Impact of coronavirus disease 2019 (COVID-19) vaccination on menstrual bleeding quantity: An observational cohort study.

OBJECTIVE: To assess whether coronavirus disease 2019 (COVID-19) vaccination impacts menstrual bleeding quantity. DESIGN: Retrospective cohort. SETTING: Five global regions. POPULATION: Vaccinated and unvaccinated individuals with regular menstrual cycles using the digital fertility-awareness application Natural Cycles°. METHODS: We used prospectively collected menstrual cycle data, multivariable longitudinal Poisson generalised estimating equation (GEE) models and multivariable multinomial logistic regression models to calculate the adjusted difference between vaccination groups. All regression models were adjusted for confounding factors. MAIN OUTCOME MEASURES: The mean number of heavy bleeding days (fewer, no change or more) and changes in bleeding quantity (less, no change or more) at three time points (first dose, second dose and post-exposure menses). RESULTS: We included 9555 individuals (7401 vaccinated and 2154 unvaccinated). About two-thirds of individuals reported no change in the number of heavy bleeding days, regardless of vaccination status. After adjusting for confounding factors, there were no significant differences in the number of heavy bleeding days by vaccination status. A larger proportion of vaccinated individuals experienced an increase in total bleeding quantity (34.5% unvaccinated, 38.4% vaccinated; adjusted difference 4.0%, 99.2% CI 0.7%-7.2%). This translates to an estimated 40 additional people per 1000 individuals with normal menstrual cycles who experience a greater total bleeding quantity following the first vaccine dose' suffice. Differences resolved in the cycle post-exposure. CONCLUSIONS: A small increase in the probability of greater total bleeding quantity occurred following the first COVID-19 vaccine dose, which resolved in the cycle after the post-vaccination cycle. The total number of heavy bleeding days did not differ by vaccination status. Our findings can reassure the public that any changes are small and transient.

Very early medical abortion: treatment with mifepristone and misoprostol before ultrasonographic visualisation of an intrauterine pregnancy.

INTRODUCTION: Abortion providers may be reluctant to commence abortion before ultrasound evidence of intrauterine pregnancy (IUP) due to concerns of missed ectopic pregnancy. In 2017, very early medical abortion (VEMA) was introduced at an abortion service in Edinburgh, UK. Following ultrasound, patients without confirmed IUP, and without symptoms or risk factors for ectopic pregnancy, could commence treatment immediately after baseline serum-human chorionic gonadotrophin (hCG) measurement, and return for follow-up serum-hCG a week later to determine treatment success (≥80% decline from baseline). This study aimed to compare clinical outcomes between two pathways: (1) VEMA; and (2) standard-of-care delayed treatment where treatment is only commenced on IUP confirmation by serial serum-hCG monitoring and/or repeat ultrasound. METHODS: A retrospective database review was conducted of VEMA eligible patients from July 2017 to December 2021. Study groups were determined by patient preference. Records were searched for abortion outcomes, duration of care, number of appointments (clinic visits, ultrasounds, serum-hCG) and clinical data entries. RESULTS: Of 181 patients included, 77 (43%) chose VEMA and 104 (57%) chose delayed treatment. 11/181 (6.1%) were lost to follow-up. Cohort ectopic prevalence was 4.4% and was not statistically different between groups (2.6% vs 5.8%, VEMA vs delayed group, respectively, p=0.305), as with complete abortion rates (93.3% vs 97.6%, p=0.256). All VEMA group ectopics were detected on the seventh day (from initial visit) while time-to-diagnosis for delayed group ectopics ranged from 7 days to 3 weeks. VEMA patients had significantly reduced duration of care (12 vs 21 days, p<0.001), number of visits (2 vs 3, p<0.001), ultrasounds (1 vs 2, p<0.001) and data entries (6 vs 9, p<0.001). CONCLUSIONS: VEMA is safe, effective and reduces the duration of care, number of appointments and clinical administrative time. It should be offered to medically eligible patients.

