Association between levonorgestrel emergency contraception and the risk of ectopic pregnancy: a multicenter case-control study.
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ABSTRACT:
SUBMITTER: Zhang J
PROVIDER: S-EPMC4325579 | biostudies-other | 2015
REPOSITORIES: biostudies-other
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Project description:BackgroundIn the United States, more intrauterine device (IUD) users select levonorgestrel IUDs than copper IUDs for long-term contraception. Currently, clinicians offer only copper IUDs for emergency contraception because data are lacking on the efficacy of the levonorgestrel IUD for this purpose.MethodsThis randomized noninferiority trial, in which participants were unaware of the group assignments, was conducted at six clinics in Utah and included women who sought emergency contraception after at least one episode of unprotected intercourse within 5 days before presentation and agreed to placement of an IUD. We randomly assigned participants in a 1:1 ratio to receive a levonorgestrel 52-mg IUD or a copper T380A IUD. The primary outcome was a positive urine pregnancy test 1 month after IUD insertion. When a 1-month urine pregnancy test was unavailable, we used survey and health record data to determine pregnancy status. The prespecified noninferiority margin was 2.5 percentage points.ResultsAmong the 355 participants randomly assigned to receive levonorgestrel IUDs and 356 assigned to receive copper IUDs, 317 and 321, respectively, received the interventions and provided 1-month outcome data. Of these, 290 in the levonorgestrel group and 300 in the copper IUD group had a 1-month urine pregnancy test. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% confidence interval [CI], 0.01 to 1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0 to 1.1) in the copper IUD group; the between-group absolute difference in both analyses was 0.3 percentage points (95% CI, -0.9 to 1.8), consistent with the noninferiority of the levonorgestrel IUD to the copper IUD. Adverse events resulting in participants seeking medical care in the first month after IUD placement occurred in 5.2% of participants in the levonorgestrel IUD group and 4.9% of those in the copper IUD group.ConclusionsThe levonorgestrel IUD was noninferior to the copper IUD for emergency contraception. (Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT02175030.).
| S-EPMC7983017 | biostudies-literature
Project description:ObjectiveWe 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 designThis 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.ResultsOf 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).ConclusionOne 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.ImplicationsCompared 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.
| S-EPMC4076674 | biostudies-literature
Project description:Since the United States Food and Drug Administration's approval of over-the-counter levonorgestrel emergency contraception, access to this time-sensitive medication has improved. However, multiple barriers, including the cost of the medication and pharmacy availability, still exist. The objective of this study was to determine the over-the-counter availability of levonorgestrel emergency contraception in pharmacies on Oahu, Hawaii. We conducted a cross-sectional population-based study using in-person simulated patient encounters at all pharmacies on Oahu. Out of 109 chain pharmacies and 13 independent pharmacies, 102 (84%) pharmacies had levonorgestrel emergency contraception available over the counter. Of pharmacies in which it was available, 12.7% required an employee to unlock the medication, 37.3% required the medication to be unlocked at the register, 29.4% were packaged in a large plastic box, and 3.9% were packaged in a blister pack. Levonorgestrel emergency contraception is widely available as an over-the-counter medication in pharmacies on Oahu, yet there are packaging and display practices that make it less accessible. Many of these practices could be improved with pharmacy education or changes in store policies. Systems-based interventions are needed to improve the access to levonorgestrel emergency contraception as an over-the-counter medication.
