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PURPOSE OF REVIEW: While major complications in second-trimester abortion are rare, blood loss and hemorrhage are among the most common and have the potential for high morbidity. Here, we review the current literature on risk factors, prevention, and treatment of blood loss in second-trimester abortion. RECENT FINDINGS: A comprehensive approach to hemorrhage during second-trimester abortions is essential. Understanding hemorrhage risk factors, prevention strategies, and treatment options makes second-trimester abortion safer. Some pharmacologic methods may both prevent and treat excessive blood loss. Mechanical methods are primarily used for treatment. Key risk factors include prior uterine scars, gestational duration, insufficient cervical preparation, high BMI, procedural inexperience, fetal demise, and halogenated anesthetics. Developing evidence-based protocols for and further research into hemorrhage related complications are crucial for improving safety in second-trimester abortion care. SUMMARY: Prevention of hemorrhage improves outcomes. However data are limited. For treatment, this includes using pharmacological interventions and mechanical methods. Identifying high-risk patients and implementing preprocedural optimization are proactive measures that aid in decreasing the occurrence and severity of blood loss and hemorrhage.
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STUDY QUESTION: Does shared biological motherhood, in which a woman gives birth to the genetic child of her female partner, result in more positive mother-child relationships than donor insemination, in which only one mother is biologically related to the child? SUMMARY ANSWER: Mothers in both family types showed high levels of bonding with their children and viewed their relationship with their child positively. WHAT IS KNOWN ALREADY: There is some evidence of feelings of inequality regarding their relationship with their child between biological and non-biological mothers in lesbian mother families formed by donor insemination, with a qualitative longitudinal study showing a tendency for children to form stronger bonds with their biological than their non-biological mother. STUDY DESIGN, SIZE, DURATION: Thirty lesbian mother families created through shared biological motherhood were compared with 30 lesbian mother families formed by donor-IVF. All families had two mothers who both participated in the study, and the children were aged from infancy up to 8 years old. Data collection took place over 20 months beginning in December 2019. PARTICIPANTS/MATERIALS, SETTING, METHODS: Each mother in the family was interviewed separately using the Parent Development Interview (PDI), a reliable and valid measure of the nature of the parent's emotional bond with their child. The interviews were transcribed verbatim and coded separately by one of two trained researchers who were unaware of the child's family type. The interview produces 13 variables that relate to the parent's representations of themselves as a parent, 5 variables that relate to the parent's representations of the child, and a global variable that assesses the extent to which the parent can reflect on the child and their relationship. MAIN RESULTS AND THE ROLE OF CHANCE: Families formed through shared biological parenthood did not differ from families created by donor-IVF in terms of the quality of mothers' relationships with their children as assessed by the PDI. Neither were differences identified between birth mothers and non-birth mothers across the entire sample, or between gestational and genetic mothers within the families formed by shared biological parenthood. Multivariate analyses were conducted to minimize the role of chance. LIMITATIONS, REASONS FOR CAUTION: Ideally, larger samples of families and a narrower age range of children would have been studied, but this was not possible as we were reliant on the small number of families formed through shared biological motherhood in the UK when the study began. To maintain the anonymity of the families, it was not possible to request information from the clinic that may have shed light on differences between those who responded to the request to participate and those who did not. WIDER IMPLICATIONS OF THE FINDINGS: The findings show that shared biological motherhood is a positive option for lesbian couples who wish to have a more equal biological relationship to their children. One type of biological connection does not appear to have a greater influence on the quality of parent-child relationships than the other. STUDY FUNDING/COMPETING INTEREST(S): This study was funded by the Economic and Social Research Council (ESRC) grant ES/S001611/1. KA is Director, and NM is Medical Director, of the London Women's Clinic. The remaining authors have no conflicts of interest to declare. TRIAL REGISTRATION NUMBER: N/A.
