The views of women and pharmacists on the desirability of a progestogen-only pill over the counter. Results of a survey in Germany, Italy and Spain.

PURPOSE: To explore the perceived need and enthusiasm for over the counter (OTC) progestogen-only pills (POP). MATERIALS AND METHODS: A web-based survey of 1000 sexually active women (16-45) and 100 pharmacists in Germany, Italy and Spain. RESULTS: Despite not wanting to conceive, 5-6% of women in each country were not using contraception and 8-20% were using methods less effective than condoms. At least 74% of respondents felt knowledgeable about the different contraceptives available but at least 1/3 had experienced difficulty accessing oral contraceptive (OCs) in the past two years. The cost of contraceptives, the need to see a doctor and long waits for appointments were cited as barriers for not using OCs. The majority agreed they would discuss with their doctor the decision to buy the POP, consult about side effects and other reproductive health issues. Over 2/3 of pharmacists in each country would be very, or fairly, likely to recommend the POP, agreeing that the benefits included improved access for women, and offered them more independence. CONCLUSIONS: Asked directly, women in Germany, Spain and Italy currently using contraception are positive about a POP OTC. Pharmacists are also positive, with the overwhelming majority in favour of providing POPs.

Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster-randomised crossover trial.

BACKGROUND: Unless women start effective contraception after oral emergency contraception, they remain at risk of unintended pregnancy. Most women in the UK obtain emergency contraception from community pharmacies. We hypothesised that pharmacist provision of the progestogen-only pill as a bridging interim method of contraception with emergency contraception plus an invitation to a sexual and reproductive health clinic, in which all methods of contraception are available, would result in increased subsequent use of effective contraception. METHODS: We did a pragmatic cluster-randomised crossover trial in 29 UK pharmacies among women receiving levonorgestrel emergency contraception. Women aged 16 years or older, not already using hormonal contraception, not on medication that could interfere with the progestogen-only pill, and willing to give contact details for follow-up were invited to participate. In the intervention group, women received a 3-month supply of the progestogen-only pill (75 µg desogestrel) plus a rapid access card to a participating sexual and reproductive health clinic. In the control group, pharmacists advised women to attend their usual contraceptive provider. The order in which each pharmacy provided the intervention or control was randomly assigned using a computer software algorithm. The primary outcome was the use of effective contraception (hormonal or intrauterine) at 4 months. This study is registered, ISRCTN70616901 (complete). FINDINGS: Between Dec 19, 2017, and June 26, 2019, 636 women were recruited to the intervention group (316 [49·6%], mean age 22·7 years [SD 5·7]) or the control group (320 [50·3%], 22·6 years [5·1]). Three women (one in the intervention group and two in the control group) were excluded after randomisation. 4-month follow-up data were available for 406 (64%) participants, 25 were lost to follow-up, and two participants no longer wanted to participate in the study. The proportion of women using effective contraception was 20·1% greater (95% CI 5·2-35·0) in the intervention group (mean 58·4%, 48·6-68·2), than in the control group (mean 40·5%, 29·7-51·3 [adjusted for recruitment period, treatment group, and centre]; p=0·011).The difference remained significant after adjusting for age, current sexual relationship, and history of effective contraception use, and was robust to the effect of missing data (assuming missingness at random). No serious adverse events occurred. INTERPRETATION: Provision of a supply of the progestogen-only pill with emergency contraception from a community pharmacist, along with an invitation to a sexual and reproductive health clinic, results in a clinically meaningful increase in subsequent use of effective contraception. Widely implemented, this practice could prevent unintended pregnancies after use of emergency contraception. FUNDING: National Institute for Health Research (Health Technology Assessment Programme project 15/113/01).

Provision of immediate postpartum intrauterine contraception after vaginal birth within a public maternity setting: Health services research evaluation.

