Describing the safety of abortion at the population level using network-based survey approaches.

BACKGROUND: Despite the negative impact of unsafe abortions on women's health and rights, the degree of abortion safety remains strikingly undocumented for a large share of abortions globally. Data on how women induce abortions (method, setting, provider) are central to the measurement of abortion safety. However, health-facility statistics and direct questioning in population surveys do not yield representative data on abortion care seeking pathways in settings where access to abortion services is highly restricted. Recent developments in survey methodologies to study stigmatized / illegal behaviour and hidden populations rely on the fact that such information circulates within social networks; however, such efforts have yet to give convincing results for unsafe abortions. OBJECTIVE: This article presents the protocol of a study whose purpose is to apply and develop further two network-based methods to contribute to the generation of reliable population-level information on the safety of abortions in contexts where access to legal abortion services is highly restricted. METHODS: This study plans to obtain population-level data on abortion care seeking in two Health and Demographic Surveillance Systems in urban Kenya and rural Burkina Faso by applying two methods: Anonymous Third-Party Reporting (ATPR) (also known as confidantes' method) and Respondent Driven Sampling (RDS). We will conduct a mixed methods formative study to determine whether these network-based approaches are pertinent in the study contexts. The ATPR will be refined notably by incorporating elements of the Network Scale-Up Method (NSUM) to correct or account for certain of its biases (transmission, barrier, social desirability, selection). The RDS will provide reliable alternative estimates of abortion safety if large samples and equilibrium can be reached; an RDS multiplex variant (also including social referents) will be tested. DISCUSSION: This study aims at documenting abortion safety in two local sites using ATPR and RDS. If successful, it will provide data on the safety profiles of abortion seekers across sociodemographic categories in two contrasted settings in sub-Saharan Africa. It will advance the formative research needed to determine whether ATPR and RDS are applicable or not in a given context. It will improve the questionnaire and correcting factors for the ATPR, improve the capacity of RDS to produce quasi-representative data on abortion safety, and advance the validation of both methods.

Representative data on how women induce abortions and their consequences are central to measurements of abortion safety. However, due to the stigmatized nature of abortion, measuring the details of the process is challenging when the latter occur out of the realm of the law and do not result in complications registered in hospital statistics. Hence, there is sparse empirical population-level data on how women terminate their pregnancies in countries where access to abortion services is highly restricted, as well as little data on the side effects and complications associated with the methods they chose and health seeking for these complications. Recent developments in indirect survey methodologies to study stigmatized/illegal behaviour and hidden populations are likely to improve the quality of data collected on abortion safety in restrictive contexts: all are based on the sharing of information on stigmatized practices in social networks. We propose to refine and pilot two such network-based methods to validate their use for collecting (quasi) representative data on abortion safety in large population health surveys. These two approaches are: (i) a modified Anonymous Third-Party Reporting method (ATPR) integrating elements of the Network-Scale-up Method (NSUM) and (ii) Respondent-Driven Sampling (RDS). We will conduct this study in two African Health and Demographic Surveillance Systems (HDSS) sites, one urban (Nairobi, Kenya), and one comprising a town and adjacent villages (Kaya, Burkina Faso).

Disclosure to social network members among abortion-seeking women in low- and middle-income countries with restrictive access: a systematic review.

BACKGROUND: Health care for stigmatized reproductive practices in low- and middle-income countries (LMICs) often remains illegal; when legal, it is often inadequate, difficult to find and / or stigmatizing, which results in women deferring care or turning to informal information sources and providers. Women seeking an induced abortion in LMICs often face obstacles of this kind, leading to unsafe abortions. A growing number of studies have shown that abortion seekers confide in social network members when searching for formal or informal care. However, results have been inconsistent; in some LMICs with restricted access to abortion services (restrictive LMICs), disclosure appears to be limited. MAIN BODY: This systematic review aims to identify the degree of disclosure to social networks members in restrictive LMICs, and to explore the differences between women obtaining an informal medical abortion and other abortion seekers. This knowledge is potentially useful for designing interventions to improve information on safe abortion or for developing network-based data collection strategies. We searched Pubmed, POPLINE, AIMS, LILACS, IMSEAR, and WPRIM databases for peer-reviewed articles, published in any language from 2000 to 2018, concerning abortion information seeking, communication, networking and access to services in LMICs with restricted access to abortion services. We categorized settings into four types by possibility of anonymous access to abortion services and local abortion stigma: (1) anonymous access possible, hyper stigma (2) anonymous access possible, high stigma (3) non-anonymous access, high stigma (4) non-anonymous access, hyper stigma. We screened 4101 references, yielding 79 articles with data from 33 countries for data extraction. We found a few countries (or groups within countries) exemplifying the first and second types of setting, while most studies corresponded to the third type. The share of abortion seekers disclosing to network members increased across setting types, with no women disclosing to network members beyond their intimate circle in Type 1 sites, a minority in Type 2 and a majority in Type 3. The informal use of medical abortion did not consistently modify disclosure to others. CONCLUSION: Abortion-seeking women exhibit widely different levels of disclosure to their larger social network members across settings/social groups in restrictive LMICs depending on the availability of anonymous access to abortion information and services, and the level of stigma.