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Homossexualidade Feminina , Minorias Sexuais e de Gênero , Humanos , Feminino , Mães/psicologia , Estudos Longitudinais , Pais/psicologia , Homossexualidade Feminina/psicologiaRESUMO
BACKGROUND: Postpartum use of long-acting reversible contraception has been found to be effective at increasing interpregnancy intervals, reducing unintended pregnancies, and optimizing health outcomes for mothers and babies. Among female active-duty military service members, reproductive planning may be particularly important, yet little is known about postpartum long-acting reversible contraceptive use among active-duty soldiers. OBJECTIVE: This study aimed to (1) quantify postpartum uptake of long-acting reversible contraception among active-duty female US Army soldiers and (2) identify demographic and military-specific characteristics associated with use. STUDY DESIGN: This retrospective cohort study used longitudinal data of all digitally recorded health encounters for active-duty US Army soldiers from 2014 to 2017. The servicewomen included in our analysis were aged 18 to 44 years with at least one delivery and a minimum of 4 months of total observed time postdelivery within the study period. We defined postpartum long-acting reversible contraception use as initiation of use within the delivery month or in the 3 calendar months following delivery and identified likely immediate postpartum initiation via the proxy of placement recorded during the same month as delivery. We then evaluated predictors of postpartum long-acting reversible contraception use with multivariable logistic regression. RESULTS: The inclusion criteria were met by 15,843 soldiers. Of those, 3162 (19.96%) initiated the use of long-acting reversible contraception in the month of or within the 3 months following delivery. Fewer than 5% of these women used immediate postpartum long-acting reversible contraception. Among women who initiated postpartum long-acting reversible contraceptive use, 1803 (57.0%) received an intrauterine device, 1328 (42.0%) received an etonogestrel implant, and 31 received both (0.98%). Soldiers of younger age, self-reported White race, and those who were married or previously married were more likely to initiate long-acting reversible contraception in the postpartum period. Race-stratified analyses showed that self-reported White women had the highest use rates overall. When compared with these women, the adjusted odds of postpartum use among self-reported Black and Asian or Pacific Islander women were 18% and 30% lower, respectively (both P<.001). There was also a trend of decreasing postpartum use with increasing age within each race group. Differences observed between age groups and race identities could partially be attributed to differential use of permanent contraception (sterilization), which was found to be significantly more prevalent among both women aged 30 years or older and among women who identified as Black. CONCLUSION: Among active-duty US Army servicewomen, 1 in 5 used postpartum long-acting reversible contraception, and fewer than 5% of these women used an immediate postpartum method. Within this population with universal healthcare coverage, we observed relatively low rates of use and significant differences in the uptake of effective postpartum long-acting contraceptive methods across self-reported race categories.
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BACKGROUND: Initiating a progestin-based contraceptive before the drop in progesterone required to start lactogenesis stage II could theoretically affect lactation. Previous studies have shown that initiating progestin-based contraception in the postnatal period before birth-hospitalization discharge has no detrimental effects on breastfeeding initiation or continuation compared with outpatient interval initiation. However, there are currently no breastfeeding data on the impact of initiating the etonogestrel contraceptive implant in the early postnatal period immediately in the delivery room. OBJECTIVE: This study examined the effect of delivery room vs delayed birth-hospitalization contraceptive etonogestrel implant insertion on breastfeeding outcomes. STUDY DESIGN: This was a noninferiority randomized controlled trial to determine if time to lactogenesis stage II (initiation of copious milk secretion) differs by timing of etonogestrel implant insertion during the birth-hospitalization. We randomly assigned pregnant people to insertion at 0 to 2 hours (delivery room) vs 24 to 48 hours (delayed) postdelivery. Participants intended to breastfeed, desired a contraceptive implant for postpartum contraception, were fluent in English or Spanish, and had no allergy or contraindication to the etonogestrel implant. We collected demographic information and breastfeeding intentions at enrollment. Onset of lactogenesis stage II was assessed daily using a validated tool. The noninferiority margin for the mean difference in time to lactogenesis stage II was defined as 12 hours in a per-protocol analysis. Additional electronic surveys collected data on breastfeeding and contraceptive continuation at 2 and 4 weeks, and 3, 6, and 12 months. RESULTS: We enrolled and randomized 95 participants; 77 participants were included in the modified intention-to-treat analysis (n=38 in the delivery room group and n=39 in the delayed group) after excluding 18 because of withdrawing consent, changing contraceptive or breastfeeding plans, or failing to provide primary outcome data. A total of 69 participants were included in the as-treated analysis (n=35 delivery room, n=34 delayed); 8 participants who received the etonogestrel implant outside the protocol windows were excluded, and 2 participants from the delivery room group received the etonogestrel implant at 24 to 48 hours and were analyzed with the delayed group. Participants were similar between groups in age, gestational age, and previous breastfeeding experience. Delivery room insertion was noninferior to delayed birth-hospitalization insertion in time to lactogenesis stage II (delivery room [mean±standard deviation], 65±25 hours; delayed, 73±61 hours; mean difference, -9 hours; 95% confidence interval, -27 to 10). Onset of lactogenesis stage II by postpartum day 3 was not significantly different between the groups. Lactation failure occurred in 5.5% (n=2) participants in the delayed group. Ongoing breastfeeding rates did not differ between the groups, with decreasing rates of any/exclusive breastfeeding over the first postpartum year. Most people continued to use the implant at 12 months, which did not differ by group. CONCLUSION: Delivery room insertion of the contraceptive etonogestrel implant does not delay the onset of lactogenesis when compared with initiation later in the birth-hospitalization and therefore should be offered routinely as part of person-centered postpartum contraceptive counseling, regardless of breastfeeding intentions.