INTRODUCTION: Expanding access to postpartum intrauterine contraception (PPIUC) can reduce unintended pregnancies and short inter-pregnancy intervals; however, provision across Europe is limited. Our aim was to determine the feasibility, clinical outcomes and patient satisfaction of providing immediate PPIUC after vaginal birth using a health services research model. MATERIAL AND METHODS: Phased introduction of PPIUC across two Lothian maternity hospitals; all women intending vaginal birth during the study period without a contraindication to use of the method were eligible to receive PPIUC. Midwives and obstetric doctors were trained in vaginal PPIUC insertion using Kelly forceps. Women received information antenatally and had PPIUC insertion of either a levonorgestrel intrauterine system or a copper intrauterine device within 48 hours of vaginal birth. Follow-up was conducted in-person at 6 weeks postpartum and by telephone at 3, 6 and 12 months. Primary outcomes were: uptake, complications (infection, uterine perforation), expulsion and patient satisfaction at 6 weeks; and method of continuation up to 12 months. Secondary outcomes included hazard ratio for expulsion adjusted for demographic and insertion-related variables. RESULTS: Uptake of PPIUC was 4.6% of all vaginal births; 465/447 (96.1%) of those requesting PPIUC successfully received it and most chose a levonorgestrel intrauterine system (73%). At 6 weeks postpartum, the infection rate was 0.8%, there were no perforations and 98.3% of women said they would recommend the service. The complete expulsion rate was 29.8% (n = 113) and most had symptoms (n = 79). Of the additional 121 devices removed, 118 were because of partial expulsion. The rate of complete/partial expulsion was higher for insertions by midwives compared with those by doctors. The re-insertion rate after expulsion/removal was 87.6% and method continuation at 12 months was 79.6%. CONCLUSIONS: Routine PPIUC at vaginal birth is feasible. Complications were extremely rare. High expulsion rates may be observed in early stages of service introduction and with inexperienced providers. Re-insertion and therefore longer-term continuation rates of intrauterine contraception were very high. In settings with low rates of attendance for interval postpartum intrauterine contraception insertion, PPIUC could be a useful intervention to prevent unintended and closely spaced pregnancies.

Women's experiences of accessing postpartum intrauterine contraception in a public maternity setting: a qualitative service evaluation.

OBJECTIVES: The aims of the study were to explore women's experiences of an immediate postpartum intrauterine contraception (PPIUC) service recently introduced in a UK maternity setting, to identify areas for improvement and inform service provision. METHODS: Qualitative research was carried out in hospital and community maternity services in Lothian, UK. In-depth interviews were conducted with 35 women who had received PPIUC at vaginal or caesarean delivery. The interview data were analysed thematically to explore the women's experiences of PPIUC service provision. RESULTS: Women's decisions to choose PPIUC were influenced by their perception of intrauterine contraception (IUC) as a suitable and effective method and the convenience of immediate postpartum insertion. Most women were satisfied with their experience of PPIUC. Women delivering vaginally sometimes reported concerns about delays to insertion, particularly where they perceived a lack of communication from staff about when and where insertion would occur. PPIUC information was described as being difficult to absorb in the context of ante/postnatal information overload. Those receiving PPIUC at caesarean delivery sometimes expressed concerns about what post-insertion support might be available in primary care. CONCLUSION: Women typically reported satisfaction with their decision to have PPIUC. For maternity services considering introducing PPIUC, our findings reinforce the importance of anticipating and addressing implementation challenges in order to enhance women's experience of the service. These include ensuring that: clear and appropriate PPIUC information and support are provided antenatally; women are able to access PPIUC immediately after delivery; robust clinical pathways are in place to support post-insertion IUC care; and both staff and women are familiar with the clinical pathways.

Contraception after pregnancy.

Whatever the outcome, pregnancy provides the opportunity to offer effective contraception to couples motivated to avoid another pregnancy. This narrative review summarizes the evidence for health providers, drawing attention to current guidelines on which contraceptive methods can be used, and when they should be started after pregnancy, whatever its outcome. Fertility returns within 1 month of the end of pregnancy unless breastfeeding occurs. Breastfeeding, which itself suppresses fertility after childbirth, influences both when contraception should start and what methods can be used. Without breastfeeding, effective contraception should be started as soon as possible if another pregnancy is to be avoided. Interpregnancy intervals of at least 6 months after miscarriage and 1-2 years after childbirth have long been recommended by the World Health Organization in order to reduce the chance of adverse pregnancy outcome. Recent research suggests that this may not be necessary, at least for healthy women <35 years old. Most contraceptive methods can be used after pregnancy regardless of the outcome. Because of an increased risk of venous thromboembolism associated with estrogen-containing contraceptives, initiation of these methods should be delayed until 6 weeks after childbirth. More research is required to settle the questions over the use of combined hormonal contraception during breastfeeding, the use of injectable progestin-only contraceptives before 6 weeks after childbirth, and the use of both hormonal and intrauterine contraception after gestational trophoblastic disease. The potential impact on the risk of ectopic pregnancy of certain contraceptive methods often confuses healthcare providers. The challenges involved in providing effective, seamless service provision of contraception after pregnancy are numerous, even in industrialized countries. Nevertheless, the clear benefits demonstrate that it is worth the effort.

