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1.
Article in English | MEDLINE | ID: mdl-38972572

ABSTRACT

STUDY OBJECTIVE: To examine racial disparities in route of hysterectomy and perioperative outcomes before and after expansion of high-volume minimally invasive surgeons (>10 minimally invasive hysterectomies (MIH)/year) DESIGN: Retrospective cohort study SETTING: Multi-center academic teaching institution PATIENTS: All patients who underwent a scheduled hysterectomy for benign indications during 2018 (pre-intervention) and 2022 (post-intervention) INTERVENTIONS: Recruitment of Fellowship in Minimally Invasive Gynecologic Surgery (FMIGS)- trained faculty and increased surgical training for academic specialists in obstetrics and gynecology occurred in 2020. MEASUREMENTS AND MAIN RESULTS: Patients in the pre-intervention cohort (n=171) were older (median age 45 years vs. 43 years, p=0.003) while patients in the post-intervention cohort (n=234) had a higher burden of comorbidities (26% ASA class III vs. 19%, p=0.03). Uterine weight was not significantly different between cohorts (p=0.328). Between the pre-intervention and post-intervention cohorts, high-volume minimally invasive surgeons increased from 27% (n=4) to 44% (n=7) of those performing hysterectomies within the division and percentage of hysterectomies performed via minimally invasive route increased (63% vs. 82%, p<0.001). In the pre-intervention cohort, Black patients had a lower percentage of hysterectomies performed via minimally invasive route compared to White patients (Black = 56% MIH vs. White = 76% MIH, p=0.014). In the post-intervention cohort, differences by race were no longer significant (Black = 78% MIH vs. White = 87% MIH, p= 0.127). There was a significant increase (22%) in MIH for Black patients between cohorts (p<0.001). After adjusting for age, BMI, ASA class, prior surgery, and uterine weight, disparities by race were no longer present in the post-intervention cohort. Perioperative outcomes including length of stay (p<0.001), infection rates (p=0.002) and blood loss (p=0.01) improved post-intervention. CONCLUSION: Increasing FMIGs-trained gynecologic surgeons and providing more opportunities in robotic/laparoscopic training for academic specialists may improve access to MIH for Black patients and reduce disparities.

2.
Clin Obstet Gynecol ; 66(1): 63-72, 2023 03 01.
Article in English | MEDLINE | ID: mdl-36044627

ABSTRACT

Equitable access to contraception and contraceptive education has the potential to mitigate health disparities related to unintended pregnancy. Pregnancy and the postpartum window frequently offer reduced insurance barriers to healthcare, increased interaction with healthcare systems and family planning providers, and an opportune time for many individuals to receive contraception; however, there are additional considerations in method type for postpartum individuals, and contraceptive counseling must be thoughtfully conducted to avoid coercion and promote shared decision-making. This commentary reviews method-specific considerations and suggests priorities for achieving equity in postpartum contraceptive access.


Subject(s)
Contraception , Postpartum Period , Pregnancy , Female , Humans , Pregnancy, Unplanned , Family Planning Services , Health Services Accessibility , Contraceptive Agents
3.
J Med Internet Res ; 25: e42559, 2023 08 28.
Article in English | MEDLINE | ID: mdl-37639302

