Continuation rates of two different-sized copper intrauterine devices among nulliparous women: Interim 12-month results of a single-blind, randomised, multicentre trial.

Background: The most widely used copper intrauterine device (IUD) in the world (the TCu380A), and the only product available in many countries, causes side effects and early removals for many users. These problems are exacerbated in nulliparous women, who have smaller uterine cavities compared to parous women. We compared first-year continuation rates and reasons/probabilities for early removal of the TCu380A versus a smaller Belgian copper IUD among nulliparous users. Methods: This 12-month interim report is derived from a pre-planned interim analysis of a sub population and focused on key secondary comparative endpoints. In this participant-blinded trial at 16 centres in the USA, we randomised participants aged 17-40 in a 4:1 ratio to the NT380-Mini or the TCu380A. In the first year, participants had follow-up visits at 6-weeks and 3, 6, and 12-months, and a phone contact at 9 months; we documented continued use, expulsions, and reasons for removal. Among participants with successful IUD placement, we compared probabilities of IUD continuation and specific reasons for discontinuation using log-rank tests. This trial is registered with ClinicalTrials.gov number NCT03124160 and is closed to recruitment. Findings: Between June 1, 2017, and February 25, 2019, we assigned 927 nulliparous women to either the NT380-Mini (n = 744) or the TCu380A (n = 183); the analysis population was 732 (NT380-Mini) and 176 (TCu380A). Participants using the NT380-Mini, compared to the TCu380A, had higher 12-month continuation rates (78·7% [95% CI: 72·9-84·5%] vs. 70·2% [95% CI: 59·7-80·7], p = 0·014), lower rates of removal for bleeding and/or pain (8·1% vs. 16·2%, p = 0·003) and lower IUD expulsion rates (4·8% vs. 8·9%, p = 0·023), respectively. Interpretation: The NT380-Mini offers important benefits for a nulliparous population compared to the TCu380A in the first twelve months, when pivotal experiences typically occur. Higher continuation rates with the NT380-Mini may avert disruptions in contraceptive use and help users avoid unintended pregnancy. Funding: Bill & Melinda Gates Foundation, Eunice Kennedy Shriver National Institute of Child Health and Human Development, and Mona Lisa, N.V. (Belgium).

Dynamic genome-wide gene expression and immune cell composition in the developing human placenta.

Despite the central role of the placenta in supporting a pregnancy, relatively little is known about transcriptomic and immune-cell changes that occur across gestation. To generate a reference gene expression map of first (T1), second (T2) and third (T3) trimester human placenta, and assess differences in transcriptome in maternal versus fetal side tissues sections of full-term placenta, we performed RNA-Seq analysis on 64 biopsy samples from 18 placentas across all three gestations. We identified 1120 differentially expressed genes in placenta tissues from T1 and T3 samples using a generalized linear model within DESeq2. In total, 411 and 709 genes were positively associated with T1 and T3 placenta, respectively. Comparison of the top 200 differentially expressed genes in the T1 placenta with T3 showed that most of the top enriched biological processes were related to cell division and proliferation. T1 and T2 tissues shared expression of fibroblast-specific COL6A2, HGF, and SPP1 genes. In T3 samples, the expression of genes relating to vasculature development and regulation were highly enriched. Monocytes and NK cell population increased in T3 compared to T1 and T2, whereas Hofbauer cell proportion expanded significantly in T2 and then decreased in T3 samples. There were no significant gene expression differences in the maternal vs. fetal side in T3 placentas. Gene expression patterns shift temporally across trimesters but not spatially across the placenta, at least at the resolution of the biopsy samples. The genes and gene set we identified here represent a valuable resource for studying pathology in pregnancy-related disorders.

Female permanent contraception trends and updates.

Permanent contraception remains one of the most popular methods of contraception worldwide. This article has reviewed recent literature related to demographic characteristics of users, prevalence of use and trends over time, surgical techniques, and barriers to obtain the procedure. We have emphasized the patient's perspective as a key element of choosing permanent contraception. This review has incorporated sections on salpingectomy, hysteroscopy, unmet need, impact of policies at religiously affiliated institutions, and reproductive coercion.

Subfascial-located contraceptive devices requiring surgical removal.