Changes in conceptions in women younger than 18 years and the circumstances of young mothers in England in 2000-12: an observational study.

BACKGROUND: In 2000, a 10-year Teenage Pregnancy Strategy was launched in England to reduce conceptions in women younger than 18 years and social exclusion in young parents. We used routinely collected data and data from Britain's National Surveys of Sexual Attitudes and Lifestyles (Natsal) to examine progress towards these goals. METHODS: In this observational study, we used random-effects meta-regression to analyse the change in conception rates from 1994-98 to 2009-13 by top-tier local authorities in England, in relation to Teenage Pregnancy Strategy-related expenditure per head, socioeconomic deprivation, and region. Data from similar probability sample surveys: Natsal-1 (1990-91), Natsal-2 (1999-2001), and Natsal-3 (2010-12) were used to assess the prevalence of risk factors and their association with conception in women younger than 18 years in women aged 18-24 years; and the prevalence of participation in education, work, and training in young mothers. FINDINGS: Conception rates in women younger than 18 years declined steadily from their peak in 1996-98 and more rapidly from 2007 onwards. More deprived areas and those receiving greater Teenage Pregnancy Strategy-related investment had higher rates of conception in 1994-98 and had greater declines to 2009-13. Regression analyses assessing the association between Teenage Pregnancy Strategy funding and decline in conception rates in women younger than 18 years showed an estimated reduction in the conception rate of 11.4 conceptions (95% CI 9.6-13.2; p<0.0001) per 1000 women aged 15-17 years for every £100 Teenage Pregnancy Strategy spend per head and a reduction of 8.2 conceptions (5.8-10.5; p<0.0001) after adjustment for socioeconomic deprivation and region. The association between conception in women younger than 18 years and lower socioeconomic status weakened slightly between Natsal-2 and Natsal-3. The prevalence of participation in education, work, or training among young women with a child conceived before age 18 years was low, but the odds of them doing so doubled between Natsal-2 and Natsal-3 (odds ratio 1.99, 95% CI 0.99-4.00). INTERPRETATION: A sustained, multifaceted policy intervention involving health and education agencies, alongside other social and educational changes, has probably contributed to a substantial and accelerating decline in conceptions in women younger than 18 years in England since the late 1990s. FUNDING: Medical Research Council, Wellcome Trust, Economic and Social Research Council, and Department of Health.

The changing body work of abortion: a qualitative study of the experiences of health professionals.

'Body work' has emerged at the nexus of sociologies of work and bodies as a means of conceptualising work focusing on the bodies of others. This article utilises this analytical tool in the context of contemporary abortion work. Abortion provision in Britain has seen significant change in the last 25 years, paralleling developments in medical methods, and the option for women under nine weeks' gestation to complete the abortion at home. These shifts raise questions around how abortion work is experienced by those who do it. We apply the conceptual lens of body work to data drawn from in-depth interviews with 37 health professionals involved in abortion provision, to draw out the character, constraints and challenges of contemporary abortion work. We explore three key themes: the instrumental role of emotional labour in facilitating body work; the temporality of abortion work; and bodily proximity, co-presence and changes in provision. By drawing on the conceptual frame of body work, we illuminate the dynamics of contemporary abortion work in Britain and, by introducing the idea of 'body work-by-proxy', highlight ways in which this context can be used to expand the conceptual boundaries of body work.

The rationale for use of Ulipristal Acetate as first line in emergency contraception: biological and clinical evidence.

