Efficacy and safety of medical termination of pregnancy in a regional primary care setting.

BACKGROUND: Australia has demonstrated high efficacy and safety of medical termination of pregnancy (MToP) using a mifepristone-buccal misoprostol regime. The provision of medical termination services in primary care has the potential to alleviate access barriers, particularly in rural and regional populations. Large-scale data are needed to support the expansion of this model. AIM: The aim was to determine the efficacy and safety of nurse-led MToP within a regional general practice clinic. METHODS: A retrospective cohort study of patients prescribed MToP from October 2014 to April 2020. Clinic nurses assessed patient eligibility and provided information, non-directive counselling and instructions. The general practitioner then confirmed eligibility, obtained informed consent and prescribed. Patients were administered 200 mg of mifepristone orally in a pharmacy and then self-administered 800-µg buccal misoprostol 36-48 h later at home. RESULTS: A total of 998 patients were included in this study, with the median patient age being 27.3 years and 30.3% of patients travelling over 100 km to access the service. MToP was successful in 965 (96.7%) patients. There were 36 (3.6%) complications, of which 33 were incomplete MToP. Haemorrhage requiring transfusion, pain requiring hospital treatment and suspected infection were rare, each having a frequency of one (0.1%). Our follow-up rate was 74.8%, with a strong correlation identified between increased gestational age and decreased follow-up (P < 0.001). CONCLUSION: This study is a large Australian example demonstrating high efficacy and safety of nurse-led MToP within regional general practice. The establishment of similar services in rural and regional Australia may address geographical and financial barriers to termination access.

Medical Termination of Pregnancy (MToP) in the 1st trimester - the role of human chorionic gonadotropin and ultrasound in pregnancy diagnosis and MToP follow-up.

OBJECTIVE: In the Czech Republic, it is possible, to carry out Medical Termination of Pregnancy (MToP) in the 1st trimester up until the 49th day of secondary amenorrhea. The aim of the study is to analyse the significance of serum/urine human chorionic gonadotropin (hCG) assessment and ultrasound (US) examination in pregnancy diagnosis and MToP follow-up. METHODS: In 2017-2018, MToP was carried out in a total of 109 women by administering a combination of mifepristone (600 mg orally) and misoprostol (400 mcg orally). Serum/urine (LSUP - low sensitivity urine pregnancy test) hCG assessment and US examination were performed at pregnancy diagnosis and MToP follow-up. RESULTS: At pregnancy diagnosis, there was a positive and medium strong correlation between serum hCG and size of the gestational sac - GS (R = 0.711; P  1,000 IU/L and LSUP test was always positive). In 5.5% of women (6/109), a subsequent surgical intervention was carried out including those with ongoing pregnancy (N = 5); missed abortion (N = 1) was treated by additional misoprostol, where surgical intervention was not necessary. CONCLUSION: At pregnancy diagnosis, there is a positive and medium strong correlation between serum hCG and CRL. In MToP follow-up, a negative LSUP test enables reliable exclusion of ongoing pregnancy and missed abortion. In case of a positive LSUP test, US examination should be performed; however, surgical intervention should not be indicated solely on the basis of uterine cavity dilatation.

Risk of preterm delivery after medically indicated termination of pregnancy with induced vaginal delivery: a case-control study.