ABSTRACT

BACKGROUND: Patients followed for a pregnancy of unknown location are generally followed by a team of clinicians through telephone calls, and their contraceptive needs at the time of pregnancy resolution may not be addressed. OBJECTIVE: This study aimed to assess contraceptive counseling and contraceptive uptake before and after a telephone-based intervention. METHODS: This was a retrospective pre-post study assessing pregnancy intendedness in patients with a pregnancy of unknown location and the proportion of patients who received contraceptive counseling and a contraceptive prescription before and after the initiation of a telephone-based intervention. We reviewed medical records 1 year before and 1 year after implementation of our intervention for demographic characteristics, pregnancy intendedness, pregnancy outcome, contraceptive counseling documentation, receipt of contraception, and repeat pregnancy within 6 months. We assessed the effects of an implementation strategy to address family planning needs once pregnancy was resolved by comparing the proportions of patients who were counseled and received contraception before and after our intervention was implemented. We performed logistic regression to identify associations between covariates and the outcomes of contraceptive counseling documentation and receipt of contraception. RESULTS: Of the 220 patients in the combined cohort, the majority were Black (161/220, 73%) and ultimately had a resolved pregnancy of unknown location (162/220, 74%), and the proportion of pregnancies documented as unintended was 60% (132/220). Before our intervention, 27 of 100 (27%) patients received contraceptive counseling, compared with 94 of 120 (78%) patients after the intervention (odds ratio [OR] 9.77, 95% CI 5.26-18.16). Before the intervention, 17 of 90 (19%) patients who did not desire repeat pregnancy received contraception, compared with 32 of 86 (37%) patients after the intervention (OR 2.54, 95% CI 1.28-5.05). Our postintervention cohort had an increased odds of receiving contraceptive counseling (OR 9.77, 95% CI 5.26-18.16) and of receiving a contraceptive prescription (OR 2.54, 95% CI 1.28-5.05) compared with our preintervention cohort. CONCLUSIONS: We found that over half of patients with a pregnancy of unknown location have an unintended pregnancy, and standardization of care through a telephone-based intervention improves contraceptive counseling and prescribing in patients with a resolved pregnancy of unknown location. This intervention could be used at any institution that follows patients with a pregnancy of unknown location remotely to improve care.


Subject(s)
Contraception , Family Planning Services , Female , Humans , Pregnancy , Contraceptive Agents , Retrospective Studies , Telephone
4.
J Med Internet Res ; 25: e43596, 2023 05 11.
Article in English | MEDLINE | ID: mdl-37166954

ABSTRACT

BACKGROUND: HIV remains a persistent health problem in the United States, especially among women. Approved in 2012, HIV pre-exposure prophylaxis (PrEP) is a daily pill or bimonthly injection that can be taken by individuals at increased risk of contracting HIV to reduce their risk of new infection. Women who are at risk of HIV face numerous barriers to HIV services and information, underscoring the critical need for strategies to increase awareness of evidence-based HIV prevention methods, such as HIV PrEP, among women. OBJECTIVE: We aimed to identify historical trends in the use of Twitter hashtags specific to women and HIV PrEP and explore content about women and PrEP shared through Twitter. METHODS: This was a qualitative descriptive study using a purposive sample of tweets containing hashtags related to women and HIV PrEP from 2009 to 2022. Tweets were collected via Twitter's API. Each Twitter user profile, tweet, and related links were coded using content analysis, guided by the framework of the Health Belief Model (HBM) to generate results. We used a factor analysis to identify salient clusters of tweets. RESULTS: A total of 1256 tweets from 396 unique users were relevant to our study focus of content about PrEP specifically for women (1256/2908, 43.2% of eligible tweets). We found that this sample of tweets was posted mostly by organizations. The 2 largest groups of individual users were activists and advocates (61/396, 15.4%) and personal users (54/396, 13.6%). Among individual users, most were female (100/166, 60%) and American (256/396, 64.6%). The earliest relevant tweet in our sample was posted in mid-2014 and the number of tweets significantly decreased after 2018. We found that 61% (496/820) of relevant tweets contained links to informational websites intended to provide guidance and resources or promote access to PrEP. Most tweets specifically targeted people of color, including through the use of imagery and symbolism. In addition to inclusive imagery, our factor analysis indicated that more than a third of tweets were intended to share information and promote PrEP to people of color. Less than half of tweets contained any HBM concepts, and only a few contained cues to action. Lastly, while our sample included only tweets relevant to women, we found that the tweets directed to lesbian, gay, bisexual, transgender, queer (LGBTQ) audiences received the highest levels of audience engagement. CONCLUSIONS: These findings point to several areas for improvement in future social media campaigns directed at women about PrEP. First, future posts would benefit from including more theoretical constructs, such as self-efficacy and cues to action. Second, organizations posting on Twitter should continue to broaden their audience and followers to reach more people. Lastly, tweets should leverage the momentum and strategies used by the LGBTQ community to reach broader audiences and destigmatize PrEP use across all communities.


