Self-managed abortion via the internet: Analysis of one year of service delivery data from Women Help Women.

Background: To better comprehend the demand for online medication abortion and to inform service delivery practice, we conducted an analysis of Women Help Women (WHW) service delivery statistics. The primary goals were to understand their user profile, evaluate self-reported outcomes and use of other medical services, and assess the overall experience both with the abortion itself and with the counseling and care provided by WHW. Methods: We retrospectively evaluated user characteristics, abortion outcomes, and acceptability of both the medication abortion and WHW's services, using consultation data and corresponding evaluation data from a one-year period. For users who did not complete the evaluation form, WHW staff reviewed email correspondences to identify key outcomes. Results: From August 2016-July 2017, 3,307 individuals received abortion pills from WHW. Users were geographically located in thirty countries and correspondence was conducted in seven languages. Most reported their gestational age to be less than eight weeks. Of the 2,295 who took the pills and provided outcome information, almost all (99.1%, n=2275) reported that they were no longer pregnant. The majority (84.1%, n=1576/1875) used symptoms to confirm outcome; one fourth (22.8%, n=428) sought an ultrasound and one sixth (18.0%, n=338) used urine and/or serum testing. One in eight users (12.6%, n=292/2317) reported seeking additional medical care after taking the abortion pills. Most (87.5%, n=1551/1773) reported being satisfied or very satisfied with the abortion. Conclusions: Our study confirms that self-managed abortion is a process that people can do safely and effectively with community support and without medical supervision. In the context of a global backlash against abortion rights, self-managed abortion is an integral part of a spectrum of options for abortion care that must be made available to all.

Deep Venous Thrombosis of Non-operative Clavicle Fracture Following Low-Energy Injury Mechanism With Extension Into the Radial Vein: A Case Report.

Clavicle fractures are relatively common with the majority treated non-operatively. However, venous thromboembolism (VTE) in association with these fractures is rare, despite conservative treatment involving immobilization rather than surgical intervention. Surgery is a risk factor for thromboembolism and therefore more common when clavicle fractures are treated operatively. There have been a few published case reports of VTE following clavicle fractures that were managed non-operatively. Here we present a unique case of VTE involving the subclavian, brachial, and radial vein following a low-energy injury, with radial involvement being the most distal to date. A literature review is also presented to compare locations of VTE, injury factors, and timeline from injury to VTE presentation.

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.

Feasibility of Multilevel Pregnancy Tests for Telemedicine Abortion Service Follow-Up: A Pilot Study.

CONTEXT: Telemedicine clients wishing to confirm a successful medication abortion outside of a clinic setting are commonly instructed to use high-sensitivity urine pregnancy tests, which can take up to four weeks to yield accurate results. Multilevel urine pregnancy tests (MLPTs), which provide accurate results in one week, are a promising alternative, but their use has not been evaluated within telemedicine services. METHODS: From November 2017 to May 2018, 165 eligible and consenting pregnant people who contacted safe2choose-an organization providing telemedicine abortion services internationally-for medication abortion were enrolled in a pilot study and mailed a package containing medication abortion drugs, two MLPTs and instructions. Data on 118 participants who completed a web-based evaluation survey two weeks after the package was sent were analyzed to examine participant experiences and satisfaction with the service. RESULTS: Responding participants were from 11 countries, including Mexico, the Philippines and Singapore. Ninety-three percent used both MLPTs, and 91% of those who used both tests used them at the correct time intervals. Among the 95% of participants whose MLPT results indicated that their pregnancy hormone levels decreased from before to after medication abortion, 86% correctly interpreted the results to mean that they were no longer pregnant. Satisfaction was high, with all indicating that the supplied information was helpful; more than nine out of 10 noted that they would want to use the MLPTs again. CONCLUSIONS: Incorporating MLPTs into telemedicine abortion services is feasible and associated with high client satisfaction. Enabling people to manage their own abortion follow-up care could greatly improve their overall abortion experience.

