Evaluation of telemedicine medical abortion using a no-test protocol in the Eastern Europe and Central Asian region: Evidence from Ukraine, Uzbekistan, and Azerbaijan.

OBJECTIVE: To evaluate safety, feasibility, and acceptability of a telemedicine medical abortion service without pre-treatment in-person tests in Ukraine, Uzbekistan, and Azerbaijan. METHODS: We conducted an open-label, prospective, observational clinical study at five clinics in the three countries. Interested and eligible participants scheduled a telemedicine consultation with a study provider by phone or video. Medical abortion pills could be obtained by mail or courier or picked up at the study clinic or a pharmacy. Study providers contacted participants 1 week after mifepristone ingestion to assess abortion outcomes based on symptoms, and 3 weeks later to review the result of an at-home, high-sensitivity, urine pregnancy test. Participants were referred to in-person visit based on symptoms, urine pregnancy test results, or initiative by the participant. RESULTS: In all, 300 women participated in the study. Almost all participants received medical abortion medications the same day as their first contact with the study clinic, and the majority (n = 297, 99.0%) did not experience any problems receiving them. All except two women (0.67%) followed provider instructions on administration of medications. The majority of participants had a complete abortion without a procedure (Ukraine: n = 115, 95.8%; Uzbekistan: n = 127, 97.7%; Azerbaijan: n = 49, 98.0%), few had in-person visits (Ukraine: n = 30, 25.0%; Uzbekistan: n = 3, 2.3%; Azerbaijan: n = 4, 8.0%), and most were very satisfied or satisfied with the service (Ukraine: n = 116, 96%; Uzbekistan: n = 128, 98%; Azerbaijan: n = 45, 90%). No serious adverse events occurred. CONCLUSION: Telemedicine medical abortion using the no-test protocol is safe, feasible and acceptable for women in Ukraine, Uzbekistan, and Azerbaijan.

Oral misoprostol alone, compared with oral misoprostol followed by oxytocin, in women induced for hypertension of pregnancy: A multicentre randomised trial.

OBJECTIVE: To assess whether, in those requiring continuing uterine stimulation after cervical ripening with oral misoprostol and membrane rupture, augmentation with low-dose oral misoprostol is superior to intravenous oxytocin. DESIGN: Open-label, superiority randomised trial. SETTING: Government hospitals in India. POPULATION: Women who were induced for hypertensive disease in pregnancy and had undergone cervical ripening with oral misoprostol, but required continuing stimulation after artificial membrane rupture. METHODS: Participants received misoprostol (25 micrograms, orally, 2-hourly) or titrated oxytocin through an infusion pump. All women had one-to-one care; fetal monitoring was conducted using a mixture of intermittent and continuous electronic fetal monitoring. MAIN OUTCOME MEASURES: Caesarean birth. RESULTS: A total of 520 women were randomised and the baseline characteristics were comparable between the groups. The caesarean section rate was not reduced with the use of misoprostol (misoprostol, 84/260, 32.3%, vs oxytocin, 71/260, 27.3%; aOR 1.23; 95% CI 0.81-1.85; P = 0.33). The interval from randomisation to birth was somewhat longer with misoprostol (225 min, 207-244 min, vs 194 min, 179-210 min; aOR 1.137; 95% CI 1.023-1.264; P = 0.017). There were no cases of hyperstimulation in either arm. The rates of fetal heart rate abnormalities and maternal side effects were similar. Fewer babies in the misoprostol arm were admitted to the special care unit (10 vs 21 in the oxytocin group; aOR 0.463; 95% CI 0.203-1.058; P = 0.068) and there were no neonatal deaths in the misoprostol group, compared with three neonatal deaths in the oxytocin arm. Women's acceptability ratings were high in both study groups. CONCLUSIONS: Following cervical preparation with oral misoprostol and membrane rupture, the use of continuing oral misoprostol for augmentation did not significantly reduce caesarean rates, compared with the use of oxytocin. There were no hyperstimulation or significant adverse events in either arm of the trial.

Evaluation of a "smart" screening tool for asynchronous assessment of medication abortion eligibility: A pilot study.