We investigated whether nonsurgical termination of pregnancy after 14 weeks of gestation increases the risk of preterm delivery in a subsequent pregnancy. We conducted a two-centre retrospective case-control study. Patients who underwent non-surgical termination of pregnancy after 14 weeks of gestation between 2012 and 2015 and who gave birth after 14 weeks of gestation to a live-born singleton infant were included. Control patients were those who gave birth after 37 weeks of gestation (the same month as a case patient) and had a second delivery of a singleton foetus after 14 weeks of gestation. The primary outcome was preterm delivery during the second pregnancy period. We included 151 cases and 302 controls and observed 13 (8.6%) preterm births during the second pregnancy in the case group versus 8 (2.6%) (odds ratio: 3.62; 95% confidence interval: 1.40-8.65, p < .001) in the control group. This result remained significant after multivariate analysis. Impact statementWhat is already known about this topic? Many studies have evaluated the association between first-trimester surgical or non-surgical termination of pregnancy and the risk of preterm birth in the subsequent pregnancy. However, no study has evaluated the association between second- or third-trimester non-surgical termination of pregnancy due to foetal disease and the risk of preterm birth in the subsequent pregnancy. A small number of studies have included a small proportion of patients who previously underwent non-surgical termination of pregnancy after 14 weeks of gestation and later experienced first-trimester termination during their second pregnancy. These studies focussed on the impact of the interpregnancy interval or pharmacological induction of labour on the risk of preterm delivery in the subsequent pregnancy.What did the results of this study add? This is the first study to specifically evaluate the association between second- and third-trimester non-surgical terminations of pregnancy and the risk of preterm birth in the subsequent pregnancy. When compared with term birth, nonsurgical termination of pregnancy was associated with the risk of spontaneous preterm birth and hospitalisation in the neonatal intensive care unit in the subsequent pregnancy.What are the implications of these findings for clinical practice and further research? Further studies are required to confirm our results, but information delivered to patients with a late termination of pregnancy and during their pregnancy follow-up for the subsequent pregnancy could be modified to provide this information.

[Medical termination of pregnancy for maternal psychosocial distress]. / L'interruption médicale de grossesse pour détresse maternelle psychosociale.

Medical termination of pregnancy when decided for maternal psychosocial distress is a new issue facing maternity field teams. Multidisciplinary work is required, as well as respect for the patients' temporality. The decision is collegial, estimating the least traumatic impact possible for them over the long term. The ethical principles of beneficence and non-maleficence guide the work of the team and the evaluation of the psychiatrist in this context.

[Specificities of antenatal grief]. / Spécificités du deuil anténatal.

Taking into account the pain of antenatal bereavement is relatively recent. If the stages of elaboration of this mourning are identical compared to those of other close persons, nevertheless it has some particularities. The status of the fetus is singular, an integral part of the mother's body, but without legal existence. The psychological context in which the mourning takes place is marked by a profound psychic transformation. Finally, the impact on parental narcissism must be taken into account.

Follow-up strategies to confirm the success of medical abortion of pregnancies up to 10 weeks' gestation: a systematic review with meta-analyses.

OBJECTIVE: To compare the effectiveness, safety, and acceptability of in-clinic and remote/self-assessment, as well as different remote/self-assessments, for confirming the success of medical abortion at ≤10+0 weeks' gestation. DATA SOURCES: Ovid Embase Classic and Embase; Ovid MEDLINE(R) and Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations and Daily; and the Cochrane Library. We also consulted experts in this field for any ongoing or missed trials. STUDY ELIGIBILITY CRITERIA: Randomized controlled trials published in English from 2000 onward, comparing in-clinic assessment with ultrasound to remote or self-assessment or comparing different remote or self-assessment strategies to confirm the success of medical abortion of pregnancies up to and including 10+0 weeks gestation, reporting any of the following outcomes: "missed ongoing pregnancy," "correct implementation of the follow-up strategy," patient satisfaction/preference, "adherence to follow-up strategy," "unscheduled visits/telephone calls to the abortion service," and surgical intervention. STUDY APPRAISAL AND SYNTHESIS METHODS: One author assessed the risk of bias in the studies using the Cochrane Collaboration checklist for randomized controlled trials. All outcomes were analyzed as risk ratios and meta-analysed in Review Manager 5.3 using the Mantel-Haenszel statistical method and a fixed effect model. The overall quality of the evidence was assessed using GRADE. RESULTS: Four randomized controlled trials (n = 5761) compared in-clinic to remote self-assessment and found no clinically significant differences apart from higher preference rates for remote follow-up, especially in the remote follow-up groups. The quality of this evidence was compromised by attrition, no blinding, inconsistency, indirectness, and low event rates. Two randomized controlled trials (n = 1125) compared different remote assessment strategies (using urine pregnancy tests) and also found no clinically significant differences apart from a clinically significantly lower rate of unscheduled visits to the abortion service in the remote follow-up group using a multilevel urine pregnancy test compared to remote follow-up using a high-sensitivity urine pregnancy test. The quality of this evidence was compromised by small event rates, lack of blinding, indirectness and high attrition rates. CONCLUSION: The published data support offering women who have had a medical abortion up to and including 10+0 weeks' gestation the choice of self-assessment, remote assessment, or clinic follow-up.