RESUMEN Contexto: Las clientas de telemedicina que desean confirmar el éxito de un aborto con medicamentos fuera del entorno de una clínica, generalmente reciben instrucciones para usar pruebas de alta sensibilidad de embarazo en orina, que pueden tomar hasta cuatro semanas para producir resultados precisos. Las pruebas multinivel de embarazo en orina (PMEO), que brindan resultados precisos en una semana, son una alternativa prometedora, pero su uso no ha sido evaluado en el contexto de los servicios de telemedicina. Métodos: De noviembre de 2017 a mayo de 2018, 165 mujeres embarazadas elegibles y que dieron su consentimiento se comunicaron con safe2choose ­organización que brinda servicios de aborto por telemedicina a nivel internacional­para obtener un aborto con medicamentos y se inscribieron en un estudio piloto que les envió por correo un paquete que contenía medicamentos para el aborto, dos PMEO e instrucciones. Se analizaron los datos de 118 participantes que completaron una encuesta de evaluación en línea dos semanas después de que se envió el paquete para examinar las experiencias de las participantes y la satisfacción con el servicio. Resultados: Las participantes que respondieron eran de 11 países, incluidos México, Filipinas y Singapur. El 93% utilizó ambos PMEO y el 91% de quienes utilizaron ambas pruebas las utilizaron en los intervalos de tiempo correctos. Del 95% de las participantes cuyos resultados de PMEO indicaron que sus niveles de hormonas del embarazo disminuyeron desde antes hasta después del aborto con medicamentos, el 86% interpretó correctamente los resultados en el sentido de que ya no estaban embarazadas. La satisfacción fue alta, y todas indicaron que la información proporcionada fue útil; más de nueve de cada 10 señalaron que querrían volver a utilizar los PMEO. Conclusiones: La incorporación de PMEO en los servicios de aborto por telemedicina es factible y está asociada con una alta satisfacción del cliente. Permitir que las mujeres manejen su propia atención de seguimiento del aborto podría mejorar en gran medida su experiencia general del aborto.

RÉSUMÉ Contexte: Les patientes en télémédecine soucieuses de confirmer la réussite d'un avortement médicamenteux effectué en dehors d'une clinique sont généralement invitées à utiliser les tests urinaires de grossesse à haute sensibilité, qui peuvent produire des résultats inexacts jusqu'à quatre semaines après l'intervention. Les tests urinaires de grossesse multiniveaux (TGMN), qui produisent des résultats exacts en l'espace d'une semaine, offrent une autre solution prometteuse, mais leur utilisation n'a pas été évaluée en télémédecine. Méthodes: De novembre 2017 à mai 2018, 165 personnes enceintes admises et consentantes qui s'étaient adressées à l'organisation safe2choose ­ prestataire de services d'avortement par télémédecine à l'échelle internationale ­ pour un avortement médicamenteux ont été inscrites à une étude pilote et un colis contenant des médicaments abortifs, deux TGMN et les instructions à suivre leur a été envoyé. Les données relatives à 118 participantes ayant répondu à un questionnaire d'évaluation en ligne deux semaines après l'envoi du colis ont été analysées pour examiner leur expérience et leur satisfaction concernant le service. Résultats: Les participantes qui avaient répondu au questionnaire étaient originaires de 11 pays, dont le Mexique, les Philippines et Singapour. Quatre-vingt-treize pour cent avaient utilisé les deux TGMN et, parmi elles, 91% les avaient utilisés aux intervalles adéquats. Parmi les 95% de participantes dont les TGMN indiquaient des niveaux d'hormone de grossesse en baisse entre les moments où elles avaient effectué les tests avant et après l'avortement médicamenteux, 86% avaient interprété correctement leurs résultats comme indiquant qu'elles n'étaient plus enceintes. Le niveau de satisfaction était élevé, toutes les participantes indiquant que l'information fournie leur avait été utile. Plus de neuf sur 10 faisaient remarquer qu'elles seraient disposées à réutiliser les TGMN. Conclusions: L'incorporation des TGMN dans les services d'avortement par télémédecine est faisable et associée à un haut degré de satisfaction. L'habilitation à gérer ses propres soins de suivi après avortement pourrait améliorer grandement l'expérience générale de l'intervention.

Multi-level pregnancy test use for medical abortion follow-up after 63 days' gestation: Evidence from prenatal hCG data.

OBJECTIVE: To explore hCG patterns using multi-level urine pregnancy tests (MLPTs) among prenatal clients to evaluate the potential use of these tests for medical abortion follow-up after 63 days' gestation. STUDY DESIGN: Prenatal clients with gestations 9-12 weeks were asked to administer an MLPT weekly for three weeks. We evaluated change in hCG range over one- and two-week intervals. RESULTS: Our analysis included 121 clients. Over one-week intervals, 26.5-43.1% of participants had a drop in hCG range. The proportion with a decline after two-weeks was 42.0-48.3%. CONCLUSION: This follow-up strategy would not work in gestations beyond 63 days.

A cross-sectional analysis of mifepristone, misoprostol, and combination mifepristone-misoprostol package inserts obtained in 20 countries.