OBJECTIVES: This study aimed to assess the feasibility, safety, and acceptability of asynchronous screening for medication abortion eligibility using a programmed questionnaire. STUDY DESIGN: For this study, we developed an informational website about medication abortion with a linked questionnaire programmed to produce a conclusion regarding eligibility according to standard criteria. We enrolled people in Colorado and Minnesota who submitted questionnaires indicating eligibility. A study physician reviewed each questionnaire and medical records if available and determined whether the responses warranted treatment without a synchronous clinical consultation or ultrasound. If so, the physician prescribed a standard regimen of mifepristone and misoprostol. We collected posttreatment data on abortion outcome, adverse events, and satisfaction. RESULTS: We received questionnaires from 197 individuals, of whom 160 remained in the study until the physician made a final treatment decision. Physicians prescribed medication abortion to 156 (97.5%) individuals based on the questionnaire responses, whereas four needed further assessment to confirm eligibility. Of the 156 individuals, 130 had sufficient follow-up to assess abortion outcome, and 123 (95%) had complete medication abortions without additional treatment. One participant was hospitalized for bleeding, and one expelled a 15-week fetus; however, it is not clear that conventional synchronous history-based screening would have averted these events. Of the 197 questionnaires, 42% were submitted outside business hours. On satisfaction questionnaires, 134 (96%) of 144 participants said they would recommend the study to a friend who needed an abortion. CONCLUSIONS: Data from this pilot project suggest that providing medication abortion based only on a self-administered, programmed questionnaire is likely to be effective, safe, efficient, and acceptable. IMPLICATIONS: A programmed self-administered patient questionnaire to assess eligibility for medication abortion could reduce the cost of the service, augment clinic efficiency, improve quality of care, and enhance access to abortion.

Introducing the participant-generated experience and satisfaction (PaGES) index: a novel, longitudinal mixed-methods evaluation tool.

BACKGROUND: Patient-Reported Outcomes or Experience Measures (PROMS / PREMS) are routinely used in clinical studies to assess participants' views and experiences of trial interventions and related quality of life. Purely quantitative approaches lack the necessary detail and flexibility to understand the real-world impact of study interventions on participants, according to their own priorities. Conversely, purely qualitative assessments are time consuming and usually restricted to a small, possibly unrepresentative, sub-sample. This paper, which reports a pilot study within a randomised controlled trial of induction of labour, reports the feasibility, and acceptability of the Participant-Generated Experience and Satisfaction (PaGES) Index, a new mixed qualitative / quantitative PREM tool. METHODS: The single-sheet PaGES Index was completed by hypertensive pregnant women in two hospitals in Nagpur, India before and after taking part in the 'Misoprostol or Oxytocin for Labour Induction' (MOLI) randomised controlled trial. Participants recorded aspects of the impending birth they considered most important, and then ranked them. After the birth, participants completed the PaGES Index again, this time also scoring their satisfaction with each item. Forms were completed on paper in the local language or in English, supported by Research Assistants. Following translation (when needed), responses were uploaded to a REDCap database, coded in Excel and analysed thematically. A formal qualitative evaluation (qMOLI) was also conducted to obtain stakeholder perspectives of the PaGES Index and the wider trial. Semi-structured interviews were conducted with participants, and focus groups with researchers and clinicians. Data were managed using NVivo 12 software and analysed using the framework approach. RESULTS: Participants and researchers found the PaGES Index easy to complete and administer; mothers valued the opportunity to speak about their experience. Qualitative analysis of the initial 68 PaGES Index responses identified areas of commonality and difference among participants and also when comparing antenatal and postnatal responses. Theme citations and associated comments scores were fairly stable before and after the birth. The qMOLI phase, comprising 53 one-to-one interviews with participants and eight focus groups involving 83 researchers and clinicians, provided support that the PaGES Index was an acceptable and even helpful means of capturing participant perspectives. CONCLUSIONS: Subjective participant experiences are an important aspect of clinical trials. The PaGES Index was found to be a feasible and acceptable measure that unites qualitative research's explanatory power with the comparative power of quantitative designs. It also offers the opportunity to conduct a before-and-after evaluation, allowing researchers to examine the expectations and actual experiences of all clinical trial participants, not just a small sub-sample. This study also shows that, with appropriate research assistant input, the PaGES Index can be used in different languages by participants with varying literacy levels. TRIAL REGISTRATION: Clinical Trials.gov (21/11/2018) (NCT03749902).