Women seeking an induced abortion in LMICs often face inexistent or inadequate, difficult to find and/ or stigmatizing legal services, leading to the use of informal methods and providers, and unsafe abortions. A growing number of studies have shown that abortion seekers contact social network members beyond their intimate circle when seeking care. However, results have been inconsistent. We searched Pubmed, POPLINE, AIMS, LILACS, IMSEAR, and WPRIM databases for peer-reviewed articles published in any language from 2000 to 2018, concerning abortion information seeking, communication, networking and access to services in restrictive LMICs. We screened 4101 references, yielding 79 articles with data from 33 countries for extraction. We grouped countries (or social groups within countries) into four types of settings: (1) anonymous access possible, hyper stigma; (2) anonymous access possible, high stigma; (3) non-anonymous access, high stigma; (4) non-anonymous access, hyper stigma. Most studies fitted Type 3. Disclosing to network members increased across setting types: no women confided in network members in Type 1 settings, a minority in Type 2 and a majority in Type 3. No setting fitted Type 4. The informal use of medical abortion did not modify disclosure to others. Abortion seekers in restrictive LMICs frequently contact their social network in some settings/groups but less frequently in others, depending on the availability of anonymous access to abortion care and the level of stigma. This knowledge is useful for designing interventions to improve information on safe abortion and for developing network-based data collection strategies.

Self-administered versus provider-administered medical abortion.

BACKGROUND: The advent of medical abortion has improved access to safe abortion procedures. Medical abortion procedures involve either administering mifepristone followed by misoprostol or a misoprostol-only regimen. The drugs are commonly administered in the presence of clinicians, which is known as provider-administered medical abortion. In self-administered medical abortion, drugs are administered by the woman herself without the supervision of a healthcare provider during at least one stage of the drug protocol. Self-administration of medical abortion has the potential to provide women with control over the abortion process. In settings where there is a shortage of healthcare providers, self-administration may reduce the burden on the health system. However, it remains unclear whether self-administration of medical abortion is effective and safe. It is important to understand whether women can safely and effectively terminate their own pregnancies when having access to accurate and adequate information, high-quality drugs, and facility-based care in case of complications. OBJECTIVES: To compare the effectiveness, safety, and acceptability of self-administered versus provider-administered medical abortion in any setting. SEARCH METHODS: We searched Cochrane Central Register of Controlled Trials, MEDLINE in process and other non-indexed citations, Embase, CINAHL, POPLINE, LILACS, ClinicalTrials.gov, WHO ICTRP, and Google Scholar from inception to 10 July 2019. SELECTION CRITERIA: We included randomized controlled trials (RCTs) and prospective cohort studies with a concurrent comparison group, using study designs that compared medical abortion by self-administered versus provider-administered methods. DATA COLLECTION AND ANALYSIS: Two reviewers independently extracted the data, and we performed a meta-analysis where appropriate using Review Manager 5. Our primary outcome was successful abortion (effectiveness), defined as complete uterine evacuation without the need for surgical intervention. Ongoing pregnancy (the presence of an intact gestational sac) was our secondary outcome measuring success or effectiveness. We assessed statistical heterogeneity with Chi2 tests and I2 statistics using a cut-off point of P < 0.10 to indicate statistical heterogeneity. Quality assessment of the data used the GRADE approach. We used standard methodological procedures expected by Cochrane. MAIN RESULTS: We identified 18 studies (two RCTs and 16 non-randomized studies (NRSs)) comprising 11,043 women undergoing early medical abortion (≤ 9 weeks gestation) in 10 countries. Sixteen studies took place in low-to-middle income resource settings and two studies were in high-resource settings. One NRS study received analgesics from a pharmaceutical company. Five NRSs and one RCT did not report on funding; nine NRSs received all or partial funding from an anonymous donor. Five NRSs and one RCT received funding from government agencies, private foundations, or non-profit bodies. The intervention in the evidence is predominantly from women taking mifepristone in the presence of a healthcare provider, and subsequently taking misoprostol without healthcare provider supervision (e.g. at home). There is no evidence of a difference in rates of successful abortions between self-administered and provider-administered groups: for two RCTs, risk ratio (RR) 0.99, 95% confidence interval (CI) 0.97 to 1.01; 919 participants; moderate certainty of evidence. There is very low certainty of evidence from 16 NRSs: RR 0.99, 95% CI 0.97 to 1.01; 10,124 participants. For the outcome of ongoing pregnancy there may be little or no difference between the two groups: for one RCT: RR 1.69, 95% CI 0.41 to 7.02; 735 participants; low certainty of evidence; and very low certainty evidence for 11 NRSs: RR 1.28, 95% CI 0.65 to 2.49; 6691 participants. We are uncertain whether there are any differences in complications requiring surgical intervention, since we found no RCTs and evidence from three NRSs was of very low certainty: for three NRSs: RR 2.14, 95% CI 0.80 to 5.71; 2452 participants. AUTHORS' CONCLUSIONS: This review shows that self-administering the second stage of early medical abortion procedures is as effective as provider-administered procedures for the outcome of abortion success. There may be no difference for the outcome of ongoing pregnancy, although the evidence for this is uncertain for this outcome. There is very low-certainty evidence for the risk of complications requiring surgical intervention. Data are limited by the scarcity of high-quality research study designs and the presence of risks of bias. This review provides insufficient evidence to determine the safety of self-administration when compared with administering medication in the presence of healthcare provider supervision. Future research should investigate the effectiveness and safety of self-administered medical abortion in the absence of healthcare provider supervision through the entirety of the medical abortion protocol (e.g. during administration of mifepristone or as part of a misoprostol-only regimen) and at later gestational ages (i.e. more than nine weeks). In the absence of any supervision from medical personnel, research is needed to understand how best to inform and support women who choose to self-administer, including when to seek clinical care.

Medical termination for pregnancy in early first trimester (≤ 63 days) using combination of mifepristone and misoprostol or misoprostol alone: a systematic review.

