Pharmacodynamic evaluation of the etonogestrel contraceptive implant initiated midcycle with and without ulipristal acetate: An exploratory study.

OBJECTIVE: To estimate the incidence of ovulation suppression within five days of etonogestrel 68 mg implant insertion in the presence of a dominant follicle with and without same-day ulipristal acetate. STUDY DESIGN: This single site non-masked, exploratory randomized trial recruited people age 18-35 years with regular menstrual cycles, no pregnancy risk, and confirmed ovulatory function. We initiated transvaginal ultrasound examinations on menstrual day 7-9 and randomized participants 1:1 to etonogestrel implant alone or with concomitant ulipristal acetate 30 mg oral when a dominant follicle reached ≥14 mm in diameter. We completed daily sonography and serum hormone levels for up to seven days or transitioned to labs alone if sonographic follicular rupture occurred. We defined ovulation as follicular rupture followed by progesterone >3 ng/mL. We calculated point estimates, risk ratios and 95% confidence intervals for ovulation for each group. Ovulation suppression of ≥44% in either group (the follicular rupture suppression rate with oral levonorgestrel emergency contraception), would prompt future method testing. RESULTS: From October 2020 to October 2022, we enrolled 40 people and 39 completed primary outcome assessments: 20 with etonogestrel implant alone (mean follicular size at randomization: 15.2 mm ± 0.9 mm) and 19 with etonogestrel implant + ulipristal acetate (mean follicular size at randomization: 15.4 mm ± 1.2 mm, p = 0.6). Ovulation suppression occurred in 13 (65%) of etonogestrel implant-alone participants (Risk ratio 0.6 (95% CI: 0.3, 1.1), p = 0.08) and seven (37%) of implant + ulipristal acetate participants. CONCLUSIONS: Ovulation suppression of the etonogestrel implant alone exceeds threshold testing for future research while the implant + ulipristal acetate does not. IMPLICATIONS: Data are lacking on midcycle ovulation suppression for the etonogestrel implant with and without oral ulipristal acetate. In this exploratory study, ovulation suppression occurred in 65% of implant participants and 37% of implant + ulipristal acetate participants. Ovulation suppression of the implant alone exceeds threshold testing for future emergency contraception research.

Efficacy of oral levonorgestrel emergency contraception with same day etonogestrel contraceptive implant: A prospective observational study.

OBJECTIVE: To determine a 1-month pregnancy rate point estimate and 95% confidence interval for guideline-supported, same-day initiation of an etonogestrel implant plus oral levonorgestrel emergency contraception. STUDY DESIGN: In this single-arm, prospective observational study, all emergency contraception clients who presented to four Planned Parenthood Association of Utah clinics from February 2021 to March 2023 received information about oral levonorgestrel with same-day etonogestrel implant insertion. Participants were ≤35 years and reported unprotected intercourse within 5 days with negative pregnancy testing. The primary outcome measure was a 1-month home pregnancy test. We calculated the efficacy using a test of proportions with Yates continuity correction. RESULTS: A total of 160 emergency contraception clients (7.6% of 2106 approached) enrolled and 153 had 1-month pregnancy outcomes. A positive pregnancy test occurred in 2 participants resulting in an overall pregnancy rate of 1.32% (95% confidence interval 0.23%-5.19%). Ultrasound gestational dating assigned conception of the first pregnancy to 8 days before enrollment. For the second pregnancy, ultrasound dating designated conception at 5 days prior to enrollment. Limiting the efficacy rate to the single pregnancy that occurred within 5 days of unprotected intercourse, we report a pregnancy rate of 0.66% (95% confidence interval 0.03%-4.19%). CONCLUSIONS: In this observational study of emergency contraception clients selecting oral levonorgestrel with same-day etonogestrel implant, we identified a pregnancy rate within the established range of oral emergency contraception methods alone. IMPLICATIONS: Clients presenting for emergency contraception may also desire ongoing highly-effective contraception, yet current clinical guidelines serve as a barrier to same-day method initiation for the etonogestrel implant and other hormonal methods. Improving access to contraceptive method initiation will reduce the ongoing risk of unwanted pregnancy for this population. CLINICAL TRIAL REGISTRATION: Clinicaltrials.gov NCT04678817; registered 12/16/20.

Effects of the Dobbs v Jackson Women's Health Organization Decision on Obstetrics and Gynecology Graduating Residents' Practice Plans.