Subject(s)
HIV Infections , Pre-Exposure Prophylaxis , Social Media , Female , Humans , United States , Male , HIV Infections/prevention & control
5.
Eur J Contracept Reprod Health Care ; 28(3): 173-176, 2023 Jun.
Article in English | MEDLINE | ID: mdl-37013727

ABSTRACT

PURPOSE: To assess the resources that oral contraceptive pill (OCP) users currently use and wish to use after missing pills. MATERIALS AND METHODS: People 18-44 years old with a OCP prescription were emailed a cross-sectional survey to assess how they obtain information about managing missed pills, what information they would prefer to access, and whether they would use additional information if it were available. We performed a logistic regression and a dominance analysis to compare independent predictors of desire for a technological resource at the time of missed pills. RESULTS: We received 166 completed surveys. Nearly half of participants (47%, n = 76, 95% CI 39.0-54.4%) did not seek information about managing their missed pills. When missing a pill, more patients preferred non-technology-based information (57.1%, n = 93, 95% CI 49.3-64.5%) over technology-based information (43%, n = 70, 95% CI 35.5-50.7%). Most reported they would appreciate more information at the time of missed pills (76%, n = 124, 95% CI 68.9-82.0%). The strongest predictors for desire for technology-based information were: current use of technology, lower parity, white race, and higher educational attainment. CONCLUSIONS: This study indicates that most OCP users would utilise additional information at the time of a missed pill if they had access to it and that they desire information in varying formats.


Patients desire more educational information at the time of missed oral contraceptive pills, and preferences are varied regarding the format of patient information. Implementation of high-quality counseling with oral contraceptive pills requires a broad range of educational materials as well as provider education.


Subject(s)
Contraception , Contraceptives, Oral , Pregnancy , Female , Humans , Adolescent , Young Adult , Adult , Cross-Sectional Studies , Logistic Models , Surveys and Questionnaires
6.
J Gen Intern Med ; 37(16): 4168-4175, 2022 12.
Article in English | MEDLINE | ID: mdl-35194746

ABSTRACT

BACKGROUND: Tubal ligation remains common in the USA, especially among low-income patients. OBJECTIVE: To compare the effectiveness and safety of intrauterine contraceptives (IUC) to laparoscopic tubal ligation for Medicaid clients. DESIGN: We partnered with patient and clinician stakeholders to conduct a retrospective cohort study using California Medicaid claims for patients who had an IUC placed or laparoscopic tubal ligation performed in 2008-2014, excluding procedures performed within 42 days of a birth. We applied log-linear (Poisson) event-history regression models for clustered person-period data to adjust for sociodemographic variables and pre-procedure health status when examining associations between these contraceptive procedures and claims related to contraceptive failure, complications, and pain in the first year post-procedure. KEY RESULTS: We identified 35,705 patients who had a levonorgestrel IUC placed, 23,628 patients who had a copper IUC placed, and 23,965 patients who underwent laparoscopic tubal ligation. In unadjusted analyses, rates of pregnancy within 1 year were similar following levonorgestrel IUC (2.40%) or copper IUC placement (2.99%) or tubal ligation (2.64%). In adjusted analyses, compared to tubal ligation, pregnancy was less common following placement of a levonorgestrel IUC (adj IRR 0.72, 95% CI 0.64-0.82) and similar with placement of a copper IUC (adj IRR 0.92, 95% CI 0.82-1.05). Procedural complications such as infection (0.35% vs. 2.91%) were significantly less common with IUC placement than tubal ligation. Claims for pelvic and abdominal pain decreased in frequency with time since all procedures; 6 to 12 months post-procedure, pelvic pain claims were less common after levonorgestrel IUC (adj IRR 0.69, 95% CI 0.65-0.73) or copper IUC placement (adj IRR 0.70, 95% CI 0.66-0.75) than tubal ligation. CONCLUSIONS: IUC appears at least as effective as laparoscopic tubal ligation at 1-year post-procedure with lower rates of infection and pelvic pain 6 to 12 months post-procedure. CLINICAL TRIAL REGISTRATION: NCT03438682.


