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BackgroundMobile health (mHealth) approaches offer potentially affordable ways to support the care of HIV-infected patients in overstretched health care systems. However, only few studies have analyzed the costs associated with mHealth solutions for HIV care. ObjectiveThe aim of this study was to estimate the total incremental costs and incremental cost per beneficiary of an interactive SMS text messaging support intervention within a clinical trial. MethodsThe Mobile WAChX trial (NCT02400671) evaluates an interactive semiautomated SMS text messaging intervention to improve adherence to antiretroviral therapy and retention in care among peripartum women infected with HIV in Kenya to reduce the mother-to-child transmission of HIV. Women were randomized to receive one-way versus two-way SMS text messages. Messages were sent weekly, and these messages included motivational and educational content and visit reminders; two-way messaging enabled prompt consultation with the nurse as needed. Microcosting methods were used to collect resource-use data related to implementing the Mobile WAChX SMS text messaging intervention. At 2 sites (Nairobi and Western Kenya), we conducted semistructured interviews with health personnel to identify startup and recurrent activities by obtaining information on the personnel, supplies, and equipment. Data on expenditures and prices from project expense reports, administrative records, and published government salary data were included to estimate the total incremental costs. Using a public provider perspective, we estimated incremental unit costs per beneficiary and per contact during 2017. ResultsThe weighted average annual incremental costs for the two-way SMS text messaging group were US $3725 per facility, US $62 per beneficiary, and US $0.85 per contact to reach 115 beneficiaries. For the one-way SMS text messaging group, the weighted average annual incremental costs were US $2542 per facility, US $41 per beneficiary, and US $0.66 per contact to reach 117 beneficiaries. The largest cost shares were for the personnel: 48.2% (US $1794/US $3725) in two-way and 32.4% (US $825/US $2542) in one-way SMS text messaging groups. Costs associated with software development and communication accounted for 29.9% (US $1872/US $6267) of the costs in both intervention arms (US $1042 vs US $830, respectively). ConclusionsCost information for budgeting and financial planning is relevant for implementing mHealth interventions in national health plans. Given the proportion of costs related to systems development, it is likely that costs per beneficiary will decline with the scale-up of the interventions.

BackgroundUse of SMS for data collection is expanding, but coverage, bias, and logistical constraints are poorly described. ObjectiveThe aim of this study is to assess the use of SMS to capture clinical outcomes that occur at home and identify potential biases in reporting compared to in-person ascertainment. MethodsIn the PrEP Implementation in Young Women and Adolescents program, which integrated pre-exposure prophylaxis (PrEP) into antenatal care, postnatal care, and family planning facilities in Kisumu County, Kenya, HIV-negative women 14 years of age or older were offered oral HIV self-tests (HIVSTs) to take home to male partners. Women that brought a phone with a Safaricom SIM to the clinic were offered registration in an automated SMS system (mSurvey) to collect information on HIVST outcomes. Women were asked if they offered the test to their male partners, and asked about the test process and results. HIVST outcomes were collected via SMS (sent 2.5 weeks later), in-person (if women returned for a follow-up scheduled 1 month later), or using both methods (if women initiated PrEP, they also had scheduled follow-up visits). The SMS prompted women to reply at no charge. HIVST outcomes were compared between women with scheduled follow-up visits and those without (follow-up visits were only scheduled for women who initiated PrEP). HIVST outcomes were also compared between women reporting via SMS and in-person. ResultsAmong 2123 women offered HIVSTs and mSurvey registration, 486 (23.89%) accepted HIVSTs, of whom 359 (73.87%) were eligible for mSurvey. Additionally, 76/170 (44.7%) women with scheduled follow-up visits and 146/189 (77.3%) without scheduled follow-up visits registered in mSurvey. Among the 76 women with scheduled follow-ups, 62 (82%) had HIVST outcomes collected: 19 (31%) in-person, 20 (32%) by SMS, and 23 (37%) using both methods. Among the 146 women without scheduled visits, 87 (59.6%) had HIVST outcomes collected: 3 (3%) in-person, 82 (94%) by SMS, and 2 (2%) using both methods. SMS increased the collection of HIVST outcomes substantially for women with scheduled follow-up visits (1.48-fold), and captured 82 additional reports from women without scheduled follow-up visits. Among 222 women with reported HIVST outcomes, frequencies of offering partners the HIVST (85/95, 89% in-person vs 96/102, 94% SMS; P=.31), partners using the HIVST (83/85, 98% vs 92/96, 96%; P=.50), women using HIVST with partners (82/83, 99% vs 91/92, 99%; P=.94), and seeing partner’s HIVST results (82/83, 99% vs 89/92, 97%; P=.56) were similar between women reporting in-person only versus by SMS only. However, frequency of reports of experiencing harm or negative reactions from partners was more commonly reported in the SMS group (17/102, 16.7% vs 2/85, 2%; P=.003). Barriers to the SMS system registration included not having a Safaricom SIM or a functioning phone. ConclusionsOur results suggest that the use of SMS substantially improves completeness of outcome data, does not bias reporting of nonsensitive information, and may increase reporting of sensitive information.