BACKGROUND: Subdermal etonogestrel implants are highly effective contraceptive methods. Despite standardization of insertion technique by the manufacturer, some implants are inadvertently placed too deeply within or below the plane of the biceps brachii fascia. Placement of these implants in a deep tissue plane results in more difficult removal, which is not always possible in the office setting. In rare cases, surgical removal by an upper extremity surgeon is warranted. CASE PRESENTATION: Here we present 6 cases of etonogestrel implants located in a subfascial plane requiring removal by an upper extremity surgeon. Implants were all localized with plain radiography and ultrasound prior to surgical removal. All cases had implants located in the subfascial plane and one was identified intramuscularly. The average age was 28 years (19-33) and BMI was 24.0 kg/m^2 (19.1-36.5), with the most common reason for removal being irregular bleeding. The majority of cases (5/6) were performed under monitored anesthesia care with local anesthetic and one case utilized regional anesthesia. All implants were surgically removed without complication. CONCLUSIONS: Insertion of etonogestrel contraceptive implants deep to the biceps brachii fascia is a rare, but dangerous complication. Removal of these implants is not always successful in the office setting and referral to an upper extremity surgeon is necessary to avoid damage to delicate neurovascular structures for safe removal.

Fetal Exosomal Platelet-activating Factor Triggers Functional Progesterone Withdrawal in Human Placenta.

In most mammals, labor is heralded by the withdrawal of progesterone. In humans, circulating progesterone levels increase as gestation advances while placental expression of progesterone receptor A (PR-A) declines. As a result of PR-A downregulation, the non-canonical NF-κB pathway is activated, an event implicated in triggering labor. Here, we sought to identify fetal-derived mediator(s) that represses placental PR-A in human placenta leading to activation of pro-labor signaling. Lipidomic profiling demonstrated enrichment of platelet-activating factor (PAF) in exosomes originating from the human fetus. Exposure of primary cytotrophoblasts to fetal exosomes from term pregnancies reduced PR-A expression by > 50%, and PAF also reduced PR-A message levels in a dose-dependent manner. Notably, fetal exosomes from preterm pregnancies had lower PAF levels and no effect on PR-A expression. Synthetic PAF-induced DNA methylation increases by 20% at the PR-A promoter, leading to recruitment of corepressors and downregulation of PR-A in cytotrophoblast. Furthermore, suppression of PR-A by PAF-stimulated expression of the pro-labor genes, corticotropin-releasing hormone (CRH) and cyclooxygenase-2 (COX-2), which was reversed by disruption of the DNA methyltransferases 3B and 3L. Taken together, PAF represents a novel fetal-derived candidate for initiation of labor by stimulating methylation and repression of PR-A and activating pro-labor signaling in trophoblast.

Efficacy, safety, and tolerability of a levonorgestrel/ethinyl estradiol transdermal delivery system: Phase 3 clinical trial results.

OBJECTIVE: To assess the contraceptive efficacy, safety, and tolerability of a contraceptive transdermal delivery system, (TDS; TWIRLAⓇ) containing levonorgestrel (LNG) and ethinyl estradiol (EE). STUDY DESIGN: This single-arm, open-label, multicenter, 1-year (13 cycle), phase 3 study enrolled sexually active women ≥18 years old at risk for pregnancy irrespective of body mass index (BMI). Women used patches in 28-day cycles (3 consecutive administrations of 7-day patches followed by 7 days off-treatment/patch-free week). We assessed contraceptive efficacy by the Pearl Index (PI) in women 18 to 35 years, excluding cycles without intercourse or when other contraceptive methods were used. RESULTS: The study enrolled 2032 demographically diverse women in the US, of which 35.3% had a BMI ≥30 kg/m2. In the primary efficacy analysis, the PI (95% confidence interval) was 5.8 (4.5-7.2) pregnancies per 100 woman-years. PIs trended higher as BMI increased; the PI was 4.3 (2.9-5.8) in women with BMI <30 kg/m2 and 8.6 (5.8-11.5) in women with BMI ≥30 kg/m2. Hormone-related treatment-emergent adverse events included nausea (4.1%) and headache (3.6%); 11% of women discontinued due to adverse events. Four women (all with BMIs ≥30 kg/m2) reported thromboembolic events considered related to treatment. CONCLUSIONS: The low-dose LNG/EE TDS was effective in preventing pregnancy in a population of women representative of US demographics. Efficacy was reduced in women with BMI ≥30 kg/m2. The TDS safety and tolerability profile was consistent with other similar dose combined hormonal contraceptives. Results of this phase 3 study supported the US Food and Drug Administration approval of TWIRLAⓇ for prevention of pregnancy in women with BMI <30 kg/m2. IMPLICATIONS: TDS (120 µg/day levonorgestrel and 30 µg/day ethinyl estradiol) is an effective, low-dose transdermal contraceptive patch with favorable tolerability profile approved for prevention of pregnancy in women with BMI <30 kg/m2. TDS has reduced effectiveness in women with BMI ≥30 kg/m2.