Pain management for medical and surgical termination of pregnancy between 13 and 24 weeks of gestation: a systematic review.

BACKGROUND: High-quality care for termination of pregnancy (TOP) requires pain to be effectively managed; however, practices differ, and the available guidelines do not specify optimal strategies. OBJECTIVE: To guide providers in effective pain management for second-trimester medical and surgical TOP. SEARCH STRATEGY: We searched PubMed, Cochrane and Embase databases, and the US National Library of Medicine clinical trials registry, from inception to the end of June 2019, and hand-searched reference lists. SELECTION CRITERIA: Trials comparing pain management strategies with no treatment, placebo or active interventions during induced medical or surgical TOP, occurring between 13 and 24 weeks of gestation, and reporting direct or indirect measures of pain. DATA COLLECTION AND ANALYSIS: Both authors summarised and systematically assessed the evidence and risk of bias using standard tools. MAIN RESULTS: We included seven medical and four surgical TOP studies, with 453 and 349 participants, respectively. The heterogeneity of interventions and outcomes prevented pooled analyses. Medical TOP: women receiving routine or continuous epidural analgesia experienced mild pain. The prophylactic use of nonsteroidal anti-inflammatory drugs (NSAIDs) decreased pain (mean difference -0.5, P < 0.001) and additional opioid requirements (3.5 versus 7 mg, P = 0.04) compared with placebo/other treatment. Paracervical block was ineffective. No studies assessed intramuscular (IM)/intravenous (IV) opioid or nonpharmacological treatment. Surgical TOP: general anaesthesia/deep IV sedation alleviated pain. Nitrous oxide was ineffective. No studies assessed moderate IV sedation, IV/IM opioid, paracervical block without sedation, NSAID or nonpharmacological treatment. CONCLUSION: Based on limited data, regional analgesia and NSAIDs mitigated second-trimester medical TOP pain; general anaesthesia/deep IV sedation alleviated surgical TOP pain. TWEETABLE ABSTRACT: Although women experience intense pain during second-trimester termination of pregnancy, few data are available to inform their treatment.

Initiation of abortion before there is definitive ultrasound evidence of intrauterine pregnancy: A systematic review with meta-analyses.

INTRODUCTION: Women are increasingly presenting for abortion at very early gestation. However, providers may be reluctant to conduct abortion at this stage as they may be concerned that they cannot exclude an ectopic pregnancy or that they may terminate a non-viable pregnancy, or may be concerned that both medical and surgical methods may be less effective at this stage of gestation. This provider concern may result in delays in the abortion as additional investigations may be required until an intrauterine pregnancy can be confirmed. Additional unnecessary visits may be distressing for women and waste health service resources. The objective of this systematic review was to determine whether it is safe and effective to initiate abortion before there is ultrasound evidence of an intrauterine pregnancy. MATERIAL AND METHODS: We searched Embase Classic, Embase; Ovid MEDLINE® Epub Ahead-of-Print, In-Process & Other Non-Indexed Citations, Ovid MEDLINE® Daily, Ovid MEDLINE®; and Cochrane Library on 25 October 2019. Eligible studies were randomized and non-randomized comparative studies, published in English from 1985, comparing initiation of abortion before there is definitive evidence of an intrauterine pregnancy with initiation afterwards. We assessed risk-of-bias using the Newcastle-Ottowa scale. All outcomes were analyzed as risk ratios (RR) and meta-analyzed using the Mantel-Haenszel method. The quality of the evidence was assessed using GRADE. RESULTS: Two non-randomized studies (n = 3785) showed no differences in "missed ectopic pregnancy" (RR = 0.26, 95% CI 0.03-2.12), "ongoing pregnancy" (RR = 1.06, 95% CI 0.34-3.34), or "complete abortion without surgical intervention" (RR = 1, 95% CI 0.98-1.02) between initiation of medical abortion before or after ultrasound evidence of an intrauterine pregnancy. A third non-randomized study (n = 1530) showed no differences between initiation of surgical abortion before or after ultrasound evidence of an intrauterine pregnancy in "missed ectopic pregnancy" (no events), "ongoing pregnancy" (RR = 0.56, 95% CI 0.03-11.59) or "complete abortion without repeat surgical intervention" (RR = 1, 95% CI 0.99-1.01). The quality of evidence was very low. CONCLUSIONS: Initiation of abortion before there is definitive ultrasound evidence of an intrauterine pregnancy in women without signs or symptoms of an ectopic pregnancy should be considered.