PAPP-A as a screening tool for assessment of gestational age before medication abortion in an intended-use population.

Introduction: Prior studies indicate that PAPP-A could serve as a marker of gestational age (GA) with the potential to determine eligibility for medication abortion. The authors validated the relationship between PAPP-A and GA in an actual-use population. Materials & methods: The authors collected blood samples, medical histories and ultrasound-determined GA from patients presenting for abortion services. They measured PAPP-A using two immunoassays and assessed diagnostic accuracy for predicting GA ≥71 days. Results: The Ansh Labs and R&D Systems immunoassays produced an area under the ROC curve of 0.982 (95% CI: 0.958-0.994) and 0.986 (95% CI: 0.963-0.996), respectively, for predicting GA ≥71 days. Conclusion: This validation study in an intended-use population confirmed that PAPP-A has a strong ability to distinguish pregnancies above and below 71 days' gestation. Clinical trial registration: NCT04232189 (ClinicalTrials.gov).

In the USA, abortion with pills is an option for people with pregnancies of less than 71 days. Usually, people use ultrasound to find out how far along a pregnancy is. Ultrasound can be pricey and hard to find. Some studies show that a protein in blood, called PAPP-A, may be another option. The authors took blood from and did ultrasounds for people who wanted an abortion. They measured how much PAPP-A was in the blood using two different methods. The level of PAPP-A in the blood did a good job of distinguishing pregnancies that were higher and lower than 71 days.

Mailing abortion pills does not delay care: A cohort study comparing mailed to in-person dispensing of abortion medications in the United States.

OBJECTIVE: Given the substantial barriers to abortion access in the United States, many clinics now mail patients abortion medications. We examined whether dispensing the medications by mail prolonged time to medication use. STUDY DESIGN: We analyzed data from no-test medication abortions with medication provided either by mail or in a clinic from 11 United States clinics from February 2020 to January 2021. We examined mean number of days from patients' first contact with the clinic to mifepristone ingestion, its two-component intervals (first contact to medication dispensing and dispensing to mifepristone ingestion), and pregnancy duration at mifepristone ingestion. We used Poisson regression to compare mean outcomes across three dispensing methods: in-person, mailed from the clinic, and mailed from a mail-order pharmacy. RESULTS: Among the 2600 records, patients took mifepristone on average at 49 days of gestation (95% CI, 47-51) and 7 days (95% CI, 4-10) after first contact. Mean time from first contact to mifepristone ingestion was 6 days when medications were dispensed in-person and 9 days when mailed (p = 0.38). While time from first contact to dispensing was similar across methods (6 days in-person, 5 days mailed, p = 0.77), more time elapsed from dispensing to mifepristone ingestion when medications were mailed (4 days from clinic, 5 days from mail-order pharmacy) versus dispensed in-person (0.3 days, p < 0.001). Time to mifepristone ingestion was shorter with higher pregnancy duration. Pregnancy duration at ingestion was similar across methods (48 days in-person, 50 days mailed). CONCLUSIONS: Mailing medications did not significantly prolong time from patients' first contact with the clinic to mifepristone ingestion or increase pregnancy duration at mifepristone ingestion. IMPLICATIONS: Abortion providers should offer a range of medication abortion dispensing options, prioritizing patient preference.

Introducing misoprostol for treatment of incomplete abortion: A feasibility and acceptability study in secondary-level health facilities in Myanmar.