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Aleitamento Materno , Anticoncepcionais Femininos , Gravidez , Feminino , Humanos , Progestinas , Período Pós-Parto , Anticoncepcionais Femininos/uso terapêutico , HospitalizaçãoRESUMO
PURPOSE OF REVIEW: To review the evidence-informed options for cervical preparation prior to second-trimester dilation and evacuation (D&E). RECENT FINDINGS: As abortion restrictions increase and the number of abortion clinics and providers decreases, pregnant people are facing more barriers to abortion access. Those in need are now often required to travel for second-trimester abortion care, only to be faced with additional restrictions, such as mandatory waiting periods. Cervical preparation is recommended prior to D&E and takes time for effect. Given the increasing time required to obtain an abortion, patients and providers may prefer same-day cervical preparation to decrease the total time required. Options for same-day cervical preparation include misoprostol alone with single or serial doses, and misoprostol combined with osmotic dilators or transcervical balloon (Foley catheter). Same-day preparation may require additional clinical space to accommodate people after initiation of cervical preparation to manage side-effects and timing of the abortion. Overnight options are also used and more frequently later in the second trimester. Overnight options include mifepristone, osmotic dilators, and transcervical balloon and are often combined with same-day misoprostol. Medication alone preparation is well tolerated and effective in the second trimester, with the addition of mechanical methods with advancing gestation. With many options and combinations being safe and effective, providers can be dynamic and alter approach with supply shortages, adjust to different clinical settings, consider patient medical and surgical factors, and accommodate provider and patient preferences. SUMMARY: Multiple pharmacologic and mechanical options have been shown to be safe and effective for cervical preparation prior to D&E. Consideration for multiple factors should influence the method of cervical preparation and methods may vary by patient, provider and setting.
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Abortivos não Esteroides , Aborto Induzido , Misoprostol , Gravidez , Feminino , Humanos , Segundo Trimestre da Gravidez , Abortivos não Esteroides/uso terapêutico , MifepristonaRESUMO
Although most abortion care takes place in the office setting, anesthesiologists are often asked to provide anesthesia for the 1% of abortions that take place later, in the second trimester. Changes in federal and state regulations surrounding abortion services may result in an increase in second-trimester abortions due to barriers to accessing care. The need for interstate travel will reduce access and delay care for everyone, given limited appointment capacity in states that continue to support bodily autonomy. Therefore, anesthesiologists may be increasingly involved in care for these patients. There are multiple, unique anesthetic considerations to provide safe and compassionate care to patients undergoing second-trimester abortion. First, a multiday cervical preparation involving cervical osmotic dilators and pharmacologic agents results in a time-sensitive, nonelective procedure, which should not be delayed or canceled due to risk of fetal expulsion in the preoperative area. In addition, a growing body of literature suggests that the older anesthesia dogma that all pregnant patients require rapid-sequence induction and an endotracheal tube can be abandoned, and that deep sedation without intubation is safe and often preferable for this patient population through 24 weeks of gestation. Finally, concomitant substance use disorders, preoperative pain from cervical preparation, and intraoperative management of uterine atony in a uterus that does not yet have mature oxytocin receptors require additional consideration.