Subject(s)
Sterilization, Tubal , Female , Humans , Pregnancy , Contraception , Copper , Levonorgestrel , Pelvic Pain/epidemiology , Pelvic Pain/etiology , Retrospective Studies , Sterilization, Tubal/adverse effects , United States/epidemiology
7.
Am J Obstet Gynecol ; 227(5): 737.e1-737.e11, 2022 11.
Article in English | MEDLINE | ID: mdl-35780811

ABSTRACT

BACKGROUND: Early pregnancy loss, also referred to as miscarriage, is common, affecting approximately 1 million people in the United States annually. Early pregnancy loss can be treated with expectant management, medications, or surgical procedures-strategies that differ in patient experience, effectiveness, and cost. One of the medications used for early pregnancy loss treatment, mifepristone, is uniquely regulated by the Food and Drug Administration. OBJECTIVE: This study aimed to compare the cost-effectiveness from the healthcare sector perspective of medical management of early pregnancy loss, using the standard of care medication regimen of mifepristone and misoprostol, with that of office uterine aspiration. STUDY DESIGN: We developed a decision analytical model to compare the cost-effectiveness of early pregnancy loss treatment with medical management with that of office uterine aspiration. Data on medical management came from the Pregnancy Failure Regimens randomized clinical trial, and data on uterine aspiration came from the published literature. The analysis was from the healthcare sector perspective with a 30-day time horizon. Costs were in 2018 US dollars. Effectiveness was measured in quality-adjust life-years gained and the rate of complete gestational sac expulsion with no additional interventions. Our primary outcome was the incremental cost per quality-adjust life-year gained. Sensitivity analysis was performed to identify the key uncertainties. RESULTS: Mean per-person costs were higher for uterine aspiration than for medical management ($828 [95% confidence interval, $789-$868] vs $661 [95% confidence interval, $556-$766]; P=.004). Uterine aspiration more frequently led to complete gestational sac expulsion than medical management (97.3% vs 83.8%; P=.0001); however, estimated quality-adjust life-years were higher for medical management than for uterine aspiration (0.082 [95% confidence interval, 0.8148-0.08248] vs 0.079 [95% confidence interval, 0.0789-0.0791]; P<.0001). Medical management dominated uterine aspiration, with lower costs and higher confidence interval. The probability that medical management is cost-effective relative to uterine aspiration is 97.5% for all willingness-to-pay values of ≥$5600/quality-adjust life-year. Sensitivity analysis did not identify any thresholds that would substantially change outcomes. CONCLUSION: Although office-based uterine aspiration more often results in treatment completion without further intervention, medical management with mifepristone pretreatment costs less and yields similar quality-adjust life-years, making it an attractive alternative. Our findings provided evidence that increasing access to mifepristone and eliminating unnecessary restrictions will improve early pregnancy care.


Subject(s)
Abortion, Spontaneous , Misoprostol , Pregnancy , Female , Humans , Abortion, Spontaneous/drug therapy , Mifepristone/therapeutic use , Cost-Benefit Analysis , Misoprostol/therapeutic use , Drug Therapy, Combination
8.
N Engl J Med ; 378(23): 2161-2170, 2018 06 07.
Article in English | MEDLINE | ID: mdl-29874535

