Expert opinion on the use of contraception in people with multiple sclerosis.

BACKGROUND: Current guidance on the selection of appropriate contraception for people with multiple sclerosis (PwMS) is lacking. OBJECTIVE: To address this gap, an expert-led consensus program developed recommendations to support clinicians in discussing family planning and contraception with women and men with multiple sclerosis (MS). METHODS: A multidisciplinary steering committee (SC) of 13 international clinical experts led the program, supported by an extended faculty of 32 experts representing 18 countries. A modified Delphi methodology was used for decision-making and consensus-building. The SC drafted 15 clinical questions focused on patient-centered care, selection of contraception, and timing of stopping/starting contraception and disease-modifying therapies (DMTs). Statements addressing each question were drafted based on evaluation of published evidence and the experts' clinical experience. Consensus was reached if ⩾75% of respondents agreed (scoring 7-9 on a 9-point scale) with each recommendation. RESULTS: Consensus was reached on 24 of 25 proposed recommendations, including how and when to discuss contraception, types and safety of contraceptives, and how to evaluate the most appropriate contraceptive options for specific patient groups, including those with significant disability or being treated with DMTs. CONCLUSION: These expert recommendations provide the first practical, relevant, and comprehensive guidance for clinicians on the selection of contraception in PwMS.

Risk factors for and outcomes of ring expulsions with a 1-year contraceptive vaginal system.

BACKGROUND: The US Food and Drug Administration-approved segesterone acetate and ethinyl estradiol ring-shaped contraceptive vaginal system, known as Annovera (Sever Pharma Solutions/QPharma, Malmö, Sweden), was inserted and removed under a woman's control for a 21 day in and 7 day out regimen for up to 13 cycles of use. OBJECTIVE: We aimed to describe the patterns of ring expulsion over time, to identify potential predictors of expulsion, and to evaluate the impact of expulsions on method discontinuation and pregnancy risk. STUDY DESIGN: Using data from 2064 participants who were enrolled in 2 multinational phase 3 clinical trials on the use of this contraceptive vaginal system, we examined data from participants' daily diaries for documentation of complete ring expulsion. We modeled the odds of reported expulsions over time with adjustment for background and demographic characteristics using mixed-effects logistic regression models with random intercepts. We compared the probability of continuation between those who did and those who did not report expulsions in the first cycle of use using survival analysis and hazards modeling. To determine if expulsions during the first cycle of use affected the risk for pregnancy, we calculated Pearl Indices. RESULTS: Most participants (75%) never experienced any expulsions during any cycle of use, and 91% to 97% did not experience an expulsion during any 1 cycle. The incidence of expulsion was highest in cycle 1 (9%). The odds of experiencing expulsions decreased by half in cycles 2 to 8 when compared with cycle 1 (0.48; 95% confidence interval, 0.40-0.58), and in cycles 9 to 13, expulsions were about a third of that in cycle 1 (0.32; 95% confidence interval, 0.26-0.41). Of those who did experience expulsions, most (62%-84%) experienced ≤2 expulsions per cycle. Participants from study sites in Latin America vs those in the United States had higher odds of not experiencing an expulsion (odds ratio, 1.95; 95% confidence interval, 1.45-2.63). Women with a higher education level had higher odds of experiencing an expulsion. Notably, parity, age, and body mass index were not associated with expulsion. Participants who experienced any expulsions in cycle 1 were more likely to discontinue use early (hazard ratio, 1.28; 95% confidence interval, 1.14-1.43) than participants who did not have an expulsion. The Pearl Index for participants who had expulsions during cycle 1 was 3.99 (95% confidence interval, 1.29-9.31), which was higher than that among participants who reported no expulsions (Pearl Index, 2.39; 95% confidence interval, 1.61-3.41), but the overlapping confidence intervals indicate that there is not sufficient evidence to demonstrate an association between expulsions and pregnancy risk. CONCLUSION: Expulsions were infrequent overall, decreased with subsequent cycles of use, and were not associated with body mass index or parity. Early discontinuation of product use was higher among participants who experienced an expulsion during cycle 1. Although it is unclear whether pregnancy risk was associated with expulsions, early recognition of expulsions among users may identify those at higher risk for discontinuation and may highlight when enhanced anticipatory counselling and guidance may be advantageous.

Unique Profile of Inflammation and Immune Activation in Pregnant People With HIV in the United States.