UNLABELLED: Ulipristal acetate (UPA) was licensed as an emergency contraceptive (EC) in Europe in 2009. By the end of May 2013, over 1.4 million courses had been used. The rationale for using UPA for EC in favor of the much more commonly used levonorgestrel (LNG) is based on data on efficacy, safety and side effects. EFFICACY: In two large clinical trials among women presenting for EC up to 120 hours after unprotected sex, UPA was as effective as LNG at preventing pregnancy. When the two trials were combined in a meta analysis UPA was superior, almost halving the risk of pregnancy compared with LNG. Biomedical studies have shown that UPA inhibits or delays ovulation more effectively than LNG at a stage of the cycle when the risk of pregnancy is highest. Safety and side effects: UPA and LNG have similar side effect profiles and to date no serious adverse events have been attributed to use of UPA for EC. Data on pregnancies conceived in association with UPA use are reassuring. There is no evidence for teratogenesis or for any increased risk of ectopic pregnancy or miscarriage. AVAILABILITY: Use of UPA will remain limited until it is available without a doctor's prescription.

ISGE statement on oral emergency contraception.

Unintended pregnancy is an important public health problem worldwide. Unwanted pregnancies may end in induced abortion (legal or illegal, safe or unsafe) or in childbirth. In many parts of the world both can be life threatening. Even where both are safe, abortion is distressing for all concerned while unwanted births often lead to poor health and social outcomes for both the mother and her child.

Myths and misconceptions about intrauterine contraception among women seeking termination of pregnancy.

BACKGROUND: Immediate initiation of an intrauterine device (IUD) or intrauterine system (IUS) following termination of pregnancy (TOP) is associated with a significant reduction in the risk of another TOP. In spite of its high efficacy, uptake of intrauterine contraception in the UK is low. Myths and misconceptions about the method may contribute to the low uptake. STUDY DESIGN: Anonymous, self-administered questionnaire among women requesting a TOP in a hospital abortion service in Scotland, UK. METHODS: Misconceptions about intrauterine contraception were extracted from an online social networking and micro-blogging service, and from existing research to develop a questionnaire containing 12 negative statements about intrauterine contraception. Respondents indicated their level of agreement with each statement. RESULTS: A total of 106/125 (85%) women requesting a TOP completed the questionnaire. The two commonest negative statements that respondents agreed with were that the IUD/IUS 'Is painful to have inserted' (n=36; 34%) and that 'It can move around inside your body' (n=25; 23.6%). The range of women who neither agreed nor disagreed with negative statements was 26.4-56.0%. Twenty-seven (25%) women indicated that the IUD/IUS was their planned method of post-TOP contraception. CONCLUSIONS: Although myths about intrauterine contraception persist among a small proportion of women requesting a TOP, lack of knowledge about the method is also evident. The consultation prior to TOP is an important opportunity to provide accurate and quality information to women about the IUD/IUS that may serve to increase uptake and prevent repeat abortions.

Evaluation of adherence to a daily progestin-only pill in a simulated over-the-counter setting.

OBJECTIVE: The Adherence with Continuous Dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS) study assessed whether consumers can adhere to the regimen for a progestin-only pill (norgestrel 0.075 mg) in an over-the-counter (OTC) setting. STUDY DESIGN: An actual use study in a simulated OTC environment assessed adherence to directions to take norgestrel 0.075 mg every day at the same time in 883 participants for up to 24 weeks. RESULTS: Eighty-five percent (747/883) of participants reported ≥85% adherence to taking norgestrel 0.075 mg every day and reported taking their dose within three hours of their scheduled dosing time on 96% of days. When accounting for use of a condom for 48 hours if a pill was missed, participants reported correctly following the label's directed use for 97% of doses overall, with 95% of participants following label directions for ≥85% of doses. The main limitations were related to finding a balance between intensely collecting data to ensure accurate assessment of adherence and leaving users to behave as they would in a real OTC situation without healthcare practitioner intervention. We observed that some participants reported taking more doses than they could have based on the supply of medication given to them. To fully examine the situation, and the impact on the conclusions, additional post hoc sensitivity analyses were performed, and showed remarkably consistent results. CONCLUSIONS: Consumers were highly adherent to taking norgestrel 0.075 mg when using only the information provided by the proposed OTC label. IMPLICATIONS: Adherence to a daily oral contraceptive pill was high when obtained OTC. This suggests that effectiveness of an OTC pill is likely to be like that of a prescribed pill and easier access to this effective contraceptive should allow more opportunity to prevent pregnancy.