A hospital-based COVID-19 abortion case in the early phase of the pandemic.

In this case report we discuss changes in hospital-based abortion care due to the COVID-19 pandemic. We highlight our experience with exposure to an asymptomatic COVID-19 positive patient. We hope early lessons from the United States epicenter will guide clinicians providing abortion care during this and future pandemics.

Experience with same-day placement of the 52 mg levonorgestrel-releasing intrauterine system.

BACKGROUND: Prescribing information for the levonorgestrel-releasing intrauterine system allows placement when the clinician is reasonably certain the patient is not pregnant. A 6 item checklist aids clinicians in determining pregnancy risk but may be too restrictive, resulting in delaying placement for many women. Same-day placement, however, may risk placement during an unrecognized luteal-phase pregnancy, that is, a preimplantation fertilized ovum not yet detectable by urine pregnancy test. OBJECTIVE: We assessed the applicability of pregnancy checklist criteria in 2 gynecology practices that routinely provide same-day placements following a negative urine pregnancy test. STUDY DESIGN: In this retrospective cohort study, we reviewed electronic medical records of all women who underwent levonorgestrel-releasing intrauterine system placement from July 2009 to August 2012. We evaluated each record to identify whether the woman met any of the checklist criteria to exclude pregnancy. We ascertained luteal-phase pregnancies and other outcomes within 12 months following placement. RESULTS: Of 885 placements, 293 (33%) were immediately after abortion. Of the remaining 592 placements, 353 (60%) met at least 1 pregnancy checklist criterion to rule out pregnancy but 239 (40%) met none. Two percent received levonorgestrel emergency contraception at the time of placement. One luteal-phase pregnancy occurred in the group not meeting pregnancy checklist criteria. Removals and expulsions were rare and similar whether or not patients met checklist criteria. CONCLUSION: In 2 practices that provide same-day intrauterine system placements, strict adherence to pregnancy checklist criteria would have resulted in 239 patients (40%) not receiving a same-day intrauterine system. Twelve month outcomes were similar whether or not patients met pregnancy checklist criteria. Providers need not withhold intrauterine system placement based on the pregnancy checklist criteria.

Best practices for collecting repeated measures data using text messages.

BACKGROUND: Researchers and clinicians use text messages to collect data with the advantage of real time capture when compared with standard data collection methods. This article reviews project setup and management for successfully collecting patient-reported data through text messages. METHODS: We review our experience enrolling over 2600 participants in six clinical trials that used text messages to relay information or collect data. We also reviewed the literature on text messages used for repeated data collection. We classify recommendations according to common themes: the text message, the data submitted and the phone used. RESULTS: We present lessons learned and discuss how to create text message content, select a data collection platform with practical features, manage the data thoughtfully and consistently, and work with patients, participants and their phones to protect privacy. Researchers and clinicians should design text messages to include short, simple prompts and answer choices. They should decide whether and when to send reminders if participants do not respond and set parameters regarding when and how often to contact patients for missing data. Data collection platforms send, receive, and store messages. They can validate responses and send error messages. Researchers should develop a protocol to append and correct data in order to improve consistency with data handling. At the time of enrollment, researchers should ensure that participants can receive and respond to messages. Researchers should address privacy concerns and plan for service interruptions by obtaining alternate participant contact information and providing participants with a backup data collection method. CONCLUSIONS: Careful planning and execution can reward clinicians and investigators with complete, timely and accurate data sets.

Factors associated with participant and provider pain rating during office-based first-trimester vacuum aspiration.