BACKGROUND: A wide range of drugs have been studied for first trimester medical abortion. Studies evaluating different regimens, including combination mifepristone and misoprostol and misoprostol alone regimens, show varying results related to safety, efficacy and other outcomes. Thus, the objectives of this systematic review were to compare the safety, effectiveness and acceptability of medical abortion and to compare medical with surgical methods of abortion ≤63 days of gestation. METHODS: Pubmed and EMBASE were systematically searched from database inception through January 2019 using a combination of MeSH, keywords and text words. Randomized controlled trials on induced abortion at ≤63 days that compared different regimens of medical abortion using mifepristone and/or misoprostol and trials that compared medical with surgical methods of abortion were included. We extracted data into a pre-designed form, calculated effect estimates, and performed meta-analyses where possible. The primary outcomes were ongoing pregnancy and successful abortion. RESULTS: Thirty-three studies composed of 22,275 participants were included in this review. Combined regimens using mifepristone and misoprostol had lower rates of ongoing pregnancy, higher rates of successful abortion and satisfaction compared to misoprostol only regimens. In combined regimens, misoprostol 800 µg was more effective than 400 µg. There was no significant difference in dosing intervals between mifepristone and misoprostol and routes of misoprostol administration in combination or misoprostol alone regimens. The rate of serious adverse events was generally low. CONCLUSION: In this systematic review, we find that medical methods of abortion utilizing combination mifepristone and misoprostol or misoprostol alone are effective, safe and acceptable. More robust studies evaluating both the different combination and misoprostol alone regimens are needed to strengthen existing evidence as well as assess patient perspectives towards a particular regimen.

Sexual and reproductive health (SRH): a key issue in the emergency response to the coronavirus disease (COVID- 19) outbreak.

The novel coronavirus disease (COVID-19) outbreak was first declared in China in December 2019, and WHO declared the pandemic on 11 March 2020. A fast-rising number of confirmed cases has been observed in all continents, with Europe at the epicentre of the outbreak at this moment.Sexual and reproductive health (SRH) and rights is a significant public health issue during the epidemics. The novel coronavirus (SARS-CoV-2) is new to humans, and only limited scientific evidence is available to identify the impact of the disease COVID-19 on SRH, including clinical presentation and outcomes of the infection during pregnancy, or for persons with STI/HIV-related immunosuppression. Beyond the clinical scope of SRH, we should not neglect the impacts at the health system level and disruptions or interruptions in regular provision of SRH services, such as pre- and postnatal checks, safe abortion, contraception, HIV/AIDS and sexually transmitted infections. Furthermore, other aspects merit attention such as the potential increase of gender-based violence and domestic abuse, and effects of stigma and discrimination associated with COVID-19 and their effects on SRH clients and health care providers. Therefore, there is an urgent need for the scientific community to generate sound clinical, epidemiological, and psycho-social behavioral links between COVID-19 and SRH and rights outcomes.

Correction to: Sexual and reproductive health (SRH): a key issue in the emergency response to the coronavirus disease (COVID- 19) outbreak.

An amendment to this paper has been published and can be accessed via the original article.

Sexual transmission of Zika virus and other flaviviruses: A living systematic review.

BACKGROUND: Health authorities in the United States and Europe reported an increasing number of travel-associated episodes of sexual transmission of Zika virus (ZIKV) following the 2015-2017 ZIKV outbreak. This, and other scientific evidence, suggests that ZIKV is sexually transmissible in addition to having its primary mosquito-borne route. The objective of this systematic review and evidence synthesis was to clarify the epidemiology of sexually transmitted ZIKV. METHODS AND FINDINGS: We performed a living (i.e., continually updated) systematic review of evidence published up to 15 April 2018 about sexual transmission of ZIKV and other arthropod-borne flaviviruses in humans and other animals. We defined 7 key elements of ZIKV sexual transmission for which we extracted data: (1) rectal and vaginal susceptibility to infection, (2) incubation period following sexual transmission, (3) serial interval between the onset of symptoms in a primary and secondary infected individuals, (4) duration of infectiousness, (5) reproduction number, (6) probability of transmission per sex act, and (7) transmission rate. We identified 1,227 unique publications and included 128, of which 77 presented data on humans and 51 presented data on animals. Laboratory experiments confirm that rectal and vaginal mucosae are susceptible to infection with ZIKV and that the testis serves as a reservoir for the virus in animal models. Sexual transmission was reported in 36 human couples: 34/36 of these involved male-to-female sexual transmission. The median serial symptom onset interval in 15 couples was 12 days (interquartile range: 10-14.5); the maximum was 44 days. We found evidence from 2 prospective cohorts that ZIKV RNA is present in human semen with a median duration of 34 days (95% CI: 28-41 days) and 35 days (no CI given) (low certainty of evidence, according to GRADE). Aggregated data about detection of ZIKV RNA from 37 case reports and case series indicate a median duration of detection of ZIKV of 40 days (95% CI: 30-49 days) and maximum duration of 370 days in semen. In human vaginal fluid, median duration was 14 days (95% CI: 7-20 days) and maximum duration was 37 days (very low certainty). Infectious virus in human semen was detected for a median duration of 12 days (95% CI: 1-21 days) and maximum of 69 days. Modelling studies indicate that the reproduction number is below 1 (very low certainty). Evidence was lacking to estimate the incubation period or the transmission rate. Evidence on sexual transmission of other flaviviruses was scarce. The certainty of the evidence is limited because of uncontrolled residual bias. CONCLUSIONS: The living systematic review and sexual transmission framework allowed us to assess evidence about the risk of sexual transmission of ZIKV. ZIKV is more likely transmitted from men to women than from women to men. For other flaviviruses, evidence of sexual transmissibility is still absent. Taking into account all available data about the duration of detection of ZIKV in culture and from the serial interval, our findings suggest that the infectious period for sexual transmission of ZIKV is shorter than estimates from the earliest post-outbreak studies, which were based on reverse transcription PCR alone.