Slow implementation of mifepristone medical termination of pregnancy in Quebec, Canada: a qualitative investigation.

Objectives: Mifepristone for first-trimester medical termination of pregnancy (MTOP) became available in Quebec in 2018, one year after the rest of Canada. Using the theory of the Diffusion of Innovation (DOI) and the transtheoretical model of change (TTM), we investigated factors influencing the implementation of mifepristone MTOP in Quebec.Material and Methods: Semi-structured interviews were conducted with 37 Quebec physicians in early 2018. Deductive thematic analysis guided by the theory of DOI explored facilitators and barriers to physicians' adoption of mifepristone MTOP. We then classified participants into five stages of mifepristone adoption based on the TTM. Follow-up data collection one year later assessed further adoption.Results: At baseline, three physicians provided mifepristone MTOP (Maintenance) and two were about to start (Action). Thirteen physicians at Preparation and Advanced Contemplation stages intended to start while, within the Slow Contemplation, two intended to start and ten were unsure. Seven had no intention to provide mifepristone MTOP (Pre-Contemplation). Major reported barriers were: complexity of local health care organisations, medical policy restrictions, lack of support, and general uncertainty. One year later, ten physicians provided mifepristone MTOP (including three at baseline) and nine still intended to, while seventeen did not intend to start provision. Seven of sixteen participants (44%) who worked in TOP clinics at baseline were still not providing MTOP with mifepristone one year later.Conclusion: Despite ideological support, mifepristone MTOP uptake in Quebec is slow and laborious, mainly due to restrictive medical policies, vested interests in surgical provision and administrative inertia.

Intra-amniotic digoxin for feticide between 21 and 30 weeks of gestation: a prospective study.

OBJECTIVE: Intra-amniotic injection of digoxin is a well-known method for feticide before inducing a termination of pregnancy (TOP) at 17-24 weeks of gestation. Information on its effectiveness when administered after 24 weeks of gestation is limited. This study evaluated the efficacy of intra-amniotic digoxin injection for inducing fetal demise within 18-24 hours, at 21-30 weeks of gestation, and its safety. DESIGN: Prospective cohort study. SETTING: Tertiary university medical centre. POPULATION: Women at 21-30 weeks of gestation with a singleton pregnancy, admitted for TOP. METHODS: Intra-amniotic injection of 2 mg of digoxin was performed 1 day before medical TOP. Fetal heart activity was evaluated by ultrasound for 18-24 hours after the injection. Serum digoxin level and maternal electrocardiogram (ECG) were evaluated 6, 10, and 20 hours after injection. MAIN OUTCOME MEASURE: Frequency of successful fetal demise. RESULTS: Fifty-nine women participated in the study. The mean gestational age was 24+2  weeks (range 21+0 -30+0 ), with 29 (49.2%) beyond 24+0  weeks of gestation. Fetal cardiac activity arrest was achieved in 55/59 cases (93.2%). Normal maternal ECG recordings were noted in all cases. Mean serum digoxin levels 6 and 10 hours after injection were in the therapeutic range (1.3 ± 0.7 ng/l and 1.24 ± 0.49 ng/l, respectively) and below the toxic level (2 ng/l). Extramural delivery following digoxin did not occur. There were no cases of chorioamnionitis. CONCLUSION: Intra-amniotic digoxin for feticide at 21-30 weeks of gestation in a singleton pregnancy appears effective and safe before TOP at advanced gestational ages. TWEETABLE ABSTRACT: This study shows that feticide by intra-amniotic digoxin injection at 21-30 weeks of gestation appears effective and safe.