OBJECTIVE: The objective was to describe factors associated with reported pain and assess correlations between participant and provider pain assessments during first-trimester vacuum aspiration. STUDY DESIGN: Participants and providers in a trial evaluating music for pain reduction reported procedure-related pain using a 100-mm visual analog scale. RESULTS: The mean participant-reported maximum pain was 65.9±23.0 compared to 41.3±22.0 by provider assessment. Provider-reported scores correlated poorly with participant maximum pain (r=0.28) and participant maximum pain adjusted for baseline (r=0.27). Previous abortion (60.5 versus 71.4, p=.02) and immediate intrauterine device insertion (46.1 versus 68.6, p=.03) were associated with lower participant-reported pain. CONCLUSIONS: Providers underestimate pain reported during vacuum aspiration; provider estimates correlate poorly with participant self-report. IMPLICATIONS: To improve management of pain during first-trimester vacuum aspiration, we need to better understand factors that influence patient and provider pain rating. When assessing patient pain in this setting, providers should not assume a baseline of zero pain.

Texting to Increase Contraceptive Initiation Among Adolescents in the Emergency Department.

PURPOSE: To evaluate the feasibility and acceptability of a text messaging intervention to increase contraception among adolescent emergency department patients. METHODS: A pilot randomized controlled trial of sexually active females aged 14-19 receiving 3 months of theory-based, unidirectional educational and motivational texts providing reproductive health information versus standardized discharge instructions. Blinded assessors measured contraception initiation via telephone follow-up and health record review at 3 months. RESULTS: We randomized 100 eligible participants (predominantly aged 18-19, Hispanic, and with a primary provider); 88.0% had follow-up. In the intervention arm, 3/50 (6.0%) participants opted out, and 1,172/1,654 (70.9%) texts were successfully delivered; over 90% of message failures were from one mobile carrier. Most (36/41; 87.7%) in the intervention group liked and wanted future reproductive health messages. Contraception was initiated in 6/50 (12.0%) in the intervention arm and in 11/49 (22.4%) in the control arm. CONCLUSIONS: A pregnancy prevention texting intervention was feasible and acceptable among adolescent females in the emergency department setting.

Feasibility of Text Message Influenza Vaccine Safety Monitoring During Pregnancy.

INTRODUCTION: The feasibility and accuracy of text messaging to monitor events after influenza vaccination throughout pregnancy and the neonatal period has not been studied, but may be important for seasonal and pandemic influenza vaccines and future maternal vaccines. METHODS: This prospective observational study was conducted during 2013-2014 and analyzed in 2015-2016. Enrolled pregnant women receiving inactivated influenza vaccination at a gestational age <20 weeks were sent text messages intermittently through participant-reported pregnancy end to request fever, health events, and neonatal outcomes. Text message response rates, Day 0-2 fever (≥100.4°F), health events, and birth/neonatal outcomes were assessed. RESULTS: Most (80.2%, n=166) eligible women enrolled. Median gestational age was 8.9 (SD=3.9) weeks at vaccination. Response rates remained high (80.0%-95.2%). Only one Day 0-2 fever was reported. Women reported via text both pregnancy- and non-pregnancy-specific health events, not all associated with medical visits. Most pregnancy-specific events in the electronic medical record (EMR) were reported via text message. Of all enrollees, 84.9% completed the study (131 reported live birth, ten reported pregnancy loss). Two losses reported via text were not medically attended; there was one additional EMR-identified loss. Gestational age and weight at birth were similar between text message-reported and EMR-abstracted data and 95% CIs were overlapping for proportions of prematurity, low birth weight, small for gestational age, and major birth defects, as identified by text message-reported versus EMR-abstracted plus text message-reported versus EMR-abstracted data only. CONCLUSIONS: This study demonstrated the feasibility of text messaging for influenza vaccine safety surveillance sustained throughout pregnancy. In these women receiving inactivated influenza vaccination during pregnancy, post-vaccination fever was infrequent and a typical pattern of maternal and neonatal health outcomes was observed.

Trends in gestational age at time of surgical abortion for fetal aneuploidy and structural abnormalities.