Re-emerging and newly recognized sexually transmitted infections: Can prior experiences shed light on future identification and control?

How do we spot the next sexually transmitted infection? Kyle Bernstein and colleagues look for lessons from past discovery.

Medical treatments for incomplete miscarriage.

BACKGROUND: Miscarriage occurs in 10% to 15% of pregnancies. The traditional treatment, after miscarriage, has been to perform surgery to remove any remaining placental tissues in the uterus ('evacuation of uterus'). However, medical treatments, or expectant care (no treatment), may also be effective, safe, and acceptable. OBJECTIVES: To assess the effectiveness, safety, and acceptability of any medical treatment for incomplete miscarriage (before 24 weeks). SEARCH METHODS: We searched Cochrane Pregnancy and Childbirth's Trials Register (13 May 2016) and reference lists of retrieved papers. SELECTION CRITERIA: We included randomised controlled trials comparing medical treatment with expectant care or surgery, or alternative methods of medical treatment. We excluded quasi-randomised trials. DATA COLLECTION AND ANALYSIS: Two review authors independently assessed the studies for inclusion, assessed risk of bias, and carried out data extraction. Data entry was checked. We assessed the quality of the evidence using the GRADE approach. MAIN RESULTS: We included 24 studies (5577 women). There were no trials specifically of miscarriage treatment after 13 weeks' gestation.Three trials involving 335 women compared misoprostol treatment (all vaginally administered) with expectant care. There was no difference in complete miscarriage (average risk ratio (RR) 1.23, 95% confidence interval (CI) 0.72 to 2.10; 2 studies, 150 women, random-effects; very low-quality evidence), or in the need for surgical evacuation (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence). There were few data on 'deaths or serious complications'. For unplanned surgical intervention, we did not identify any difference between misoprostol and expectant care (average RR 0.62, 95% CI 0.17 to 2.26; 2 studies, 308 women, random-effects; low-quality evidence).Sixteen trials involving 4044 women addressed the comparison of misoprostol (7 studies used oral administration, 6 studies used vaginal, 2 studies sublingual, 1 study combined vaginal + oral) with surgical evacuation. There was a slightly lower incidence of complete miscarriage with misoprostol (average RR 0.96, 95% CI 0.94 to 0.98; 15 studies, 3862 women, random-effects; very low-quality evidence) but with success rate high for both methods. Overall, there were fewer surgical evacuations with misoprostol (average RR 0.05, 95% CI 0.02 to 0.11; 13 studies, 3070 women, random-effects; very low-quality evidence) but more unplanned procedures (average RR 5.03, 95% CI 2.71 to 9.35; 11 studies, 2690 women, random-effects; low-quality evidence). There were few data on 'deaths or serious complications'. Nausea was more common with misoprostol (average RR 2.50, 95% CI 1.53 to 4.09; 11 studies, 3015 women, random-effects; low-quality evidence). We did not identify any difference in women's satisfaction between misoprostol and surgery (average RR 1.00, 95% CI 0.99 to 1.00; 9 studies, 3349 women, random-effects; moderate-quality evidence). More women had vomiting and diarrhoea with misoprostol compared with surgery (vomiting: average RR 1.97, 95% CI 1.36 to 2.85; 10 studies, 2977 women, random-effects; moderate-quality evidence; diarrhoea: average RR 4.82, 95% CI 1.09 to 21.32; 4 studies, 757 women, random-effects; moderate-quality evidence).Five trials compared different routes of administration, or doses, or both, of misoprostol. There was no clear evidence of one regimen being superior to another. Limited evidence suggests that women generally seem satisfied with their care. Long-term follow-up from one included study identified no difference in subsequent fertility between the three approaches. AUTHORS' CONCLUSIONS: The available evidence suggests that medical treatment, with misoprostol, and expectant care are both acceptable alternatives to routine surgical evacuation given the availability of health service resources to support all three approaches. Further studies, including long-term follow-up, are clearly needed to confirm these findings. There is an urgent need for studies on women who miscarry at more than 13 weeks' gestation.

The Botswana Medical Eligibility Criteria Wheel: Adapting a Tool to Meet the Needs of Botswana's Family Planning Program.

In efforts to strive for family planning repositioning in Botswana, the Ministry of Health convened a meeting to undertake an adaptation of the Medical eligibility criteria for contraceptive use (MEC) wheel. The main objectives of this process were to present technical updates of the various contraceptive methods, to update the current medical conditions prevalent to Botswana and to adapt the MEC wheel to meet the needs of the Botswanian people. This commentary focuses on the adaptation process that occurred during the week-long stakeholder workshop. It concludes with the key elements learned from this process that can potentially inform countries who are interested in undergoing a similar exercise to strengthen their family planning needs.

Doctors or mid-level providers for abortion.