Snapshot of medication abortion provision in the primary health care setting of regional and rural Victoria.

OBJECTIVE: This study aimed to identify enablers and barriers to the provision of medication abortion in the primary health care setting of regional and rural areas of Victoria, Australia. DESIGN: An online cross-sectional questionnaire was used. SETTING: Regional and rural areas of Victoria, Australia. PARTICIPANTS: Thirty-nine GPs and 30 primary health care nurses. MAIN OUTCOME MEASURES: Abortion views, medication abortion knowledge and practice, interest in medication abortion training and provision, and perceived uptake barriers. RESULTS: Most participants reported being consulted by women with unintended pregnancies and most of them included abortion counselling in their consultation. However, familiarity with provision of medication abortion was limited, and only five GPs and two primary health care nurses were currently medication abortion providers. The majority of participants expressed a high level of interest in receiving medication abortion training, but indicated a wide range of barriers to service provision, such as a lack of training opportunities, legal uncertainties or surgical access concerns in case of complications. CONCLUSIONS: Findings demonstrate the need for education on medication abortion and training opportunities. Most identified barriers to service uptake are addressable and relate to a lack of local support services, including the absence of a 24-hour contact advice service, insufficient follow-up access and a lack of local ultrasound facilities. These barriers require educational programs at professional, organisational and community level to ensure that interested rural and regional primary health care providers can start offering medication abortion for their patients.

Medical termination of pregnancy service delivery in the context of decentralization: social and structural influences.

BACKGROUND: Medical termination of pregnancy (MToP) is a safe and acceptable abortion option. Depending on country context, MToP can be administered by general practitioners and mid-level healthcare providers in the first and second trimesters of pregnancy. Like other high-income countries, a range of social and structural barriers to MToP service provision exist in Australia. To counter some of these barriers, geographic decentralization of MToP was undertaken in rural Victoria, Australia, through training service providers about MToP to increase service delivery opportunities. The aim of this study was to investigate the factors that enabled and challenged the decentralization process. METHODS: Face-to-face and telephone interviews were undertaken between April and June 2016 with a purposeful sample of six training providers and 13 general practitioners (GP) and nurse training participants. Study participants were asked about their perceptions of motivations, enablers and challenges to MToP provision. A published conceptual framework of synergies between decentralization and service delivery was used to analyse the study findings. RESULTS: Three key themes emerged from the study findings. First, the effort to decentralize MToP was primarily supported by motivations related to making service access more equitable as well as the willingness of training providers to devolve their informal power, in the form of MToP medical expertise, to training participants. Next, the enablers for MToP decentralization included changes in the regulatory environment relating to decriminalization of abortion and availability of required medication, formation of partnerships to deliver training, provision of MToP clinical resources and local collegial support. Finally, challenges to MToP decentralization were few but significant. These included a lack of a state-wide strategy for service provision, provider concerns about coping with service demand, and provider stigma in the form of perceived negative community or collegial attitudes. These were significant enough to create caution for GPs and nurses considering service provision. CONCLUSIONS: Decentralization concepts offer an innovative way for reframing and tackling issues associated with improving MToP service delivery. There is scope for more research about MToP decentralization in other country contexts. These findings are important for informing future rural MToP service expansion efforts that improve equity in service access.

Complexity of consenting for medical termination of pregnancy: prospective and longitudinal study in Paris.