OBJECTIVE: To explore the association of the Dobbs v Jackson Women's Health Organization ( Dobbs ) decision on future practice locations of graduating obstetrics and gynecology residents. METHODS: This is a mixed-methods survey study of obstetrics and gynecology residents graduating from sites with Ryan Program abortion training programs (109 sites) between March 8, 2023, and April 25, 2023. We conducted both univariate and multivariable logistic regression analyses to identify factors that were associated with post- Dobbs change in career plans, particularly location. We also performed a thematic analysis using responses to the survey's optional, open-ended prompt, "Please describe how the Dobbs v Jackson Women's Health Organization decision impacted your professional plans." RESULTS: Of an estimated 724 residents graduating from residencies with Ryan Program abortion training programs, 349 participated in the survey (48.2% response rate); 17.6% of residents indicated that the Dobbs decision changed the location of intended future practice or fellowship plans. Residents who before the Dobbs decision intended to practice in abortion-restrictive states were eight times more likely to change their practice plans than those who planned to practice in protected states before the Dobbs decision (odds ratio 8.52, 95% CI 3.81-21.0). In a thematic analysis of open-ended responses, 90 residents wrote responses related to "not living in a state with abortion restrictions." Of residents pursuing fellowship, 36 indicated that they did not rank or ranked lower programs in restrictive states. CONCLUSION: These findings demonstrate reduced desire of residents in obstetrics and gynecology to practice or pursue fellowship in restrictive states after residency. This reduction in obstetrics and gynecology workforce could significantly exacerbate maternity care deserts.

Barriers to and facilitators of hormonal and long-acting reversible contraception access and use in the US among reproductive-aged women who use opioids: A scoping review.

Existing research has found that women who use opioids (WWUO) experience challenges to hormonal and long-acting reversible contraception (HC-LARC) access and use. Facilitators of such use are unclear. We conducted a scoping review to comprehensively map the literature on barriers to and facilitators of HC-LARC access and use in the United States among reproductive-aged WWUO. In accordance with the JBI Manual of Evidence Synthesis, we conducted literature searches for empirical articles published from 1990 to 2021. Independent reviewers screened references, first by titles and abstracts, then by full-text, and charted data of eligible articles. We coded and organized HC-LARC barriers and facilitators according to a four-level social-ecological model (SEM) and categorized findings within each SEM level into domains. We screened 4,617 records, of which 28 articles focusing on HC-LARC (n = 18), LARC only (n = 6), or testing an intervention to increase HC-LARC uptake (n = 4) met inclusion criteria. We identified 13 domains of barriers and 11 domains of facilitators across four SEM levels (individual, relationship, community, societal). The most frequently cited barriers and facilitators were methods characteristics, partner and provider relations, transportation, healthcare availability and accessibility, cost, insurance, and stigma. Future studies would benefit from recruiting participants and collecting data in community settings, targeting more diverse populations, and identifying neighborhood, social, and policy barriers and facilitators. Reducing barriers and improving equity in HC-LARC access and use among WWUO is a complex, multifaceted issue that will require targeting factors simultaneously at multiple levels of the social-ecological hierarchy to effect change.

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.

One-year pregnancy and continuation rates after placement of levonorgestrel or copper intrauterine devices for emergency contraception: a randomized controlled trial.

BACKGROUND: Recent evidence demonstrates the effectiveness of the levonorgestrel 52-mg intrauterine device for emergency contraception vs the copper T380A intrauterine device. Of note, 1-year pregnancy and continuation rates after intrauterine device placement for emergency contraception remain understudied. OBJECTIVE: This study compared 1-year pregnancy and intrauterine device continuation rates and reasons for discontinuation among emergency contraception users randomized to the levonorgestrel 52-mg intrauterine device or the copper intrauterine device. STUDY DESIGN: This participant-masked, randomized noninferiority trial recruited emergency contraception individuals desiring an intrauterine device from 6 Utah family planning clinics between August 2016 and December 2019. Participants were randomized 1:1 to the levonorgestrel 52-mg intrauterine device group or the copper T380A intrauterine device group. Treatment allocation was revealed to participants at the 1-month follow-up. Trained personnel followed up the participants by phone, text, or e-mail at 5 time points in 1 year and reviewed electronic health records for pregnancy and intrauterine device continuation outcomes for both confirmation and nonresponders. We assessed the reasons for the discontinuation and used Cox proportional-hazard models, Kaplan-Meier estimates, and log-rank tests to assess differences in the continuation and pregnancy rates between the groups. RESULTS: The levonorgestrel and copper intrauterine device groups included 327 and 328 participants, respectively, receiving the respective interventions. By intention-to-treat analysis at 1 year, the pregnancy rates were similar between intrauterine device types (2.8% [9/327] in levonorgestrel 52-mg intrauterine device vs 3.0% [10/328] in copper intrauterine device; risk ratio, 0.9; 95% confidence interval, 0.4-2.2; P=.82). Most pregnancies occurred in participants after intrauterine device removal, with only 1 device failure in each group. Of note, 1-year continuation rates did not differ between groups with 204 of 327 levonorgestrel 52-mg intrauterine device users (62.4%) and 183 of 328 copper T380A intrauterine device users (55.8%) continuing intrauterine device use at 1 year (risk ratio, 1.1; 95% confidence interval, 1.0-1.2; P=.09). There were differences concerning the reasons for discontinuation between intrauterine device types, with more bleeding and cramping cited among copper intrauterine device users. CONCLUSION: The pregnancy rates were low and similar between intrauterine device types. Of note, 6 of 10 intrauterine device emergency contraception users continued use at 1 year. Moreover, 1-year continuation rates were similar between intrauterine device types.