BACKGROUND: The World Health Organization recommends that abortion can be provided at the lowest level of the healthcare system. Training mid-level providers, such as midwives, nurses and other non-physician providers, to conduct first trimester aspiration abortions and manage medical abortions has been proposed as a way to increase women's access to safe abortion procedures. OBJECTIVES: To assess the safety and effectiveness of abortion procedures administered by mid-level providers compared to doctors. SEARCH METHODS: We searched the CENTRAL Issue 7, MEDLINE and POPLINE databases for comparative studies of doctor and mid-level providers of abortion services. We searched for studies published in any language from January 1980 until 15 August 2014. SELECTION CRITERIA: Randomised controlled trials (RCTs) (clustered or not clustered), prospective cohort studies or observational studies that compared the safety or effectiveness (or both) of any type of first trimester abortion procedure, administered by any type of mid-level provider or doctors, were eligible for inclusion in the review. DATA COLLECTION AND ANALYSIS: Two independent review authors screened abstracts for eligibility and double-extracted data from the included studies using a pre-tested form. We meta-analysed primary outcome data using both fixed-effect and random-effects models to obtain pooled risk ratios (RR) with 95% confidence intervals (CIs). We carried out separate analyses by study design (RCT or cohort) and type of abortion procedure (medical versus surgical). MAIN RESULTS: Eight studies involving 22,018 participants met our eligibility criteria. Five studies (n = 18,962) assessed the safety and effectiveness of surgical abortion procedures administered by mid-level providers compared to doctors. Three studies (n = 3056) assessed the safety and effectiveness of medical abortion procedures. The surgical abortion studies (one RCT and four cohort studies) were carried out in the United States, India, South Africa and Vietnam. The medical abortion studies (two RCTs and one cohort study) were carried out in India, Sweden and Nepal. The studies included women with gestational ages up to 14 weeks for surgical abortion and nine weeks for medical abortion.Risk of selection bias was considered to be low in the three RCTs, unclear in four observational studies and high in one observational study. Concealment bias was considered to be low in the three RCTs and high in all five observational studies. Although none of the eight studies performed blinding of the participants to the provider type, we considered the performance bias to be low as this is part of the intervention. Detection bias was considered to be high in all eight studies as none of the eight studies preformed blinding of the outcome assessment. Attrition bias was low in seven studies and high in one, with over 20% attrition. We considered six studies to have unclear risk of selective reporting bias as their protocols had not been published. The remaining two studies had published their protocols. Few other sources of bias were found.Based on an analysis of three cohort studies, the risk of surgical abortion failure was significantly higher when provided by mid-level providers than when procedures were administered by doctors (RR 2.25, 95% CI 1.38 to 3.68), however the quality of evidence for this outcome was deemed to be very low. For surgical abortion procedures, we found no significant differences in the risk of complications between mid-level providers and doctors (RR 0.99, 95% CI 0.17 to 5.70 from RCTs; RR 1.38, 95% CI 0.70 to 2.72 from observational studies). When we combined the data for failure and complications for surgical abortion we found no significant differences between mid-level providers and doctors in both the observational study analysis (RR 1.36, 95% CI 0.86 to 2.14) and the RCT analysis (RR 3.07, 95% CI 0.16 to 59.08). The quality of evidence of the outcome for RCT studies was considered to be low and for observational studies very low. For medical abortion procedures the risk of failure was not different for mid-level providers or doctors (RR 0.81, 95% CI 0.48 to 1.36 from RCTs; RR 1.09, 95% CI 0.63 to 1.88 from observational studies). The quality of evidence of this outcome for the RCT analysis was considered to be high, although the quality of evidence of the observational studies was considered to be very low. There were no complications reported in the three medical abortion studies. AUTHORS' CONCLUSIONS: There was no statistically significant difference in the risk of failure for medical abortions performed by mid-level providers compared with doctors. Observational data indicate that there may be a higher risk of abortion failure for surgical abortion procedures administered by mid-level providers, but the number of studies is small and more robust data from controlled trials are needed. There were no statistically significant differences in the risk of complications for first trimester surgical abortions performed by mid-level providers compared with doctors.

COVID-19 in pregnant women: a systematic review and meta-analysis on the risk and prevalence of pregnancy loss.