ABSTRACT

BACKGROUND: Medical management of early pregnancy loss is an alternative to uterine aspiration, but standard medical treatment with misoprostol commonly results in treatment failure. We compared the efficacy and safety of pretreatment with mifepristone followed by treatment with misoprostol with the efficacy and safety of misoprostol use alone for the management of early pregnancy loss. METHODS: We randomly assigned 300 women who had an anembryonic gestation or in whom embryonic or fetal death was confirmed to receive pretreatment with 200 mg of mifepristone, administered orally, followed by 800 µg of misoprostol, administered vaginally (mifepristone-pretreatment group), or 800 µg of misoprostol alone, administered vaginally (misoprostol-alone group). Participants returned 1 to 4 days after misoprostol use for evaluation, including ultrasound examination, by an investigator who was unaware of the treatment-group assignments. Women in whom the gestational sac was not expelled were offered expectant management, a second dose of misoprostol, or uterine aspiration. We followed all participants for 30 days after randomization. Our primary outcome was gestational sac expulsion with one dose of misoprostol by the first follow-up visit and no additional intervention within 30 days after treatment. RESULTS: Complete expulsion after one dose of misoprostol occurred in 124 of 148 women (83.8%; 95% confidence interval [CI], 76.8 to 89.3) in the mifepristone-pretreatment group and in 100 of 149 women (67.1%; 95% CI, 59.0 to 74.6) in the misoprostol-alone group (relative risk, 1.25; 95% CI, 1.09 to 1.43). Uterine aspiration was performed less frequently in the mifepristone-pretreatment group than in the misoprostol-alone group (8.8% vs. 23.5%; relative risk, 0.37; 95% CI, 0.21 to 0.68). Bleeding that resulted in blood transfusion occurred in 2.0% of the women in the mifepristone-pretreatment group and in 0.7% of the women in the misoprostol-alone group (P=0.31); pelvic infection was diagnosed in 1.3% of the women in each group. CONCLUSIONS: Pretreatment with mifepristone followed by treatment with misoprostol resulted in a higher likelihood of successful management of first-trimester pregnancy loss than treatment with misoprostol alone. (Funded by the National Institute of Child Health and Human Development; PreFaiR ClinicalTrials.gov number, NCT02012491 .).


Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Abortifacient Agents, Steroidal/administration & dosage , Abortion, Spontaneous/drug therapy , Mifepristone/administration & dosage , Misoprostol/administration & dosage , Abortifacient Agents, Nonsteroidal/adverse effects , Abortifacient Agents, Steroidal/adverse effects , Abortion, Spontaneous/diagnostic imaging , Administration, Intravaginal , Administration, Oral , Adult , Drug Therapy, Combination , Embryo, Mammalian , Female , Fetal Death , Gestational Sac/diagnostic imaging , Hemorrhage/chemically induced , Humans , Mifepristone/adverse effects , Misoprostol/adverse effects , Pregnancy , Pregnancy Trimester, First , Ultrasonography
9.
Sex Transm Dis ; 48(12): 967-972, 2021 12 01.
Article in English | MEDLINE | ID: mdl-34108411

ABSTRACT

BACKGROUND: Although daily preexposure prophylaxis (PrEP) is now widely accepted as a safe and effective method for reducing the risk of HIV in high-risk groups, uptake has been slow. The goal of this analysis was to identify factors associated with PrEP awareness among individuals at risk for HIV. METHODS: This investigation analyzed data from the Centers for Disease Control and Prevention nationally representative survey, National Survey of Family Growth, for the years 2017 to 2019. Logistic regression was used to explore the relationship between PrEP awareness and demographics, HIV risk factors, and provider HIV risk screening. RESULTS: Only 37% of survey respondents with an increased risk of HIV were aware of PrEP. Several segments of the at-risk population had lower odds of being aware of PrEP, including heterosexual women, heterosexual men, individuals younger than 20 years, and individuals with lower levels of education. Those who participate in sex in exchange for money or drugs had significantly lower odds of being aware of PrEP. In comparison, PrEP awareness was significantly higher among nonheterosexual men and both men and women whose partners were HIV positive. Lastly, those who had been screened by a provider for HIV risk had significantly higher odds of being aware of PrEP. CONCLUSIONS: This research supports the need for policies and programs to increase awareness of PrEP, especially among certain segments of the population at increased risk for HIV.