Evaluation of consumer self-selection of a proposed over-the-counter, progestin-only daily oral contraceptive.

OBJECTIVES: In an effort to switch a norgestrel 0.075 mg progestin-only pill (Opill) from prescription to over-the-counter, we conducted this study to assess whether consumers can use the drug facts label alone to guide appropriate self-selection. STUDY DESIGN: Two studies assessed self-selection: (1) an all-comers, actual-use study evaluating self-selection before purchasing and using norgestrel 0.075 mg and (2) the Targeted Breast Cancer Self-Selection Study evaluating theoretical self-selection among participants with a history of breast cancer. RESULTS: In the actual-use study, based on the label, 1670/1772 participants (94%) were appropriate for use of norgestrel 0.075 mg; 102 (6%) were not appropriate. Of the 102, 66 (65%) correctly did not select and 36 (35%) responded it was okay for them to use norgestrel 0.075 mg. Of the 36 participants who incorrectly self-selected, one had a history of breast cancer and thus might have been adversely affected had they taken norgestrel 0.075 mg. In the Targeted Breast Cancer Self-Selection Study (N = 206), 97% of participants correctly stated norgestrel 0.075 mg was not appropriate for them. CONCLUSIONS: The proposed over-the-counter label enables 98% of potential users to self-select norgestrel 0.075 mg appropriately. Only 2% of potential purchasers may have bought and started to use norgestrel 0.075 mg inappropriately. For two-thirds of these, the potential benefits of their use of the method outweighed any theoretical risks. Adverse clinical consequences of norgestrel 0.075 mg use are unlikely even in those rare cases when the drug facts label was not followed. IMPLICATIONS: The balance of the risk of inappropriate selection to the benefit of taking an over-the-counter progestin-only pill appears to be very much in favor of an overall benefit in terms of unintended pregnancy prevention.

Does a full bladder assist insertion of intrauterine contraception? A randomised trial.

BACKGROUND: Bladder distension is thought to cause the uterine axis to become more aligned with the cervical canal. Among women undergoing assisted conception it has been demonstrated that having a full bladder facilitates the passage of an intrauterine catheter for embryo transfer. OBJECTIVE: To determine if insertion of intrauterine contraceptive devices is easier in women who have a full bladder at the time of insertion. METHODS: 200 women requesting intrauterine contraception with a pre-filled bladder were randomised to delayed emptying (after insertion; n=100) or immediate emptying (before insertion; n=100). Comparisons were made between doctors' reported ease of insertion and women's pain scores. RESULTS: There was no significant difference with reported ease of insertion between the groups. Doctors reported that insertions were either 'very easy' or 'quite easy' in 82% and 83% of women in the immediate and delayed emptying groups, respectively (95% CIs for difference -10% to +11%). There was no significant difference in reported pain scores, with mean pain scores (out of 10) of 3.8 and 4.4 in the delayed and immediate emptying groups, respectively. CONCLUSIONS: Bladder filling does not have a significant effect on ease of insertion of an intrauterine method of contraception. Insertion is mostly associated with low levels of discomfort, even in the presence of a full bladder.

Modeling the potential benefit of an over-the-counter progestin-only pill in preventing unintended pregnancies in the U.S.

OBJECTIVES: To develop a model to estimate the possible impact of use of an over-the-counter (OTC) progestin-only pill (POP) on the number of unintended pregnancies in the United States. STUDY DESIGN: Using typical use failure rates (7% for POPs), we compared the expected number of unintended pregnancies for two theoretical cohorts of 100,000 women: one which purchased and used an OTC POP exclusively for contraception, the other using contraceptive methods at proportions obtained from an actual-use clinical trial simulating OTC use of norgestrel 0.075 mg (including 35% using no method and only 19% using hormonal contraception or long-acting contraceptives). Sensitivity analyses were conducted using alternative model inputs such as different failure rates for OTC POPs and varied alternative contraceptive method mix. RESULTS: An estimated 37,624 unintended pregnancies would occur annually if 100,000 women continued their usual contraceptive method as used at baseline in the actual use trial. This would be reduced by 81% to 7,000 pregnancies with the exclusive use of an OTC POP - a net reduction of 30,624 unintended pregnancies annually. While the number of unintended pregnancies prevented varied as the model parameters were modified (ranging from 1,461 to 34,124), a net benefit of OTC POP use was observed over a wide range of input values. CONCLUSIONS: Using data from a real-world contraception user profile, our model suggests that use of an OTC POP could reduce the overall number of unintended pregnancies in the United States. This conclusion remains true across a wide range of modeled scenarios. IMPLICATIONS: The estimates suggested by this model are supportive of an OTC switch for a POP.