BACKGROUND: Pregnant women infected with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) are more likely to experience preterm birth and their neonates are more likely to be stillborn or admitted to a neonatal unit. The World Health Organization declared in May 2023 an end to the coronavirus disease 2019 (COVID-19) pandemic as a global health emergency. However, pregnant women are still becoming infected with SARS-CoV-2 and there is limited information available regarding the effect of SARS-CoV-2 infection in early pregnancy on pregnancy outcomes. OBJECTIVE AND RATIONALE: We conducted this systematic review to determine the prevalence of early pregnancy loss in women with SARS-Cov-2 infection and compare the risk to pregnant women without SARS-CoV-2 infection. SEARCH METHODS: Our systematic review is based on a prospectively registered protocol. The search of PregCov19 consortium was supplemented with an extra electronic search specifically on pregnancy loss in pregnant women infected with SARS-CoV-2 up to 10 March 2023 in PubMed, Google Scholar, and LitCovid. We included retrospective and prospective studies of pregnant women with SARS-CoV-2 infection, provided that they contained information on pregnancy losses in the first and/or second trimester. Primary outcome was miscarriage defined as a pregnancy loss before 20 weeks of gestation, however, studies that reported loss up to 22 or 24 weeks were also included. Additionally, we report on studies that defined the pregnancy loss to occur at the first and/or second trimester of pregnancy without specifying gestational age, and for second trimester miscarriage only when the study presented stillbirths and/or foetal losses separately from miscarriages. Data were stratified into first and second trimester. Secondary outcomes were ectopic pregnancy (any extra-uterine pregnancy), and termination of pregnancy. At least three researchers independently extracted the data and assessed study quality. We calculated odds ratios (OR) and risk differences (RDs) with corresponding 95% CI and pooled the data using random effects meta-analysis. To estimate risk prevalence, we performed meta-analysis on proportions. Heterogeneity was assessed by I2. OUTCOMES: We included 120 studies comprising a total of 168 444 pregnant women with SARS-CoV-2 infection; of which 18 233 women were in their first or second trimester of pregnancy. Evidence level was considered to be of low to moderate certainty, mostly owing to selection bias. We did not find evidence of an association between SARS-CoV-2 infection and miscarriage (OR 1.10, 95% CI 0.81-1.48; I2 = 0.0%; RD 0.0012, 95% CI -0.0103 to 0.0127; I2 = 0%; 9 studies, 4439 women). Miscarriage occurred in 9.9% (95% CI 6.2-14.0%; I2 = 68%; 46 studies, 1797 women) of the women with SARS CoV-2 infection in their first trimester and in 1.2% (95% CI 0.3-2.4%; I2 = 34%; 33 studies; 3159 women) in the second trimester. The proportion of ectopic pregnancies in women with SARS-CoV-2 infection was 1.4% (95% CI 0.02-4.2%; I2 = 66%; 14 studies, 950 women). Termination of pregnancy occurred in 0.6% of the women (95% CI 0.01-1.6%; I2 = 79%; 39 studies; 1166 women). WIDER IMPLICATIONS: Our study found no indication that SARS-CoV-2 infection in the first or second trimester increases the risk of miscarriages. To provide better risk estimates, well-designed studies are needed that include pregnant women with and without SARS-CoV-2 infection at conception and early pregnancy and consider the association of clinical manifestation and severity of SARS-CoV-2 infection with pregnancy loss, as well as potential confounding factors such as previous pregnancy loss. For clinical practice, pregnant women should still be advised to take precautions to avoid risk of SARS-CoV-2 exposure and receive SARS-CoV-2 vaccination.

Viral shedding of SARS-CoV-2 in body fluids associated with sexual activity: a systematic review and meta-analysis.

OBJECTIVE: To identify and summarise the evidence on the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA detection and persistence in body fluids associated with sexual activity (saliva, semen, vaginal secretion, urine and faeces/rectal secretion). ELIGIBILITY: All studies that reported detection of SARS-CoV-2 in saliva, semen, vaginal secretion, urine and faeces/rectal swabs. INFORMATION SOURCES: The WHO COVID-19 database from inception to 20 April 2022. RISK OF BIAS ASSESSMENT: The National Institutes of Health tools. SYNTHESIS OF RESULTS: The proportion of patients with positive results for SARS-CoV-2 and the proportion of patients with a viral duration/persistence of at least 14 days in each fluid was calculated using fixed or random effects models. INCLUDED STUDIES: A total of 182 studies with 10 023 participants. RESULTS: The combined proportion of individuals with detection of SARS-CoV-2 was 82.6% (95% CI: 68.8% to 91.0%) in saliva, 1.6% (95% CI: 0.9% to 2.6%) in semen, 2.7% (95% CI: 1.8% to 4.0%) in vaginal secretion, 3.8% (95% CI: 1.9% to 7.6%) in urine and 31.8% (95% CI: 26.4% to 37.7%) in faeces/rectal swabs. The maximum viral persistence for faeces/rectal secretions was 210 days, followed by semen 121 days, saliva 112 days, urine 77 days and vaginal secretions 13 days. Culturable SARS-CoV-2 was positive for saliva and faeces. LIMITATIONS: Scarcity of longitudinal studies with follow-up until negative results. INTERPRETATION: SARS-CoV-2 RNA was detected in all fluids associated with sexual activity but was rare in semen and vaginal secretions. Ongoing droplet precautions and awareness of the potential risk of contact with faecal matter/rectal mucosa are needed. PROSPERO REGISTRATION NUMBER: CRD42020204741.

Effectiveness and safety of COVID-19 vaccines on maternal and perinatal outcomes: a systematic review and meta-analysis.

OBJECTIVE: To assess the effects of COVID-19 vaccines in women before or during pregnancy on SARS-CoV-2 infection-related, pregnancy, offspring and reactogenicity outcomes. DESIGN: Systematic review and meta-analysis. DATA SOURCES: Major databases between December 2019 and January 2023. STUDY SELECTION: Nine pairs of reviewers contributed to study selection. We included test-negative designs, comparative cohorts and randomised trials on effects of COVID-19 vaccines on infection-related and pregnancy outcomes. Non-comparative cohort studies reporting reactogenicity outcomes were also included. QUALITY ASSESSMENT, DATA EXTRACTION AND ANALYSIS: Two reviewers independently assessed study quality and extracted data. We undertook random-effects meta-analysis and reported findings as HRs, risk ratios (RRs), ORs or rates with 95% CIs. RESULTS: Sixty-seven studies (1 813 947 women) were included. Overall, in test-negative design studies, pregnant women fully vaccinated with any COVID-19 vaccine had 61% reduced odds of SARS-CoV-2 infection during pregnancy (OR 0.39, 95% CI 0.21 to 0.75; 4 studies, 23 927 women; I2=87.2%) and 94% reduced odds of hospital admission (OR 0.06, 95% CI 0.01 to 0.71; 2 studies, 868 women; I2=92%). In adjusted cohort studies, the risk of hypertensive disorders in pregnancy was reduced by 12% (RR 0.88, 95% CI 0.82 to 0.92; 2 studies; 115 085 women), while caesarean section was reduced by 9% (OR 0.91, 95% CI 0.85 to 0.98; 6 studies; 30 192 women). We observed an 8% reduction in the risk of neonatal intensive care unit admission (RR 0.92, 95% CI 0.87 to 0.97; 2 studies; 54 569 women) in babies born to vaccinated versus not vaccinated women. In general, vaccination during pregnancy was not associated with increased risk of adverse pregnancy or perinatal outcomes. Pain at the injection site was the most common side effect reported (77%, 95% CI 52% to 94%; 11 studies; 27 195 women). CONCLUSION: COVID-19 vaccines are effective in preventing SARS-CoV-2 infection and related complications in pregnant women. PROSPERO REGISTRATION NUMBER: CRD42020178076.