BACKGROUND: Little is known about inflammation/immune activation during pregnancy in people with HIV (PWH) and growth in their children who are HIV-exposed and uninfected (CHEU). METHODS: Using data from the Pediatric HIV/AIDS Cohort Study and an HIV-seronegative comparison group, we assessed associations of (1) HIV status, mode of HIV acquisition (perinatally vs nonperinatally acquired), and type of antiretroviral therapy (ART) with inflammation/immune activation in pregnancy; and (2) inflammation/immune activation in pregnancy with growth of CHEU at 12 months. Interleukin 6 (IL-6), high-sensitivity C-reactive protein (hs-CRP), soluble(s) TNF-α receptor 1 and 2 (sTNFR1, sTNFR2), sCD14, and sCD163 were measured between 13 and 27 weeks' gestation. Linear regression models were fit to estimate differences between groups for each log-transformed biomarker, adjusted for confounders. RESULTS: Pregnant PWH (188 total, 39 perinatally acquired, 149 nonperinatally acquired) and 76 HIV-seronegative persons were included. PWH had higher IL-6, sTNFR1, sCD14, and sCD163 and lower sTNFR2 compared to HIV-seronegative persons in adjusted models. Among PWH, sCD163 was higher in those with perinatally versus nonperinatally acquired HIV and on PI-based versus INSTI-based ART. Higher maternal concentrations of IL-6, sTNFR2, and hs-CRP were associated with poorer growth at 12 months. CONCLUSIONS: Maternal HIV status is associated with a distinct profile of inflammation/immune activation during pregnancy, which may influence child growth.

The Effect of Antiretroviral Therapy for the Treatment of Human Immunodeficiency Virus (HIV)-1 in Pregnancy on Gestational Weight Gain.

BACKGROUND: Gestational weight gain above Institute of Medicine recommendations is associated with increased risk of pregnancy complications. The goal was to analyze the association between newer HIV antiretroviral regimens (ART) on gestational weight gain. METHODS: A retrospective cohort study of pregnant women with HIV-1 on ART. The primary outcome was incidence of excess gestational weight gain. Treatment effects were estimated by ART regimen type using log-linear models for relative risk (RR), adjusting for prepregnancy BMI and presence of detectable viral load at baseline. RESULTS: Three hundred three pregnant women were included in the analysis. Baseline characteristics, including prepregnancy BMI, viral load at prenatal care entry, and gestational age at delivery were similar by ART, including 53% of the entire cohort had initiated ART before pregnancy (P = nonsignificant). Excess gestational weight gain occurred in 29% of the cohort. Compared with non-integrase strand transfer inhibitor (-INSTI) or tenofovir alafenamide fumarate (TAF)-exposed persons, receipt of INSTI+TAF showed a 1.7-fold increased RR of excess gestational weight gain (95% CI: 1.18-2.68; P < .01), while women who received tenofovir disoproxil fumarate had a 0.64-fold decreased RR (95% CI: .41-.99; P = .047) of excess gestational weight gain. INSTI alone was not significantly associated with excess weight gain in this population. The effect of TAF without INSTI could not be inferred from our data. There was no difference in neonatal, obstetric, or maternal outcomes between the groups. CONCLUSIONS: Pregnant women receiving ART with a combined regimen of INSTI and TAF have increased risk of excess gestational weight gain.

Sexually Transmitted Infections in Pregnant People With Human Immunodeficiency Virus: Temporal Trends, Demographic Correlates, and Association With Preterm Birth.

BACKGROUND: We describe trends in prevalence and identify factors associated with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), syphilis, and Trichomonas vaginalis (TV) diagnosed in pregnancy among US people with human immunodeficiency virus (PWH) and evaluate associations of sexually transmitted infections (STIs) with preterm birth (PTB). METHODS: We included pregnant PWH enrolled in the Surveillance Monitoring for ART Toxicities dynamic cohort of the Pediatric HIV/AIDS Cohort Study network who delivered between 2010 and 2019. Multivariable log-binomial or Poisson generalized estimating equation models were used to estimate the association of calendar year with each STI, controlling for confounders; the association of demographic and clinical factors with each STI; and the association of each STI with PTB. RESULTS: The sample included 2241 pregnancies among 1821 PWH. Median age at delivery was 29.2 years; 71% of participants identified as Black or African American. STI prevalence was: CT 7.7%, NG 2.3%, syphilis 2.4%, and TV 14.5%; 30% had unknown TV status. There were no temporal changes in STI prevalence. Younger age and initial HIV viral load ≥400 copies/mL were associated with increased risk of CT, NG, and TV. Recreational substance use was a risk factor for NG, syphilis, and TV. No STI was associated with PTB. CONCLUSIONS: Unlike nationwide trends, no changes in STI prevalence during the study period were observed. The large proportion with unknown TV status underscores the need for increased adherence to screening guidelines. STIs diagnosed during pregnancy in PWH were not associated with risk of PTB.