OBJECTIVES: To evaluate the characteristics, clinical information, and storage instructions contained in package inserts from medical abortion commodities collected in low- and middle-income countries. STUDY DESIGN: From November 2017 to February 2018 mifepristone, misoprostol, and combined mifepristone-misoprostol (combipack) products were collected to populate the Medical Abortion Commodities Database. We extracted stated indications for use, storage instructions, and date of last revision from each package insert obtained. For those inserts listing medical abortion as an indication, we also extracted eligibility criteria, recommended regimens, side effects, and contraindications. RESULTS: We identified 41 package inserts from 20 countries; 19 (46%) listed medical abortion as an indication including all 7 combipacks, all 7 mifepristone products, and 5/27 (19%) misoprostol products. Date of last insert revision ranged from 1991 to 2016. Gestational age limits for early medical abortion ranged from 49 days to "first trimester." Three (43%) mifepristone products recommended a 600 mg oral dose and two (29%) recommended regimens with gemeprost. Eighteen (67%) misoprostol and one (14%) combipack inserts recommended protection from moisture. CONCLUSIONS: The characteristics, clinical information, and storage instructions in medical abortion product package inserts from a variety of field settings in low- and middle-income countries included inadequate storage instructions and outdated gestational age limits and regimens. IMPLICATIONS: There is an urgent need to revisit approved inserts for medical abortion products in low- and middle-income countries to ensure information is accurate and reflects the current evidence base. Simultaneously, providing supplemental instructions targeted at users may fill some gaps. People have a right to accurate information to ensure a safe and effective medical abortion experience.

Advance misoprostol distribution to pregnant women for preventing and treating postpartum haemorrhage.

BACKGROUND: Advance community distribution of misoprostol for preventing or treating postpartum haemorrhage (PPH) has become an attractive strategy to expand uterotonic coverage to places where conventional uterotonic use is not feasible. However, the value and safety of this strategy remain contentious. This is an update of a Cochrane Review first published in 2012. OBJECTIVES: To assess the effectiveness and safety of the strategy of advance misoprostol distribution to pregnant women for the prevention or treatment of PPH in non-facility births. SEARCH METHODS: For this update, we searched the Cochrane Pregnancy and Childbirth Trial Register, ClinicalTrials.gov, the World Health Organization (WHO) International Clinical Trials Registry Platform (ICTRP) (19 December 2019), and reference lists of retrieved studies. SELECTION CRITERIA: We included randomised, cluster-randomised or quasi-randomised controlled trials of advance misoprostol distribution to pregnant women compared with usual (or standard) care for the prevention or treatment of PPH in non-facility births. We excluded studies without any form of random design and those that were available in abstract form only. DATA COLLECTION AND ANALYSIS: At least two review authors independently assessed trials for inclusion, extracted data and assessed the risk of bias in included studies. Two review authors independently assessed the certainty of the evidence using the GRADE approach. MAIN RESULTS: Two studies conducted in rural Uganda met the inclusion criteria for this review. One was a stepped-wedge cluster-randomised trial (involving 2466 women) which assessed the effectiveness and safety of misoprostol distribution to pregnant women compared with standard care for PPH prevention during non-facility births. The other study (involving 748 women) was a pilot individually randomised placebo-controlled trial which assessed the logistics and feasibility of community antenatal distribution of misoprostol, as well as the effectiveness and safety of self-administration of misoprostol for PPH prevention. Only 271 (11%) of women in the cluster-randomised trial and 299 (40%) of the women in the individually randomised trial had non-facility births. Data from the two studies could not be meta-analysed as the data available from the stepped-wedge trial were not adjusted for the study design. Therefore, the analysed effects of advance misoprostol distribution on PPH prevention largely reflect the findings of the placebo-controlled trial. Neither of the included studies addressed advance misoprostol distribution for the treatment of PPH. Primary outcomes Severe PPH was not reported in the studies. In both the intervention and standard care arms of the two studies, no cases of severe maternal morbidity or death were recorded among women who had a non-facility birth. Secondary outcomes Compared with standard care, it is uncertain whether advance misoprostol distribution has any effect on blood transfusion (no events, 1 study, 299 women), the number of women not using misoprostol (2% in the advance distribution group versus 4% in the usual care group; risk ratio (RR) 0.50, 95% confidence interval (CI) 0.13 to 1.95, 1 study, 299 women), the number of women not using misoprostol correctly (RR 4.86, 95% CI 0.24 to 100.46, 1 study, 290 women), inappropriate use of misoprostol (RR 4.97, 95% CI 0.24 to 102.59, 1 study, 299 women) or maternal transfer or referral to a health facility (RR 0.66, 95% CI 0.11 to 3.91, 1 study, 299 women). Compared with standard care, it is uncertain whether advance misoprostol provision increases the number of women experiencing minor adverse effects: shivering/chills (RR 1.84, CI 95% 1.35 to 2.50, 1 study, 299 women), fever (RR 1.87, 95% CI 1.16 to 3.00, 1 study, 299 women), or diarrhoea (RR 3.92, 95% CI 0.44 to 34.64, 1 study, 299 women); major adverse effects: placenta retention (RR 1.49, 95% CI 0.25 to 8.79, 1 study, 299 women) or hospital admission for longer than 24 hours (RR 0.99, 95% CI 0.66 to 15.73, 1 study, 299 women) after non-facility birth. For all the outcomes included in the 'Summary of findings' table, we assessed the certainty of the evidence as very low, according to GRADE criteria. AUTHORS' CONCLUSIONS: Whilst it might be considered reasonable and feasible to provide advance misoprostol to pregnant women where there are no suitable alternative options for the prevention or treatment of PPH, the evidence on the benefits and harms of this approach remains uncertain. Expansion of uterotonic coverage through this strategy should be cautiously implemented either in the context of rigorous research or with targeted monitoring and evaluation of its impact.