Switching and discontinuation of participant-masked randomization to a copper or levonorgestrel intrauterine device when presenting for emergency contraception.

OBJECTIVES: Examine intrauterine device (IUD) switching or discontinuation up to 6 months after participant-masked randomization to different IUDs. STUDY DESIGN: Participants were randomized 1:1 to the copper T380A or levonorgestrel 52 mg IUD for emergency contraception and informed they could switch IUD type without cost at any time. RESULTS: Of the 327 subjects allocated to the levonorgestrel IUD, 7 (2.1%) switched their IUD type by 6 months versus 18 (5.5%) of the 328 copper IUD users (RR: 0.4 [95% CI: 0.2, 0.9], p = 0.03). Six-month IUD discontinuation occurred in 34 (10.4%) levonorgestrel and 35 (10.7%) copper IUD users. CONCLUSION: Individuals randomly assigned to IUD type at presentation for emergency contraception continue their assigned IUDs at high rates over 6 months. IMPLICATIONS: While many recruited individuals declined enrollment, those who accepted randomization had high continuation rates; the high continuation and low cross-over supports using IUD randomization as a tool for future investigation. Participants' similar rates of and reasons for switching and discontinuation by IUD type over the study period may impact clinical counseling.

Mifepristone for miscarriage treatment in Utah: A survey of clinician knowledge and assessment of an educational video on future use.

Objectives: We aimed to: (a) describe current use of mifepristone for early pregnancy loss (EPL) management in Utah, (b) identify predictors of knowledge pre- and posteducational video, and (c) explore postvideo impacts on the likelihood to use mifepristone. Mifepristone is subject to the Food and Drug Administration's (FDA) Risk Evaluation and Mitigation Strategy (REMS) requirements. Methods: Between September 2020 and March 2021 we surveyed Utah clinicians from six specialties caring for people experiencing EPL, recruited through professional organizations and hospital listservs. Participants viewed a 3.5-minute educational video on mifepristone for EPL and completed pre- and postvideo questionnaires. We evaluated predictors of high prevideo and improved postvideo knowledge using random forest regression conditional importance measures and partial dependency plots. We described current mifepristone use and video effects on likelihood to use mifepristone. Results: Of 506 participants, most specialize in emergency medicine (172, 34%) and practice in private settings (253, 51%). Two-thirds had heard of mifepristone (328/471, 70%). Of 176/471 (37%) attempting provision of mifepristone, actual provision occurred for 59% (104/176). Baseline knowledge scores were low (mean 4.81/13 [37%] correct). Predictors of high prevideo knowledge include provision or attempted provision of mifepristone, having heard of mifepristone, providing EPL management expectantly or via medication, and specialty type. Mean postvideo knowledge scores improved by 3.27 points (68% improvement, paired t-test; 95% confidence interval 2.82-3.72, p < 0.0001). Postvideo, 66% (242/364) stated they are much more or somewhat more likely to use mifepristone, with compliance with FDA requirements cited as a barrier to utilization. Conclusions: Among Utah providers, baseline mifepristone knowledge and use for EPL management are low. An educational video improved knowledge and likelihood of use, but FDA REMS requirements continue to be a barrier to including mifepristone in medication management of EPL.

Quantitative and qualitative impact of One Key Question on primary care providers' contraceptive counseling at routine preventive health visits.