Trichomonas vaginalis and Spontaneous Preterm Birth in a High-Risk Obstetric Cohort in Atlanta, GA.

BACKGROUND: Trichomonas vaginalis (TV) is the most prevalent nonviral sexually transmitted infection globally, but routine screening is not recommended in HIV-negative individuals. There is a significant racial/ethnic health disparity in TV infection rates. Evidence regarding the association between TV and adverse perinatal outcomes is conflicting, but a recent large meta-analysis found a modest increased risk of preterm birth with TV infection (odds ratio, 1.27; 95% confidence interval, 1.08-1.50). The current study was undertaken to evaluate whether TV infection increases the risk of spontaneous preterm birth (sPTB) in a high-risk obstetric cohort in Atlanta, GA. METHODS: We conducted a retrospective cohort study of women delivering at a safety-net hospital in Atlanta between July 2016 and June 2018. Women delivering a singleton live fetus at >20 weeks' gestation were included. The diagnosis of TV was by nucleic acid amplification testing. The outcome of interest was sPTB before 37 weeks' gestation. Multivariable Cox proportional hazards modeling was used to estimate the effect of TV on sPTB, controlling for confounding variables, including clinical and demographic characteristics. Several sensitivity analyses were undertaken. RESULTS: There were 3723 deliveries during the study period, and approximately half (46%) were screened for TV with nucleic acid amplification testing. After exclusions, the analytic cohort included 1629 women. Median age was 26 years (interquartile range, 22-31 years), and 70% of participants were listed as non-Hispanic Black in the electronic medical record. The prevalence of TV was 16% (n = 257). The sPTB rate was 7% (n = 112). In multivariable Cox proportional hazards modeling, TV infection was not associated with a statistically significantly increased risk of sPTB (hazard ratio, 1.34; 95% confidence interval, 0.84-2.13; P = 0.22). Factors associated with sPTB included history of PTB, adequate plus or transfer of prenatal care (vs. adequate/intermediate prenatal care utilization using the Kotelchuck index), recreational substance use, and Chlamydia trachomatis diagnosed during the current pregnancy. Results were not substantively different in sensitivity analyses. CONCLUSIONS: The prevalence of TV was high in this cohort. Its infection was not associated with a statistically significantly increased risk of sPTB. Nevertheless, the magnitude of effect is consistent with prior meta-analyses.

Interest in and Uptake of Postabortion Long-Acting Reversible Contraception After Counseling at a Free-Standing Abortion Care Ambulatory Surgery Center, Atlanta, Georgia, 2017‒2018.

We sought to determine the impact of brief previsit counseling on long-acting reversible contraception (LARC) interest and uptake immediately after abortion. We conducted a randomized controlled trial at a free-standing abortion care ambulatory surgery center in metro-Atlanta, Georgia (2017-2018). Among 1270 women, a brief previsit counseling intervention increased interest in LARC by 4.5 percentage points, and interest in LARC after the intervention increased uptake by 9.6 percentage points. Providing brief previsit counseling significantly increased postabortion LARC uptake. (Am J Public Health. 2022;112(9):1257-1260. https://doi.org/10.2105/AJPH.2022.306940).

Baby's First Macrophage: Temporal Regulation of Hofbauer Cell Phenotype Influences Ligand-Mediated Innate Immune Responses across Gestation.