Feasibility of a hospital outpatient day procedure for medication abortion at 13-18 weeks gestation: Findings from Nepal.

OBJECTIVES: To evaluate the safety, acceptability and feasibility of a one-day outpatient medication abortion service at gestations 13-18 weeks. STUDY DESIGN: Open-label prospective study in which participants received mifepristone 200 mg orally to swallow at home or at the clinic followed 24 h later by misoprostol 400 mcg buccally. They presented to the outpatient clinic 24-48 h after mifepristone for misoprostol 400 mcg buccally every three hours (no maximum dose). The primary outcome was successful abortion without transfer to overnight inpatient care. Secondary outcomes included time to abortion from initial misoprostol dose, safety, additional interventions and side effects. RESULTS: We enrolled 230 women from December 2017 to November 2018. Approximately nine of ten (n = 206, 89.6%) achieved a successful abortion without transfer to overnight care. Twenty-four were transferred to overnight inpatient care; of these 18 were to manage a complication, five for incomplete abortion and two by choice. Among these 24, three women experienced an SAE. The median time to successful abortion from time of the first misoprostol dose was 7.2 h (range: 0.75-92.3), with an average of three misoprostol doses. Most participants expelled the fetus and the placenta at or around the same time; median time between fetal and placental expulsion was 15 minutes (range: 0-4.5 h). Fifteen participants (6.6%) received more than five misoprostol doses and were transferred to inpatient care. Administration of more than five doses of misoprostol was associated with nulliparity. Provision of antibiotics (27.9%, n = 64), manual removal of placenta (15.3%, n = 35), uterotonics (4.4%, n = 10) and surgical interventions (4.4%, n = 10) were also reported. About one in four participants experienced nausea, vomiting and chills; fever was infrequent (2.5%, n = 5). CONCLUSIONS: For gestations 13-18 weeks, an outpatient day process for medication abortion is safe, effective and feasible. IMPLICATIONS: Medication abortion in 13 - 18 weeks need not be limited to inpatient care; nine of ten cases can be managed as an outpatient day service.

Could second-trimester medical abortion be offered as a day service? Assessing the feasibility of a 1-day outpatient procedure using pooled data from six clinical studies.

OBJECTIVES: Current service delivery models for second-trimester medical abortion typically include routine inpatient admission and overnight stays. To assess the feasibility of a day-service model, we evaluated outpatient administration of abortion medications and analyzed the proportion of clients who could avoid an overnight stay. We also examined additional key elements of medical abortion care to evaluate the practicality of this model. STUDY DESIGN: We pooled data from six clinical studies of second-trimester medical abortion conducted by Gynuity over the past 10 years. We include 868 individuals receiving mifepristone-misoprostol abortion between 13 and 22 weeks' gestation. RESULTS: At 8 h post misoprostol initiation, 309/521 (59.3%) participants at 13-18 weeks' gestation had a successful abortion; by 10 h, 382/521 (73.3%) were successful. Taking the mifepristone at home lowered neither the efficacy of the method nor satisfaction with the experience. Nonphysician providers played a significant role in the provision of care. Needed interventions were relatively rare; serious complications were very rare. CONCLUSIONS: Our findings support the provision of second-trimester medical abortion in a day-clinic setting, especially at ≤18 weeks' gestation. Such a model could increase access to quality care in many settings. IMPLICATIONS: Second-trimester medical abortion can safely and effectively be offered as a day service. Nonphysician providers are well suited to provide the majority of care. Developing guidelines for a 1-day model could increase access to quality care in many settings worldwide.

Results of a pilot study in the U.S. and Vietnam to assess the utility and acceptability of a multi-level pregnancy test (MLPT) for home monitoring of hCG trends after assisted reproduction.