OBJECTIVES: One Key Question (OKQ) is a clinical screening tool to assess pregnancy desire in the next year. We aimed to 1) describe the effect of OKQ implementation on contraceptive counseling rates at preventive health visits and 2) evaluate primary care providers' perception of OKQ implementation on their contraceptive counseling practices. STUDY DESIGN: We performed a quantitative retrospective chart review of preventive health visits at eight federally qualified health centers in Utah between 2014 and 2017. Implementation of OKQ included a brief training and inclusion of OKQ in the electronic medical record. Providers received OKQ training in August 2015 and re-training in March 2017. We assessed OKQ and contraceptive counseling documentation rates using interrupted-time-series analysis. We then conducted semi-structured interviews with providers and queried them about the impact of OKQ. We identified dominant themes using modified grounded theory to create an explanatory framework. RESULTS: Abstracting 6634 charts yielded 9840 visits with 56 unique providers (51% physician assistant, 34% physician, 14% nurse practitioner). Interrupted-time-series analysis showed a documentation increase of OKQ in late 2015 (2.6%) and again in spring 2017 (9%), however rates remained low. Contraceptive counseling rates (39.7%) did not change after OKQ implementation. Charts with evidence of a current contraceptive method were less likely to have a OKQ response documented. Interviewees reported OKQ's algorithm did not alter their contraceptive counseling. CONCLUSIONS: OKQ did not change documented rates of contraceptive counseling and uptake was low in quantitative and qualitative analyses. Our study suggests limited usefulness of OKQ in the primary care setting. IMPLICATIONS: Implementation of the One Key Question tool through training and optional EHR field did not increase documented rates of contraceptive counseling in a large federally qualified health center or affect provider contraceptive counseling. Our study suggests limited usefulness of OKQ as a robust screening tool in this primary care setting.

Association of Hormonal Contraceptive Use With Adverse Health Outcomes: An Umbrella Review of Meta-analyses of Randomized Clinical Trials and Cohort Studies.

Importance: Meta-analyses have reported conflicting data on the safety of hormonal contraception, but the quality of evidence for the associations between hormonal contraceptive use and adverse health outcomes has not been quantified in aggregate. Objective: To grade the evidence from meta-analyses of randomized clinical trials (RCTs) and cohort studies that assessed the associations between hormonal contraceptive use and adverse health outcomes among women. Data Sources: MEDLINE, Embase, and the Cochrane Database of Systematic Reviews were searched from database inception to August 2020. Search terms included hormonal contraception, contraceptive agents, progesterone, desogestrel, norethindrone, megestrol, algestone, norprogesterones, and levonorgestrel combined with terms such as systematic review or meta-analysis. Evidence Review: The methodological quality of each meta-analysis was graded using the Assessment of Multiple Systematic Reviews, version 2, which rated quality as critically low, low, moderate, or high. The Grading of Recommendation, Assessment, Development and Evaluations approach was used to assess the certainty of evidence in meta-analyses of RCTs, with evidence graded as very low, low, moderate, or high. Evidence of associations from meta-analyses of cohort studies was ranked according to established criteria as nonsignificant, weak, suggestive, highly suggestive, or convincing. Results: A total of 2996 records were screened; of those, 310 full-text articles were assessed for eligibility, and 58 articles (13 meta-analyses of RCTs and 45 meta-analyses of cohort studies) were selected for evidence synthesis. Sixty associations were described in meta-analyses of RCTs, and 96 associations were described in meta-analyses of cohort studies. Among meta-analyses of RCTs, 14 of the 60 associations were nominally statistically significant (P ≤ .05); no associations between hormonal contraceptive use and adverse outcomes were supported by high-quality evidence. The association between the use of a levonorgestrel-releasing intrauterine system and reductions in endometrial polyps associated with tamoxifen use (odds ratio [OR], 0.22; 95% CI, 0.13-0.38) was graded as having high-quality evidence, and this evidence ranking was retained in the subgroup analysis. Among meta-analyses of cohort studies, 40 of the 96 associations were nominally statistically significant; however, no associations between hormonal contraceptive use and adverse outcomes were supported by convincing evidence in the primary and subgroup analyses. The risk of venous thromboembolism among those using vs not using oral contraception (OR, 2.42; 95% CI, 1.76-3.32) was initially supported by highly suggestive evidence, but this evidence was downgraded to weak in the sensitivity analysis. Conclusions And Relevance: The results of this umbrella review supported preexisting understandings of the risks and benefits associated with hormonal contraceptive use. Overall, the associations between hormonal contraceptive use and cardiovascular risk, cancer risk, and other major adverse health outcomes were not supported by high-quality evidence.