The importance of fetal placental macrophages (Hofbauer cell [HCs]) is underscored by their appearance 18 d postconception and maintenance through term; however, how human HCs evolve during healthy pregnancy and how microenvironment and ontogeny impact phenotype and function remain unknown. In this study, we comprehensively classify human HCs ex vivo, interrogate phenotypic plasticity, and characterize antiviral immune responses through gestation. Activated HCs were abundant in early pregnancy and decreased by term; molecular signatures emphasize inflammatory phenotypes early in gestation. Frequency of HCs with regulatory phenotypes remained high through term. Furthermore, term HCs exhibited blunted responses to stimulation, indicating reduced plasticity. IFN-λ1 is a key placental IFN that appeared less protective than IFN-α, suggesting a potential weakness in antiviral immunity. Ligand-specific responses were temporally regulated: we noted an absence of inflammatory mediators and reduced antiviral gene transcription following RIG-I activation at term despite all HCs producing inflammatory mediators following IFN-γ plus LPS stimulation. Collectively, we demonstrate sequential, evolving immunity as part of the natural history of HCs through gestation.

Evaluating the impact of three progestin-based hormonal contraceptive methods on immunologic changes in the female genital tract and systemically (CHIME Study): a prospective cohort study protocol.

BACKGROUND: Gonadal hormones can modify immune function, which may impact susceptibility to infectious diseases, including Human Immunodeficiency Virus (HIV). There is limited knowledge about how hormonal contraceptives (HC) influence the immune response during the course of use. The CHIME study aims to evaluate the effect of long-acting progestin-based hormonal contraceptives (depot medroxyprogesterone acetate, etonogestrel implant, and levonorgestrel intrauterine device) on immunologic changes in the female genital tract (FGT) and systemic compartment. METHODS: CHIME is an observational cohort study where participants attend 2 visits prior to initiating the HC method of their choice, and then attend 6 visits over 12 months with biological sampling (vaginal swabs, cervicovaginal lavage, cytobrush and blood) for immunological, bacteriological, and virological analyses at each visit. Immune profiling will be evaluated by multi-color flow cytometry to determine how different T-cell subsets, in particular the CD4 T-cell subsets, change during the course of contraceptive use and whether they have different profiles in the FGT compared to the systemic compartment. The study aims are (1) to characterize the alterations in FGT and systemic immune profiles associated with three long-acting progestin-only HC and (2) to evaluate the vaginal microenvironment, determined by 16 s rRNA sequencing, as an individual-level risk factor and moderator of genital and systemic immune profile changes following exposure to three commonly used HC. Data collection started in March 2019 and is scheduled to be completed in October 2024. DISCUSSION: The CHIME study aims to contribute to the body of research designed to evaluate the comparative impact of three long-acting progestin-only HC on innate and adaptive immune functions to understand how immunologic effects alter STI and HIV susceptibility.

Genital Abnormalities, Hormonal Contraception, and Human Immunodeficiency Virus Transmission Risk in Rwandan Serodifferent Couples.

BACKGROUND: We explored the role of genital abnormalities and hormonal contraception in human immunodeficiency virus (HIV) transmission among heterosexual serodifferent couples in Rwanda. METHODS: From 2002 to 2011, HIV-serodifferent couples who were not using antiretroviral treatment were followed up, and sociodemographic and clinical data were collected, family planning provided, and HIV-negative partners retested. Couples were assessed for genital ulcers; nonulcerative genital sexually transmitted infection (STIs), including gonorrhea, chlamydia, and trichomoniasis; and non-STI vaginal infections, including bacterial vaginosis and candida. Multivariable models evaluated associations between covariates and HIV transmission genetically linked to the index partner. RESULTS: Among 877 couples in which the man was HIV positive, 37 linked transmissions occurred. Factors associated with women's HIV acquisition included genital ulceration in the female partner (adjusted hazard ratio, 14.1) and nonulcerative STI in the male partner (8.6). Among 955 couples in which the woman was HIV positive, 46 linked transmissions occurred. Factors associated with HIV acquisition in men included nonulcerative STI in the female partner (adjusted hazard ratio, 4.4), non-STI vaginal dysbiosis (7.1), and genital ulceration in the male partner (2.6). Hormonal contraception use was not associated with HIV transmission or acquisition. CONCLUSIONS: Our findings underscore the need for integrating HIV services with care for genital abnormalities. Barriers (eg, cost of training, demand creation, advocacy, and client education; provider time; and clinic space) to joint HIV/STI testing need to be considered and addressed.

Association of Delayed Treatment of Chlamydial Infection and Gonorrhea in Pregnancy and Preterm Birth.