BACKGROUND: To evaluate the utility and acceptability of using multi-level pregnancy tests (MLPTs) at home to monitor hCG trends following assisted reproductive technology (ART). METHODS: One hundred and four women presenting for ART at either Stanford Medicine Fertility and Reproductive Health Clinic (Stanford, CA) or Hung Vuong Hospital (Ho Chi Minh City, Vietnam) participated in this pilot study. Women were asked to perform the MLPT at home, primarily on days when they were also scheduled to receive standard clinic-based serum hCG testing. These tests were administered up to 6 times over the 6-week period following embryo transfer or intrauterine insemination (IUI). Concordance of serial hCG readings for each time point was assessed by comparing trends in urine MLPT results with trends in serum hCG. Stable or increasing hCG level was interpreted as an indication of a progressing pregnancy, while a declining hCG was interpreted as a lack of established or progressing pregnancy. At study end, all participants were asked about the acceptability and convenience of using the MLPT at home for monitoring hCG trends following ART. RESULTS: Data from both urine and serum testing are available for 156 of 179 clinic visits (87.2%). There was high concordance of serial trend results between the two types of tests: among the 156 sets of serum and urine hCG data points, 150 (96.2%) showed a matching trend in hCG pattern and 6 (3.8%) resulted in a discordant trend. Seventy-three percent of women reported being satisfied or very satisfied with using the MLPTs at home. Almost all (96.6%) said that the MLPT was easy or very easy to use. CONCLUSION: The MLPT offers women and health care providers a client-friendly diagnostic tool to detect very early pregnancy and monitor its progress. TRIAL REGISTRATION: This study was registered on clinicaltrials.gov as NCT01846403 (May 1, 2013), and NCT01919502 (August 5, 2013).

Serial multilevel urine pregnancy testing to assess medical abortion outcome: a meta-analysis.

OBJECTIVES: To summarize data on the accuracy of a strategy designed to exclude ongoing pregnancy after medical abortion treatment by observing a decline in urine human chorionic gonadotropin (hCG) concentration as estimated by multilevel urine pregnancy tests (MLPTs) performed before and after treatment. STUDY DESIGN: We collated original data from seven studies performed by our organization that evaluated the accuracy of the MLPT strategy for assessment of outcome of medical abortion. Our first analysis included data from the five studies in which each participant was evaluated both with the MLPT strategy and with ultrasound or other clinical assessment. Our second analysis combined data from two randomized trials that compared the MLPT strategy to assessment by ultrasound. Both analyses included only participants treated at ≤63 days of gestation. RESULTS: In the first analysis, 1482 (93%) of 1599 participants had a decline in hCG concentration after treatment. Twenty-one (1.3%) had an ongoing pregnancy, none of whom had a decline (predictive value 100%, 95% CI 93.3%, 100%). The remaining 96 women (6.0%) had no decline without an ongoing pregnancy. The second analysis, which included 3762 participants with follow-up, found no significant difference in the rates of ongoing pregnancy ascertained in the randomized groups (RR 0.88; 95% CI 0.50, 1.54). Nearly all of the post-treatment MLPTs in the seven studies (3484/3535; 99%) were performed by the participants themselves. CONCLUSIONS: Serial multilevel urine pregnancy testing is a highly reliable and efficient strategy for excluding ongoing pregnancy after medical abortion at≤63 days of gestation. IMPLICATIONS STATEMENT: Serial urine testing using MLPTs can obviate the need for routine ultrasound or examination after medical abortion treatment and can allow most women to avoid an in-person follow-up visit to the abortion facility.

Simultaneous Administration Compared With a 24-Hour Mifepristone-Misoprostol Interval in Second-Trimester Abortion: A Randomized Controlled Trial.

OBJECTIVE: To compare outcomes with simultaneous administration of mifepristone and misoprostol with a regimen in which the drugs are administered at a 24-hour interval for second-trimester abortion. METHODS: In this placebo-controlled, double-blind trial, participants were randomized to receive mifepristone either 24 hours before or at the same time as misoprostol. Participants were hospitalized to receive 400 micrograms buccal misoprostol at 3-hour intervals up to 48 hours or until uterine expulsion. The primary outcome was the proportion of women who experienced uterine expulsion within 24 hours after the first misoprostol dose and this required 504 women to examine our hypothesis that this rate would be 85% in the 24-hour interval arm compared with 70% in the simultaneous arm. Secondary outcomes included total abortion time from mifepristone and misoprostol. RESULTS: From February 2013 to April 2014, 509 women were enrolled. Women in the 24-hour interval arm were more likely to abort within 24 hours (94.4% compared with 85.0%, relative risk 1.11, 95% confidence interval [CI] 1.05-1.18). At 48 hours, the rate was similar in the two arms (96.8% [24-hour interval] and 95.7% [simultaneous], relative risk 1.01, 95% CI 0.97-1.04). Median misoprostol dosing time was shorter in the 24-hour interval arm (7.7 compared with 13 hours; P<.001) and consistent with the median misoprostol doses required (three compared with five; P<.001). Median time from mifepristone to uterine expulsion was longer in the 24-hour interval arm (32.3 compared with 13 hours; P<.001). Both regimens had high acceptability rates and reported similar side effects and pain scores. CONCLUSION: Administering mifepristone and misoprostol simultaneously results in lower expulsion rates within 24 hours of taking misoprostol, longer median misoprostol treatment times, and requires more misoprostol doses. At 48 hours, both regimens work equally well. Simultaneous dosing results in less total time from the first clinical contact to complete abortion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, https://clinicaltrials.gov, NCT01768299.