OBJECTIVE: To assess the feasibility and acceptability of misoprostol as a treatment option for incomplete abortion in secondary hospitals in Yangon and Mandalay, Myanmar. METHODS: An explanatory sequential mixed methods study was conducted. Women seeking treatment for an incomplete abortion with a uterine size <12 weeks were eligible to participate in the prospective cohort including sublingual administration of 400 µg misoprostol, clinical assessment 7-10 days after administration, and patient interview. Treatment efficacy was assessed, defined as proportion of participants with complete uterine evacuation with misoprostol alone. After the cohort, provider interviews were conducted to understand how their experiences with misoprostol may have influenced cohort findings. Study sites included seventeen secondary health facilities in four townships in Yangon and Mandalay, Myanmar. RESULTS: A total of 110 women were enrolled from July 2018 to January 2019; 96 completed follow-up. In 75 % of cases, incomplete abortion was successfully treated with misoprostol. Treatment efficacy varied significantly by region (Yangon 85 %, Mandalay 67 %; p = 0.048), driven by providers' variable comfort with misoprostol and proclivity to intervene with additional treatment. With experience, all were willing to incorporate the protocol into practice by study end. Patient acceptability and satisfaction were high. CONCLUSION: Misoprostol is an acceptable and feasible treatment option for women seeking postabortion care at secondary facilities in Myanmar. Extensive health provider training and support systems and continued implementation experience are crucial to effectively translate clinical PAC guidelines into practice in Myanmar.

Abortion bans and their impacts: A view from the United States.

A retrospective study of abortion facilities in and around Texas by White et al.1 and a spatial analysis by Rader et al.2 are combined to illustrate the detrimental effects of abortion bans enacted in the United States.

Single dose letrozole and misoprostol for termination of pregnancy through 63 days' gestation: A pilot study.

OBJECTIVES: We conducted a pilot study to evaluate a single dose of letrozole 30 mg prior to misoprostol 800 mcg buccally for medication abortion STUDY DESIGN: We enrolled 40 participants seeking medication abortion up to 63 days' gestation at a site in Salt Lake City, UT. Participants received a single dose of letrozole 30 mg in-clinic followed 2 days later by misoprostol 800 mcg buccally at home. They took a second dose of misoprostol if they had no bleeding within 24 hours of the first. Participants returned 7 to 10 days later for assessment of abortion outcome and side effects RESULTS: Thirty-seven participants (93%) returned for follow-up and 2 (5%) went to another facility from which research staff obtained outcome data. Three-fourths (29/39, 74%, 95% CI: 60%-89%) had a complete abortion; 4 (10%, 95% CI: 0.3%-20%) had an incomplete abortion and opted for aspiration, and 6 (15%, 95% CI: 4%-27%) had an ongoing pregnancy. All subjects with follow-up reported taking the first dose of misoprostol. Ten (27%) took the second dose as well; only three did so due to no bleeding. Nineteen participants (51%) reported side effects after letrozole prior to misoprostol and two people (5%) rated these effects as severe. Side effects following misoprostol occurred in 33 participants (89%) and were as expected based on previous literature. No serious adverse events were reported CONCLUSION: A single dose of letrozole 30 mg followed by misoprostol had lower than desirable efficacy and does not warrant further study. IMPLICATIONS: A single dose of letrozole does not appear to be an effective adjunct to misoprostol for medication abortion.

'Of course, women will adopt it!': A qualitative study on the acceptability of medical menstrual regulation in Senegal.

OBJECTIVE: Medical menstrual regulation (MMR) may offer a promising way to reach Senegalese women and girls in need of fertility management, especially in rural contexts. To assess the feasibility of introducing a MMR service in Senegal, the study aimed to (1) understand how women and girls manage their menses and fertility, and (2) document acceptability of MMR among women, youth, and health providers. METHODS: Six focus group discussions and 34 in-depth interviews were conducted with women, youth, and health providers in Kaolack, Mbour, and Thiès, Senegal. RESULTS: All participants characterized the pubescent period by a lack of sexual education, familial support, and access to reproductive health services. Reproductive health service utilization in Senegal was portrayed as highly stigmatized, creating barriers to contraception and reliable information on family planning. Unwanted pregnancy and clandestine abortion were depicted as common occurrences among many participants. Senegalese women and youth perceived MMR services as an acceptable method to manage a missed period with discretion, rid of moral and legal ramifications - and framed MMR as a needed mechanism to prevent abortion and avoid undesired pregnancies. The majority of health providers, with the exception of female health volunteers, were reluctant to endorse the service, comparing MMR to abortion. CONCLUSIONS: In a context fraught with restrictive abortion laws and limited uptake of modern contraception, MMR is an acceptable among potential service users. Nonetheless, introduction and implementation of MMR will be feasible in Senegal only if policymakers approve and support the service and health provider buy-in is achieved.

