Using telemedicine to improve early medical abortion at home (UTAH): a randomised controlled trial to compare telemedicine with in-person consultation for early medical abortion.

OBJECTIVES: To compare telephone consultations with in-person consultations for the provision of medical abortion (using mifepristone 200 mg and misoprostol 800 µg). We hypothesised that telemedicine consultations would be non-inferior to in-person consultations with a non-inferiority limit of 3%. DESIGN: Randomised controlled trial with 1:1 allocation. SETTING: Community abortion service housed within an integrated sexual and reproductive health service in Edinburgh, UK. PARTICIPANTS: The trial began on 13 January 2020, but was stopped early due to COVID-19; recruitment was suspended on 31 March 2020, and was formally closed on 31 August 2021. A total of 125 participants were randomised, approximately 10% of the total planned, with 63 assigned to telemedicine and 62 to in-person consultation. PRIMARY AND SECONDARY OUTCOME MEASURES: Primary outcome: efficacy of medical abortion, defined as complete abortion without surgical intervention. SECONDARY OUTCOMES: satisfaction with consultation type, preparedness, unscheduled contact with care, complication rate, time spent in clinical contact and uptake of long-acting contraception. RESULTS: Primary outcome was available for 115 participants (lost-to-follow-up telemedicine=2, in-person=8), secondary outcomes were available for 110 participants (n=5 and n=10 in telemedicine and in-person groups did not complete questionnaires). There were no significant differences between groups in treatment efficacy (telemedicine 57/63 (90.5%), in-person 48/62 (77.4%)). However, non-inferiority was not demonstrated (+3.3% in favour of telemedicine, CI -6.6% to +13.3%, lower than non-inferiority margin). There were no significant differences in most secondary outcomes, however, there was more unscheduled contact with care in the telemedicine group (12 (19%) vs 3 (5%), p=0.01). The overall time spent in clinical contact was statistically significantly lower in the telemedicine group (mean 94 (SD 24) vs 111 (24) min, p=0.0005). CONCLUSIONS: Telemedicine for medical abortion appeared to be effective, safe and acceptable to women, with less time spent in the clinic. However, due to the small sample size resulting from early cessation, the study was underpowered to confirm this conclusion. These findings warrant further investigation in larger scale studies. TRIAL REGISTRATION NUMBER: NCT04139382.

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.

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.

Views of clinicians towards providing contraceptive advice and contraception to women following early pregnancy loss: a qualitative study.

INTRODUCTION: National guidelines advise that clinicians caring for women post-pregnancy should give women opportunities to discuss contraception, regardless of pregnancy outcome, and provide contraception to women who choose to take up a method. This study aimed to explore knowledge, views and needs of Early Pregnancy Unit (EPU) clinicians around discussing and offering contraception and discussing pregnancy intendedness with women after early pregnancy loss using a qualitative approach. METHODS: Semi-structured, audio-recorded interviews with 11 clinicians from a single regional EPU in Edinburgh, Scotland. Interviews were transcribed verbatim and analysed thematically. RESULTS: Clinicians were reluctant to discuss contraception as they believed women would find the topic overwhelming and distressing. Thoughts on discussing pregnancy intendedness were polarised; some considered it insensitive, and others essential. Barriers to discussing contraception and providing it were numerous and included time pressure, and inadequate knowledge and training on contraception. Participants suggested training on contraception, closer working with sexual and reproductive health (SRH) services, and availability of information on contraception specifically aimed at women who have experienced an early pregnancy loss could facilitate discussions and method provision. CONCLUSIONS: EPU clinicians require ongoing training and support to be effective at discussing pregnancy intendedness and discussing and providing post-pregnancy contraception. This will require close working with SRH services and development of sensitive information around contraception for women experiencing an early pregnancy loss.

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.

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.

UTAH: Using Telemedicine to improve early medical Abortion at Home: a protocol for a randomised controlled trial comparing face-to-face with telephone consultations for women seeking early medical abortion.

INTRODUCTION: Early medical abortion (EMA) is a two-stage process of terminating pregnancy using oral mifepristone (a progesterone-receptor antagonist) followed usually 1-2 days later by sublingual, vaginal or buccal misoprostol (a prostaglandin analogue). There are no published randomised controlled trials (RCTs) on the use of telemedicine for EMA. Our proposed research will determine if telephone consultations for EMA (the most common method of abortion in the UK) is non-inferior to standard face-to-face consultations with regard to the efficacy of EMA. METHODS AND ANALYSIS: This study will be conducted as an RCT. The recruitment target is 1222 participants.The primary outcome is success of EMA (complete abortion rate). This will be determined based on a negative low-sensitivity urine pregnancy test result (2 weeks after misoprostol use) and absence of surgical intervention or diagnosis of ongoing pregnancy (within 6 weeks of misoprostol).Secondary outcomes include total time spent at a clinic appointment to receive EMA, self-reported preparedness for EMA, level of satisfaction with consultation and effective contraception uptake compared with when women attend for a face-to-face consultation.The main analysis will be a modified intention-to-treat analysis. This will include all randomised women (with a viable pregnancy) using EMA and follow-up for the main outcome. The study initiated on 13 January 2020 and is anticipated to finish in late 2021. ETHICS AND DISSEMINATION: Ethical approval was given by the South East Scotland NHS Research Ethics Committee, reference: 19/SS/0111. Results will be published in peer-reviewed journals, presented at clinical and academic meetings, and shared with participants via the clinic website. TRIAL REGISTRATION NUMBER: NCT04139382.