BackgroundPrevention of mother-to-child HIV transmission (PMTCT) relies on long-term adherence to antiretroviral therapy (ART). Mobile health approaches, such as text messaging (short message service, SMS), may improve adherence in some clinical contexts, but it is unclear what SMS content is desired to improve PMTCT-ART adherence. ObjectiveWe aimed to explore the SMS content preferences related to engagement in PMTCT care among women, male partners, and health care workers. The message content was used to inform an ongoing randomized trial to enhance the PMTCT-ART adherence. MethodsWe conducted 10 focus group discussions with 87 HIV-infected pregnant or postpartum women and semistructured individual interviews with 15 male partners of HIV-infected women and 30 health care workers from HIV and maternal child health clinics in Kenya. All interviews were recorded, translated, and transcribed. We analyzed transcripts using deductive and inductive approaches to characterize women’s, partners’, and health care workers’ perceptions of text message content. ResultsAll women and male partners, and most health care workers viewed text messages as a useful strategy to improve engagement in PMTCT care. Women desired messages spanning 3 distinct content domains: (1) educational messages on PMTCT and maternal child health, (2) reminder messages regarding clinic visits and adherence, and (3) encouraging messages that provide emotional support. While all groups valued reminder and educational messages, women highlighted emotional support more than the other groups (partners or health care workers). In addition, women felt that encouraging messages would assist with acceptance of their HIV status, support disclosure, improve patient-provider relationship, and provide support for HIV-related challenges. All 3 groups valued not only messages to support PMTCT or HIV care but also messages that addressed general maternal child health topics, stressing that both HIV- and maternal child health–related messages should be part of an SMS system for PMTCT. ConclusionsWomen, male partners, and health care workers endorsed SMS text messaging as a strategy to improve PMTCT and maternal child health outcomes. Our results highlight the specific ways in which text messaging can encourage and support HIV-infected women in PMTCT to remain in care, adhere to treatment, and care for themselves and their children. Trial RegistrationClinicalTrials.gov NCT02400671; https://clinicaltrials.gov/ct2/show/NCT02400671 (Archived by WebCite at http://www.webcitation.org/70W7SVIVJ)

Mobile health (mHealth) short message system (SMS) interventions for maternal and child health (MCH) are being implemented globally. In many low- and middle-income settings in which these mHealth interventions are being rolled out, stillbirths and neonatal and infant deaths are common. It is important that mHealth solutions do not exacerbate emotional stress and pain by continuing with routine messaging for pregnancy or infant care when someone has experienced loss. In this brief viewpoint paper, we argue that SMS programs for maternal and child health need to adapt and make available messaging for miscarriage, stillbirth, and infant loss.