Outcomes and Safety of History-Based Screening for Medication Abortion: A Retrospective Multicenter Cohort Study.

Importance: Screening for medication abortion eligibility typically includes ultrasonography or pelvic examination. To reduce physical contact during the COVID-19 pandemic, many clinicians stopped requiring tests before medication abortion and instead screened patients for pregnancy duration and ectopic pregnancy risk by history alone. However, few US-based studies have been conducted on the outcomes and safety of this novel model of care. Objective: To evaluate the outcomes and safety of a history-based screening, no-test approach to medication abortion care. Design, Setting, and Participants: This retrospective cohort study included patients obtaining a medication abortion without preabortion ultrasonography or pelvic examination between February 1, 2020, and January 31, 2021, at 14 independent, Planned Parenthood, academic-affiliated, and online-only clinics throughout the US. Exposures: Medications for abortion provided without preabortion ultrasonography or pelvic examination and dispensed to patients in person or by mail. Main Outcomes and Measures: Effectiveness, defined as complete abortion after 200 µg of mifepristone and up to 1600 µg of misoprostol without additional intervention, and major abortion-related adverse events, defined as hospital admission, major surgery, or blood transfusion. Results: The study included data on 3779 patients with eligible abortions. The study participants were racially and ethnically diverse and included 870 (23.0%) Black patients, 533 (14.1%) Latinx/Hispanic patients, 1623 (42.9%) White patients, and 327 (8.7%) who identified as multiracial or with other racial or ethnic groups. For most (2626 [69.5%]), it was their first medication abortion. Patients lived in 34 states, and 2785 (73.7%) lived in urban areas. In 2511 (66.4%) abortions, the medications were dispensed in person; in the other 1268 (33.6%), they were mailed to the patient. Follow-up data were obtained for 2825 abortions (74.8%), and multiple imputation was used to account for missing data. Across the sample, 12 abortions (0.54%; 95% CI, 0.18%-0.90%) were followed by major abortion-related adverse events, and 4 patients (0.22%; 95% CI, 0.00%-0.45%) were treated for ectopic pregnancies. Follow-up identified 9 (0.40%; 95% CI, 0.00%-0.84%) patients who had pregnancy durations of greater than 70 days on the date the mifepristone was dispensed that were not identified at screening. The adjusted effectiveness rate was 94.8% (95% CI, 93.6%-95.9%). Effectiveness was similar when medications were dispensed in person (95.4%; 95% CI, 94.1%-96.7%) or mailed (93.3%; 95% CI, 90.7%-95.9%). Conclusions and Relevance: In this cohort study, screening for medication abortion eligibility by history alone was effective and safe with either in-person dispensing or mailing of medications, resulting in outcomes similar to published rates of models involving ultrasonography or pelvic examination. This approach may facilitate more equitable access to this essential service by increasing the types of clinicians and locations offering abortion care.

"Who is driving you home today?" Escort policies as a barrier to abortion access.

Post-sedation escort policies are not evidence-based but traditional consensus recommendations made by professional societies. As people travel further for abortion care, escort policies are increasingly difficult to navigate and force people to delay care, compromise privacy, or undergo procedures without sedation. At worst, clinics may turn away people who present without an escort. Recent research shows that patients can be discharged safely after sedation using rideshare or transport services without a known escort. Updating escort policies lowers barriers to abortion and preserves autonomy, comfort, and choice.

A descriptive analysis of medical abortion commodity availability and pricing at retail outlets in 44 countries across four regions globally.