The effect of deliberate non-adherence to a norgestrel progestin-only pill: A randomized, crossover study.

OBJECTIVES: To estimate the effects on cervical mucus, ovarian activity and theoretical contraceptive protection of a 6-hour delay and of missing one norgestrel 0.075 mg progestogen-only pill. STUDY DESIGN: In a prospective, two-site, randomized, crossover study, healthy women aged 18 to 35 with BMI <32.0 kg/m² and regular ovulatory cycles completed a baseline 28-day cycle with correct daily pill use followed by two intervention cycles in which, around mid-cycle, one pill was taken 6 hours late or missed completely. We undertook ovarian ultrasonography, estradiol and progesterone measurement, and cervical mucus assessments every 3 to 4 days (daily around the time of the incorrect use) and based the theoretical contraceptive protection score on ovarian activity status, cervical mucus and their temporal relationship. RESULTS: Of 91 potential participants screened, 52 started the study and 46 provided complete data for each intervention cycle. Fourteen participants (30%) ovulated in each of the two intervention cycles, with four during the delayed pill cycle and two during the missed pill cycle having an abnormal luteal phase. Seven participants in the delayed pill cycle, and six with a missed pill had elevated cervical mucus scores temporally associated with the intervention. However only two women, one in the delayed pill cycle and one in the missed pill cycle, had cervical mucus scores in the range considered favorable for fertility. CONCLUSIONS: Delayed or missed intake of a single norgestrel 0.075 mg progestogen-only pill appears to have little effect on theoretical contraceptive efficacy. IMPLICATIONS: This biomedical study suggests that taking a norgestrel 0.075mg progestogen-only pill 6 hours late or missing one pill have little effect on ovarian activity or cervical mucus and may not jeopardize contraceptive efficacy. Correlation with typical use outcomes is necessary to confirm pregnancy risk with delayed or missed norgestrel intake.

How do women feel about their cervical cytology samples being used for research?

BACKGROUND AND METHODOLOGY: The introduction of liquid-based cytology (LBC) for cervical screening in the UK has enabled research into human papillomavirus as an adjunct to screening and provides potential opportunities for population-based research into women's health. The authors explored women's views on the use of remnant LBC samples for sexual and reproductive health research. A pilot study was conducted to assess the acceptability of collecting and storing remnant LBC specimens for future use in sexual and reproductive health research. Women attending a clinic for their routine smear test were recruited to the study. Semi-structured interviews were conducted with a subsample of the women to explore acceptability issues. RESULTS: Of women invited to participate (n=369), 86% (n=316) consented to the storage and use of their remnant sample for research. Of these, 96% (n=304) consented to their sample being linked to reproductive health records. Women interviewed (n=23) were happy with the research process although unclear about what future research might be conducted on their specimen and what health records would be accessed. DISCUSSION AND CONCLUSION: As research becomes technically and ethically more complex the challenge remains to find the right balance between providing sufficient relevant information to ensure informed consent and allay participant's fears, while guarding against the inclusion of excessive detail. The introduction of LBC for cervical screening across the UK brings a new opportunity to integrate research studies within a national cervical screening programme. Our study suggests this is acceptable to women.

Assessment of a 'fast-track' referral service for intrauterine contraception following early medical abortion.