BACKGROUND: Screening for fetal aneuploidy has evolved over the past 2 decades. Whether these advances impact gestational age at abortion has received little study. OBJECTIVE: We sought to describe trends in the gestational age at the time of abortion by fetal diagnosis over an 11-year study period. We hypothesized that gestational age at time of abortion would decrease for fetal aneuploidy but remain unchanged for structural abnormalities. STUDY DESIGN: We conducted a retrospective case series of all women undergoing surgical abortion for fetal aneuploidy or structural abnormalities up to 24 weeks' gestation from 2004 through 2014 in a hospital operating room setting at a single, urban medical center. We excluded labor induction abortions (<1% of abortions at our medical center) and suction aspirations performed in the office practice. We performed suction aspiration up to 14 weeks and dilation and evacuation after that gestational age. We describe the median gestational age at abortion by fetal indication and year. RESULTS: For women undergoing abortion for fetal aneuploidy (n = 392), the median gestational age at time of abortion decreased from 19.0 weeks (interquartile range 18.0-21.0) in 2004 to 14.0 weeks (interquartile range 13.0-17.0) in 2014 (Kruskal-Wallis P < .0001). For women undergoing abortion for fetal structural abnormalities (n = 586), the median gestational age was ≥20 weeks for each year during the study interval (P = .1). As gestational age decreased in the fetal aneuploidy group, fewer women underwent dilation and evacuation and more became eligible for suction aspiration (<14 weeks). In 2004, >90% of women underwent dilation and evacuation for either indication. By 2014, 31% of women with fetal aneuploidy were eligible for suction aspiration compared to 11% of those with structural anomalies. CONCLUSION: Gestational age at the time of abortion for fetal aneuploidy decreased substantially from 2004 through 2014; earlier abortion is safer for women. In contrast, women seeking abortion for fetal structural abnormalities did not experience a change in timing. Legislation restricting gestational age at the time of abortion could disproportionately affect women with fetal structural abnormalities.

Adolescent Female Text Messaging Preferences to Prevent Pregnancy After an Emergency Department Visit: A Qualitative Analysis.

BACKGROUND: Over 15 million adolescents use the emergency department (ED) each year in the United States. Adolescent females who use the ED for medical care have been found to be at high risk for unintended pregnancy. Given that adolescents represent the largest users of text messaging and are receptive to receiving text messages related to their sexual health, the ED visit represents an opportunity for intervention. OBJECTIVE: The aim of this qualitative study was to explore interest in and preferences for the content, frequency, and timing of an ED-based text message intervention to prevent pregnancy for adolescent females. METHODS: We conducted semistructured, open-ended interviews in one urban ED in the United States with adolescent females aged 14-19 years. Eligible subjects were adolescents who were sexually active in the past 3 months, presented to the ED for a reproductive health complaint, owned a mobile phone, and did not use effective contraception. Using an interview guide, enrollment continued until saturation of key themes. The investigators designed sample text messages using the Health Beliefs Model and participants viewed these on a mobile phone. The team recorded, transcribed, and coded interviews based on thematic analysis using the qualitative analysis software NVivo and Excel. RESULTS: Participants (n=14) were predominantly Hispanic (13/14; 93%), insured (13/14; 93%), ED users in the past year (12/14; 86%), and frequent text users (10/14; 71% had sent or received >30 texts per day). All were interested in receiving text messages from the ED about pregnancy prevention, favoring messages that were "brief," "professional," and "nonaccusatory." Respondents favored texts with links to websites, repeated information regarding places to receive "confidential" care, and focused information on contraception options and misconceptions. Preferences for text message frequency varied from daily to monthly, with random hours of delivery to maintain "surprise." No participant feared that text messages would violate her privacy. CONCLUSIONS: Adolescent female patients at high pregnancy risk are interested in ED-based pregnancy prevention provided by texting. Understanding preferences for the content, frequency, and timing of messages can guide in designing future interventions in the ED.

Comparison of a Timing-Based Measure of Unintended Pregnancy and the London Measure of Unplanned Pregnancy.

CONTEXT: Unintended pregnancy is a universal benchmark for reproductive health, but whether variations reflect differences in measurement and how well measures predict pregnancy outcomes warrant further examination. U.S. and British measures of unintended and unplanned pregnancy offer a useful comparison. METHODS: Some 220 women seeking pregnancy testing at the Columbia University Medical Center in 2005 responded to three pregnancy measures: a binary timing-based measure of unintended pregnancy (TMUP); a multi-item measure of timing-based intentions and planning behaviors, the London Measure of Unplanned Pregnancy (LMUP); and a measure combining intentions (from the TMUP) and how women would feel about a positive pregnancy test. Six-month pregnancy status was assessed among 159 respondents. Estimates of unintended and unplanned pregnancy were calculated using the TMUP and the LMUP, and receiver operating characteristic (ROC) curves were generated to assess congruence. RESULTS: According to the TMUP, 76% of pregnancies were unintended; by contrast, LMUP scores categorized 39% as unplanned. The ROC curve indicated that expanding the range of scores for classifying pregnancies as unplanned on the LMUP would achieve greater congruence between these measures. At six months, the proportion of pregnancies that had ended in abortion was 42% of those classified as unintended using the TMUP, 60% of those classified as unplanned using the LMUP and 71% of those that women said they had not intended and were very upset about. CONCLUSIONS: U.S. and British measures of unintended pregnancy are not directly comparable, and a measure combining intentions and feelings may better predict pregnancy outcomes.