BACKGROUND: Treating chlamydia and gonorrhea in pregnancy has been shown to decrease the associated risk of preterm birth in some studies. Delayed treatment of these infections among nonpregnant patients carries known consequences. It is unclear whether delayed treatment in pregnancy similarly increases adverse outcomes. METHODS: We conducted a retrospective cohort study of women who delivered at a safety-net hospital from July 2016 to June 2018. Women with at least one visit who were tested for chlamydia and gonorrhea were included. Women diagnosed after 36 weeks (preterm analysis) or 31 weeks (early preterm analysis) were excluded. We used multivariable logistic regression to examine the association between no infection, timely treatment (<1 week), and delayed treatment (>1 week, not treated) with preterm (<37 weeks) and early preterm (<32 weeks) birth. RESULTS: Among 3154 deliveries, 389 (12%) were preterm. Among 3107 deliveries, 74 (2%) were early preterm. In adjusted models, women with timely (adjusted odds ratio [aOR]; 1.7, 95% confidence interval [CI], 1.0-2.7) and delayed (aOR, 1.7; 95% CI, 1.1-2.5) treatments had increased odds of preterm birth. Similarly, women with timely (aOR, 2.5; 95% CI, 1.0-6.2) and delayed (aOR, 2.4; 95% CI, 1.2-4.9) treatments had increased odds of early preterm birth. Among women who tested positive, multiple infections were not associated with an increase in preterm birth (preterm: 17% vs. 20%, P = 0.53; early preterm: 5% vs. 6%, P = 0.74). CONCLUSIONS: Chlamydia and gonorrhea are associated with preterm and early preterm births, regardless of time to treatment. Creative solutions are needed to improve the prevention of these infections in pregnancy.

Pre-exposure Prophylaxis Implementation in Family Planning Services Across the Southern United States: Findings from a Survey Among Staff, Providers and Administrators Working in Title X-Funded Clinics.

To improve women's access to pre-exposure prophylaxis (PrEP) in family planning (FP) clinics, we examined readiness to provide PrEP, and barriers and facilitators at the clinic level to integrate PrEP services into Title X-funded FP clinics across the Southern US. Title X-funded FP clinics across DHHS regions III (Mid-Atlantic), IV (Southeast), and VI (Southwest), comprising the Southern US. From February to June, 2018, we conducted a web-based, geographically targeted survey of medical staff, providers and administrators of Title X-funded FP clinics in DHHS regions III (Mid-Atlantic), IV (Southeast), and VI (Southwest). Survey items were developed using the Consolidated Framework for Implementation Research to assess constructs relevant to PrEP implementation. One-fifth of 283 unique Title X clinics across the South provided PrEP. Readiness for PrEP implementation was positively associated with a climate supportive of HIV prevention, leadership engagement, and availability of resources, and negatively associated with providers holding negative attitudes about PrEP's suitability for FP. The Title X FP network is a vital source of sexual health care for millions of individuals across the US. Clinic-level barriers to providing PrEP must be addressed to expand onsite PrEP delivery in Title X FP clinics in the Southern US.

Contraceptive Technologies: Looking Ahead to New Approaches to Increase Options for Family Planning.

With persistently high global rates of unintended pregnancy and contraceptive nonuse, nonadherence and discontinuation, new contraceptive methods must address the needs of women and men who seek alternatives to their current options. Methods under development aim to reduce potential side effects, improve access and ease of use, ensure safety, increase secondary benefits associated with method use and expand options for both women and men. Developmental approaches employed to enhance current methods utilize new delivery systems and novel active pharmaceutical ingredients. This will improve overall user satisfaction with the methods used while expanding the number of options available to provide choice and value user autonomy in the highly diverse contraceptive markets around the world.

Health Literacy and Associated Outcomes in the Postpartum Period at Grady Memorial Hospital.