Pharmacies in low- and middle-income countries play an important role in increasing the availability of medical abortion to individuals for self-use. We aimed to document the costs to users of medical abortion products at outlets across geographies and understand the diversity of available products, primarily in low- and middle-income countries or in places where access to abortion is restricted. A descriptive analysis of price data was completed for identified medical abortion products at retail outlets visited in 44 countries from November 2017 to February 2018. Median prices and ranges are reported in $US for mifepristone 200 mg tablets, misoprostol 200 mcg tablets, and combipacks. Misoprostol, mifepristone, and combipacks were found in 44, 19, and 16 countries, respectively. Nearly two-thirds of products (321/508) required a prescription. The median price of misoprostol was $0.63 per tablet (range $0.09-$27.63) based on 304 price points. Mifepristone and combipacks had fewer price points available (n = 59 and n = 44, respectively). Median prices were $11.78 per mifepristone tablet (range $1.77-$37.83) and $11.18 per combipack (range $3.50-$35.86). Overall, prices were highest in Latin America and lowest in South/Southeast Asia. Only 11.5% (7/61) of the total unique misoprostol brands were quality-assured (i.e. approved by a stringent regulatory authority or pre-qualified by the World Health Organization), compared to 25.0% (4/16) of unique combipack products. There was wide variation in product pricing and availability across settings. The infrequent availability of mifepristone and combipacks, in addition to the limited availability of quality-assured medicines and high cost of abortion medications, are important factors affecting access to high-quality abortion care.

The Induction with Foley OR Misoprostol (INFORM) Study dataset. A dataset of 602 women with hypertensive disease in pregnancy, in India, randomised to either Foley catheter or oral misoprostol for induction of labour.

OBJECTIVES: Induction of labour (IOL), or starting labour artificially, can be a lifesaving intervention for pregnant women and their babies, and rates are rising significantly globally. As rates increase, it becomes increasingly important to fully evaluate all available data, especially that from low income settings where the potential benefits and harms are greater. The goal of this paper is to describe the datasets collected as part of the Induction with Foley OR Misoprostol (INFORM) Study, a randomised trial comparing two of the recommended methods of cervical ripening for labour induction, oral misoprostol and Foley catheter, in women being induced for hypertension in pregnancy, at two sites in India during 2013-15. DATA DESCRIPTION: This dataset includes comprehensive data on 602 women who underwent IOL for hypertensive disorders in pregnancy. Women were randomly assigned to cervical ripening with oral misoprostol or a transcervical Foley catheter in two government hospitals in India. The main dataset has 367 variables including monitoring during the induction of labour, medications administered, timing and mode of delivery, measures of neonatal morbidity and mortality, maternal mortality and morbidity, maternal satisfaction and health economic data. The dataset is anonymised and available on ReShare.

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.

Analytical Comparison of Pregnancy-Associated Plasma Protein-A (PAPP-A) Immunoassays for Biochemical Determination of Gestational Age.

BACKGROUND: Accurate pregnancy dating is critical for maternal and child health and for counseling on safe and effective abortion methods. While last menstrual period and first trimester ultrasound are often used together to determine gestational age (GA), they have limited accuracy and availability, respectively. Prior studies have shown that pregnancy-associated plasma protein-A (PAPP-A) increases exponentially during pregnancy and has the potential to serve as a biochemical marker of GA. We aimed to analyze the relationship between sonographically determined GA and serum PAPP-A concentration measured by different immunoassays and to derive cutoff levels informative for the 70 days GA commonly recommended limit for medical abortion in outpatient settings. METHODS: We compared technical characteristics of 4 commercially available PAPP-A immunoassays and tested 120 maternal serum samples (GA range: 34-231 days) along with contrived pool samples and traceable quality controls. These characteristics included area under the receiver operator characteristic (AUROC) plot, sensitivity and specificity based on cutoffs defined by the Youden Index, and likelihood ratios. RESULTS: All 4 immunoassays had sensitivities and specificities ≥80%, and AUROC values ranging from 0.948 to 0.968. Marked differences among absolute PAPP-A values were noted depending on immunoassay. PAPP-A cutoff values at 70 days GA for each individual immunoassay were established along with procedural recommendations that increase equivalence among immunoassays. CONCLUSIONS: Maternal serum PAPP-A levels correlated strongly with GA despite differences in immunoassay formats and absolute data output. Serum PAPP-A has biomarker potential for future development of a point-of-care test aimed at increasing access to medical abortion.

Clinical and service delivery implications of omitting ultrasound before medication abortion provided via direct-to-patient telemedicine and mail in the U.S.