INTRODUCTION: Long-acting pre-exposure prophylaxis (PrEP) options could overcome barriers to oral PrEP persistence during pregnancy and postpartum. We evaluated long-acting PrEP preferences among oral PrEP-experienced pregnant and postpartum women in South Africa and Kenya, countries with high PrEP coverage with pending regulatory approvals for long-acting injectable cabotegravir and the dapivirine vaginal ring (approved in South Africa, under review in Kenya). METHODS: From September 2021 to February 2022, we surveyed pregnant and postpartum women enrolled in oral PrEP studies in South Africa and Kenya. We evaluated oral PrEP attitudes and preferences for long-acting PrEP methods in multivariable logistic regression models adjusting for maternal age and country. RESULTS: We surveyed 190 women in South Africa (67% postpartum; median age 27 years [IQR = 22-32]) and 204 women in Kenya (79% postpartum; median age 29 years [IQR = 25-33]). Seventy-five percent of participants reported oral PrEP use within the last 30 days. Overall, forty-nine percent of participants reported negative oral PrEP attributes, including side effects (21% South Africa, 30% Kenya) and pill burden (20% South Africa, 25% Kenya). Preferred PrEP attributes included long-acting method, effectiveness, safety while pregnant and breastfeeding, and free medication. Most participants (75%, South Africa and Kenya) preferred a potential long-acting injectable over oral PrEP, most frequently for a longer duration of effectiveness in South Africa (87% South Africa, 42% Kenya) versus discretion in Kenya (5% South Africa, 49% Kenya). Eighty-seven percent of participants preferred oral PrEP over a potential long-acting vaginal ring, mostly due to concern about possible discomfort with vaginal insertion (82% South Africa, 48% Kenya). Significant predictors of long-acting PrEP preference included past use of injectable contraceptive (aOR = 2.48, 95% CI: 1.34, 4.57), disliking at least one oral PrEP attribute (aOR = 1.72, 95% CI: 1.05, 2.80) and preferring infrequent PrEP use (aOR = 1.58, 95% CI: 0.94, 2.65). CONCLUSIONS: Oral PrEP-experienced pregnant and postpartum women expressed a theoretical preference for long-acting injectable PrEP over other modalities, demonstrating potential acceptability among a key population who must be at the forefront of injectable PrEP rollout. Reasons for PrEP preferences differed by country, emphasizing the importance of increasing context-specific options and choice of PrEP modalities for pregnant and postpartum women.

: Introduction: Pharmacy‐delivered HIV prevention services might create more options for pregnant women to use HIV prevention tools earlier and more consistently during pregnancy. We quantified preferences for attributes of potential HIV prevention services among women of childbearing age in Western Kenya. Methods: From June to November 2023, we administered a face‐to‐face discrete choice experiment survey to women aged 15–44 in Kenya's Homa Bay, Kisumu and Siaya counties. The survey evaluated preferences for HIV prevention services, described by seven attributes: service location, travel time, type of HIV test, sexually transmitted infection (STI) testing, partner HIV testing, pre‐exposure prophylaxis (PrEP) and service fee. Participants answered a series of 12‐choice questions. Each question asked them to select one of two service options or no services—an opt‐out option. We used hierarchical Bayesian modelling levels to estimate each attribute level's coefficient and understand how attributes influenced service choice. Results: Overall, 599 participants completed the survey, among whom the median age was 23 years (IQR: 18–27); 33% were married, 20% had a job and worked regularly, and 52% had been pregnant before. Participants, on average, strongly preferred having any HIV prevention service option over none (opt‐out preference weight: −5.84 [95% CI: −5.97, −5.72]). The most important attributes were the availability of PrEP (relative importance 27.04% [95% CI: 25.98%, 28.11%]), followed by STI testing (relative importance 20.26% [95% CI: 19.52%, 21.01%]) and partner HIV testing (relative importance: 16.35% [95% CI: 15.79%, 16.90%]). While, on average, participants preferred obtaining services at the clinic more than pharmacies, women prioritized the availability of PrEP, STI testing and partner HIV testing more than the location or cost. Conclusions: These findings suggest the importance of providing comprehensive HIV prevention services and ensuring PrEP, STI testing and partner HIV testing are available. If pharmacies can offer these services, women are likely to access those services at pharmacies even if they prefer clinics., INTRODUCTION Pharmacy‐delivered HIV prevention services are creating more options for care among priority populations globally [1–3]. These services could accelerate progress towards reducing HIV incidence, especially among women of childbearing [...]