A narrative review of key studies on the Heart Manual – looking back on 30 years of evidence on home-based cardiac rehabilitation

BackgroundThe Heart Manual (HM) Programme is the UK’s leading home-based self-managed cardiac rehabilitation programme (HBCRP) for individuals recovering from acute myocardial infarction and/or revascularisation. This year marks 30 years of HM implementation in the NHS and overseas.AimThe aim of this study is to conduct a narrative review of the HM over the last 30 years, considering its outcomes as a HBCRP.MethodsDatabases AHMED, Embase, APA PsychInfo, Ovid Medline were used to source studies where the HM outcomes were a key focus. Grey literature was searched by the HM department. Narrative synthesis was used to capture the qualitative element of extracted papers dated after the Heart Manual 2011 Systematic Review.ResultsThe search revealed 48 papers;7 studies were already included in the 2011 systematic review (SR), with 4 new papers remaining and 1 grey-paper, others were duplicates.Of the studies and those included in SR, 9 reported on efficacy, 4 on programme adherence, and 2 on qualitative outcomes (1 digital-HM, 1 HM patient reported outcomes). Outcomes on efficacy and adherence were all positive. Qualitative findings (n=2) cited positive attitudes towards the HM from patient representatives, general user-friendliness and useful content. An audit on HM patient feedback reported high engagement with health behaviour change(s), positive gains from psychosocial support, and improved understanding and awareness of condition. A grey-paper on patient reported outcomes during COVID-19 reported improvements in managing other health conditions, including diabetes, blood pressure, and mental health, through using the HM. Patients also reported feeling reassured by the HM.ConclusionThe HM continues to be the most widely studied HBCRP, and has played a key role in demonstrating the effectiveness of HBCRP over the last 30 years. Recent surveys have shown reported benefits in managing other health conditions, accessibility, and providing psychological support.

Association between menstrual cycle length and covid-19 vaccination: global, retrospective cohort study of prospectively collected data.

OBJECTIVES: To identify whether covid-19 vaccines are associated with menstrual changes in order to address concerns about menstrual cycle disruptions after covid-19 vaccination. DESIGN: Global, retrospective cohort study of prospectively collected data. SETTING: International users of the menstrual cycle tracking application, Natural Cycles. PARTICIPANTS: 19 622 individuals aged 18-45 years with cycle lengths of 24-38 days and consecutive data for at least three cycles before and one cycle after covid (vaccinated group; n=14 936), and those with at least four consecutive cycles over a similar time period (unvaccinated group; n=4686). MAIN OUTCOME MEASURES: The mean change within individuals was assessed by vaccination group for cycle and menses length (mean of three cycles before vaccination to the cycles after first and second dose of vaccine and the subsequent cycle). Mixed effects models were used to estimate the adjusted difference in change in cycle and menses length between the vaccinated and unvaccinated. RESULTS: Most people (n=15 713; 80.08%) were younger than 35 years, from the UK (n=6222; 31.71%), US and Canada (28.59%), or Europe (33.55%). Two thirds (9929 (66.48%) of 14 936) of the vaccinated cohort received the Pfizer-BioNTech (BNT162b2) covid-19 vaccine, 17.46% (n=2608) received Moderna (mRNA-1273), 9.06% (n=1353) received Oxford-AstraZeneca (ChAdOx1 nCoV-19), and 1.89% (n=283) received Johnson & Johnson (Ad26.COV2.S). Individuals who were vaccinated had a less than one day adjusted increase in the length of their first and second vaccine cycles, compared with individuals who were not vaccinated (0.71 day increase (99.3% confidence interval 0.47 to 0.96) for first dose; 0.56 day increase (0.28 to 0.84) for second dose). The adjusted difference was larger in people who received two doses in a cycle (3.70 days increase (2.98 to 4.42)). One cycle after vaccination, cycle length was similar to before the vaccine in individuals who received one dose per cycle (0.02 day change (99.3% confidence interval -0.10 to 0.14), but not yet for individuals who received two doses per cycle (0.85 day change (99.3% confidence interval 0.24 to 1.46)) compared with unvaccinated individuals. Changes in cycle length did not differ by the vaccine's mechanism of action (mRNA, adenovirus vector, or inactivated virus). Menses length was unaffected by vaccination. CONCLUSIONS: Covid-19 vaccination is associated with a small and likely to be temporary change in menstrual cycle length but no change in menses length.

Adherence to treatment and prevalence of side effects when medical abortion is delivered via telemedicine: a prospective observational cohort study during COVID-19.