Subject(s)
Anti-HIV Agents , HIV Infections , Pre-Exposure Prophylaxis , Sexual and Gender Minorities , Anti-HIV Agents/therapeutic use , Female , HIV Infections/drug therapy , HIV Infections/epidemiology , HIV Infections/prevention & control , Health Knowledge, Attitudes, Practice , Heterosexuality , Homosexuality, Male , Humans , Male
10.
Am J Obstet Gynecol ; 225(5): 513.e1-513.e19, 2021 11.
Article in English | MEDLINE | ID: mdl-34058170

ABSTRACT

BACKGROUND: Historically, published guidelines for care after molar pregnancy recommended monitoring human chorionic gonadotropin levels for the development of gestational trophoblastic neoplasia until normal and then for 6 months after the first normal human chorionic gonadotropin. However, there are little data underlying such recommendations, and recent evidence has demonstrated that gestational trophoblastic neoplasia diagnosis after human chorionic gonadotropin normalization is rare. OBJECTIVE: We sought to estimate the cost-effectiveness of alternative strategies for surveillance for gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after complete and partial molar pregnancy. STUDY DESIGN: A Markov-based cost-effectiveness model, using monthly cycles and terminating after 36 months/cycles, was constructed to compare alternative strategies for asymptomatic human chorionic gonadotropin surveillance after the first normal (none; monthly testing for 1, 3, 6, and 12 months; or every 3-month testing for 3, 6, and 12 months) for both complete and partial molar pregnancy. The risk of reduced surveillance was modeled by increasing the probability of high-risk disease at diagnosis. Probabilities, costs, and utilities were estimated from peer-reviewed literature, with all cost data applicable to the United States and adjusted to 2020 US dollars. The primary outcome was cost per quality-adjusted life year ($/quality-adjusted life year) with a $100,000/quality-adjusted life year willingness-to-pay threshold. RESULTS: Under base-case assumptions, we found no further surveillance after the first normal human chorionic gonadotropin to be the dominant strategy from both the healthcare system and societal perspectives, for both complete and partial molar pregnancy. After complete mole, this strategy had the lowest average cost (healthcare system, $144 vs maximum $283; societal, $152 vs maximum $443) and highest effectiveness (2.711 vs minimum 2.682 quality-adjusted life years). This strategy led to a slightly higher rate of death from gestational trophoblastic neoplasia (0.013% vs minimum 0.009%), although with high costs per gestational trophoblastic neoplasia death avoided (range, $214,000 to >$4 million). Societal perspective costs of lost wages had a greater impact on frequent surveillance costs than rare gestational trophoblastic neoplasia treatment costs, and no further surveillance was more favorable from this perspective in otherwise identical analyses. No further surveillance remained dominant or preferred with incremental cost-effectiveness ratio of <$100,000 in all analyses for partial mole, and most sensitivity analyses for complete mole. Under the assumption of no disutility from surveillance, surveillance strategies were more effective (by quality-adjusted life year) than no further surveillance, and a single human chorionic gonadotropin test at 3 months was found to be cost-effective after complete mole with incremental cost-effectiveness ratio of $53,261 from the healthcare perspective, but not from the societal perspective (incremental cost-effectiveness ratio, $288,783). CONCLUSION: Largely owing to the rare incidence of gestational trophoblastic neoplasia after human chorionic gonadotropin normalization after molar pregnancy, prolonged surveillance is not cost-effective under most assumptions. It would be reasonable to reduce, and potentially eliminate, current recommendations for surveillance after human chorionic gonadotropin normalization after molar pregnancy, particularly among partial moles. With any reduction in surveillance, patients should be counseled on symptoms of gestational trophoblastic neoplasia and established in routine gynecologic care.


Subject(s)
Continuity of Patient Care/economics , Gestational Trophoblastic Disease/diagnosis , Hydatidiform Mole/epidemiology , Uterine Neoplasms/epidemiology , Adult , Chorionic Gonadotropin/blood , Cost-Benefit Analysis , Female , Humans , Markov Chains , Pregnancy , Quality-Adjusted Life Years
11.
JAMA ; 326(5): 390-400, 2021 08 03.
Article in English | MEDLINE | ID: mdl-34342619

