The impact of third-party authorization requirements on abortion-related outcomes: a synthesis of legal and health evidence.

OBJECTIVES: This review synthesizes legal and health evidence to demonstrate the health and human rights impacts of third-party authorization requirements (TPAs) on abortion seekers. RESULTS: The synthesized evidence substantiates the pre-existing position in international human rights law that requirements that abortion be authorized by third parties like parents, spouses, committees, and courts create barriers to abortion, should not be introduced at all, or should be repealed where they exist. CONCLUSIONS: The review establishes that rights-based regulation of abortion should not impose TPAs in any circumstances. Instead, the provision and management of abortion should be treated in a manner cognizant with the general principles of informed consent in international human rights law, presuming capacity in all adults regardless of marital status and treatment sought, and recognizing the evolving capacity of young people in line with their internationally-protected rights.

The Impact of 'conscientious objection' on abortion-related outcomes: A synthesis of legal and health evidence.

The World Health Organization (WHO) and international human rights bodies have long urged states to take steps to ensure that 'conscientious objection' does not undermine access to abortion in practice. This review uses an established methodology to identify and integrate evidence of the health and human rights impacts of the practice of conscientious objection/refusal. The evidence identified in this review suggests strongly that conscientious objection negatively affects the rights of abortion seekers and has negative implications for the rights of non-objecting health workers. This is exacerbated in situations where an exercise of 'conscience' goes beyond 'opting out' of providing care and extends into seeking to prevent abortion through dissuasion, misinformation, misdirection, delay, and sometimes abuse. The insights from this review suggest that states must take better and further action to centre abortion seekers in the regulation of conscientious objection, and to prevent and ensure accountability for rights-limiting manifestations of conscience that go beyond opting out of direct provision of abortion care in non-emergency settings.

Information flow as reproductive governance. Patient journey analysis of information barriers and facilitators to abortion care in the republic of Ireland.

Background: Information flow - information communication and transmission pathways and practices within healthcare systems - impacts patient journeys. Historically, regulating information flow was a key technology of reproductive governance in the Republic of Ireland. Pre-2018, law and the State sustained informational barriers to and through abortion care in Ireland. An expanded abortion service was implemented in January 2019. Method: Patient Journey Analysis (PJA) interrogates informational facilitators and barriers to/through post-2019 abortion care in Ireland. We focus on information flow at the interfaces between the 'public' sphere and 'point of entry', 'point of entry' and primary care, and primary and secondary care. Materials: The paper uses data from a mixed-method study. A tool for assessing online abortion service information (ASIAT), desktop research, and qualitative data from 108 in-depth interviews with providers, policy-makers, advocacy groups, and service users informed the analysis. Results: Abortion patient journeys vary. Information flow issues, e.g. communication of how to access services, referral systems, and information handover, act as barriers and facilitators. Barriers increase where movement from primary to secondary is needed. Applications: The article identifies good practice in information flow strategy, as well as areas for development. It illustrates the significance of information flow in accomplishing reproductive governance.

Abortion policy implementation in Ireland: Lessons from the community model of care.

BACKGROUND: In 2018, the right to lawful abortion in the Republic of Ireland significantly expanded, and service provision commenced on 1 January, 2019. Community provision of early medical abortion to 9 weeks plus 6 days gestation delivered by General Practitioners constitutes the backbone of the Irish abortion policy implementation. We conducted a study in 2020-2021 to examine the barriers and facilitators of the Irish abortion policy implementation. METHODS: We collected data using qualitative in-depth interviews (IDIs) which were conducted in-person or remotely. We coded and analysed interview transcripts following the grounded theory approach. RESULTS: We collected 108 IDIs in Ireland from May 2020 to March 2021. This article draws on 79 IDIs with three participant samples directly relevant to the community model of care: (a) 27 key informants involved in the abortion policy development and implementation representing government healthcare administration, medical professionals, and advocacy organisations, (b) 22 healthcare providers involved in abortion provision in community settings, and (c) 30 service users who sought abortion services in 2020. Facilitators of community-based abortion provision have been: a collaborative approach between the Irish government and the medical community to develop the model of care, and strong support systems for providers. The MyOptions helpline for service users is a successful national referral model. The main barriers to provision are the mandatory 3-day wait, unclear or slow referral pathways from primary to hospital care, barriers for migrants, and a shortage and incomplete geographic distribution of providers, especially in rural areas. CONCLUSIONS: We conclude that access to abortion care in Ireland has been greatly expanded since the policy implementation in 2019. The community delivery of care and the national helpline constitute key features of the Irish abortion policy implementation that could be duplicated in other contexts and countries. Several challenges to full abortion policy implementation remain.