BACKGROUND: We analyzed the patients' perception of prenatal diagnosis of fetal cardiac pathology, and the reasons for choosing to continue with pregnancy despite being eligible to receive a medical termination of pregnancy. We also identified the challenges, the motives interfering in decision-making, and the consequences of the decisions on pregnancy, child and mother. METHODS: This descriptive, prospective and longitudinal study was conducted in France, amongst pregnant women who wished to continue their pregnancy despite an unfavorable medical advice (incurable fetal cardiac pathologies). Socio-demographic data were collected through a questionnaire. Such questionnaire covered information assessing the parents/mother's perception of prenatal diagnosis, and medical termination of pregnancy, their interpretation of the established diagnosis and their motives for not considering pregnancy termination. RESULTS: 72 eligible patients were analyzed over one year: mean age 33 ± 6.89 years, 47 patients had already given birth to ≥1 healthy child. Mean gestational age at the detection of fetal cardiac pathologies was 30 ± 4.37 weeks of amenorrhea. Patients decided to keep the child after 3 ± 1.25 consultations. 56 (77.78%) patients made their decision with their husbands and 16 made their decision alone. Reasons for declining the medical termination were culpability and responsibility (n = 36), ideologies and convictions (n = 24), mistrust and hope (n = 12). Newborns of 67 patients died with a mean survival duration of 38 days. CONCLUSIONS: Patient informed consent should be sought before any decision in neonatology, even if conflicting with the medical team's knowledge and the pregnant mother's benefits. Decisions to accept or decline pregnancy termination depend on the patients' psychological character, ideologies, convictions, and mistrust in the diagnosis/prognosis, or hope in the fetus survival.

Outcome of first trimester medical termination of pregnancy: definitions and management.

OBJECTIVE: Medical termination of pregnancy (MToP, or medical abortion) is a highly effective method with a reported efficacy of 95-98%. However, different criteria are currently used to define success, and there are different recommendations for the treatment of what is considered a failure of MToP. This work was undertaken to develop a consensus around a set of well-defined MToP outcomes, as recommended by the Core Outcomes in Women's and Newborn Health initiative. METHODS: A literature search was made of national and international guidelines and of recommendations of expert groups for various outcomes of MToP and subsequent management. Based on a review of the findings, a group of European experts in MToP undertook a consensus process to agree on a set of core MToP outcomes. RESULTS: The following core MToP outcomes were defined: success, failure (ongoing pregnancy), need for additional treatment (medical or surgical) to complete MToP (missed abortion, incomplete abortion), complications and the woman's request for additional treatment (medical or surgical). Recommendations for the management of unsuccessful outcomes were also formulated. CONCLUSION: New definitions of MToP outcomes that are more focused on objective criteria and consequently less dependent on provider interpretation are proposed. This should allow better comparison of the efficacy of different regimens and improve the management of failed or incomplete abortion.

Abortion of Fetus with Down's Syndrome: India Joins the Worldwide Controversy Surrounding Abortion Laws.

Abortion continues to be a moral and ethical dilemma in medicine. While abortions in general have always faced social stigmas, the abortion of fetuses with Down's syndrome in particular remains the subject of debate across the globe. In India, under the Medical Termination of Pregnancy Act, abortion is legal under prescribed circumstances only till 20 weeks of gestation. Laws for abortion after 20 week of gestation are ill defined. In a recent ruling of the Supreme Court in India, a woman was denied the right to abortion of her 26 week old fetus. With this ruling, India has joined the rest of the world in the debate surrounding abortion laws and the ethics of abortion.

Comparison of groups with medical and surgical terminations of pregnancy.