BACKGROUND: The Scottish government introduced legislation during the COVID-19 outbreak to permit medical abortion at home with telemedicine. All women received an initial telephone consultation. For those choosing medical abortion, we provided self-administered medications to eligible women with pregnancies under 12 weeks' gestation. AIMS: To assess adherence to the recommended abortion drug regimen, with particular focus on the number of misoprostol doses used and the interval between mifepristone and misoprostol administration and the induction-expulsion interval. Additionally, to evaluate use of analgesia, antiemetics and antibiotics, and the side effects, pain and bleeding profile of medical abortion at home. METHODS: We conducted a prospective cohort study of 663 women choosing medical abortion at home via telemedicine at an NHS abortion service in Edinburgh, Scotland between 1 April and 9 July 2020. Interviewer-administered questionnaires were completed at telephone follow-up 4 and 14 days following treatment. Outcome measures were self-reported and included use of mifepristone and misoprostol, induction-expulsion interval (time from misoprostol administration until expulsion of pregnancy), antiemetics, antibiotics, analgesia use, pain scores, rates of side effects, bleeding and preparedness for treatment. RESULTS: Among the respondents, 652/663 women (98%) answered at least one questionnaire, and 594/663 (89.6%) used both abortion medications as directed (24-72 hours between medications). The mean (SD) induction-expulsion interval was 4.3 (4.3) hours. Antiemetics were used by 611/663 (92%), 383/599 (64%) completed the course of prophylactic antibiotics, and 616/663 (93%) used analgesia, with mean (SD) worst-pain scores of 6.7 (2.2) out of 10. Regarding side effects, 510/663 (77%) experienced either nausea, vomiting, diarrhoea or headache, 101/663 (15%) experienced headache and 510/663 (77%) experienced bleeding that was heavier than a period; 554/663, (84%) felt prepared for their treatment by teleconsultation. CONCLUSION: Patients are able to correctly self-administer abortion medications following a telemedicine consultation. Further research is required to optimise pain management and gastrointestinal side effects during medical abortion.

Self-reported contraceptive use and satisfaction among women accessing telemedicine medical abortion at the onset of the COVID-19 pandemic at 3-6-month follow-up.

BACKGROUND: Changes in legislation due to COVID-19 led to the introduction of telemedicine for early medical abortion (EMA) at home in Scotland. The opportunity to provide contraception at presentation may be more limited with this model of care. We compared contraceptive use immediately post-abortion with 3-6 months later to determine if contraceptive needs were being met. METHODS: We contacted 579 women by telephone call or text message who agreed to be involved in a service evaluation of telemedicine EMA in NHS Lothian at 3-6 months post-abortion. A research nurse administered a questionnaire on the women's current contraception use. The research nurses also offered women support in switching or initiating contraception via the abortion service if desired. RESULTS: The response rate to the contact was 57% (331/579). Under a third of the women (30%, 98/331) were using the progestogen-only pill (POP) at 3-6 month follow-up, a significant decrease (p<0.00) compared with 65% (215/331) who were provided with POP at the time of abortion. Thirty-nine women (12%) were provided with contraception through this telephone contact, leading to a significant increase in the proportion using subdermal implants, the progestogen injectable or intrauterine contraception. CONCLUSIONS: This study shows that there was a decrease in the use of the POP 3-6 months after telemedicine EMA during the COVID-19 pandemic. Telephone contact at 3-6 months to facilitate obtaining contraception may be a promising strategy to improve access to effective methods with this model of abortion care.

Uptake of long-acting reversible contraception after telemedicine delivered abortion during Covid-19.

BACKGROUND: During COVID-19, early medical abortion (EMA) at home in Scotland was largely delivered by telemedicine. Short-acting post-abortion contraception was provided with EMA medications, but long-acting reversible contraception (LARC) (implant, injectable and intrauterine device) required an in-person visit. We wished to assess LARC uptake following telemedicine abortion, and factors associated with method receipt. METHODS: A prospective observational cohort study of patients accessing abortion via NHS Lothian (October 2020 to February 2021). Patients were offered contraception at telemedicine consultation and their choice was recorded in their clinical notes. Those wishing LARC were directed to the service's rapid-access LARC clinic. We reviewed electronic patient records six weeks post-abortion to determine whether patients received their chosen method. RESULTS: 944 patients had an abortion; 768 (81.4%) had EMA, 131 (13.9%) had a medical or surgical abortion in hospital. The most popular contraceptive method was the progestogen-only pill (n = 324, 34%). 330 patients (35%) requested LARC but less than half (153/330; 46%) received this. Of patients choosing LARC, those who attended the clinic for a pre-abortion ultrasound, or had an abortion in hospital, were more likely to initiate LARC than those having full telemedicine EMA. Nulliparity, gestation over 7 weeks, and age under-26 years were also positively associated with initiating LARC. CONCLUSION: During COVID-19 there was demand for post-abortion LARC but less than half of patients received this by six weeks. Provision was enhanced when in-person clinical interactions took place. Interventions are required to facilitate timely access and initiation of LARC with telemedicine delivered abortion care.

Should COVID-specific arrangements for abortion continue? The views of women experiencing abortion in Britain during the pandemic.