Determining the impact of the Zika pandemic on primary care providers' contraceptive counseling of non-pregnant patients in the US: a mixed methods study.

BACKGROUND: Global pandemics like Zika (ZIKV) factor into pregnancy planning and avoidance, yet little is known about how primary care providers (PCPs) incorporate public health guidance into contraceptive counseling. Study objectives include: 1) determining the impact of the ZIKV pandemic on contraceptive counseling changes; and 2) assessing PCP knowledge and practice regarding contraception, ZIKV, and CDC ZIKV guidelines. METHODS: Study components included: (1) a retrospective review of electronic health records of non-pregnant, reproductive age women presenting for preventive health visits between 2014 and 2017 assessed using interrupted time series analyses (ITSA) to identify changes in documentation of ZIKV risk assessment and contraceptive counseling; and (2) a sequential, cross-sectional study with quantitative surveys and qualitative, semi-structured interviews of PCPs providing preventive care to non-pregnant patients at eight federally qualified health centers in Utah. We performed descriptive analyses on survey data and analyzed qualitative data for dominant themes using a modified Health Belief Model. RESULTS: We conducted 6634 chart reviews yielding 9840 visits. The ITSA did not reveal changes in ZIKV risk assessment or contraceptive counseling. Twenty-two out of 40 (55%) eligible providers participated in the provider component. Participants averaged 69 and 81% correct on contraceptive and ZIKV knowledge questions, respectively. Sixty-five percent reported counseling consistent with CDC ZIKV guidelines. Qualitative analysis found providers unlikely to prioritize ZIKV risk assessment in contraceptive counseling for non-pregnant patients. CONCLUSIONS: PCPs who care for non-pregnant women are knowledgeable about contraception and ZIKV; however, there was no change in ZIKV risk assessment or contraceptive counseling. This stresses the importance of developing strategies to improve guideline uptake.

Rates of pregnancy among levonorgestrel and copper intrauterine emergency contraception initiators: Implications for backup contraception recommendations.

OBJECTIVE: This study assessed the timing, frequency, use of backup method and 1-month pregnancy rates among individuals who had an intrauterine device (IUD) placed as emergency contraception and reported intercourse within 7 days post-placement. STUDY DESIGN: In this secondary analysis of a randomized control trial of IUDs for emergency contraception, 518 individuals reporting unprotected intercourse in the preceding 5 days had a 52 mg levonorgestrel intrauterine system (IUS) or 380 mm2 copper IUD placed outside the first week of their menstrual cycle. All participants were advised to use backup contraception for 7 days. We assessed pregnancy status 1 month after placement by urine testing or, when not available, by survey responses and electronic health record review.  Participants reported whether their first sexual activity after device placement occurred within 7 days of their placement, the frequency of intercourse and whether they used backup contraception. RESULTS: Rapid return to sexual activity was common and use of backup contraception was rare, regardless of type of IUD placed. Of participants who resumed penile-vaginal intercourse in the first month, most (286/446, 64.1%) participants reported intercourse within 7 days of IUD placement; only 16.4% (74/446) used condoms or withdrawal. No pregnancies occurred among users of the levonorgestrel IUS who reported intercourse within 7 days of placement (0/138, 0.0%, 95% CI 0.0%, 2.6%) nor among users of the 380mm2 copper IUD (0/148, 0.0%, 95% CI 0.0%, 2.5%). CONCLUSION: Pregnancy rates are low after placement of an IUD for emergency contraception, even among the many who resume intercourse within days following IUD placement without use of backup contraception. IMPLICATIONS: Clinical guidelines should facilitate access to contraception, including elimination of unnecessary recommendations for backup contraception or abstinence in the 7 days following 52 mg levonorgestrel intrauterine system.

Levonorgestrel vs. Copper Intrauterine Devices for Emergency Contraception.