School-related factors may influence retention in care and adherence to antiretroviral therapy (ART) among adolescents with human immunodeficiency virus (HIV). We analyzed data from in-depth interviews with 40 adolescents with HIV (aged 14-19 years), 40 caregivers of adolescents with HIV, and 4 focus group discussions with healthcare workers to evaluate contextual factors affecting adherence to ART and clinic attendance among adolescents, with a focus on the school environment. Informed by Anderson's Model of Health Services Utilization, transcripts were systematically coded and synthesized to identify school-related themes. All groups identified the school environment as a critical barrier to engagement in HIV care and medication adherence for adolescents with HIV. Adolescent participants reported inflexible school schedules and disclosure to school staff as the biggest challenges adhering to clinic appointments and ART. Adolescents described experiencing stigma and discrimination by peers and school staff and would adjust when, where and how often they took ART to avoid inadvertent disclosure. Boarding school students faced challenges because they had limited private space or time. Caregivers were often instrumental in navigating school permissions, including identifying a treatment supporter among school staff. Additional research engaging school staff may guide interventions for schools to reduce stigma and improve adherence and retention.

Information on the extent of drug exposure to mothers and infants during pregnancy and lactation normally becomes available years after regulatory approval of a drug. Clinicians face knowledge gaps on drug selection and dosing in pregnancy and infant exposure during breastfeeding. Physiological changes during pregnancy often result in lower drug exposures of antiretrovirals, and in some cases a risk of reduced virologic efficacy. The International Maternal Pediatric Adolescent AIDS Clinical Trials (IMPAACT) network and the World Health Organization (WHO)-convened Pediatric Antiretrovirals Working Group collaboratively organized a workshop of key stakeholders in June 2019 to define key standards to generate pharmacology data for antiretrovirals to be used among pregnant and lactating women; review the antiretroviral product pipeline; describe key gaps for use in low-income and middle-income countries; and identify opportunities to undertake optimal studies allowing for rapid implementation in the clinical field. We discussed ethical and regulatory principles, systemic approaches to obtaining data for pregnancy pharmacokinetic/pharmacodynamic (PK/PD) studies, control groups, optimal sampling times during pregnancy, and pharmacokinetic parameters to be considered as primary end points in pregnancy PK/PD studies. For lactation studies, the type of milk to collect, ascertainment of maternal adherence, and optimal PK methods to estimate exposure were discussed. Participants strongly recommended completion of preclinical reproductive toxicology studies prior to phase III, to allow study protocols to include pregnant women or to allow women who become pregnant after enrolment to continue in the trial. The meeting concluded by developing an algorithm for design and interpretation of results and noted that recruitment of pregnant and lactating women into clinical trials is critical.

Pregnancy is a high-risk period for HIV acquisition in African women, and pregnant women who become acutely infected with HIV account for up to a third of vertical HIV transmission cases in African settings. To protect women and eliminate vertical transmission, WHO recommends offering oral pre-exposure prophylaxis (PrEP) based on tenofovir to HIV-negative pregnant and post-partum women with a substantial risk of HIV acquisition. PrEP implementation for pregnant and post-partum women lags behind implementation for other high-risk populations. Unique considerations for PrEP implementation arise during pregnancy and post partum, including the integration of provider training with clinical delivery and monitoring of PrEP exposure and outcomes within existing maternal health systems, yet scarce implementation data are available to generate evidence in this context.

IntroductionHIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.MethodsWe used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.Results and discussionWe identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.ConclusionsExpanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.