The impact of 'grounds' on abortion-related outcomes: a synthesis of legal and health evidence.

Where abortion is legal, it is often regulated through a grounds-based approach. A grounds-based approach to abortion provision occurs when law and policy provide that lawful abortion may be provided only where a person who wishes to have an abortion satisfies stipulated 'grounds', sometimes described as 'exceptions' or 'exceptional grounds'. Grounds-based approaches to abortion are, prima facie, restrictive as they limit access to abortion based on factors extraneous to the preferences of the pregnant person. International human rights law specifies that abortion must be available (and not 'merely' lawful) where the life or health of the pregnant woman or girl is at risk, or where carrying a pregnancy to term would cause her substantial pain or suffering, including but not limited to situations where the pregnancy is the result of rape or incest or the pregnancy is not viable. However, international human rights law does not specify a grounds-based approach as the way to give effect to this requirement. The aim of this review is to address knowledge gaps related to the health and non-health outcomes plausibly related to the effects of a grounds-based approach to abortion regulation. The evidence from this review shows that grounds have negative implications for access to quality abortion and for the human rights of pregnant people. Further, it shows that grounds-based approaches are insufficient to meet states' human rights obligations. The evidence presented in this review thus suggests that enabling access to abortion on request would be more rights-enhancing than grounds-based approaches to abortion regulation.

The impact of provider restrictions on abortion-related outcomes: a synthesis of legal and health evidence.

Many components of abortion care in early pregnancy can safely be provided on an outpatient basis by mid-level providers or by pregnant people themselves. Yet, some states impose non-evidence-based provider restrictions, understood as legal or regulatory restrictions on who may provide or manage all or some aspects of abortion care. These restrictions are inconsistent with the World Health Organization's support for the optimization of the roles of various health workers, and do not usually reflect evidence-based determinations of who can provide abortion. As a matter of international human rights law, states should ensure that the regulation of abortion is evidence-based and proportionate, and disproportionate impacts must be remedied. Furthermore, states are obliged take steps to ensure women do not have to undergo unsafe abortion, to reduce maternal morbidity and mortality, and to effectively protect women and girls from the physical and mental risks associated with unsafe abortion. States must revise their laws to ensure this. Where laws restrict those with the training and competence to provide from participating in abortion care, they are prima facie arbitrary and disproportionate and thus in need of reform. This review, developed by experts in reproductive health, law, policy, and human rights, examined the impact of provider restrictions on people seeking abortion, and medical professionals. The evidence from this review suggests that provider restrictions have negative implications for access to quality abortion, contributing inter alia to delays and recourse to unsafe abortion. A human rights-based approach to abortion regulation would require the removal of overly restrictive provider restrictions. The review provides evidence that speaks to possible routes for regulatory reform by expanding the health workforce involved in abortion-related care, as well as expanding health workers' roles, both of which could improve timely access to first trimester surgical and medical abortion, reduce costs, save time, and reduce the need for travel.

This review identifies evidence of the impacts of provider restrictions on people seeking to access abortion and on abortion providers. It pursues a methodology designed to ensure the full integration of public health and human rights standards developed by the research team and published elsewhere. The evidence from this review points clearly to provider restrictions having negative implications for health outcomes, health systems, and human rights. This is especially important as international guidance provided by the WHO indicates best practice in provision and management of abortion and shows clearly that undue provider restrictions are not justified by reference to the nature and complexity of abortion.

A systematic review exploring the contraception values and preferences of sex workers, transmasculine individuals, people who inject drugs, and those living in humanitarian contexts.

OBJECTIVE: We sought to systematically review the literature on values and preferences regarding contraception among individuals within selected key populations. STUDY DESIGN: As part of a larger set of reviews on patients' and providers' values and preferences related to contraception globally, we searched ten electronic databases for articles from January 1, 2005 to July 27, 2020. No language restrictions were applied. Data was independently abstracted by two authors and study rigor was assessed using an 8-item measure developed by the Evidence Project for quantitative studies and an adapted CASP checklist for qualitative studies. RESULTS: We identified 12 studies that met our inclusion criteria examining selected key populations, including sex workers, transmasculine individuals, people who inject drugs, or those living in humanitarian contexts. Seven key themes that spoke to values and preferences emerged related to: autonomy, perceived effectiveness and safety, birth spacing and family outcomes, impacts on sexual experience, hormonal effects (e.g. desire for non-hormonal method or perception that the method is more natural as compared to hormonal methods), physical attributes (e.g. appearance and/or ease of use), and stigma. Six studies were of high rigor, five were of moderate rigor, and one was of low rigor. One study described the values and preferences of two of the selected key populations. The research available on the values and preferences of sex workers regarding methods of contraception was limited to female condoms. CONCLUSION: Consideration of the values and preferences of individuals within selected key populations can inform providers, programme managers and policy makers participating in the delivery of contraceptive care. Contraceptive research among sex workers, transmasculine individuals, people who inject drugs, or those living in humanitarian contexts is quite limited; further research is needed to better understand the values and preferences of these populations.