OBJECTIVE: The aim of this study was to compare two cohorts of subjects who underwent termination of pregnancy up to 49 days of amenorrhoea by medical (pharmacological) termination (faUUT) and surgical instrumental termination of pregnancy (inUUT). DESIGN: Prospective clinical study. SETTING: Department of Gynecology and Obstetrics, Charles University in Prague, 1st Faculty of Medicine, Hospital Na Bulovce. METHODS: From August 2014 to July 2017, a total of 838 terminations of pregnancy up to 49 days of amenorrhoea were performed at our department. Altogether 474 of subjects underwent faUUT and inUUT was performed in 364 of women. We compared the anamnestic, sociodemographic, and health characteristics of women and we evaluated the efficacy, required medical interventions, medication use, the number and characteristics of complications in both groups. RESULTS: Women who underwent faUUT, were fewer with previous delivery (40.9% vs. 75.0%; p < 0.001), but they had more often previous artificial termination of pregnancy (27.8% vs. 19.5%; p = 0.003). The total number of outpatient visits was significant different between both cohorts, both in median (4 vs 1; p < 0.001) and arithmetic mean (3.8 vs. 1.2; p < 0.001). The usage of uterotonics was much higher in faUUT group (25.7% vs. 8.2%; p < 0.001). On the other side, the antibiotic use was similar in both groups (3.2% vs. 4.4%; p < 0.17). The surgical intervention (revisio cavi uteri instrumentalis, RCUI) required after termination of pregnancy was performed in 7.4% of faUUT cases and in 3.0% of inUUT group (p < 0.001). The failure of faUUT was found in 2 (0.4%) subjects. CONCLUSION: The complications and other followed parameters were various between both groups. Medical termination of pregnancy is a safe method with some potential non life-threatening complications.

Efficacy and safety of very early medical termination of pregnancy: a cohort study.

OBJECTIVE: To assess the efficacy and safety of medical termination of pregnancy (MTOP) when no intrauterine pregnancy (IUP) is confirmed on ultrasound. DESIGN: Retrospective case-note review. SETTING: Two gynaecological clinics in Vienna, Austria, and Gothenburg, Sweden. POPULATION: All women with gestations of ≤49 days undergoing an MTOP during 2004-14 (Vienna) and 2012-15 (Gothenburg). METHODS: Two study cohorts were created: women with and women without a confirmed IUP. An IUP was defined as the intrauterine location of a yolk sac or fetal structure visible by ultrasound. Women with an IUP were selected randomly and included in the IUP cohort. MAIN OUTCOME MEASURES: Efficacy of MTOP, defined as no continuing pregnancy and with no need of surgery for incomplete TOP. RESULTS: After excluding 11 women diagnosed with an extra-uterine or molar pregnancy, 2643 cases were included in the final analysis; 1120 (98.2%) had a successful TOP in the no-IUP group, compared with 1458 (97.1%) in the IUP group, with a risk difference of 1.09% (95% confidence interval, 95% CI, -0.14, 2.32%; P = 0.077). Significantly more women with confirmed IUP were diagnosed with incomplete TOP, and were treated with either surgery or additional medical treatment of misoprostol [64 (4.3%) versus 21 (1.8%); risk difference -2.42%; 95% CI -3.9, -1.1%; P < 0.001]. CONCLUSIONS: There was no difference between the groups in efficacy of MTOP, whereas early treatment resulted in significantly fewer interventions for incomplete TOP. The risk of ectopic pregnancy needs to be considered if treatment is initiated before an IUP is confirmed, but with structured clinical protocols the possibility of the early detection of an ectopic pregnancy in an asymptomatic phase may increase. TWEETABLE ABSTRACT: MTOP before confirmed intrauterine pregnancy is as effective as at later gestation with less incomplete TOP.

A research agenda for moving early medical pregnancy termination over the counter.

Given the overall safety profile and increasing availability of medical pregnancy termination drugs, we asked: would the mifepristone-misoprostol regimen for medical termination at ≤10 weeks of gestation meet US Food and Drug Administration regulatory criteria for over-the-counter (OTC) approval, and if not, what are the present research gaps? We conducted a literature review of consumer behaviours necessary for a successful OTC application for medical termination at ≤10 weeks of gestation and identified crucial research gaps. If we were to embark on a development programme for OTC or more generally, self-use of medical termination, the critical elements missing are the label comprehension, self-selection and actual use studies. TWEETABLE ABSTRACT: Considering medical pregnancy termination through the over-the-counter regulatory lens clarifies critical evidence gaps.