IntroductionHIV incidence is high during pregnancy and breastfeeding with HIV acquisition risk more than doubling during pregnancy and the postpartum period compared to when women are not pregnant. The World Health Organization recommends offering pre-exposure prophylaxis (PrEP) to pregnant and postpartum women at substantial risk of HIV infection. However, maternal PrEP national guidelines differ and most countries with high maternal HIV incidence are not offering PrEP. We conducted a systematic review of recent research on PrEP safety in pregnancy to inform national policy and rollout.MethodsWe used a standard Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) approach to conduct a systematic review by searching for completed, ongoing, or planned PrEP in pregnancy projects or studies from clinicaltrials.gov, PubMed and NIH RePORTER from 2014 to March 2019. We performed a systematic review of studies that assess tenofovir disoproxil fumarate (TDF)-based oral PrEP safety in pregnant and breastfeeding HIV-uninfected women.Results and discussionWe identified 14 completed (n = 5) and ongoing/planned (n = 9) studies that evaluate maternal and/or infant outcomes following PrEP exposure during pregnancy or breastfeeding. None of the completed studies found differences in pregnancy or perinatal outcomes associated with PrEP exposure. Nine ongoing studies, to be completed by 2022, will provide data on >6200 additional PrEP-exposed pregnancies and assess perinatal, infant growth and bone health outcomes, expanding by sixfold the data on PrEP safety in pregnancy. Research gaps include limited data on (1) accurately measured PrEP exposure within maternal and infant populations including drug levels needed for maternal protection; (2) uncommon perinatal outcomes (e.g. congenital anomalies); (3) infant outcomes such as bone growth beyond one year following PrEP exposure; (4) outcomes in HIV-uninfected women who use PrEP during pregnancy and/or lactation.ConclusionsExpanding delivery of PrEP is an essential strategy to reduce HIV incidence in pregnancy and breastfeeding women. Early safety studies of PrEP among pregnant women without HIV infection are reassuring and ongoing/planned studies will contribute extensive new data to bolster the safety profile of PrEP use in pregnancy. However, addressing research gaps is essential to expanding PrEP delivery for women in the context of pregnancy.

This article explores the need to reevaluate policy implementation science in a global context, particularly in low-resource settings in the Global South. It highlights the limitations of existing frameworks, which are often based on Global North perspectives and may not be applicable to diverse settings. The article suggests incorporating traditional implementation science and political science theories to develop more effective frameworks that consider power dynamics and stakeholder collaboration. It also emphasizes the importance of adapting universal health coverage policies to fit different governance structures and resource contexts. The text includes case studies from Pakistan and Rwanda to illustrate the importance of tailoring policies to local contexts. The authors argue for refining policy implementation science frameworks to address these issues and promote evidence-based policymaking in global health. The article provides a list of references that offer valuable insights and research findings for library patrons conducting research on related topics. [Extracted from the article]