Reducing the harms of unsafe abortion: a systematic review of the safety, effectiveness and acceptability of harm reduction counselling for pregnant persons seeking induced abortion.

BACKGROUND: Globally, access to safe abortion is limited. We aimed to assess the safety, effectiveness and acceptability of harm reduction counselling for abortion, which we define as the provision of information about safe abortion methods to pregnant persons seeking abortion. METHODS: We searched PubMed, EMBASE, ClinicalTrials.gov, Cochrane, Global Index Medicus and the grey literature up to October 2021. We included studies in which healthcare providers gave pregnant persons information on safe use of abortifacient medications without providing the actual medications. We conducted a descriptive summary of results and a risk of bias assessment using the ROBINS-I tool. Our primary outcome was the proportion of pregnant persons who used misoprostol to induce abortion rather than other methods among those who received harm reduction counselling. RESULTS: We included four observational studies with a total of 4002 participants. Most pregnant persons who received harm reduction counselling induced abortion using misoprostol (79%-100%). Serious complication rates were low (0%-1%). Uterine aspiration rates were not always reported but were in the range of 6%-22%. Patient satisfaction with the harm reduction intervention was high (85%-98%) where reported. We rated the risk of bias for all studies as high due to a lack of comparison groups and high lost to follow-up rates. DISCUSSION: Based on a synthesis of four studies with serious methodological limitations, most recipients of harm reduction counselling use misoprostol for abortion, have low complication rates, and are satisfied with the intervention. More research is needed to determine abortion success outcomes from the harm reduction approach. FUNDING: This work did not receive any funding. PROSPERO REGISTRATION NUMBER: We registered the review in the PROSPERO database of systematic reviews (ID number: CRD42020200849).

Rhesus isoimmunisation in unsensitised RhD-negative individuals seeking abortion at less than 12 weeks' gestation: a systematic review.

AIM: The aim of this review was to systematically review the outcome of routine anti-D administration among unsensitised rhesus (RhD)-negative individuals who have an abortion. This review is registered with Prospero. METHODS: A search for all published and ongoing studies, without restrictions on language or publication status, was performed using the following databases from their inception: EBM Reviews Ovid - Cochrane Central Register of Controlled Trials, MEDLINE Ovid (Epub Ahead of Print, In-Process & Other Non-Indexed Citations and Daily), Embase.com, Popline and Google Scholar. Study types included: randomised controlled trials, controlled trials, cohort and case-control studies from 1971 onwards. The population included women who undergo an abortion (induced, incomplete, spontaneous or septic abortion), medical or surgical <12 weeks, and isoimmunisation in a subsequent pregnancy. The primary outcomes were: (1) development of a positive Kleihauer-Betke test and (2) development of Rh alloimmunisation in a subsequent pregnancy. RESULTS: A total of 2652 studies were screened with 105 accessed for full-text review. Two studies have been included with high bias appreciated. Both studies found few women to be sensitised in forming antibodies after an abortion. The limited studies available and heterogeneity prevent the conduction of a meta-analysis. CONCLUSIONS: Rh immunoglobulin has well-documented safety. However, it is not without risks and costs, is a possible barrier to delivering efficient services, and may have limited availability in some countries. The evidence base and quality of studies are currently limited. There is unclear benefit from the recommendation for Rh testing and immunoglobulin administration in early pregnancy. More research is needed as clinical practice guidelines are varied, based on expert opinions and moving away from testing and administration at time of abortion. IMPLICATIONS: There is limited evidence surrounding medical benefit of Rh testing and immunoglobulin administration in early pregnancy. Further research is needed to define alloimmunisation and immunoglobulin benefit to update standards of care. Additionally, other factors should be considered in forming clinical policies and guidelines such as costs, feasibility and impact on access to care for patients.

Health systems analysis and evaluation of the barriers to availability, utilisation and readiness of sexual and reproductive health services in COVID-19-affected areas: a WHO mixed-methods study protocol.

INTRODUCTION: COVID-19 has led to an unprecedented increase in demand on health systems to care for people infected, necessitating the allocation of significant resources, especially medical resources, towards the response. This, compounded by the restrictions on movement instituted may have led to disruptions in the provision of essential services, including sexual and reproductive health (SRH) services. This study aims to assess the availability of contraception, comprehensive abortion care, sexually transmitted infection prevention and treatment and sexual and gender-based violence care and support services in local health facilities during COVID-19 pandemic. This is a standardised generic protocol designed for use across different global settings. METHODS AND ANALYSIS: This study adopts both quantitative and qualitative methods to assess health facilities' SRH service availability and readiness, and clients' and providers' perceptions of the availability and readiness of these services in COVID-19-affected areas. The study has two levels: (1) perceptions of clients (and the partners) and healthcare providers, using qualitative methods, and (2) assessment of infrastructure availability and readiness to provide SRH services through reviews, facility service statistics for clients and a qualitative survey for healthcare provider perspectives. The health system assessment will use a cross-sectional panel survey design with two data collection points to capture changes in SRH services availability as a result of the COVID-19 epidemic. Data will be collected using focus group discussions, in-depth interviews and a health facility assessment survey. ETHICS AND DISSEMINATION: Ethical approval for this study was obtained from the WHO Scientific and Ethics Review Committee (protocol ID CERC.0103). Each study site is required to obtain the necessary ethical and regulatory approvals that are required in each specific country.