Randomized trial assessing home use of two pregnancy tests for determining early medical abortion outcomes at 3, 7 and 14days after mifepristone.

OBJECTIVE: To evaluate the accuracy, feasibility and acceptability of two urine pregnancy tests in assessing abortion outcomes at three time points after mifepristone administration. STUDY DESIGN: This randomized trial enrolled women seeking early medical abortion at two hospitals in Vietnam. Investigators randomly allocated participants to at-home administration of a multilevel urine pregnancy test (MLPT) or a high sensitivity urine pregnancy test (HSPT) to assess their abortion outcomes. A baseline test was administered on the same day as mifepristone. Participants performed and interpreted results of pregnancy tests taken 3, 7 and 14days after mifepristone. Ultrasound exam determined continuing pregnancy. RESULTS: Six hundred women enrolled, and 300 received each test. A percentage of 97.4 (584) had follow-up, of whom 13 women had continuing pregnancies. The specificity of MLPT at detecting absence of continuing pregnancy was 63.9%, 90.4% and 97.1% at study day 3, 7 and 14. The specificity of HSPT was 6.0%, 19.8% and 62.2%, respectively. The positive predictive value (PPV) of MLPT at detecting continuing pregnancy was 6.4% at day 3 and rose to 46.7% at day 14. In contrast, the PPV for HSPT was 2.2% at day 3 and rose to 6.5% at day 14. At all three time points, the sensitivity and negative predictive values for both tests were 100.0%. Most women found their assigned tests easy to use and would prefer future home follow-up with a pregnancy test. CONCLUSIONS: The MLPT enables women to assess their abortion outcomes more reliably than with HSPT. With MLPT, women can know their outcomes as early as 3 days after mifepristone. IMPLICATIONS: Medical abortion service delivery with an MLPT to obtain a baseline (preabortion) human chorionic gonadotropin (hCG) estimate and a second follow-up MLPT 1 to 2 weeks later can establish whether there has been a drop in hCG, signifying absence of a continuing pregnancy. Used this way, MLPTs can enable women to assess their abortion status outside of a clinic setting and without serum hCG testing and/or ultrasound.

Oxytocin via Uniject (a prefilled single-use injection) versus oral misoprostol for prevention of postpartum haemorrhage at the community level: a cluster-randomised controlled trial.

BACKGROUND: Access to injectable uterotonics for management of postpartum haemorrhage remains limited in Senegal outside health facilities, and misoprostol and oxytocin delivered via Uniject have been deemed viable alternatives in community settings. We aimed to compare the efficacy of these drugs when delivered by auxiliary midwives at maternity huts. METHODS: We did an unmasked cluster-randomised controlled trial at maternity huts in three districts in Senegal. Maternity huts with auxiliary midwives located 3-21 km from the closest referral centre were randomly assigned (1:1; via a computer-generated random allocation overseen by Gynuity Health Projects) to either 600 µg oral misoprostol or 10 IU oxytocin in Uniject (intramuscular), stratified by reported previous year clinic volume (deliveries) and geographical location (inland or coastal). Maternity huts that had been included in a previous study of misoprostol for prevention of postpartum haemorrhage were excluded to prevent contamination. Pregnant women in their third trimester were screened for eligibility either during community outreach or at home-based prenatal visits. Only women delivered by the auxiliary midwives in the maternity huts were eligible for the study. Women with known allergies to prostaglandins or pregnancy complications were excluded. The primary outcome was mean change in haemoglobin concentration measured during the third trimester and after delivery. This study was registered with ClinicalTrials.gov, number NCT01713153. FINDINGS: 28 maternity hut clusters were randomly assigned-14 to the misoprostol group and 14 to the oxytocin group. Between June 6, 2012, and Sept 21, 2013, 1820 women were recruited. 647 women in the misoprostol group and 402 in the oxytocin group received study drug and had recorded pre-delivery and post-delivery haemoglobin concentrations, and overall 1412 women delivered in the study maternity huts. The mean change in haemoglobin concentrations was 3·5 g/L (SD 16·1) in the misoprostol group and 2·7 g/L (SD 17·8) in the oxytocin group. When adjusted for cluster design, the mean difference in haemoglobin decreases between groups was not significant (0·3 g/L, 95% CI -8·26 to 8·92, p=0·71). Both drugs were well tolerated. Shivering was common in the misoprostol group, and nausea in the oxytocin group. Postpartum haemorrhage was diagnosed in one woman allocated to oxytocin, who was referred and transferred to a higher-level facility for additional care, and fully recovered. No other women were transferred. INTERPRETATION: In terms of effects on haemoglobin concentrations, neither oxytocin nor misoprostol was significantly better than the other, and both drugs were safe and efficacious when delivered by auxiliary midwives. The programmatic limitations of oxytocin, including short shelf life outside the cold chain, mean that misoprostol could be more appropriate for community-level prophylaxis of postpartum haemorrhage. FUNDING: Bill & Melinda Gates Foundation.