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Aborto Induzido , Anestésicos , Gravidez , Feminino , Humanos , Segundo Trimestre da Gravidez , Aborto Induzido/métodosRESUMO
OBJECTIVE: The objective of the study was to examine child deaths in motor vehicle crashes by rurality, restraint use, and state child passenger restraint laws. STUDY DESIGN: 2015-2019 Fatality Analysis Reporting System data were analyzed to determine deaths and rates by passenger and crash characteristics. Optimal restraint use was defined using age and the type of the restraint according to child passenger safety recommendations. RESULTS: Death rates per 100â000 population were highest for non-Hispanic Black (1.96; [1.84, 2.07]) and American Indian or Alaska Native children (2.67; [2.14, 3.20]) and lowest for Asian or Pacific Islander children (0.57; [0.47, 0.67]). Death rates increased with rurality with the lowest rate (0.88; [0.84, 0.92]) in the most urban counties and the highest rate (4.47; [3.88, 5.06]) in the most rural counties. Children who were not optimally restrained had higher deaths rates than optimally restrained children (0.84; [0.81, 0.87] vs 0.44; [0.42, 0.46], respectively). The death rate was higher in counties where states only required child passenger restraint use for passengers aged ≤6 years (1.64; [1.50, 1.78]) than that in those requiring child passenger restraint use for passengers aged ≤7 or ≤8 years (1.06; [1.01, 1.12]). CONCLUSIONS: Proper restraint use and extending the ages covered by child passenger restraint laws reduce the risk for child crash deaths. Additionally, racial and geographic disparities in crash deaths were identified, especially among Black and Hispanic children in rural areas. Decision makers can consider extending the ages covered by child passenger restraint laws until at least age 9 to increase proper child restraint use and reduce crash injuries and deaths.
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Acidentes de Trânsito , População Rural , Humanos , Criança , Estados Unidos/epidemiologia , Lactente , Grupos Raciais , Família , Veículos AutomotoresRESUMO
BACKGROUND: Clinical guidelines support inpatient postpartum intrauterine device insertion. However, inpatient placement remains infrequent, in part because of inconsistent private insurance reimbursement. OBJECTIVE: The purpose of this study was to explore how the payer's costs and number of unintended pregnancies associated with a postpartum intrauterine device differed on the basis of placement timing. STUDY DESIGN: Using a decision tree model and following a hypothetical cohort of people who intend to use an intrauterine device after their delivery, we conducted a cost analysis comparing the planned approach of inpatient vs outpatient postpartum insertion. Using a 2-year time horizon, the probability and cost estimates were derived from literature review. Our primary outcome was the total accrued costs to the payer. Secondarily, we examined the rates of early repeat pregnancy and sensitivity to estimates of key inputs, including the expulsion rates and the intrauterine device cost. RESULTS: Although an inpatient intrauterine device placement's upfront costs were higher, the total cost of this approach was lower. Including the costs of managing expulsions and complications, our model suggests that for every 1000 people desiring a postpartum intrauterine device, the intended inpatient intrauterine device placement resulted in total cost savings of $211,100 and the prevention of 37 additional pregnancies compared with outpatient placement. The inpatient cost savings were superior to the outpatient savings, largely because of a known high proportion not returning for outpatient placement and the resulting higher number of unintended pregnancies among the patients desiring outpatient placement. In sensitivity analyses, we found that the total cost to the payer was sensitive to the probability of expulsion after immediate postpartum intrauterine device placement. CONCLUSION: For beneficiaries desiring postpartum intrauterine device, payers are likely to save money by fully reimbursing inpatient intrauterine device placement rather than incentivizing placement at the frequently missed postpartum visit. These results support the financial case for private insurers to fully and separately reimburse (ie, "unbundle" from the single payment for delivery) inpatient postpartum intrauterine device placement.
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Dispositivos Intrauterinos , Estudos de Coortes , Feminino , Humanos , Expulsão de Dispositivo Intrauterino , Período Pós-Parto , Gravidez , Gravidez não PlanejadaRESUMO
OBJECTIVE: The aim of this study was to quantify the likelihood of assessing all mandated fetal views during the second-trimester anatomy ultrasound prior to the proposed federal 20-week abortion ban. STUDY DESIGN: Retrospective cohort study of a random sample of 1,983 patients undergoing anatomy ultrasound in 2017 at a tertiary referral center. The difference in proportion of incomplete anatomic surveys prior compared with after 20-week gestation was analyzed using X 2 and adjusted logistic regression; difference in mean days elapsed from anomaly diagnosis to termination tested using t-tests and survival analysis. RESULTS: Incomplete views were more likely with initial ultrasound before 20 weeks (adjusted relative risk: 1.70; 95% confidence interval: 1.50-1.94); 43.5% versus 26.1% were incomplete before and after 20 weeks, respectively. Fetal structural anomalies were identified in 6.4% (n = 127/1,983) scans, with 38.0% (n = 49) identified at follow-up after initial scan was incomplete. 22.8% (n = 29) with an anomaly terminated. CONCLUSIONS: A complete assessment of fetal views during an anatomy ultrasound prior to 20-week gestation is often not technically feasible. Legislation limiting abortion to this gestational age would greatly impact patient's ability to make informed choices about their pregnancies. KEY POINTS: · It is often not technically possible to complete anatomy ultrasound prior to 20-week gestation.. · Often, anomalies are missed during early, incomplete anatomy ultrasounds.. · After the diagnosis of a structural anomaly, one in five chose to terminate the pregnancy..