BACKGROUND: In the United States, more intrauterine device (IUD) users select levonorgestrel IUDs than copper IUDs for long-term contraception. Currently, clinicians offer only copper IUDs for emergency contraception because data are lacking on the efficacy of the levonorgestrel IUD for this purpose. METHODS: This randomized noninferiority trial, in which participants were unaware of the group assignments, was conducted at six clinics in Utah and included women who sought emergency contraception after at least one episode of unprotected intercourse within 5 days before presentation and agreed to placement of an IUD. We randomly assigned participants in a 1:1 ratio to receive a levonorgestrel 52-mg IUD or a copper T380A IUD. The primary outcome was a positive urine pregnancy test 1 month after IUD insertion. When a 1-month urine pregnancy test was unavailable, we used survey and health record data to determine pregnancy status. The prespecified noninferiority margin was 2.5 percentage points. RESULTS: Among the 355 participants randomly assigned to receive levonorgestrel IUDs and 356 assigned to receive copper IUDs, 317 and 321, respectively, received the interventions and provided 1-month outcome data. Of these, 290 in the levonorgestrel group and 300 in the copper IUD group had a 1-month urine pregnancy test. In the modified intention-to-treat and per-protocol analyses, pregnancy rates were 1 in 317 (0.3%; 95% confidence interval [CI], 0.01 to 1.7) in the levonorgestrel group and 0 in 321 (0%; 95% CI, 0 to 1.1) in the copper IUD group; the between-group absolute difference in both analyses was 0.3 percentage points (95% CI, -0.9 to 1.8), consistent with the noninferiority of the levonorgestrel IUD to the copper IUD. Adverse events resulting in participants seeking medical care in the first month after IUD placement occurred in 5.2% of participants in the levonorgestrel IUD group and 4.9% of those in the copper IUD group. CONCLUSIONS: The levonorgestrel IUD was noninferior to the copper IUD for emergency contraception. (Supported by the Eunice Kennedy Shriver National Institute of Child Health and Human Development and others; ClinicalTrials.gov number, NCT02175030.).

Clinical Variables Associated With Adverse Maternal Outcomes in Puerperal Group A Streptococci Infection.

OBJECTIVE: To identify clinical variables associated with increased risk of composite adverse outcome in a cohort of women with puerperal group A streptococci infection. METHODS: Our prospective case registry enrolled patients between 1991 and 2017. Chart abstraction was conducted for admission demographic and clinical data in patients with culture-proven puerperal group A streptococci infection. We created a composite variable of signs of capillary leakage including pulmonary edema, pleural effusion, ascites, and abdominal distention. The composite adverse outcome included death, hysterectomy, intensive care unit admission, mechanical ventilation, and blood transfusion. Clinical characteristics were compared between those with a composite adverse outcome and those without. We fit unadjusted log-linear models with robust error variance to measure the relative risk of a composite adverse outcome associated with clinical and demographic variables among patients with group A streptococci. RESULTS: Thirty-five of 71 (49%) patients had an adverse outcome. Women who had adverse outcomes had higher admission heart rates (126±19 vs 112±22 beats per minute, P=.008) and respiratory rates (26±10 vs 20±5 breaths per minute, P=.01), lower systolic blood pressure (98±24 vs 114±19 mm Hg, P=.004), and were more likely to have signs of capillary leakage (77% vs 20%, P<.001) and symptoms of capillary leakage (dyspnea, cough, shoulder pain, abdominal bloating, and chest pain) (40% vs 17%, P=.03) compared with those without adverse outcomes. Log-linear models indicated that these clinical variables were individually associated with increased risk of a composite adverse outcome. The relative risk of an adverse outcome was 3.5 times higher among women with signs of capillary leakage (relative risk 3.67, 95% CI 1.94-6.94, P<.001). CONCLUSION: Vital sign parameters consistent with severe infection correlate with adverse outcomes in women with puerperal group A streptococci infection. Signs of capillary leakage are most strongly associated with a composite adverse outcome. These clinical characteristics, particularly signs of capillary leakage, are potentially useful to guide clinical care.

Impact of Deployment on Reproductive Health in U.S. Active-Duty Servicewomen and Veterans.

Reproductive-age women are a fast-growing component of active-duty military personnel who experience deployment and combat more frequently than previous service-era women Veterans. With the expansion of the number of women and their roles, the United States Departments of Defense and Veterans Affairs have prioritized development and integration of reproductive services into their health systems. Thus, understanding associations between deployments or combat exposures and short- or long-term adverse reproductive health outcomes is imperative for policy and programmatic development. Servicewomen and women Veterans may access reproductive services across civilian and military or Veteran systems and providers, increasing the need for awareness and communication regarding deployment experiences with a broad array of providers. An example is the high prevalence of military sexual trauma reported by women Veterans and the associated mental health diagnoses that may lead to a lifetime of high risk-coping behaviors that increase reproductive health risks, such as sexually transmitted infections, unintended pregnancies, and others. Care coordination models that integrate reproductive healthcare needs, especially during vulnerable times such as at the time of military separation and in the immediate postdeployment phase, may identify risk factors for early intervention with the potential to mitigate lifelong risks.