Effectiveness, safety, and acceptability of first-trimester medical termination of pregnancy performed by non-doctor providers: a systematic review.

BACKGROUND: Previous systematic reviews have concluded that medical termination of pregnancy (TOP) performed by non-doctor providers may be as effective and safe as when provided by doctors. Medical treatment of incomplete miscarriage by non-doctor providers and the treated women's acceptance of non-doctor providers of TOP has not previously been reviewed. OBJECTIVES: To review the effectiveness, safety, and acceptability of first-trimester medical TOP, including medical treatment for incomplete miscarriage, by trained non-doctor providers. SEARCH STRATEGY AND SELECTION CRITERIA: A search strategy using appropriate medical subject headings was developed. Electronic databases (PubMed, Popline, Cochrane, CINAHL, Embase, and ClinicalTrials.gov) were searched from inception through April 2016. Randomised controlled trials and comparative observational studies were included. DATA COLLECTION AND ANALYSIS: Meta-analyses were performed for included randomised controlled trials regarding the outcomes of effectiveness and acceptability to women. Certainty of evidence was established using the GRADE approach assessing study limitations, consistency of effect, imprecision, indirectness and publication bias. MAIN RESULTS: Six papers were included. Medical TOP and medical treatment of incomplete miscarriage is probably equally effective when performed by non-doctor providers as when performed by doctors (RR 1.00; 95% CI 0.99-1.01). Women's acceptance, reported as overall satisfaction with the allocated provider, is probably equally high between groups (RR 1.00; 95% CI 1.00-1.01). CONCLUSION: Medical TOP and medical treatment of incomplete miscarriage provided by trained non-doctor providers is probably equally as effective and acceptable to women as when provided by doctors. TWEETABLE ABSTRACT: Medical termination of pregnancy performed by doctors and non-doctors can be equally effective and acceptable.

Expulsions and adverse events following immediate and later insertion of a levonorgestrel-releasing intrauterine system after medical termination of late first- and second-trimester pregnancy: a randomised controlled trial.

OBJECTIVES: To compare expulsions and adverse events (AEs) between immediate and delayed insertion of a levonorgestrel-releasing intrauterine system (LNG-IUS) following medical termination of pregnancy (MTOP). DESIGN: Randomised controlled trial. SETTING: Helsinki University Hospital, Finland, January 2013-December 2014. POPULATION: Cohorts of 102 (gestational age 64-84 days, late first trimester) and 57 (gestational age 85-140 days, second trimester) women requesting MTOP and LNG-IUS contraception. METHODS: LNG-IUS insertion occurred immediately (same day) or 2-4 weeks following MTOP. Follow-up visits were at 2-4 weeks, 3 months, and 1 year. MAIN OUTCOME MEASURES: LNG-IUS expulsion by 3 months and 1 year. AEs and bleeding profiles within 3 months. RESULTS: Following late first-trimester MTOP the LNG-IUS expulsion rates by 3 months were 14 (27.5%) in the immediate-insertion group and two (4.0%) in the delayed-insertion group (risk ratio, RR 6.86; 95% confidence interval, 95% CI 1.64-28.66). By 1 year the expulsion rates were 17 (33.3%) and six (12.0%) (RR 2.78, 95% CI 1.19-6.47). Following second-trimester MTOP LNG-IUS expulsion rates by 3 months and 1 year were five (18.5%) in the immediate-insertion group and one (3.6%) in the delayed-insertion group (RR 5.19, 95% CI 0.65-41.54). No differences in AEs and bleeding profiles emerged between the groups. CONCLUSIONS: Immediate LNG-IUS insertion after late first- or second-trimester MTOP is feasible, does not increase the complication rate, or alter the uterine bleeding patterns; however, immediate insertion increased the expulsion rate, which may limit the cost-effectiveness. TWEETABLE ABSTRACT: Immediate insertion of LNG-IUS following MTOP at 9-20 weeks of gestation is feasible and safe.