BACKGROUND: During the COVID-19 pandemic, the British governments issued temporary approvals enabling the use of both medical abortion pills, mifepristone and misoprostol, at home. This permitted the introduction of a fully telemedical model of abortion care with consultations taking place via telephone or video call and medications delivered to women's homes. The decision was taken by the governments in England and Wales to continue this model of care beyond the original end date of April 2022, while at time of writing the approval in Scotland remains under consultation. METHODS: We interviewed 30 women who had undergone an abortion in England, Scotland or Wales between August and December 2021. We explored their views on the changes in abortion service configuration during the pandemic and whether abortion via telemedicine and use of abortion medications at home should continue. RESULTS: Support for continuation of the permission to use mifepristone and misoprostol at home was overwhelmingly positive. Reasons cited included convenience, comfort, reduced stigma, privacy and respect for autonomy. A telemedical model was also highly regarded for similar reasons, but for some its necessity was linked to safety measures during the pandemic, and an option to have an in-person interaction with a health professional at some point in the care pathway was endorsed. CONCLUSIONS: The approval to use abortion pills at home via telemedicine is supported by women having abortions in Britain. The voices of patients are essential to shaping acceptable and appropriate abortion service provision.

Perspectives of obstetricians and midwives on the provision of immediate postpartum intrauterine devices: a qualitative service evaluation.

BACKGROUND: Immediate postpartum intrauterine device (PPIUD) insertion is safe and effective but largely unavailable in Europe. Data on maternity staff views on the provision and implementation of PPIUD services are limited. The objective of this qualitative evaluation was to explore the views and experiences of obstetricians and midwives providing PPIUD within a UK maternity setting, in order to identify areas for improvement and inform service provision in other areas. METHODS: Qualitative health services research within two public maternity hospitals in Lothian (Edinburgh and surrounding region), UK. Interviews with 30 maternity staff (obstetricians n=8; midwives n=22) involved in PPIUD provision. Data were analysed thematically. RESULTS: Maternity staff were positive about the benefits of PPIUD for women. Midwives reported initial concerns about PPIUD safety, and the impact on workload; these views shifted following training, and as PPIUD was embedded into practice. Having a large pool of PPIUD-trained staff was identified as an important factor in successful service implementation. Having PPIUD 'champions' was important to address staff concerns, encourage training uptake, and advocate for the service to ensure continued resourcing. CONCLUSIONS: PPIUD in maternity services can help address unmet need for effective contraception in the immediate postpartum period. We emphasise the importance of widespread engagement around PPIUD among all healthcare professionals involved in the care of women, to ensure staff are informed and supported. Clinical champions and leaders play a key role in amplifying the benefits of PPIUD, and advancing organisational learning.

Utility of a routine ultrasound for detection of ectopic pregnancies among women requesting abortion: a retrospective review.

INTRODUCTION: Routine ultrasound may be used in abortion services to determine gestational age and confirm an intrauterine pregnancy. However, ultrasound adds complexity to care and results may be inconclusive, delaying abortion. We sought to determine the rate of ectopic pregnancy and the utility of routine ultrasound in its detection, in a community abortion service. METHODS: Retrospective case record review of women requesting abortion over a 5-year period (2015-2019) with an outcome of ectopic pregnancy or pregnancy of unknown location (PUL) at a service (Edinburgh, UK) conducting routine ultrasound on all women. Records were searched for symptoms at presentation, development of symptoms during clinical care, significant risk factors and routine ultrasound findings. RESULTS: Only 29/11 381 women (0.25%, 95% CI 0.18%, 0.33%) had an ectopic pregnancy or PUL (tubal=18, caesarean scar=1, heterotopic=1, PUL=9). Eleven (38%) cases had either symptoms at presentation (n=8) and/or significant risk factors for ectopic pregnancy (n=4). A further 12 women developed symptoms during their clinical care. Of the remaining six, three were PUL treated with methotrexate and three were ectopic (salpingectomy=2, methotrexate=1). In three cases, the baseline ultrasound indicated a probable early intrauterine pregnancy. CONCLUSIONS: Ectopic pregnancies are uncommon among women presenting for abortion. The value of routine ultrasound in excluding ectopic pregnancy in symptom-free women without significant risk factors is questionable as it may aid detection of some cases but may provide false reassurance that a pregnancy is intrauterine.

A qualitative study of abortion care providers' perspectives on telemedicine medical abortion provision in the context of COVID-19.