Treatment for primary postpartum haemorrhage.

BACKGROUND: Primary postpartum haemorrhage (PPH) is one of the top five causes of maternal mortality in both developed and developing countries. OBJECTIVES: To assess the effectiveness and safety of any intervention used for the treatment of primary PPH. SEARCH METHODS: We searched the Cochrane Pregnancy and Childbirth Group's Trials Register (31 August 2013). SELECTION CRITERIA: Randomised controlled trials comparing any interventions for the treatment of primary PPH. DATA COLLECTION AND ANALYSIS: We assessed studies for eligibility and quality and extracted data independently. We contacted authors of the included studies to request more information. MAIN RESULTS: Ten randomised clinical trials (RCTs) with a total of 4052 participants fulfilled our inclusion criteria and were included in this review.Four RCTs (1881 participants) compared misoprostol with placebo given in addition to conventional uterotonics. Adjunctive use of misoprostol (in the dose of 600 to 1000 mcg) with simultaneous administration of additional uterotonics did not provide additional benefit for our primary outcomes including maternal mortality (risk ratio (RR) 6.16, 95% confidence interval (CI) 0.75 to 50.85), serious maternal morbidity (RR 0.34, 95% CI 0.01 to 8.31), admission to intensive care (RR 0.79, 95% CI 0.30 to 2.11) or hysterectomy (RR 0.93, 95% CI 0.16 to 5.41).  Two RCTs (1787 participants) compared 800 mcg sublingual misoprostol versus oxytocin infusion as primary PPH treatment; one trial included women who had received prophylactic uterotonics, and the other did not. Primary outcomes did not differ between the two groups, although women given sublingual misoprostol were more likely to have additional blood loss of at least 1000 mL (RR 2.65, 95% CI 1.04 to 6.75). Misoprostol was associated with a significant increase in vomiting and shivering.Two trials attempted to test the effectiveness of estrogen and tranexamic acid, respectively, but were too small for any meaningful comparisons of pre-specified outcomes.One study compared lower segment compression but was too small to assess impact on primary outcomes.We did not identify any trials evaluating surgical techniques or radiological interventions for women with primary PPH unresponsive to uterotonics and/or haemostatics. AUTHORS' CONCLUSIONS: Clinical trials included in the current review were not adequately powered to assess impact on the primary outcome measures. Compared with misoprostol, oxytocin infusion is more effective and causes fewer side effects when used as first-line therapy for the treatment of primary PPH. When used after prophylactic uterotonics, misoprostol and oxytocin infusion worked similarly. The review suggests that among women who received oxytocin for the treatment of primary PPH, adjunctive use of misoprostol confers no added benefit.The role of tranexamic acid and compression methods requires further evaluation. Furthermore, future studies should focus on the best way to treat women who fail to respond to uterotonic therapy.

Acceptability and feasibility of phone follow-up after early medical abortion in Vietnam: a randomized controlled trial.

OBJECTIVE: To investigate phone follow-up with a semiquantitative urine pregnancy test and symptom checklist as a replacement for universal clinic follow-up after medical abortion. METHODS: One thousand four hundred thirty-three women seeking early medical abortion at four hospitals in Vietnam were randomized to clinic or phone follow-up. Women allocated to clinic follow-up returned to the hospital for confirmation of abortion outcome 2 weeks after mifepristone administration. Women assigned to phone follow-up completed a semiquantitative pregnancy test at initial visit to determine baseline human chorionic gonadotropin range and again at home 2 weeks later. Clinic staff called women to review the pregnancy test results and symptom checklist. Women who screened positive were referred to the clinic. Effectiveness, feasibility, and acceptability of the follow-up methods were assessed. RESULTS: The rate of ongoing pregnancy was not significantly different between the two groups (clinic: 2.7% phone, 2.5%, relative risk 0.9, 95% confidence interval 0.99-1.02). Eighty-five percent of women in the phone group did not need an additional clinic visit. Phone follow-up was highly effective in screening for ongoing pregnancy with a sensitivity and specificity of 92.8% and 90.6%, respectively. Specificity of the pregnancy test alone (eg, without the symptom checklist) was higher (95.7%). CONCLUSION: Phone follow-up offers a feasible and effective approach to identify women with ongoing pregnancy after early medical abortion. When used with the semiquantitative pregnancy test, the symptom checklist offered no additional benefit and decreased the specificity of the screening. Given its effectiveness and ease of use, the semiquantitative pregnancy test alone could replace routine clinic follow-up after early medical abortion. CLINICAL TRIALS REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01150422. LEVEL OF EVIDENCE: I.

Results from a study using misoprostol for management of incomplete abortion in Vietnamese hospitals: implications for task shifting.