OBJECTIVES: To compare outcomes among patients who did or did not have pre-abortion ultrasound or pelvic exam before obtaining medication abortion (MA) via direct-to-patient telemedicine and mail. STUDY DESIGN: We analyzed data from participants screened for enrollment into the TelAbortion study at five sites from March 25 to September 15, 2020. We compared participants who had preabortion ultrasound or pelvic exam ("test-MA") to those who did not ("no-test MA"). Outcomes were: abortion not complete with pills alone (i.e., had procedure intervention or ongoing pregnancy), ongoing pregnancy separately, ectopic pregnancy, hospitalization and/or blood transfusion, and unplanned clinical encounters. We used propensity score weighting and multivariable logistic regression to adjust for baseline characteristics. RESULTS: Our analysis included 287 participants who had no-test MA and 125 who had test-MA. Abortion was not complete with pills alone in 16of 287 (5.6%) no-test MA patients compared to 2of 123 (1.9%) test-MA patients (adjusted risk difference [aRD] = 4.3%, 95% confidence interval [CI]: 1.4%-7.1%). No ectopic pregnancies were detected. Groups did not differ regarding hospitalization and/or blood transfusion (p = 0.76) or ongoing pregnancy diagnosis (p = 0.59). Unplanned clinical encounters were more common in no-test MA patients (35of 287, 12.5%) than test-MA patients (10of 125, 8.0%, aRD = 6.7%, 95% CI: 0.5%-13.1%). CONCLUSIONS: Compared to patients who had pre-abortion ultrasound, patients who had no-test MA via telemedicine were more likely to have abortions that were not complete with pills alone and/or unplanned clinical encounters. However, both no-test and test-MA patients had similar and very low rates of ongoing pregnancy and hospitalization or blood transfusion. IMPLICATIONS: Omitting pre-abortion ultrasound before provision of medication abortion via telemedicine does not appear to compromise safety or result in more ongoing pregnancies. However, compared to patients who have preabortion ultrasound, patients who do not have pre-abortion tests may be more likely to seek post-treatment care and have procedural interventions.

Oral Misoprostol alone versus oral misoprostol followed by oxytocin for labour induction in women with hypertension in pregnancy (MOLI): protocol for a randomised controlled trial.

BACKGROUND: Every year approximately 30,000 women die from hypertensive disease in pregnancy. Magnesium sulphate and anti-hypertensives reduce morbidity, but delivery is the only cure. Low dose oral misoprostol, a prostaglandin E1 analogue, is a highly effective method for labour induction. Usually, once active labour has commenced, the misoprostol is replaced with an intravenous oxytocin infusion if ongoing stimulation is required. However, some studies have shown that oral misoprostol can be continued into active labour, a simpler and potentially more acceptable protocol for women. To date, these two protocols have never been directly compared. METHODS: This pragmatic, open-label, randomised trial will compare a misoprostol alone labour induction protocol with the standard misoprostol plus oxytocin protocol in three Indian hospitals. The study will recruit 520 pregnant women being induced for hypertensive disease in pregnancy and requiring augmentation after membrane rupture. Participants will be randomised to receive either further oral misoprostol 25mcg every 2 h, or titrated intravenous oxytocin. The primary outcome will be caesarean birth. Secondary outcomes will assess the efficacy of the induction process, maternal and fetal/neonatal complications and patient acceptability. This protocol (version 1.04) adheres to the SPIRIT checklist. A cost-effectiveness analysis, situational analysis and formal qualitative assessment of women's experience are also planned. DISCUSSION: Avoiding oxytocin and continuing low dose misoprostol into active labour may have a number of benefits for both women and the health care system. Misoprostol is heat stable, oral medication and thus easy to store, transport and administer; qualities particularly desirable in low resource settings. An oral medication protocol requires less equipment (e.g. electronic infusion pumps) and may free up health care providers to assist with other aspects of the woman's care. The simplicity of the protocol may also help to reduce human errors associated with the delivery of intravenous infusions. Finally, women may prefer to be mobile during labour and not restricted by an intravenous infusion. There is a need, therefore, to assess whether augmentation using oral misoprostol is superior clinically and economically to the standard protocol of intravenous oxytocin. TRIAL REGISTRATION: Clinical Trials.gov, NCT03749902 , registered on 21st Nov 2018.