BACKGROUND: Telemedicine for medical abortion care was rapidly introduced in Great Britain in response to the COVID-19 pandemic. A growing body of literature demonstrates that telemedicine abortion care is safe, effective and highly acceptable to patients. Less is known about the perspectives of abortion care providers (ACPs). METHODS: Qualitative research within the telemedicine abortion service in Lothian (Edinburgh and surrounding region), UK. We conducted qualitative in-depth interviews with ACPs between May and July 2020 (doctors, n=6; nurses, n=10) and analysed the data thematically. RESULTS: We present three themes from our qualitative analysis: (1) Selective use of ultrasound - the move away from routine ultrasound for determination of gestational age was generally viewed positively. Initial anxiety about non-detection of ectopic pregnancy and later gestations was expressed by some ACPs, but concerns were addressed through clinical practice and support structures within the clinic. (2) Identifying safeguarding issues - in the absence of visual cues some ACPs reported concerns about their ability to identify safeguarding issues, specifically domestic violence. Conversely it was acknowledged that teleconsultations may improve detection of this in some situations. (3) Provision of information during the consultation - telephone consultations were considered more focused than in-person consultations and formed only part of the overall 'package' of information provided to patients, supplemented by online and written information. CONCLUSIONS: ACPs providing telemedicine abortion care value this option for patients and believe it should remain beyond the COVID-19 pandemic. Safeguarding patients and the selective use of ultrasound can be initially challenging; however, with experience, staff confidence improves.

Telemedicine medical abortion at home under 12 weeks' gestation: a prospective observational cohort study during the COVID-19 pandemic.

BACKGROUND: In response to the COVID-19 pandemic, legislation and guidance were introduced in Scotland permitting medical abortion at home by telemedicine for pregnancies at less than 12 weeks' gestation. Women had a telephone consultation with a clinician. Routine ultrasound was not performed. Medications and a low-sensitivity pregnancy test to confirm success of treatment were collected by or delivered to the woman, with telephone support provided as needed. METHODS: A prospective cohort study of 663 women choosing medical abortion at home via the NHS Lothian telemedicine abortion service between 1 April and 9 July 2020. Interviewer-administered questionnaires were completed 4 and 14 days following treatment. Regional hospital databases were reviewed to verify abortion outcomes and complications within 6 weeks. Outcome measures included efficacy, complications and acceptability. RESULTS: Almost all (642/663, 98.2%) the women were under 10 weeks' gestation. For 522/663 (78.7%) women, gestation was determined using last menstrual period alone. Some 650/663 (98%) women had a complete abortion, 5 (0.8%) an ongoing pregnancy and 4 (0.6%) an incomplete abortion. No one was treated inadvertently beyond 12 weeks' gestation, but one woman was never pregnant. One woman who had a pre-abortion ultrasound was later managed as a caesarean scar ectopic. There were two cases of haemorrhage and no severe infections. Some 123 (18.5%) women sought advice by telephone for a concern related to the abortion and 56 (8.4%) then attended a clinic for review. Most (628, 95%) women rated their care as very or somewhat acceptable. CONCLUSIONS: This model of telemedicine abortion without routine ultrasound is safe, and has high efficacy and high acceptability among women.

Abortion regulation in Europe in the era of COVID-19: a spectrum of policy responses.

BACKGROUND: Unprecedented public health actions restricting movement and non-COVID related health services are likely to have affected abortion care during the pandemic in Europe. In the absence of a common approach to ensure access to this essential health service, we sought to describe the variability of abortion policies during the outbreak in Europe in order to identify strategies that improve availability and access to abortion in times of public health crises. METHODS: We collected information from 46 countries/regions: 31 for which country-experts completed a survey and 15 for which we conducted a desk review. We describe abortion regulations and changes to regulations and practice during the pandemic. RESULTS: During COVID-19, abortions were banned in six countries and suspended in one. Surgical abortion was less available due to COVID-19 in 12 countries/regions and services were not available or delayed for women with COVID-19 symptoms in eleven. No country expanded its gestational limit for abortion. Changes during COVID-19, mostly designed to reduce in-person consultations, occurred in 13 countries/regions. Altogether eight countries/regions provided home medical abortion with mifepristone and misoprostol beyond 9 weeks (from 9 weeks+6 days to 11 weeks+6 days) and 13 countries/regions up to 9 weeks (in some instances only misoprostol could be taken at home). Only six countries/regions offered abortion by telemedicine. CONCLUSIONS: The lack of a unified policy response to COVID-19 restrictions has widened inequities in abortion access in Europe, but some innovations including telemedicine deployed during the outbreak could serve as a catalyst to ensure continuity and equity of abortion care.