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BACKGROUND: Cancer care coordination across major academic medical centers and their networks is evolving rapidly, but the spectrum of organizational efforts has not been described. We conducted a mixed-methods survey of leading cancer centers and their networks to document care coordination and identify opportunities to improve geographically dispersed care. METHODS: A mixed-methods survey was sent to 91 cancer centers in the United States and Canada. We analyzed the number and locations of network sites; access to electronic medical records (EMRs); clinical research support and participation at networks; use of patient navigators, care paths, and quality measures; and physician workforce. Responses were collected via Qualtrics software between September 2017 and December 2018. RESULTS: Of the 69 responding cancer centers, 74% were NCI-designated. Eighty-seven percent of respondents were part of a matrix health system, and 13% were freestanding. Fifty-six reported having network sites. Forty-three respondents use navigators for disease-specific populations, and 24 use them for all patients. Thirty-five respondents use ≥1 types of care path. Fifty-seven percent of networks had complete, integrated access to their main center's EMRs. Thirty-nine respondents said the main center provides funding for clinical research at networks, with 22 reporting the main center provides all funding. Thirty-five said the main center provided pharmacy support at the networks, with 15 indicating the main center provides 100% pharmacy support. Certification program participation varied extensively across networks. CONCLUSIONS: The data show academic cancer centers have extensive involvement in network cancer care, often extending into rural communities. Coordinating care through improved clinical trial access and greater use of patient navigation, care paths, coordinated EMRs, and quality measures is likely to improve patient outcomes. Although it is premature to draw firm conclusions, the survey results are appropriate for mapping next steps and data queries.
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Neoplasias , Navegação de Pacientes , Médicos , Certificação , Registros Eletrônicos de Saúde , Humanos , Neoplasias/epidemiologia , Neoplasias/terapia , Inquéritos e Questionários , Estados UnidosRESUMO
PURPOSE OF REVIEW: To review the current literature focusing on pain management and experiences during abortion care. RECENT FINDINGS: Analgesic options in abortion care address pain associated with the procedure, osmotic dilator insertion, and cervical preparation. The paracervical block (PCB) is effective for pain control in first and second trimester abortions. Lower volume PCBs demonstrate non inferiority with osmotic dilator placement compared with higher volume PCBs with lower potential for toxicity. Self-administered vaginal lidocaine gel is noninferior to PCB in first trimester abortions. Preoperative oral narcotics and sedation do not reduce pain in first trimester abortions; however, the latter may reduce anxiety. For second trimester abortions, narcotics or gabapentin do not improve postoperative pain, yet up to half of patients will use narcotics if offered. Nonpharmacological methods have shown success in pain management. Music and doula support do not improve pain; however, patients would recommend these modalities, indicating some benefit that went unmeasured. Auricular acupuncture and transcutaneous electrical nerve stimulation (TENS) reduce pain and anxiety during first trimester abortions. SUMMARY: Several modalities reduce pain during abortion care; however, pain alone does not reflect patient satisfaction. Development of multidimensional measures for pain control assessment has the potential to capture the patient's overall experience.
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Aborto Induzido , Manejo da Dor , Aborto Induzido/efeitos adversos , Feminino , Humanos , Lidocaína , Pacientes Ambulatoriais , Dor Pós-Operatória/tratamento farmacológico , Gravidez , Primeiro Trimestre da GravidezRESUMO
Access to first trimester abortions has increased significantly in the past few decades in low and middle-income countries. Manual vacuum aspiration is now standard of care for procedural abortion and postabortion care. Medication abortion has shifted abortions to being performed earlier in pregnancy and is becoming more widely available with new service delivery strategies to broaden access. Widespread availability of misoprostol has made abortions induced outside of the formal medical sector overall safer. In both legally restrictive and supportive environments, there is increased interested in self-managed abortions as part of a shift towards demedicalizing abortion through task-sharing.