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.

High rates of treatment failure for Mycoplasma genitalium among men and women attending a sexual health clinic.

BACKGROUND: Mycoplasma genitalium (Mgen) causes non-gonococcal urethritis (NGU) and is believed to cause pelvic inflammatory disease (PID). High rates of macrolide resistance are well documented globally for Mgen. In Brighton, patients with NGU and PID are tested for Mgen and test of cure (TOC) offered post-treatment. METHODS: Demographic, clinical and treatment history data were collected over a 12-month period for all Mgen-positive patients in a Brighton-based genitourinary clinic. RESULTS: There were 114 patients with Mgen. 18% (61/339) of men with NGU and 9% (15/160) of women with PID had Mgen. 62/114 (54%) returned for first test TOC 4 weeks after treatment. 27/62 (44%) had a positive TOC; 25/27 (92.6%) had received azithromycin first line (500 mg stat then 250 mg OD for 4 days), 1/27 (3.7%) had received moxifloxacin first line (400 mg OD for 14 days) and 1/27 (3.7%) had received doxycycline first line (100 mg BD for 7 days). 20/27 (74%) returned for a second TOC 4 weeks later. 5/20 (25%) patients were positive on second TOC; 3/5 (60%) had received azithromycin second line and 2/5 (40%) had received moxifloxacin second line. Patients were more likely to have a positive TOC if they were at risk of reinfection (9/27 positive TOC vs 3/35 negative TOC; p=0.02). Patients given moxifloxacin were more likely to have a negative TOC (1/27 positive TOC vs 9/35 negative TOC; p=0.03) than those who received other antibiotic regimens. CONCLUSIONS: Treatment failure rates for Mgen following azithromycin use are substantial, raising concerns regarding resistance. However, reinfection risk may contribute, suggesting a requirement for improved public awareness and clinician knowledge.

Male contraception: where are we going and where have we been?

Progress in developing new reversible male contraception has been slow. While the hormonal approach has been clearly shown to be capable of providing effective and reversible contraception, there remains no product available. Currently, trials of a self-administered gel combination of testosterone and the progestogen Nestorone® are under way, complementing the largely injectable methods previously investigated. Novel long-acting steroids with both androgenic and progestogenic activity are also in early clinical trials. The non-hormonal approach offers potential advantages, with potential sites of action on spermatogenesis, and sperm maturation in the epididymis or at the vas, but remains in preclinical testing. Surveys indicate the willingness of men, and their partners, to use a new male method, but they continue to lack that opportunity.

Delayed presentation of uterine and bowel perforation following insertion of an intrauterine device.

INTRODUCTION: Insertion of intrauterine methods of contraception (IUC) carries an inherent but small risk of perforation of the uterus, usually quoted at 2 in 1000. If perforation occurs, it is usually discovered either when a patient presents with 'missing threads' or with an unplanned pregnancy. Rarely, if the IUC has perforated bowel, patients can present acutely unwell although this sometimes occurs years after insertion. Asymptomatic perforation of the bowel (with IUC insertion or otherwise) is not common. CASE HISTORY: In January 2018, a 41-year-old woman attended our community sexual and reproductive health service requesting removal of her intrauterine system (IUS). The clinic nurse performed this and during the consultation the patient revealed that several days earlier she had passed a previous 'lost' intrauterine device (IUD) when she opened her bowels. She came to believe this was an IUD inserted in 2006 that had been 'lost' and resulted in a pregnancy with her third child. We counselled her about her options and she had the IUS removed as she was worried this could happen again and opted to use condoms. CONCLUSION: This case reports an unusual presentation of a delayed and importantly 'silent' perforation of the uterus and bowel on insertion of IUC. The case highlights the importance of cross-specialty communication when an IUD has perforated or expelled resulting in a continuing pregnancy, so that appropriate imaging can be arranged following delivery of the baby.

Accuracy of a point-of-care test for quantifying human chorionic gonadotrophin (hCG) in the management of pregnancy of unknown location in an abortion service.

INTRODUCTION: Women may seek abortion at gestations when there is no visible intrauterine pregnancy on ultrasound scanning. Clinical protocols for pregnancy of unknown location (PUL) require measurement of serum human chorionic gonadotrophin (hCG), with the National Institute for Health and Care Excellence recommending that values above 1500 IU/L be further investigated to exclude ectopic pregnancy. Our aim was to determine whether a point-of-care test (POCT) could be used instead of laboratory serum hCG measurement. METHODS: Over 12 months, women who presented to an abortion service with a PUL had a POCT for blood or urine hCG and laboratory serum hCG measurement. The POCT machine used provides a discrete hCG value below 1000 IU/L and above this gives results as a range. The sensitivity and specificity of the POCT in identifying cases where laboratory serum hCG results were above 1500 IU/L were calculated. RESULTS: A total of 118 women presented with a PUL, of whom 70 had a POCT on blood (n=49) or urine (n=21) and a corresponding laboratory serum hCG. The sensitivity of the blood POCT was 0.67 (95% CI 0.38 to 0.87) and the specificity was 0.97 (95% CI 0.83 to 0.99). The sensitivity of the urine POCT was 0.25 (CI 0.01 to 0.78) and the specificity was 0.94 (CI 0.69 to 0.99). CONCLUSION: Although both the blood and urine POCTs had a high level of specificity, neither test was acceptably sensitive. While promising, this POCT for hCG is not sufficiently reliable to replace laboratory serum hCG testing in the management of women with PUL in an abortion service.