Issues related to pregnancy, pregnancy prevention and abortion in the context of the COVID-19 pandemic: a WHO qualitative study protocol.

INTRODUCTION: WHO has generated standardised clinical and epidemiological research protocols to address key public health questions for SARS-CoV-2 (COVID-19) pandemic. We present a standardised protocol with the aim to fill a gap in understanding the needs, attitudes and practices related to sexual and reproductive health in the context of COVID-19 pandemic, focusing on pregnancy, pregnancy prevention and abortion. METHODS AND ANALYSIS PLAN: This protocol is a prospective qualitative research, using semi-structured interviews with at least 15 pregnant women at different gestational ages and after delivery, 6 months apart from the first interview. At least 10 partners, 10 non-pregnant women and 5 healthcare professionals will be interviewed once during the course of the research. Higher number of subjects may be needed if a saturation is not achieved with these numbers. Data collection will be performed in a standardised way by skilled trained interviewers using written notes or audio-record of the interview. The data will be explored using the thematic content analysis and the researchers will look for broad patterns, generalisations or theories from these categories. ETHICS AND DISSEMINATION: The current protocol was first technically assessed and approved by the WHO scientific committee and then approved by its ethics review committee as a guidance document. It is expected that each country/setting implementing such a generic protocol adapted to their conditions also obtain local ethical approval. Comments for the user's consideration are provided the document, as the user may need to modify methods slightly because of the local context in which this study will be carried out.

Level and determinants of contraceptive uptake among women attending facilities with abortion-related complications in East and Southern Africa.

OBJECTIVE: To investigate the level and determinants of nonreceipt of contraception among women admitted to facilities with abortion-related complications in East and Southern Africa. METHODS: Cross-sectional data from Kenya, Malawi, Mozambique, and Uganda collected as part of the World Health Organization (WHO) Multi-Country Survey on Abortion-related morbidity. Medical record review and the audio computer-assisted self-interviewing system were used to collect information on women's demographic and clinical characteristics and their experience of care. The percentage of women who did not receive a contraceptive was estimated and the methods of choice for different types of contraceptives were identified. Potential determinants of nonreceipt of contraception were grouped into three categories: sociodemographic, clinical, and service-related characteristics. Generalized estimating equations were used to identify the determinants of nonreceipt of a contraceptive following a hierarchical approach. RESULTS: A total of 1190 women with abortion-related complications were included in the analysis, of which 33.9% (n = 403) did not receive a contraceptive. We found evidence that urban location of facility, no previous pregnancy, and not receiving contraceptive counselling were risk factors for nonreceipt of a contraceptive. Women from nonurban areas were less likely not to receive a contraceptive than those in urban areas (AOR 0.52; 95% CI, 0.30-0.91). Compared with women who had a previous pregnancy, women who had no previous pregnancy were 60% more likely to not receive a contraceptive (95% CI, 1.14-2.24). Women who did not receive contraceptive counselling were over four times more likely to not receive a contraceptive (AOR 4.01; 95% CI, 2.88-5.59). CONCLUSION: Many women leave postabortion care having not received contraceptive counselling and without a contraceptive method. There is a clear need to ensure all women receive high-quality contraceptive information and counselling at the facility to increase contraceptive acceptance and informed decision-making.

Abortion-related infections across 11 countries in Sub-Saharan Africa: Prevalence, severity, and management.

OBJECTIVE: To estimate the prevalence of infection among abortion-related complications in health facilities, describe their management, and identify sociodemographic and clinical factors associated with abortion-related infections. METHODS: A secondary analysis of the WHO Multi-Country Survey on Abortion-related morbidity (MCS-A) conducted in 210 health facilities of 11 Sub-Saharan African countries between 2017 and 2018. The outcome variable was abortion-related infections, categorized into three mutually exclusive groups of abortion-related complications: infections only, infection with other complications, and other complications without infection. We described the sociodemographic and clinical characteristics and the management of abortion-related infection and identified the factors associated with abortion-related infections using a multinomial logistic model. RESULTS: A total of 9232 women with abortion-related complications were included, with infection occurring among 10.6% of women (n = 974). Infection was involved in 47.4% (n = 153) of severe maternal outcomes with a case fatality rate of 27.4% (n = 42). The most common management approach was antibiotics, uterine evacuation, and uterotonics combined: 43.2% (n = 384) in the group of women with infection only and 48.6% (n = 4235) among those with infection and other complications. In addition, 85.9% (n = 7095) of women without infection also received therapeutic antibiotics. Factors associated with an increased odds of infection only compared with complication without infection were age younger than 20 years compared with those aged over 30 (aOR 1.84; 95% CI,1.24-2.74), not living in a couple (aOR 2.05, 95% CI,1.52-2.76), and gestational age of 13 weeks or more (aOR 1.70, 95% CI,1.27-2.26). The same factors were associated with infection and other complications. CONCLUSION: Infection is frequent among severe abortion-related complications, and its case fatality rate is high. Further research to assess the relationship between abortion-related infections and outcomes is needed. There is also a need to question the quality of postabortion care and improve adequate use of antibiotics.