BACKGROUND: A 'fast-track' referral system for intrauterine contraception was established in 2007 between the medical abortion service at the Royal Infirmary of Edinburgh and the principal family planning clinic (FPC) in Edinburgh. METHODS: Case note review of women fast-tracked for intrauterine contraception after medical abortion between January 2007 and June 2009. Main outcome measures were numbers of women referred, attendance rates, interval to insertion, devices chosen and known complication rates. RESULTS: Of the 237 women referred, 126 (53%) attended for intrauterine contraception insertion. Attenders were slightly but significantly older than non-attenders (mean ages of 30 and 27 years, respectively; p=0.003), less likely to live in an area of deprivation (p=0.045) and were significantly more likely to have attended the FPC in the past (p<0.0001). Most attenders (90%; n=113) proceeded to have an intrauterine method inserted; 57% (n=64) chose the levonorgestrel intrauterine system and 43% (n=49) chose a copper intrauterine device. The median interval to insertion was 21 (range 0-54) days. Of those women (n=55) who attended for routine follow-up 6 weeks later (49%), there were four (7.2%) cases of expulsion, two (3.6%) requests for removal and four (7.2%) cases of suspected infection. CONCLUSIONS: Only half the women fast-tracked for intrauterine contraception actually attended and these tended to be women who were pre-existing clients of the FPC. Consideration should therefore be given to provision of immediate insertion where possible.

A review of the effectiveness of a progestogen-only pill containing norgestrel 75 µg/day.

OBJECTIVES: To review published data on the effectiveness of a progestogen-only pill containing norgestrel 75 µg/day which should be under consideration by the FDA in 2022 for sale over the counter in the US. STUDY DESIGN: A literature search in MEDLINE, EMBASE, and COCHRANE REVIEWS using specified search terms and adding related cross-references. RESULTS: We identified a total of thirteen relevant studies of women using norgestrel 75 µg/day. None were reported with the rigor characteristic of trial reporting today. Nevertheless, six studies provided data on 3,184 women who were not breastfeeding, followed for over 35,000 months and reported a range of overall failure rates during typical use of norgestrel 75 µg/day from 0 to 2.4/hundred woman-years giving an aggregate Pearl Index of 2.2. Seven additional studies involved 5,445 women some of whom were breastfeeding for at least part of the period of follow-up. More than 36,000 months of use yielded 12-month life table cumulative pregnancy rates for norgestrel 75 µg/day ranging from 0 to 3.4. We were unable to calculate an aggregate Pearl Index for the breastfeeding studies because of lack of crucial data. CONCLUSIONS: The data support that norgestrel 75 µg/day is highly effective in clinical use, with similar estimates of failure in breastfeeding and non-breastfeeding women, providing support to the case for approval without the need to see a healthcare provider.

Adherence among a cohort taking progestin-only pills prescribed by a healthcare provider: Results of the BENCHMARK study.

OBJECTIVES: To measure adherence over six months of progestin-only pill (POP) use. STUDY DESIGN: Prospective observational cohort study measuring adherence to daily dosing and timing of dose in patients prescribed a POP, with up to six months of follow-up, conducted from January to October 2020. A pharmacy benefit manager identified potential participants with a newly prescribed POP and extended an invitation to participate. We enrolled qualified respondents by telephone, trained them to use an electronic diary to report daily whether they had taken their POP and at what time. We followed participants for up to six months. We calculated adherence to daily pill taking as the proportion of evaluable days in which a participant took a POP, and the proportion of participants reporting ≥85% adherence. We calculated adherence to same time each day as the proportion of doses taken no later than three hours after the previous dose time of day. RESULTS: The user population comprised 199 participants, 154 (77.4%) of whom completed six months of follow-up. The majority (n = 170, 85.4%) were taking norethindrone. Norethindrone users reported POP intake on 22,327 (96.4%) of 23,156 evaluable days, with 155 (91.2%) participants reporting ≥85% adherence; less than half (n = 73, 42.9%) reported 100% adherence. Participants reported adherence to same time each day on 21,698 of 22,157 (97.9%) evaluable days. CONCLUSIONS: Among participants taking a prescribed POP, participants demonstrated high adherence for daily pill taking and the same time of day, though the majority were not 100% adherent. IMPLICATIONS: This study reports data specific to adherence among those taking a progestin-only pill (POP) in the prescription setting. Clinicians who counsel patients about POP use should be aware that majority of patients were not 100% adherent, although most report ≥85% adherence.