estimated continuation and unintended pregnancy rates through 24months. Intent-to-treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also examined how satisfaction levels varied by cohort and how baseline negative LARC attitudes were associated with satisfaction over time. RESULTS: Forty-three percent chose randomization, and 57% chose the preference option. Complete loss to follow-up was<2%. The 24-month LARC continuation probability was 64.3% [95% confidence interval (CI): 56.6-70.9], statistically higher than SARC groups [25.5% (randomized) and 40.0% (preference)]. The 24-month cumulative unintended pregnancy probabilities were 9.9% (95% CI: 7.2-12.6) (preference-SARC), 6.9% (95% CI: 3.3-10.6) (randomized-SARC) and 3.6% (95% CI: 1.8-6.4) (randomized-LARC). Statistical tests for comparing randomized groups on unintended pregnancy were mixed: binomial at 24-month time point (p=.02) and log-rank survival probabilities (p=.14 for first pregnancies and p=.07 when including second pregnancies). LARC satisfaction was high (80% happy/neutral, 73% would use LARC again, 81% would recommend to a friend). Baseline negative attitudes toward LARC (27%) were not clearly associated with satisfaction or early discontinuation. CONCLUSIONS: The decision to try LARC resulted in high continuation rates and substantial protection from unintended pregnancy over 24months. Despite participants' initial desires to begin short-acting regimens, they had high satisfaction with LARC. Voluntary decisions to try LARC will benefit large proportions of typical SARC users. IMPLICATIONS: Even women who do not necessarily view LARC as a first choice may have a highly satisfying experience and avoid unintended pregnancy if they try it.

Long-acting reversible contraceptive acceptability and unintended pregnancy among women presenting for short-acting methods: a randomized patient preference trial.

BACKGROUND: Measures of contraceptive effectiveness combine technology and user-related factors. Observational studies show higher effectiveness of long-acting reversible contraception compared with short-acting reversible contraception. Women who choose long-acting reversible contraception may differ in key ways from women who choose short-acting reversible contraception, and it may be these differences that are responsible for the high effectiveness of long-acting reversible contraception. Wider use of long-acting reversible contraception is recommended, but scientific evidence of acceptability and successful use is lacking in a population that typically opts for short-acting methods. OBJECTIVE: The objective of the study was to reduce bias in measuring contraceptive effectiveness and better isolate the independent role that long-acting reversible contraception has in preventing unintended pregnancy relative to short-acting reversible contraception. STUDY DESIGN: We conducted a partially randomized patient preference trial and recruited women aged 18-29 years who were seeking a short-acting method (pills or injectable). Participants who agreed to randomization were assigned to 1 of 2 categories: long-acting reversible contraception or short-acting reversible contraception. Women who declined randomization but agreed to follow-up in the observational cohort chose their preferred method. Under randomization, participants chose a specific method in the category and received it for free, whereas participants in the preference cohort paid for the contraception in their usual fashion. Participants were followed up prospectively to measure primary outcomes of method continuation and unintended pregnancy at 12 months. Kaplan-Meier techniques were used to estimate method continuation probabilities. Intent-to-treat principles were applied after method initiation for comparing incidence of unintended pregnancy. We also measured acceptability in terms of level of happiness with the products. RESULTS: Of the 916 participants, 43% chose randomization and 57% chose the preference option. Complete loss to follow-up at 12 months was <2%. The 12-month method continuation probabilities were 63.3% (95% confidence interval, 58.9-67.3) (preference short-acting reversible contraception), 53.0% (95% confidence interval, 45.7-59.8) (randomized short-acting reversible contraception), and 77.8% (95% confidence interval, 71.0-83.2) (randomized long-acting reversible contraception) (P < .001 in the primary comparison involving randomized groups). The 12-month cumulative unintended pregnancy probabilities were 6.4% (95% confidence interval, 4.1-8.7) (preference short-acting reversible contraception), 7.7% (95% confidence interval, 3.3-12.1) (randomized short-acting reversible contraception), and 0.7% (95% confidence interval, 0.0-4.7) (randomized long-acting reversible contraception) (P = .01 when comparing randomized groups). In the secondary comparisons involving only short-acting reversible contraception users, the continuation probability was higher in the preference group compared with the randomized group (P = .04). However, the short-acting reversible contraception randomized group and short-acting reversible contraception preference group had statistically equivalent rates of unintended pregnancy (P = .77). Seventy-eight percent of randomized long-acting reversible contraception users were happy/neutral with their initial method, compared with 89% of randomized short-acting reversible contraception users (P < .05). However, among method continuers at 12 months, all groups were equally happy/neutral (>90%). CONCLUSION: Even in a typical population of women who presented to initiate or continue short-acting reversible contraception, long-acting reversible contraception proved highly acceptable. One year after initiation, women randomized to long-acting reversible contraception had high continuation rates and consequently experienced superior protection from unintended pregnancy compared with women using short-acting reversible contraception; these findings are attributable to the initial technology and not underlying factors that often bias observational estimates of effectiveness. The similarly patterned experiences of the 2 short-acting reversible contraception cohorts provide a bridge of generalizability between the randomized group and usual-care preference group. Benefits of increased voluntary uptake of long-acting reversible contraception may extend to wider populations than previously thought.