ABSTRACT

Importance: Women with an early nonviable pregnancy of unknown location are at high risk of ectopic pregnancy and its inherent morbidity and mortality. Successful and timely resolution of the gestation, while minimizing unscheduled interventions, are important priorities. Objective: To determine if active management is more effective in achieving pregnancy resolution than expectant management and whether the use of empirical methotrexate is noninferior to uterine evacuation followed by methotrexate if needed. Design, Setting, and Participants: This multicenter randomized clinical trial recruited 255 hemodynamically stable women with a diagnosed persisting pregnancy of unknown location between July 25, 2014, and June 4, 2019, in 12 medical centers in the United States (final follow up, August 19, 2019). Interventions: Eligible patients were randomized in a 1:1:1 ratio to expectant management (n = 86), active management with uterine evacuation followed by methotrexate if needed (n = 87), or active management with empirical methotrexate using a 2-dose protocol (n = 82). Main Outcomes and Measures: The primary outcome was successful resolution of the pregnancy without change from initial strategy. The primary hypothesis tested for superiority of the active groups combined vs expectant management, and a secondary hypothesis tested for noninferiority of empirical methotrexate compared with uterine evacuation with methotrexate as needed using a noninferiority margin of -12%. Results: Among 255 patients who were randomized (median age, 31 years; interquartile range, 27-36 years), 253 (99.2%) completed the trial. Ninety-nine patients (39%) declined their randomized allocation (26.7% declined expectant management, 48.3% declined uterine evacuation, and 41.5% declined empirical methotrexate) and crossed over to a different group. Compared with patients randomized to receive expectant management (n = 86), women randomized to receive active management (n = 169) were significantly more likely to experience successful pregnancy resolution without change in their initial management strategy (51.5% vs 36.0%; difference, 15.4% [95% CI, 2.8% to 28.1%]; rate ratio, 1.43 [95% CI, 1.04 to 1.96]). Among active management strategies, empirical methotrexate was noninferior to uterine evacuation followed by methotrexate if needed with regard to successful pregnancy resolution without change in management strategy (54.9% vs 48.3%; difference, 6.6% [1-sided 97.5% CI, -8.4% to ∞]). The most common adverse event was vaginal bleeding for all of the 3 management groups (44.2%-52.9%). Conclusions and Relevance: Among patients with a persisting pregnancy of unknown location, patients randomized to receive active management, compared with those randomized to receive expectant management, more frequently achieved successful pregnancy resolution without change from the initial management strategy. The substantial crossover between groups should be considered when interpreting the results. Trial Registration: ClinicalTrials.gov Identifier: NCT02152696.


Subject(s)
Abortifacient Agents, Nonsteroidal/administration & dosage , Methotrexate/administration & dosage , Pregnancy, Ectopic/drug therapy , Pregnancy, Ectopic/surgery , Watchful Waiting , Abortion, Spontaneous , Adult , Chorionic Gonadotropin/blood , Combined Modality Therapy , Dilatation and Curettage , Female , Humans , Patient Satisfaction , Pregnancy , Ultrasonography, Prenatal , Uterine Hemorrhage
12.
Am J Obstet Gynecol ; 223(4): 551.e1-551.e7, 2020 10.
Article in English | MEDLINE | ID: mdl-32305259