BACKGROUND: Complications following spontaneous or induced abortion are a major cause of maternal morbidity. To manage these complications, post-abortion care (PAC) services should be readily available and easy to access. Standard PAC treatment includes surgical interventions that are highly effective but require surgical providers and medical centers that have the necessary space and equipment. Misoprostol has been shown to be an effective alternative to surgical evacuation and can be offered by lower level clinicians. This study sought to assess whether 400 mcg sublingual misoprostol could effectively evacuate the uterus after incomplete abortion and to confirm its applicability for use at lower level settings. METHODS: All women presenting with incomplete abortion at one of three hospitals in Vietnam were enrolled. Providers were not asked to record if the abortion was spontaneous or induced. It is likely that all were spontaneous given the legal status and easy access to abortion services in Vietnam. Participants were given 400 mcg sublingual misoprostol and instructed to hold the pills under their tongue for 30 minutes and then swallow any remaining fragments. They were then asked to return one week later to confirm their clinical status. Study clinicians were instructed to confirm a complete expulsion clinically. All women were asked to complete a questionnaire regarding satisfaction with the treatment. RESULTS: Three hundred and two women were enrolled between September 2009 and May 2010. Almost all participants (96.3%) had successful completions using a single dose of 400 mcg misoprostol. The majority of women (87.2%) found the side effects to be tolerable or easily tolerable. Most women (84.3%) were satisfied or very satisfied with the treatment they received; only one was dissatisfied (0.3%). Nine out of ten women would select this method again and recommend it to a friend (91.0% and 90.0%, respectively). CONCLUSIONS: This study confirms that 400 mcg sublingual misoprostol effectively evacuates the uterus for most women experiencing incomplete abortion. The high levels of satisfaction and side effect tolerability also attest to the ease of use of this method. From these data and given the international consensus around the effectiveness of misoprostol for incomplete abortion care, it seems timely that use of the drug for this indication be widely expanded both throughout Vietnam and wherever access to abortion care is limited. TRIAL REGISTRATION: ClinicalTrials.gov, NCT00670761.

A systematic review of the relationship between blood loss and clinical signs.

INTRODUCTION: This systematic review examines the relationship between blood loss and clinical signs and explores its use to trigger clinical interventions in the management of obstetric haemorrhage. METHODS: A systematic review of the literature was carried out using a comprehensive search strategy to identify studies presenting data on the relationship of clinical signs & symptoms and blood loss. Methodological quality was assessed using the STROBE checklist and the general guidelines of MOOSE. RESULTS: 30 studies were included and five were performed in women with pregnancy-related haemorrhage (other studies were carried in non-obstetric populations). Heart rate (HR), systolic blood pressure (SBP) and shock index were the parameters most frequently studied. An association between blood loss and HR changes was observed in 22 out of 24 studies, and between blood loss and SBP was observed in 17 out of 23 studies. An association was found in all papers reporting on the relationship of shock index and blood loss. Seven studies have used Receiver Operating Characteristic Curves to determine the accuracy of clinical signs in predicting blood loss. In those studies the AUC ranged from 0.56 to 0.74 for HR, from 0.56 to 0.79 for SBP and from 0.77 to 0.84 for shock index. In some studies, HR, SBP and shock index were associated with increased mortality. CONCLUSION: We found a substantial variability in the relationship between blood loss and clinical signs, making it difficult to establish specific cut-off points for clinical signs that could be used as triggers for clinical interventions. However, the shock index can be an accurate indicator of compensatory changes in the cardiovascular system due to blood loss. Considering that most of the evidence included in this systematic review is derived from studies in non-obstetric populations, further research on the use of the shock index in obstetric populations is needed.

Simplified medical abortion using a semi-quantitative pregnancy test for home-based follow-up.

OBJECTIVE: To simplify follow-up after medical abortion by examining whether women could use a semi-quantitative pregnancy test at home to screen for ongoing pregnancy. METHODS: Three hundred women seeking medical abortion at a tertiary hospital in Vietnam participated in the study. Participants used a semi-quantitative pregnancy test at the hospital to estimate baseline human chorionic gonadotropin (hCG) levels and administered another test at home 2 weeks later for comparison. Women interpreted the test result at home and then returned to hospital for follow-up care. At this visit, self-assessment was verified. To assess further the feasibility of the test as a follow-up tool in service delivery, 200 additional women completed a user comprehension survey. RESULTS: The tests identified all 11 ongoing pregnancies among study participants (100% sensitivity; 89.7% specificity). Women reported that the test was easy to use (255/292 [87.3%]) and that provider instructions helped them to use the test (291/292 [99.7%]). CONCLUSION: Semi-quantitative pregnancy tests offer high sensitivity and negative predictive value. If user instructions can be further simplified, the tests could be used in lieu of transvaginal ultrasound and/or serum hCG at clinic-based follow-up or by women themselves for home-based follow-up. Clinical trials.gov:NCT01150279.