OBJECTIVES: Many studies correlate lower health literacy with poorer health outcomes and inferior provider-patient communication. Little is known about how impaired health literacy among women receiving prenatal care at inner city public hospitals may impact reproductive health behaviors and outcomes. The objective of this study was to assess health literacy among postpartum women receiving care at a public tertiary care center and to explore the association of impaired health literacy with prenatal care attendance and postpartum outcomes. METHODS: Written consent was obtained before completing the 7-item REALM-SF study tool to assess health literacy. A score of zero to three indicated low health literacy, four to six moderately low health literacy, and seven adequate health literacy. Patients completed a 25-item demographic questionnaire, and medical outcomes were obtained via this questionnaire and chart review. Descriptive statistics were generated, and bivariate and multivariate analyses evaluated the association between REALM-SF score and study outcomes. RESULTS: We recruited 300 adult English-speaking postpartum women and 293 were included in the final analysis. The majority of participants (53.9%) experienced impaired health literacy (score zero to six). Most respondents completed high school or higher education (77.1%), 17.8% had no prenatal care, and 83.6% reported that this pregnancy was unplanned. After adjusting for age, race, and education, women in the lowest health literacy group were less likely to indicate a plan to exclusively breastfeed (aRR = 0.54, p = 0.03). CONCLUSIONS FOR PRACTICE: Impaired health literacy affects a majority of our patients and is associated with reproductive health outcomes, including exclusive breastfeeding. Health care providers should attempt to overcome differences in health literacy through strong breastfeeding promotion. Verbal and written patient education materials should be tailored to the needs of patients with impaired health literacy.

Chronic Stress and Preconception Health Among Latina Women in Metro Atlanta.

BACKGROUND: Underserved subgroups are less likely to have optimal health prior to pregnancy. We describe preconception health indicators (behavior, pregnancy intention, and obesity) among pregnant Latina women with and without chronic stress in metro Atlanta. DESIGN: We surveyed 110 pregnant Latina women enrolled in prenatal care at three clinics in Atlanta. The survey assessed chronic stress, pregnancy intention, preconception behavior changes (taking folic acid or prenatal vitamins, seeking healthcare advice, any reduction in smoking or drinking), and previous trauma. RESULTS: Specific behaviors to improve health prior to pregnancy were uncommon (e.g., taking vitamins (25.5%) or improving nutrition (20.9%)). Just under half of women were experiencing a chronic stressor at the time of conception (49.5%). Chronically stressed women were more likely to be obese (aOR: 3.0 (1.2, 7.4)), less likely to intend their pregnancy (aOR: 0.3 (0.1, 0.7)), and possibly less likely to report any PHB (45.5% vs. 57.4%; aOR: 0.5 (0.2-1.1)). CONCLUSIONS: Chronically stress women were less likely to enter prenatal care with optimal health. However, preconception behaviors were uncommon overall.

Interleukin-36γ Is Elevated in Cervicovaginal Epithelial Cells in Women With Bacterial Vaginosis and In Vitro After Infection With Microbes Associated With Bacterial Vaginosis.

In recent studies, the interleukin (IL)-36 cytokines were shown to be elevated in women with non-Lactobacillus-dominated vaginal microbiomes. In this study, we evaluated IL36G expression in clinical samples from women with and without bacterial vaginosis (BV) and a human 3-dimensional cervical epithelial cell model. IL36G expression was significantly elevated in cervicovaginal epithelial cells isolated from BV-positive women and corresponded with increased neutrophil counts relative to BV-negative women. In addition, specific BV-associated bacterial species as well as a polymicrobial cocktail significantly induced IL36G expression in vitro. These findings suggest that IL-36γ may exhibit an important function in the host response to BV and other sexually transmitted infections.

Gabapentin as an adjunct to paracervical block for perioperative pain management for first-trimester uterine aspiration: a randomized controlled trial.