| S-EPMC7151709 | biostudies-literature
Project description:ObjectiveTo evaluate the association between the risk of ectopic pregnancy (EP) and the use of common contraceptives during the previous and current conception/menstrual cycle.MethodsA multi-center case-control study was conducted in Shanghai. Women diagnosed with EP were recruited as the case group (n = 2,411). Women with intrauterine pregnancy (IUP) (n = 2,416) and non-pregnant women (n = 2,419) were matched as controls at a ratio of 1∶1. Information regarding the previous and current use of contraceptives was collected. Multivariate logistic regression analyses were performed to calculate odds ratios (ORs) and the corresponding 95% confidential intervals (CIs).ResultsPrevious use of intrauterine devices (IUDs) was associated with a slight risk of ectopic pregnancy (AOR1 = 1.87 [95% CI: 1.48-2.37]; AOR2 = 1.84 [1.49-2.27]), and the risk increased with the duration of previous use (P1 for trend <10-4, P2 for trend <10-4). The current use of most contraceptives reduced the risk of both unwanted IUP (condom: AOR = 0.04 [0.03-0.05]; withdrawal method: AOR = 0.10 [0.07-0.13]; calendar rhythm method: AOR = 0.54 [0.40-0.73]; oral contraceptive pills [OCPs]: AOR = 0.03 [0.02-0.08]; levonorgestrel emergency contraception [LNG-EC]: AOR = 0.22 [0.16-0.30]; IUDs: AOR = 0.01 [0.005-0.012]; tubal sterilization: AOR = 0.01 [0.001-0.022]) and unwanted EP (condom: AOR1 = 0.05 [0.04-0.06]; withdrawal method: AOR1 = 0.13 [0.09-0.19]; calendar rhythm method: AOR1 = 0.66 [0.48-0.91]; OCPs: AOR1 = 0.14 [0.07-0.26]; IUDs: AOR1 = 0.17 [0.13-0.22]; tubal sterilization: AOR1 = 0.04 [0.02-0.08]). However, when contraception failed and pregnancy occurred, current use of OCPs (AOR2 = 4.06 [1.64-10.07]), LNG-EC (AOR2 = 4.87 [3.88-6.10]), IUDs (AOR2 = 21.08 [13.44-33.07]), and tubal sterilization (AOR2 = 7.68 [1.69-34.80]) increased the risk of EP compared with the non-use of contraceptives.ConclusionCurrent use of most contraceptives reduce the risk of both IUP and EP. However, if the contraceptive method fails, the proportions of EP may be higher than those of non-users. In the case of contraceptive failure in the current cycle, EP cases should be differentiated according to current use of OCPs, LNG-EC, IUDs, and tubal sterilization. In addition, attention should be paid to women with previous long-term use of IUDs.
| S-EPMC4262460 | biostudies-literature
Project description:ObjectiveTo identify the risk factors for ectopic pregnancy (EP) in a population of Cameroonian women.Sample and methodsWe performed a matched case-control study; 88 women with diagnosed EP (cases), and 176 women with first trimester intrauterine pregnancy (IUP) (controls), who underwent questionnaires. Odds Ratio (OR) and 95% confidence intervals (CIs) were calculated and adjusted for potential confounding factors via multivariate logistic regression analysis.ResultsOf the fifteen identified risk factors, 4 were independently associated with increased odds of EP: prior pelvic inflammatory disease (PID) (adjusted odds ratio [AOR] 13.18; 95% CI 6.19-27.42), followed by current use of levonorgestrel-only pills for emergency contraception (LNG-EC) (AOR 10.15; 95% CI 2.21-46.56), previous use of depot medroxyprogesterone acetate (DMPA) (AOR 3.01; 95% CI 1.04-8.69) and smoking at the time of conception (AOR 2.68; 95% CI 1.12-6.40).ConclusionThe present study confirms the wide variety of EP's risk factors. Moreover, some new findings including current use of LNG-EC, previous use of DMPA, smoking at the time of conception are noteworthy. Thus, in our limited resources country where prevention remains the cornerstone for reducing EP chances of occurrence, clinicians should do enough counselling, especially to women with known risk factors. The necessity to facilitate access to more equipment to enable early diagnosis of EP is very crucial and should be seriously considered, in order to reduce the burden of EP in Cameroonian women.
| S-EPMC6291129 | biostudies-literature
Project description: Not available
| S-EPMC10031393 | biostudies-literature
Project description:To determine if differences exist in the pharmacokinetics (PK) of levonorgestrel-based emergency contraception (LNG-EC) in obese and normal body mass index (BMI) users and test whether doubling the dose of LNG-EC in obese women increases total and free (active) LNG serum concentrations.Healthy, reproductive-age women with obese and normal BMIs received 1.5mg LNG orally (ECx1) and then in a subsequent menstrual cycle, the obese group also received 3mg LNG (ECx2). Dosing occurred during the follicular phase. Total and free LNG PK parameters were obtained via serum samples through an indwelling catheter at 0, 0.5, 1, 1.5, 2, and 2.5h. The primary outcome was the difference in total and free LNG concentration maximum (Cmax) between ECx1 and ECx2 in the obese group.A total of 10 women enrolled and completed the study (normal BMI=5, median 22.8kg/m(2), range 20.8-23.7; obese BMI=5, 39.5kg/m(2), range 35.9-46.7). The total LNG Cmax for obese subjects following ECx1 (5.57±2.48ng/mL) was significantly lower than the level observed in normal BMI women (10.30±2.47, p=.027). Notably, ECx2 increased the Cmax significantly (10.52±2.76, p=.002); approximating the level in normal BMI subjects receiving ECx1. Free LNG Cmax followed a similar pattern.Obesity adversely impacts both the total and free Cmax levels of LNG EC and this likely explains its lack of efficacy in obese women. Doubling the dose appears to correct the obesity-related PK changes but additional research is needed to determine if this also improves EC effectiveness in obese women.This study demonstrates that obesity interferes with the pharmacokinetics of LNG EC, and that doubling the dose may be an effective strategy to improve its efficacy in obese women.