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Aborto Induzido , Misoprostol , Países em Desenvolvimento , Feminino , Humanos , Gravidez , Primeiro Trimestre da Gravidez , Curetagem a VácuoRESUMO
PURPOSE OF REVIEW: Recent evidence supports elective induction of labor after 39 weeks; however, labor induction in patients with an unfavorable cervix, a Bishop score less than 6, may take several days. In this review, we focus on the efficacy and safety of methods of labor induction for the unfavorable cervix. RECENT FINDINGS: Recent evidence on the use of mechanical cervical preparation with transcervical balloons suggests balloons are the most effective option for decreasing time to delivery in the nulliparous patient. Single and double balloons are equally effective, with a volume of more 30âml being more effective. The addition of misoprostol or oxytocin concurrently with a balloon further expedites time to delivery. SUMMARY: Mechanical dilation should be considered when available and technically possible for labor induction in patients with an unfavorable cervix. Misoprostol is an effective adjunct to trans-cervical balloons, further decreasing time to delivery as compared with balloon alone. When misoprostol is contraindicated, oxytocin is a safe, effective, alternative adjunct to trans-cervical balloons. More research is needed to evaluate safe outpatient options, induction methods in the setting of prior cesarean with an unfavorable cervix, and to directly compare misoprostol with oxytocin as adjuncts to transcervical balloons.
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Cateterismo/métodos , Maturidade Cervical/efeitos dos fármacos , Trabalho de Parto Induzido/métodos , Ocitócicos/administração & dosagem , Prostaglandinas/administração & dosagem , Feminino , Humanos , Ocitócicos/efeitos adversos , Gravidez , Prostaglandinas/efeitos adversos , Ensaios Clínicos Controlados Aleatórios como Assunto , Fatores de TempoRESUMO
PURPOSE OF REVIEW: With over 50 million abortions annually and 25% of pregnancies ending in abortion worldwide, abortion is one of the most common medical procedures. Yet abortion-related topics are glaringly absent from medical school curricula in the USA with half of medical schools including no formal training or only a single lecture. We explore abortion education in US medical schools and Obstetrics and Gynecology (Ob/Gyn) residency programs. Specifically, we review efforts to improve and standardize this training. RECENT FINDINGS: Despite documented interest in both learning and in the benefits of early exposure, medical students face a lack of educational opportunities in abortion care. Meanwhile, Ob/Gyn residency has standardized requirements for abortion care, greatly improving training and education, despite persistent challenges in universal compliance with these standards. SUMMARY: Education in abortion care is crucially important in fostering and training future abortion providers, thereby ensuring and expanding access to safe abortion. The improvements made by standardizing abortion education in Ob/Gyn residency should encourage similar efforts in medical school in order to increase earlier and wider exposure to future physicians of all specialties. On a national level, standardizing exams for medical students by which to evaluate their understanding of abortion care would hold schools accountable for medical student education.