Standardizing abortion research outcomes (STAR): Results from an international consensus development study.

OBJECTIVE: To develop a minimum data set, known as a core outcome set, for future abortion randomized controlled trials. STUDY DESIGN: We extracted outcomes from quantitative and qualitative systematic reviews of abortion studies to assess using a modified Delphi method. Via email, we invited researchers, clinicians, patients, and healthcare organization representatives with expertise in abortion to rate the importance of the outcomes on a 9-point Likert scale. After 2 rounds, we used descriptive analyses to determine which outcomes met the predefined consensus criteria. We finalized the core outcome set during a series of consensus development meetings. RESULTS: We entered 42 outcomes, organized in 15 domains, into the Delphi survey. Two-hundred eighteen of 251 invitees (87%) provided responses (203 complete responses) for round 1 and 118 of 218 (42%) completed round2. Sixteen experts participated in the development meetings. The final outcome set includes 15 outcomes: 10 outcomes apply to all abortion trials (successful abortion, ongoing pregnancy, death, hemorrhage, uterine infection, hospitalization, surgical intervention, pain, gastrointestinal symptoms, and patients' experience of abortion); 2 outcomes apply to only surgical abortion trials (uterine perforation and cervical injury), one applies only to medical abortion trials (uterine rupture); and 2 apply to trials evaluating abortions with anesthesia (over-sedation/respiratory depression and local anesthetic systemic toxicity). CONCLUSION: Using robust consensus science methods we have developed a core outcome set for future abortion research. IMPLICATIONS: Standardized outcomes in abortion research could decrease heterogeneity among trials and improve the quality of systematic reviews and clinical guidelines. Researchers should select, collect, and report these core outcomes in future abortion trials. Journal editors should advocate for core outcome set reporting.

Abortion hotlines around the world: a mixed-methods systematic and descriptive review.

Barriers to access abortion services globally have led to the development of alternative methods to assist and support women who seek an abortion. One such method is the use of hotlines, currently utilised globally for abortion care. This review aimed to understand (1) how abortion hotlines facilitate access to abortion; and (2) how women and stakeholders describe the impact of hotlines on abortion access. Published quantitative and qualitative studies and grey literature were systematically reviewed alongside an identification and description of abortion hotlines in the public domain. Our findings highlight that the existence of abortion hotlines is highly context-dependent. They may exist either as an independent community-based model of care, or as part of formal care pathways within the health system. Hotlines operating in contexts with legal restrictions seem to be broader in scope and will use innovative approaches to adapt to their setting and reach hard-to-reach populations. All the abortion hotlines that provided information on a data extraction form used evidence-based guidelines but women seeking medical abortion still struggle to access quality medications. There is limited data in general on abortion hotlines, especially on the user and provider experience. Abortion hotlines have the potential to facilitate access to safe abortion care through evidence-based information and to decrease maternal mortality and morbidity from unsafe abortions for women and girls globally.

Drugs used to induce fetal demise prior to abortion: a systematic review.