We examined the association between serum aflatoxin B1‐lysine adduct (AFB1‐lys) levels in pregnant women and adverse pregnancy outcomes (low birthweight, miscarriage and stillbirth) through a nested matched case–control study of pregnant women enroled at ≤28 weeks' gestation in Mombasa, Kenya, from 2017 to 2019. Cases comprised women with an adverse birth outcome, defined as either delivery of a singleton infant weighing <2500 g, or a miscarriage, or a stillbirth, while controls were women who delivered a singleton live infant with a birthweight of ≥2500 g. Cases were matched to controls at a ratio of 1:2 based on maternal age at enrolment, gestational age at enrolment and study site. The primary exposure was serum AFB1‐lys. The study included 125 cases and 250 controls. The median gestation age when serum samples were collected was 23.0 weeks (interquartile range [IQR]: 18.1–26.0) and 23.5 (IQR: 18.1–26.5) among cases and controls, respectively. Of the 375 tested sera, 145 (38.7%) had detectable serum AFB1‐lys: 36.0% in cases and 40.0% in controls. AFB1‐lys adduct levels were not associated with adverse birth outcomes on multivariable analysis. Mid‐upper arm circumference was associated with a 6% lower odds of adverse birth outcome for every unit increase (p = 0.023). Two‐fifths of pregnant women had detectable levels of aflatoxin midway through pregnancy. However, we did not detect an association with adverse pregnancy outcomes, likely because of low serum AFB1‐lys levels and low power, restricting meaningful comparison. More research is needed to understand the public health risk of aflatoxin in pregnant women to unborn children. Key messages: Aflatoxin B1 (AFB1), a commonly ingested toxin, can cross the placental barrier and cause adverse pregnancy outcomes.Two‐fifths of participants had detectable serum AFB1‐lys levels, a marker of aflatoxin exposure, but the low levels recorded were not associated with adverse pregnancy outcomes.Every unit increase in mid‐upper arm circumference (MUAC) during pregnancy was associated with a 6% reduced likelihood of adverse pregnancy outcomes, highlighting the potential protective role of adequate maternal nutrition.There is need for additional studies in different settings on the determinants and mechanisms of the relationship between aflatoxin exposure and adverse pregnancy outcomes. [ABSTRACT FROM AUTHOR]

We evaluated hair tenofovir (TFV) concentrations as an adherence metric for HIV preexposure prophylaxis during pregnancy and postpartum and compared hair levels with TFV-diphosphate levels in dried blood spots (DBSs). Overall 152 hair samples from 102 women and 36 hair-DBS paired samples from 29 women were collected from a subset of women in a cluster-randomized trial. Having a partner with HIV was associated with higher hair TFV levels (P <.001). Hair TFV concentrations were strongly correlated with DBS TFV-diphosphate levels (r = 0.76, P <.001), indicating hair as a promising cumulative adherence metric for perinatal preexposure prophylaxis assessment. [ABSTRACT FROM AUTHOR]

Background: Studies evaluating the association between the vaginal microbiota and miscarriage have produced variable results. Objective: This study evaluated the association between periconceptual and first‐trimester vaginal microbiota and women's risk for miscarriage. Methods: At monthly preconception visits and at 9–12 weeks gestation, women collected vaginal swabs for molecular characterisation of the vaginal microbiota. Participants who became pregnant were followed to identify miscarriage versus pregnancy continuing to at least 20 weeks gestation. Results: Forty‐five women experienced miscarriage and 144 had pregnancies continuing to ≥20 weeks. A principal component analysis of periconceptual and first‐trimester vaginal bacteria identified by 16S rRNA gene PCR with next‐generation sequencing did not identify distinct bacterial communities with miscarriage versus continuing pregnancy. Using taxon‐directed quantitative PCR assays, increasing concentrations of Megasphaera hutchinsoni, Mageeibacillus indolicus, Mobiluncus mulieris and Sneathia sanguinegens/vaginalis were not associated with miscarriage. In exploratory analyses, these data were examined as a binary exposure to allow for multivariable modelling. Detection of Mobiluncus mulieris in first‐trimester samples was associated with miscarriage (adjusted relative risk [aRR] 2.14, 95% confidence interval [CI] 1.08, 4.22). Additional analyses compared women with early first‐trimester miscarriage (range 4.7–7.3 weeks) to women with continuing pregnancies. Mobiluncus mulieris was detected in all eight (100%) first‐trimester samples from women with early first‐trimester miscarriage compared to 101/192 (52.6%) samples from women with continuing pregnancy (model did not converge). Detection of Mageeibacillus indolicus in first‐trimester samples was also associated with early first‐trimester miscarriage (aRR 4.10, 95% CI 1.17, 14.31). Conclusions: The primary analyses in this study demonstrated no association between periconceptual or first‐trimester vaginal microbiota and miscarriage. Exploratory analyses showing strong associations between first‐trimester detection of Mobiluncus mulieris and Mageeibacillus indolicus and early first‐trimester miscarriage suggest the need for future studies to determine if these findings are reproducible. [ABSTRACT FROM AUTHOR]