Evaluation of Smartphone Menstrual Cycle Tracking Applications Using an Adapted APPLICATIONS Scoring System.

OBJECTIVE: To identify smartphone menstrual cycle tracking applications (apps) and evaluate their accuracy, features, and functionality. METHODS: In this systematic evaluation, we searched the Apple iTunes store for free menstrual cycle tracking apps for patient use. We considered an application accurate if menstrual cycle predictions were based on average cycle lengths of at least three previous cycles, ovulation (when included) was predicted at 13-15 days before the start of the next cycle, and the application contained no misinformation. We modified the APPLICATIONS Scoring System to evaluate the features and functionality of accurate apps. RESULTS: Our search criteria yielded 1,116 apps; 108 remained after excluding duplicate, non-English, nonmenstrual cycle tracking, and priced apps. We further eliminated 88 that did not meet inclusion or accuracy criteria. Of the 20 accurate, free apps, 80% contained information for conception and 50% for contraception. Common features and functionality included password protection (55%); no requirement for Internet connectivity (80%); no advertisements (65%); in-application technical support (70%); medical disclaimers (65%); health education (55%); tracking of menstrual flow (70%), symptoms (70%), and intercourse (75%); alerts for next menses (65%) and fertility (55%); and cycle length information (75%). Forty percent were available for Android. Usefulness for fertility medications (15%), professional involvement (5%), and cited literature (5%) were rare. CONCLUSION: Most free smartphone menstrual cycle tracking apps for patient use are inaccurate. Few cite medical literature or health professional involvement. We list accurate apps to aid health care providers in understanding the key components they can use to evaluate and recommend apps for patients.

A randomized controlled trial of daily text messages versus monthly paper diaries to collect bleeding data after intrauterine device insertion.

OBJECTIVE: Bleeding data in contraceptive trials are often collected using daily diaries, but data quality may vary due to compliance and recall bias. Text messaging is a widespread and promising modality for data collection. STUDY DESIGN: This trial randomized participants 1:1 to use text messages or paper diaries to report on bleeding experienced during the 90 days after intrauterine device (IUD) insertion. Participants chose either the copper T380A or the 52-mg levonorgestrel IUD. Our primary outcome was number of days of reported bleeding data. We hypothesized that data gathered with daily text messages would have fewer missing values than paper diaries. Intention to treat analyses used the rank-sum test to compare medians. RESULTS: Two hundred thirty women enrolled, and randomization yielded groups similar in baseline characteristics. Twenty percent of participants provided no bleeding data; of these, 77% were assigned to paper diaries. With 90 days of reporting, approximately 20% in each group provided complete bleeding data. The text group reported a median of 82 days [interquartile range (IQR) 40-89] and the paper group reported a median of 36 days (IQR 0-88) (p≤.001). The number of responses received decreased gradually over the 90-day period but was always higher in the text group. Women who had attained higher levels of education did well regardless of data collection modality, while response rates of text messages were greater among those with a high school education or less (p<.01). CONCLUSIONS: Participants reporting bleeding via text messages provided more complete data than women using paper diaries. IMPLICATIONS: Depending on resources and population of interest, text messages may be a useful modality to improve data collection for patient-reported outcomes.

Barriers to and enablers of contraceptive use among adolescent females and their interest in an emergency department based intervention.