Clinicians have used feticidal agents prior to second trimester abortion for many years. Despite the widespread use of various agents to induce fetal demise, a comprehensive or systematic review of the evidence is lacking on the safety, effectiveness, and most effective routes of administration. OBJECTIVES: To evaluate the existing drugs and routes of administration used in inducing fetal demise prior to abortion, and to determine the safety, effectiveness, and acceptability of these feticidal agents. METHODS: We searched PubMed, EMBASE, CINAHL, POPLINE, and Global Index Medicus to identify studies describing pharmacologic agents used to induce fetal demise prior to termination of pregnancy. We included randomized controlled trials and observational studies comparing digoxin, potassium chloride (KCL), and lidocaine to induce fetal demise. We included studies that evaluated the primary outcomes of safety and effectiveness, including success in achieving fetal demise, induction to expulsion time for medical abortion, dilation and evacuation time, as well as maternal side effects and complications. Two authors independently screened abstracts and full texts. One reviewer extracted data from the included studies, which was counterchecked by a second reviewer. RESULTS: We identified eight studies that met inclusion criteria: three randomized controlled trials, and five observational studies. A total of 4505 women received drugs to induce fetal demise at 17 to 38 weeks' gestation, including digoxin (n = 4174), KCL (n = 324), and lidocaine (n = 7). Intra-fetal digoxin was superior to intra-amniotic digoxin in achieving fetal demise (OR 3.51, 95% CI 1.60, 7.78). Intracardiac KCL 15% 2-3 mL reduced induction to expulsion time by 320 min (p <.006).Similarly, intracardiac KCL 15% 1-3 ml reduced dilation and evacuation time from 16.1 ± 7.9 min to 12.7 ± 5 min (p < 0.001). Intracardiac lidocaine 2% 10 mL was more effective at achieving fetal demise than intracardiac KCL 6 mmol (85.7% vs. 57.9%). Intra-amniotic and intra-fetal digoxin 1 mg, as compared to no feticidal agent, led to greater pre-procedure expulsion, hospital readmission, and the presence of one or more signs of infection. CONCLUSIONS: Evidence from included cohort studies demonstrates that digoxin, KCL, and lidocaine are all effective in inducing fetal demise. Intra-fetal administration of digoxin is superior to intra-amniotic digoxin administration. Administration of feticide using intracardiac KCL may shorten the abortion experience. Limited data from observational studies also supports an increase in maternal side effects and/or complications related to the administration of digoxin. IMPLICATIONS: Intra-fetal administration of digoxin is more effective in achieving fetal demise when compared to intra-amniotic administration. There is a knowledge gap in determining the single best drug for inducing fetal demise prior to abortion. Additional research is needed to compare different feticidal agents in terms of safety and effectiveness.

EviSIP: using evidence to change practice through mentorship - an innovative experience for reproductive health in the Latin American and Caribbean regions.

Maternal mortality is unacceptably high in our region. In 2015, the Latin American Center for Perinatology and Women´s Reproductive Health (CLAP) created a regional network of institutions including 16 countries, committed to improving epidemiological surveillance and healthcare of women in a situation of abortion or near miss event, using a common platform, the Perinatal Information System (SIP). The objective of the current pilot project was to test a new method of study called EviSIP (Evidence from SIP), a method of generating information on maternal near miss and abortion for the region. We describe the implementation of this initiative in reproductive healthcare facilities using SIP. Junior researchers/clinicians from these countries were included, along with expert researchers in reproductive health from across the world. Articles were produced with data on maternal near miss and abortion gathered from the SIP of each participating sentinel center; and recommendations from experts. EviSIP was the first joint workspace to discuss patient outcomes after treatment of abortion or near miss cases, with data analysis of each Sentinel Center; discuss and analyze data among centers, at a country and regional level; discuss the main outcomes and their impact on changing procedures and policies; strengthen the operational research capacity of the centers; develop and encourage the publication of scientific articles. The EviSIP initiative also promoted training of healthcare professionals in research. EviSIP provided a unique opportunity to train for research and mentorship and was pivotal to the production of scientific knowledge of reproductive health in the region.

Global Abortion Policies Database: A descriptive analysis of the regulatory and policy environment related to abortion.

The World Health Organization (WHO) Safe abortion: technical and policy guidance for health systems states that regulatory, policy, and programmatic barriers that hinder access to and timely provision of safe abortion care should be removed. Although some regulatory requirements facilitate access, where they act as barriers, they can deter women from seeking safe abortion care. We use data available in the Global Abortion Policies Database as of February 2019 to review policies related to regulatory requirements identified as access barriers in the Safe abortion guidance. We include only countries where such policies apply, i.e., where abortion is lawful on the woman's request, with no requirement for justification and/or for one or more legal grounds. The results demonstrate the variation that exists in regulatory requirements, but little remains known about how they are implemented in practice and the implications on how women access and how providers offer safe abortion services.

Global Abortion Policies Database: a descriptive analysis of the legal categories of lawful abortion.