| S-EPMC4944814 | biostudies-literature
Project description:ObjectiveTo evaluate the cost-effectiveness of ulipristal acetate and levonorgestrel in minors in France, and analyze whether it is worthwhile to provide ulipristal acetate to minors free of charge.MethodsThe cost-effectiveness of two emergency contraceptive methods was compared based on a decision-analytical model. Pregnancy rates, outcomes of unintended pregnancies, and resource utilization were derived from the literature. Resources and their costs were considered until termination or a few days after delivery. Deterministic and probabilistic sensitivity analyses were performed.ResultsThe cost of an unintended pregnancy in a French minor is estimated to be 1,630 € (range 1,330 € - 1,803 €). Almost 4 million € (3.1 € - 13.7 € million) in unintended pregnancy spending in 2010 could have been saved by the use of ulipristal acetate instead of levonorgestrel. The incremental cost of ulipristal acetate compared to levonorgestrel is 3.30 € per intake, or 418 € per pregnancy avoided (intake within 72 hours). In the intake within 24 hours subgroup, ulipristal acetate was found to be more efficacious at a lower cost compared to levonorgestrel.ConclusionsUlipristal acetate dominates levonorgestrel when taken within 24 hours after unprotected intercourse, i.e., it is more effective at a lower cost. When taken within 72 hours, ulipristal acetate is a cost- effective alternative to levonorgestrel, given that the cost of avoiding an additional pregnancy with ulipristal acetate is less than the average cost of these pregnancies. In the light of these findings, it is worthwhile to provide free access to minors.
| S-EPMC4589416 | biostudies-literature
Project description: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 designThis 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.ResultsOne 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.ImplicationsProviding IUD options for EC users presents an opportunity to increase availability of highly effective contraception.
| S-EPMC6040824 | biostudies-literature
Project description:ObjectiveTo assess pregnancy risk after intrauterine device (IUD) placement by the number and timing of unprotected intercourse episodes in the prior 14 days.MethodsThis was a secondary analysis of a randomized trial that compared the copper T380A IUD and levonorgestrel 52-mg intrauterine system for emergency contraception. At enrollment, participants had a negative urine pregnancy test result and reported the frequency and timing of any unprotected intercourse in the preceding 14 days. We assessed pregnancies 1 month after IUD placement and compared pregnancy risk by single or multiple unprotected intercourse episodes and by timing (5 or fewer days before IUD placement or 6 or more days before).ResultsAmong the 655 participants, one pregnancy occurred in a patient who reported intercourse once 48 hours before IUD placement. Multiple unprotected intercourse episodes were reported by 286 participants (43.7%), and 95 participants (14.4%) reported at least one unprotected intercourse episode 6 or more days before IUD placement. No pregnancies occurred among those with multiple unprotected intercourse episodes (0%, 97.5% CI 0-1.3%) or with any unprotected intercourse episode 6-14 days before IUD placement (0.0%, 97.5% CI 0.0-3.8%). Pregnancy risk difference did not significantly differ by single compared with multiple unprotected intercourse episodes (0.3%, 95% CI -0.3% to 0.8%), nor by unprotected intercourse 5 or fewer days before IUD placement or 6 or more days before (0.2%, 95% CI -0.2% to 0.5%).ConclusionWith a negative urine pregnancy test result at IUD placement, 1-month pregnancy risk remains low, regardless of frequency or timing of unprotected intercourse in the prior 14 days.Clinical trial registrationClinicalTrials.gov, NCT02175030.
| S-EPMC8216596 | biostudies-literature