Rationale and enrollment results for a partially randomized patient preference trial to compare continuation rates of short-acting and long-acting reversible contraception.

OBJECTIVES: Most published contraceptive continuation rates have scientific limitations and cannot be compared; this is particularly true for dissimilar contraceptives. This study uses a new approach to determine if high continuation rates of long-acting reversible contraception (LARC) and protection from unintended pregnancy are observable in a population not self-selecting to use LARC. STUDY DESIGN: We are conducting a partially randomized patient preference trial (PRPPT) to compare continuation rates of short-acting reversible contraception (SARC) and LARC. Only women seeking SARC were invited to participate. Participants chose to be in the preference cohort (self-selected method use) or opted to be randomized to SARC or LARC; only those in the randomized cohort received free product. We compared participant characteristics, reasons for not trying LARC previously and the contraceptive choices that were made. RESULTS: We enrolled 917 eligible women; 57% chose to be in the preference cohort and 43% opted for the randomized trial. The preference and randomized cohorts were similar on most factors. However, the randomized cohort was more likely than the preference cohort to be uninsured (48% versus 36%, respectively) and to cite cost as a reason for not trying LARC previously (50% versus 10%) (p<.01 for both comparisons). In the preference cohort, fear of pain/injury/side effects/health risks were the predominant reasons (cited by over 25%) for not trying LARC previously (p<.01 in comparison to randomized cohort). CONCLUSIONS: Enrollment was successful and the process created different cohorts to compare contraceptive continuation rates and unintended pregnancy in this ongoing trial. The choices participants made were associated with numerous factors; lack of insurance was associated with participation in the randomized trial. IMPLICATIONS: This PRPPT will provide new estimates of contraceptive continuation rates, such that any benefits of LARC will be more easily attributable to the technology and not the user. Combined with measuring level of satisfaction with LARC, the results will help project the potential role and benefits of expanding voluntary use of LARC.

Pregnancy success after hysteroscopic sterilization reversal.

OBJECTIVE: To evaluate the effectiveness of hysteroscopic sterilization reversal by assessing pregnancy rates and identifying surgical complications. METHODS: All patients at a single center undergoing elective reversal of hysteroscopic sterilization for fertility were followed from January 2009 to May 2014. Eligible patients met prespecified criteria for outpatient surgery. Patients underwent outpatient reversal using a transverse suprapubic abdominal incision with tubouterine implantation performed with either bilateral cornual or single transverse posterior-fundal uterine incisions. Patients were evaluated on postoperative day 1, called the following day, and e-mailed at 2 weeks and 12 months. Pregnancy outcomes were assessed through a 12-month questionnaire and self-reporting using an Internet-based patient portal. Univariate analysis of patient and operative characteristics was performed. RESULTS: Seventy patients underwent bilateral tubouterine implantation and completed at least 12 months of follow-up. All surgeries were outpatient without any immediate operative complications. Four patients had complications between 2 and 30 days, none requiring extended hospitalization. Women who became pregnant were younger (mean age 34 years) than those who did not become pregnant (mean age 38 years). Twenty-five patients (36%, 95% confidence interval [CI] 25-47%) reported a total of 31 naturally conceived pregnancies. Twenty-seven percent (19/70, 95% CI 17-37%) of those undergoing surgery subsequently reported live births. A single pregnancy complication of postpartum hemorrhage after cesarean delivery requiring transfusion was reported; no ectopic pregnancies were reported. CONCLUSION: Hysteroscopic sterilization can be reversed using tubouterine implantation and both pregnancy and live birth rates are promising.