BACKGROUND: Texts and interpretations on the lawfulness of abortion and associated administrative requirements can be vague and confusing. It can also be difficult for a woman or provider to know exactly where to look for and how to interpret laws on abortion. To increase transparency, the Global Abortion Policies Database (GAPD), launched in 2017, facilitates the strengthening of knowledge and understanding of the complexities and nuances around lawful abortion as explicitly stated in laws and policies. METHODS: We report on data available in the GAPD as of May 2018. We reviewed the content and wording of laws, policies, standards and guidelines, judgments and other official statements for all countries where data is available in the GAPD. We analyzed data for 158 countries, where abortion is lawful on the woman's request with no requirement for justification and/or for at least one legal ground, including additional indications that are nonequivalent to a single common legal ground. We classified laws on the basis of the explicit wording of the text. The GAPD treats legal categories as the circumstances under which abortion is lawful, that is, allowed or not contrary to law, or explicitly permitted or specified by law. RESULTS: 32% of countries allow or permit abortion at the woman's request with no requirement for justification. Approximately 82% of countries allow or permit abortion to save the woman's life. 64% of countries specify health, physical health and/or mental (or psychological) health. 51% allow or permit abortion based on a fetal condition, 46% of countries allow or permit abortion where the pregnancy is the result of rape, and 10% specify an economic or social ground. Laws may also specify several additional indications that are nonequivalent to a single legal ground. CONCLUSIONS: The GAPD reflects details that exist within countries' laws and highlights the nuance within legal categories of abortion; no assumptions are made as to how laws are interpreted or applied in practice. By examining the text of the law, additional complexities related to the legal categories of abortion become more apparent.

The pharmacokinetics of 12-week continuous contraceptive patch use.

OBJECTIVES: We sought to assess the change in serum ethinyl estradiol (EE2) and norelgestromin (NGMN) levels over 12 weeks of continuous contraceptive patch use. STUDY DESIGN: We asked participants (n=30) to apply consecutive patches to be worn continuously (without a patch-free interval) for 12 weeks. We collected blood samples at the end of each patch week and two times during weeks 4, 8, and 12 (with the additional blood draw occurring mid-week). Liquid chromatography-tandem triple quadrupole mass spectrometry (LC-MS/MS) was utilized to assess EE2 and NGMN levels. RESULTS: Twenty-seven women completed the study; 26 were compliant with patch use. Ethinyl estradiol levels ranged from 0 to 193 pg/mL over the period. We observed an accumulation over the 12-week time at an estimated rate of 2.15 pg/mL per week (95% confidence interval 0.95-3.35, p<.001). The change in NGMN levels ranged from 0 to 2.52 ng/mL over the 12 weeks (95% confidence interval 0.021-0.019, p=.915). The most common side effects reported were vaginal spotting, breast tenderness and abdominal pain/cramping. There were no serious adverse events reported. CONCLUSION: While the range of weekly EE2 values was quite wide, the absolute values remain low and generally within the expected range described in product labeling. Providers may consider prescribing continuous use of the patch, but given the slow accumulation of EE2 over time, 12 weeks should not be exceeded in the absence of safety data.

Pregnancy outcomes in solid organ transplant recipients with exposure to mycophenolate mofetil or sirolimus.

BACKGROUND: Animal and limited human studies have raised concerns as to the safety of in utero exposure to mycophenolate mofetil (MMF) and sirolimus (SRL) in transplant recipients. This study examined the outcomes of pregnancies with exposure to MMF or SRL from 30 female transplant recipients (39 pregnancies) who have reported pregnancies to the National Transplantation Pregnancy Registry. METHODS: Data were collected via questionnaires, phone interviews and medical records. RESULTS: There were 18 kidney recipients reporting 26 pregnancies with exposure to MMF: 15 livebirths (LB), 11 spontaneous abortions (SA). Structural malformations were reported in four of the 15 children (26.7%) including: hypoplastic nails and shortened fifth fingers (one), microtia with cleft lip and palate (one), microtia alone (one), and neonatal death with multiple malformations (one). One kidney/pancreas (K/P) recipient reported one SA. Three liver recipients reported three pregnancies; two LB (no malformations), and one second trimester SA. Two heart recipients reported one LB (no malformations) and two SA. SRL exposures included seven recipients (four kidney, one K/P and two liver) reporting four LB (one infant whose mother was switched from MMF to SRL during late pregnancy had cleft lip and palate and microtia) and three SA. CONCLUSIONS: A higher incidence of structural malformations was seen with MMF exposures during pregnancy compared to the overall kidney transplant recipient offspring, while no structural defects have as yet been reported with early pregnancy sirolimus exposures. Centers are encouraged to report all pregnancy exposures in transplant recipients.