OBJECTIVE: Over 15 million adolescents, many at high risk for pregnancy, use emergency departments (EDs) in the United States annually, but little is known regarding reasons for failure to use contraceptives in this population. The purpose of this study was to identify the barriers to and enablers of contraceptive use among adolescent females using the ED and determine their interest in an ED-based pregnancy prevention intervention. STUDY DESIGN: We conducted semistructured, open-ended interviews with females in an urban ED. Eligible females were 14-19 years old, sexually active, presenting for reproductive health complaints and at risk for pregnancy, defined as nonuse of effective (per the World Health Organization) contraception. Interviews were recorded, transcribed and coded based on thematic analysis. Enrollment continued until no new themes emerged. A modified Health Belief Model guided the organization of the data. RESULTS: Participants (n=14) were predominantly Hispanic (93%), insured (93%) and in a sexual relationship (86%). The primary barrier to contraceptive use was perceived health risk, including effects on menstruation, weight and future fertility. Other barriers consisted of mistrust in contraceptives, ambivalent pregnancy intentions, uncertainty about the future, partner's desire for pregnancy and limited access to contraceptives. Enablers of past contraceptive use included the presence of a school-based health clinic and clear plans for the future. All participants were receptive to ED-based pregnancy prevention interventions. CONCLUSIONS: The identified barriers and enablers influencing hormonal contraceptive use can be used to inform the design of future ED-based adolescent pregnancy prevention interventions. IMPLICATIONS: Adolescents who visit the emergency department (ED) identify contraceptive side effects, mistrust in contraceptives, limited access, pregnancy ambivalence and partner pregnancy desires as barriers to hormonal contraception use. They expressed interest in an ED-based intervention to prevent adolescent pregnancy; such an intervention could target these themes to maximize effectiveness.

The influence of oral contraceptive knowledge on oral contraceptive continuation among young women.

BACKGROUND: Using a multidimensional approach, we assessed young women's knowledge of oral contraceptives (OC) and its influence on OC continuation rates. METHODS: We used data from 659 women aged 13-25 years participating in a randomized controlled trial of an educational text message OC continuation intervention. Women received 6 months of daily text messages or routine care. At baseline and 6 months, we administered a comprehensive 41-item questionnaire measuring knowledge of OC's mechanism, effectiveness, use, side effects, risks, and benefits. We ascertained OC continuation status and reasons for discontinuation at 6 months. We analyzed relationships between OC knowledge and continuation with multivariable logistic regression. RESULTS: Young women scored, on average, 22.8 out of 41 points on the OC knowledge assessment at baseline and 24.7 points at 6 months. The 6-month OC continuation rate was 59%. OC continuers had >2-points-higher OC knowledge scores at 6 months than discontinuers (p<0.001). Those who reported discontinuing their OCs for side effects and forgetfulness scored >2 points lower than women who discontinued for other reasons (p-values<0.001). In multivariable regression models, each correct response on the baseline and 6-month knowledge assessments was associated with a 4% and 6% increased odds of OC continuation, respectively. Six-month OC knowledge scores were negatively associated with OC discontinuation due to side effects (odds ratio [OR] 0.94) and forgetfulness (OR 0.88). CONCLUSIONS: OC knowledge, which was low among young women in our study, was associated with OC continuation and common reasons for discontinuation. Continued efforts to characterize relationships between OC knowledge and behavior and to test the effectiveness of different components of interventions aimed at increasing knowledge, addressing side effects, and improving use of OCs are warranted.

The folate status of reproductive-aged women in a randomised trial of a folate-fortified oral contraceptive: dietary and blood assessments.

OBJECTIVE: To assess the folate status of US women in a study of a folate-fortified oral contraceptive (OC) using the Short Folate Food Frequency Questionnaire and plasma and red blood cell (RBC) folate samples. DESIGN: Sub-analysis from a multi-centre, randomised, double-blind, controlled contraceptive trial with assessments at baseline and 6 months. We calculated dietary folate equivalents (DFE) consumed and the proportion of participants meeting folate adequacy benchmarks. SETTING: Eight centres in the USA. SUBJECTS: Healthy women aged 18-40 years requesting contraception with no contraindications for OC use. RESULTS: Overall, 385 participants were randomised to either a novel folate-fortified OC or a marketed OC. The 262 (68 %) participants compliant with the protocol were included in the analysis set. Baseline daily DFE consumption was 529·8 (sd 342·1) µg and similar in both groups. At follow-up, the fortified OC group had higher intake than the conventional OC group (1225·9 (sd 346·2) µg compared with 500·6 (sd 361·2) µg). Mean plasma folate level increased from 44·5 (sd 17·2) to 55·8 (sd 21·1) nmol/l. Mean RBC folate level increased from 996·7 (sd 369·8) to 1311·9 (sd 436·0) nmol/l. The proportion meeting selected folate adequacy benchmarks increased in the fortified OC group (P < 0·001). CONCLUSIONS: Lack of adequate folate intake in reproductive-aged women from dietary sources or supplements alone suggests the need for novel approaches. Use of folate-fortified OC ensures adequate folate levels and meeting of folate benchmarks.