BACKGROUND: Pain management approaches during uterine aspiration vary, which include local anesthetic, oral analgesics, moderate sedation, deep sedation, or a combination of approaches. For local anesthetic approaches specifically, we continue to have suboptimal pain control. Gabapentin as an adjunct to pain management has proven to be beneficial in gynecologic surgery. We sought to evaluate the impact of gabapentin on perioperative pain during surgical management of first-trimester abortion or early pregnancy loss with uterine aspiration under local anesthesia. OBJECTIVE: We hypothesized that adding gabapentin to local anesthesia will reduce perioperative and postoperative pain associated with uterine aspiration. Secondary outcomes included tolerability of gabapentin and postoperative pain, nausea, vomiting, and anxiety. STUDY DESIGN: We conducted a randomized double-blinded placebo-controlled trial of gabapentin 600 mg given 1 to 2 hours preoperatively among subjects receiving a first-trimester uterine aspiration under paracervical block in an outpatient ambulatory surgery center. There were 111 subjects randomized. The primary outcome was pain at time of uterine aspiration as measured on a 100-mm visual analog scale. Secondary outcomes included pain at other perioperative time points. To assess changes in pain measures, an intention to treat mixed effects model was fit with treatment groups (gabapentin vs control) as a between-subjects factor and time point as a within-subjects factor plus their interaction term. Because of a non-normal distribution of pain scores, the area under the curve was calculated for secondary outcomes with comparison of groups utilizing Mann-Whitney U tests. RESULTS: Among the 111 randomized, most subjects were Black or African American (69.4%), mean age was 26 years (±5.5), and mean gestational age was 61.3 days (standard deviation, 14.10). Mean pain scores at time of uterine aspiration were 66.77 (gabapentin) vs 71.06 (placebo), with a mean difference of -3.38 (P=.51). There were no significant changes in pain score preoperatively or intraoperatively. Subjects who received gabapentin had significantly lower levels of pain at 10 minutes after surgery (mean difference [standard error (SE)]=-13.0 [-5.0]; P=.01) and 30 minutes after surgery (mean difference [SE]=-10.8 [-5.1]; P=.03) compared with subjects who received placebo. Median nausea scores and incidence of emesis pre- and postoperatively did not differ between groups. Similarly, anxiety scores did not differ between groups, before or after the procedure. At 10 and 30 minutes after the procedure, most participants reported no side effects or mild side effects, and this did not differ between groups. CONCLUSION: Preoperative gabapentin did not reduce pain during uterine aspiration. However, it did reduce postoperative pain, which may prove to be a desired attribute of its use, particularly in cases where postoperative pain may be a greater challenge.

Fertility intentions and long-acting reversible contraceptive use among HIV-negative single mothers in Zambia.

BACKGROUND: Integrating family planning interventions with HIV studies in developing countries has been shown to prevent mother-to-child HIV transmission and simultaneously reduce HIV and unintended pregnancy in high-risk populations. As part of a prospective cohort study on HIV incidence and risk factors in Zambian women having unprotected sex, we also offered family planning counseling and immediate access to long-acting reversible contraceptives. Although long-acting reversible contraceptives are the most effective form of contraception, many Zambian women are limited to oral or injectable methods because of a lack of knowledge or method availability. This project offers to single mothers who are enrolled in a cohort study information about and access to long-acting reversible contraceptives at enrollment and at each follow-up visit. OBJECTIVE: This study evaluates how fertility intentions affect long-acting reversible contraceptive use in HIV-negative single mothers in Zambia. Our primary outcome was long-acting reversible contraceptive use throughout the study participation. We also estimated rates of long-acting reversible contraceptive uptake and discontinuation. We specifically studied single mothers because they are at high risk for unintended pregnancy, which can have significant negative ramifications on their financial, social, and psychologic circumstances. STUDY DESIGN: From 2012-2017, Zambia Emory HIV Research Project recruited 521 HIV-negative single mothers ages 18-45 years from government clinics in Lusaka and Ndola, Zambia's 2 largest cities. Participants were followed every 3 months for up to 5 years. At each visit, we discussed fertility goals and contraceptive options and offered a long-acting reversible method to any woman who was not pregnant or who already was using a long-acting reversible or permanent contraceptive method. Data were collected on demographic factors, sexual behavior, and reproductive history. Multivariable logistic regression was used to model baseline fertility intentions with long-acting reversible contraceptive use. RESULTS: We enrolled 518 women; 57 women did not return for any follow-up visits. There was a significant increase in long-acting reversible contraceptive use during the study. At baseline, 93 of 518 women (18%) were using a long-acting reversible method, and 151 of 461 women (33%) used a long-acting reversible method at the end of follow-up period (P<.0001). Four women chose an intrauterine device, and 91 women chose an implant for their first uptake event. After we adjusted the data for other confounders, we found that women in Ndola who did not desire any more children were more likely to use a long-acting reversible contraceptive (adjusted prevalence ratio, 2.02; 95% confidence interval, 1.88-3.42). During follow up, 37 of 183 long-acting reversible contraceptive users (20%) discontinued their method; women who desired future children at baseline were more likely to discontinue earlier (P=.016). CONCLUSION: This study demonstrates that integrated family planning services can increase long-acting reversible contraceptive use successfully among Zambian single mothers, who are a vulnerable population that disproportionately is affected by unintended pregnancy. A steady increase in use over time confirms the importance of repeated messaging about these unfamiliar methods. Thus, it is imperative that family planning interventions target single mothers in developing countries to promote effective contraceptive use.