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Aborto Induzido , Ginecologia , Internato e Residência , Obstetrícia , Feminino , Ginecologia/educação , Humanos , Obstetrícia/educação , Gravidez , Faculdades de MedicinaAssuntos
Aborto Induzido , Aborto Espontâneo , Gravidez , Feminino , Humanos , Segundo Trimestre da Gravidez , Aborto Espontâneo/etiologia , MamaRESUMO
BACKGROUND: A major barrier to intrauterine device use is fear of pain during insertion. Trials exploring analgesic interventions for intrauterine device insertion have yielded mixed results, and no standardized pain management guidelines currently exist for this procedure. In an abortion-related study, self-administered lidocaine gel over a prolonged time interval showed promise as a method of pain control. OBJECTIVE(S): The objective of the study was to assess pain control with intrauterine device insertion after patient-administered lidocaine gel compared with placebo. STUDY DESIGN: We conducted a randomized, blinded trial of women undergoing levonorgestrel or copper intrauterine device insertion in an outpatient gynecology clinic between July 2016 and April 2017. Participants self-administered either 20 mL of 2% lidocaine gel or placebo gel vaginally at least 15 minutes prior to intrauterine device insertion. No other analgesics were administered. The primary outcome was pain during intrauterine device insertion, measured on a 100-mm visual analog scale (0 being no pain and 100 being worst pain imaginable). Secondary outcomes included anticipated and baseline pain and pain with speculum insertion and tenaculum placement. In a postprocedure questionnaire, participants reported acceptability of vaginal gel and willingness to wait for pain control. Median values were assessed because of the nonnormal distribution of visual analog scale scores using the Mann-Whitney U test. Predictors of intrauterine device insertion pain were assessed using a multiple linear regression. RESULTS: In total, 220 women were randomized and 215 were included in analysis (108 in lidocaine gel, 107 in placebo gel groups). Median (range) time from gel administration to speculum insertion was 21 (14-74) and 20 (12-43) minutes in the lidocaine and placebo groups, respectively (P = .13). The median pain scores during intrauterine device insertion were not significantly different: 65 (1-99) mm in the lidocaine group and 59 (5-100) mm in the placebo group (P = .09). Among secondary outcome time points, only median pain scores at speculum insertion were significantly different between the lidocaine and placebo groups (7 [0-81] mm vs 11 [0-80] mm, respectively; P = .046). Anticipated pain and menstrual pain were both predictors of pain with intrauterine device insertion. The majority of women in both groups found the amount of vaginal leakage following gel insertion to be acceptable (>80%). Ninety-two percent of participants (n = 194) stated they would be willing to wait before intrauterine device placement for a potential analgesic effect. CONCLUSION: Self-administered lidocaine gel at least 15 minutes before intrauterine device insertion does not appear to reduce pain compared with placebo but may help with speculum insertion. We found that women are willing to extend visit time to gain pain control. Self-administration of local anesthetic is acceptable to patients and should be considered in future research.
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Anestésicos Locais/administração & dosagem , Dispositivos Intrauterinos Medicados/efeitos adversos , Lidocaína/administração & dosagem , Dor Processual/prevenção & controle , Adolescente , Adulto , Anestésicos Locais/uso terapêutico , Anticoncepcionais Femininos/administração & dosagem , Método Duplo-Cego , Feminino , Humanos , Levanogestrel/administração & dosagem , Lidocaína/uso terapêutico , Pessoa de Meia-Idade , Medição da Dor , Dor Processual/diagnóstico , Resultado do Tratamento , Cremes, Espumas e Géis Vaginais , Adulto JovemRESUMO
BACKGROUND: Tobacco smoking is highly prevalent among people attending treatment for a substance-use disorder (SUD). In the United Kingdom, specialist support to stop smoking is largely delivered by a national network of stop smoking services, and typically comprises of behavioral support delivered by trained practitioners on an individual (one-to-one) or group basis combined with a pharmacological smoking-cessation aid. We evaluate the cost-effectiveness of these interventions and compare cost-effectiveness for interventions using group- and individual-based support, in populations under treatment for SUD. METHODS: Economic modeling was used to evaluate the incremental cost-per-quality-adjusted-life-years (QALYs) gained for smoking-cessation interventions compared with alternative methods of quitting for the SUD treatment population. Allowance was made for potentially lower abstinence rates in the SUD population. RESULTS: The incremental cost-per-QALY gained from quit attempts supported through more frequently provided interventions in England ranged from around £4,700 to £12,200. These values are below the maximum cost-effectiveness threshold adopted by policy makers in England for judging whether health programs are a cost-effective use of resources. The estimated cost-per-QALY gained for interventions using group-based behavioral support were estimated to be at least half the magnitude of those using individual support due to lower intervention costs and higher reported quit rates. Conclusions reached regarding the cost-effectiveness of group-based interventions were also found to be more robust to changes in modeling assumptions. CONCLUSIONS: Smoking-cessation interventions were found to be cost-effective when applied to the SUD population, particularly when group-based behavioral support is offered alongside pharmacological treatment. IMPLICATIONS: This analysis has shown that smoking-cessation interventions combining pharmacological treatment with behavioral support can offer a cost-effective method for increasing rates of smoking cessation in populations being treated for a substance-use disorder. This is despite evidence of lower comparative success rates in terms of smoking abstinence in populations with SUD. Our evaluation suggests that medication combined with group-based behavioral support may offer better value for money in this population compared with interventions using individual support, though further evidence on the comparative effectiveness and cost of interventions delivered to SUD treatment populations would facilitate a more robust comparison.