Successful pregnancies after removal of intratubal microinserts.

BACKGROUND: Patients with intratubal microinsert sterilization later may request reversal. CASE: Each patient underwent mini-laparotomy and removal of intratubal microinserts. One patient underwent unilateral tubotubal anastomosis and unilateral tubouterine implantation through a cornual uterine incision. The other patient underwent bilateral tubouterine implantation through a posterior transfundal uterine incision. The first patient became pregnant 4 months after surgery, had an uncomplicated pregnancy, and underwent an elective cesarean delivery at term. The second patient became pregnant 8 months after surgery and had a pregnancy complicated by unexplained abdominal pain at 34 weeks of gestation that resulted in early cesarean delivery. CONCLUSION: Proximal tubal occlusion from intratubal microinserts can be corrected surgically and can provide patients an alternative to in vitro fertilization.

Normal pregnancy after outpatient tubouterine implantation in patient with Adiana sterilization.

OBJECTIVE: To demonstrate the feasibility of outpatient correction of Adiana proximal tubal occlusion by surgical implantation of the fallopian tubes. DESIGN: Case study. SETTING: Outpatient surgical center. PATIENT(S): A 36-year-old woman with a history of bilateral proximal tubal occlusion secondary to Adiana sterilization who desired surgical correction and natural conception. INTERVENTION(S): Outpatient surgical correction of proximal Adiana tubal occlusion by use of a minilaparotomy to perform bilateral tubouterine implantation. MAIN OUTCOME MEASURE(S): Natural conception of pregnancy. RESULT(S): The patient underwent a successful outpatient bilateral tubouterine implantation to correct Adiana sterilization. The procedure was performed through a minilaparotomy abdominal incision by use of a posterior transfundal uterine incision to implant the isthmic sections of each tube into the uterine cavity. The patient's postoperative course was uncomplicated. Natural conceptions occurred at 6 and 9 months after surgery. The first pregnancy was of unknown location and aborted spontaneously. The second pregnancy was uncomplicated and was delivered at 39 weeks' gestation by elective cesarean delivery. CONCLUSION(S): Adiana hysteroscopic tubal occlusion can be surgically corrected in an outpatient setting through tubouterine implantation and this surgical technique can provide patients with an alternative to in vitro fertilization.

Impact of increased access to emergency contraceptive pills: a randomized controlled trial.

OBJECTIVE: To assess how a strategy to maximize access to emergency contraceptive pills would affect rates of pregnancy and sexually transmitted infections. METHODS: Sexually active women, 14-24 years old, were randomly assigned to two methods of access to emergency contraceptive pills: increased access (two packages of pills dispensed in advance with unlimited resupply at no charge) or standard access (pills dispensed when needed at usual charges). Participants were followed for 1 year to assess incidence of pregnancy, gonorrhea, chlamydia, and trichomonas. RESULTS: The numbers of women enrolled in the increased and standard access groups were 746 and 744, respectively. More than 93% of participants completed a full year of follow-up. The incidence of pregnancy was similar in both groups (increased access group: 9.9/100 woman years, 95% confidence interval [CI] 7.7-12.6; standard access group: 10.5/100 woman years, 95% CI 8.2-13.2). Aggregate rates of gonorrhea, chlamydia, and trichomonas were also similar in the two groups (increased access group: 6.9/100 woman years, 95% CI 5.1-9.1; standard access group: 7.6/100 woman years, 95% CI 5.7-9.9). The increased access group used emergency contraceptive pills substantially more often and sooner after coitus than the standard access group. No other differences were noted between groups in self-reported measures of sexual behavior and contraceptive use. CONCLUSION: This intensive strategy to enhance access to emergency contraceptive pills substantially increased use of the method and had no adverse impact on risk of sexually transmitted infections. However, it did not show benefit in decreasing pregnancy rates. LEVEL OF EVIDENCE: II-1.