A couple-focused, integrated unplanned pregnancy and HIV prevention program in urban and rural Zambia.

BACKGROUND: Zambia's total fertility rate (5 births per woman) and adult HIV prevalence (11.5%) are among the highest in the world, with heterosexual couples being the most affected group. Jointly counseling and testing couples for HIV has reduced up to 58% of new HIV infections in Zambian clinics. Married women using contraceptives in Zambia have a high (20%) unmet need for family planning and low (8.6%) uptake of cost-effective long-acting reversible contraceptives. We present an integrated counseling, testing, and family-planning program to prevent HIV and unplanned pregnancy in Zambia. OBJECTIVE: The objective of this study was to integrate effective HIV prevention and family-planning services for Zambian couples. STUDY DESIGN: A 3 year program (2013-2016) progressively integrated the promotion and provision of couples' voluntary HIV counseling and testing and long-acting reversible contraceptives. The program was based in 55 urban and 215 rural government clinics across 33 districts. In the first year, a couples' family-planning counseling training program was developed and combined with existing couples HIV counseling training materials. To avoid congestion during routine clinic hours, joint counseling services were initially provided on weekends, while nurses were trained in intrauterine device and hormonal implant insertion and removal during weekday family-planning services. Demand was created through mutual referral between weekend and weekday programs and by clinic staff, community health workers, and satisfied family-planning clients. When the bulk of integrated service training was completed, the program transitioned services to routine weekday clinic hours, ensuring access to same-day services. Performance indicators included number of staff trained, clients served, integrated service referrals, HIV infections averted, and unplanned pregnancies averted. RESULTS: A stepwise approach trained high-performing service providers to be trainers and used high-volume clinics for practicum training of the next generation. In total, 1201 (391 urban, 810 rural) counselors were trained and served 120,535 urban and 87,676 rural couples. In urban clinics, 236 nurses inserted 65,619 long-acting reversible contraceptives, while in rural clinics, 243 nurses inserted 35,703 implants and intrauterine devices. The program prevented an estimated 12,869 urban and 8279 rural adult HIV infections, and 98,626 unintended urban pregnancies. In the final year, the proportion of clients receiving joint counseling services on weekdays rose from 11% to 89%, with many referred from within clinics including HIV testing and treatment services (32%), outpatient department (31%), family planning (16%), and infant vaccination (15%). The largest group of clients requesting long-acting reversible contraceptives (45%) did so after joint fertility goal-based counseling, confirming the high impact of this couple-focused demand creation approach. Remaining family-planning clients responded to referrals from clinic nurses (34%), satisfied implant/intrauterine device users (13%), or community health workers (8%). CONCLUSION: Integrated HIV and unplanned pregnancy prevention can be implemented in low-resource public sector facilities. Combination services offered to couples mutually leverage HIV prevention and unplanned pregnancy prevention. The addition of long-acting reversible contraceptives is an important complement to the method mix available in government clinics. Demand creation in the clinic and in the community must be coordinated with a growing supply of well-trained providers.

Abortion Trends in Georgia Following Enactment of the 22-Week Gestational Age Limit, 2007-2017.

Objectives. To measure trends before, during, and after implementation of Georgia House Bill 954, a limit on abortion at 22 or more weeks of gestation passed in 2012, in total abortions and abortions by gestational age and state residence.Methods. We analyzed aggregate year-level induced termination of pregnancy data from the Georgia Department of Public Health from 2007 to 2017. We used linear regression to describe annual trends in the number of abortions and χ2 analyses to describe changes in proportions of abortions by gestational age (< 20 weeks, 20-21 weeks, and > 21 weeks) across policy implementation periods (before, partial, and full implementation) for Georgia residents and nonresidents.Results. Although the total number of abortions and abortions at 21 weeks or less remained stable from 2007 to 2017, the number of abortions at more than 21 weeks declined (P = .02). The decline in number of abortions at more than 21 weeks was steeper for nonresidents (31/year; Β = -31.3; P = .02) compared with Georgia residents (14/year; Β = -13.9; P = .06).Conclusions. Findings suggest that implementation of Georgia's 22-week gestational age limit has effectively limited access to needed abortion services in Georgia and beyond. (Am J Public Health. Published online ahead of print May 21, 2020: e1-e5. doi:10.2105/AJPH.2020.305653).