ABSTRACT

BACKGROUND: Early pregnancy loss is a common event in the first trimester, occurring in 15%-20% of confirmed pregnancies. A common evidence-based medical regimen for early pregnancy loss uses misoprostol, a prostaglandin E1 analog, with a dosage of 800 µg, self-administered vaginally. The clinical utility of this regimen is limited by suboptimal effectiveness in patients with a closed cervical os, with 29% of patients experiencing early pregnancy loss requiring a second dose after 3 days and 16% of patients eventually requiring a uterine aspiration procedure. OBJECTIVE: This study aimed to evaluate clinical predictors associated with treatment success in patients receiving medical management with mifepristone-misoprostol or misoprostol alone for early pregnancy loss. STUDY DESIGN: We performed a planned secondary analysis of a randomized trial comparing mifepristone-misoprostol with misoprostol alone for management of early pregnancy loss. The published prediction model for treatment success of single-dose misoprostol administered vaginally included the following variables: active bleeding, type of early pregnancy loss (anembryonic pregnancy or embryonic and/or fetal demise), parity, gestational age, and treatment site; previous significant predictors were vaginal bleeding within the past 24 hours and parity of 0 or 1 vs >1. To determine if these characteristics predicted differential proportions of patients with treatment success or failure, we performed bivariate analyses; given the small proportion of treatment failures in the combined treatment arm, both arms were combined for analysis. Thereafter, we performed a logistic regression analysis to assess the effect of these predictors collectively in each of the 2 treatment groups separately as well as in the full cohort as a proxy for the combined treatment arm. Finally, by using receiver operating characteristic curves, we tested the ability of these predictors in association with misoprostol treatment success to discriminate between treatment success and treatment failure. To quantify the ability of the score to discriminate between treatment success and treatment failure in each treatment arm as well as in the entire cohort, we calculated the area under the curve. Using multivariable logistic regression, we then assessed our study population for other predictors of treatment success in both treatment groups, with and without mifepristone pretreatment. RESULTS: Overall, 297 evaluable participants were included in the primary study, with 148 in the mifepristone-misoprostol combined treatment group and 149 in the misoprostol-alone treatment group. Among patients who had vaginal bleeding at the time of treatment, 15 of 17 (88%) in the mifepristone-misoprostol combined treatment group and 12 of 17 (71%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. Among patients with a parity of 0 or 1, 94 of 108 (87%) in the mifepristone-misoprostol treatment group and 66 of 95 (69%) in the misoprostol-alone treatment group experienced expulsion of pregnancy tissue. These clinical characteristics did not predict treatment success in the combined cohort alone (area under the curve=0.56; 95% confidence interval, 0.48-0.64). No other baseline clinical factors predicted treatment success in the misoprostol-alone treatment arm or mifepristone pretreatment arm. In the full cohort, the significant predictors of treatment success were pretreatment with mifepristone (adjusted odds ratio=2.51; 95% confidence interval, 1.43-4.43) and smoking (adjusted odds ratio=2.15; 95% confidence interval, 1.03-4.49). CONCLUSION: No baseline clinical factors predicted treatment success in women receiving medical management with misoprostol for early pregnancy loss. Adding mifepristone to the medical management regimen of early pregnancy loss improved treatment success; thus, mifepristone treatment should be considered for management of early pregnancy loss regardless of baseline clinical factors.


Subject(s)
Abortifacient Agents, Nonsteroidal , Abortifacient Agents, Steroidal , Abortion, Spontaneous/drug therapy , Mifepristone/therapeutic use , Misoprostol/therapeutic use , Parity , Uterine Hemorrhage/epidemiology , Adult , Drug Therapy, Combination , Female , Humans , Pregnancy , Treatment Outcome
15.
Am J Obstet Gynecol ; 219(2): 183.e1-183.e9, 2018 08.
Article in English | MEDLINE | ID: mdl-29870737

ABSTRACT

BACKGROUND: Immediate placement of an intrauterine device after vaginal delivery is safe and convenient, but longitudinal data describing clinical outcomes have been limited. OBJECTIVE: We sought to determine the proportion of TCu380A (copper) intrauterine devices expelled, partially expelled, malpositioned, and retained, as well as contraceptive use by 6 months postpartum, and determine risk factors for expulsion and partial expulsion. STUDY DESIGN: In this prospective, observational study, women who received a postplacental TCu380A intrauterine device at vaginal delivery were enrolled postpartum. Participants returned for clinical follow-up at 6 weeks, and for a research visit with a pelvic exam and ultrasound at 6 months. We recorded intrauterine device outcomes and 6-month contraceptive use. Partial expulsion was defined as an intrauterine device protruding from the external cervical os, or a transvaginal ultrasound showing the distal end of the intrauterine device below the internal os of the cervix. Multinomial logistic regression models identified risk factors associated with expulsion and partial expulsion by 6 months. The area under the receiver operating characteristics curve was used to assess the ability of a string check to predict the correct placement of a postplacental intrauterine device. The primary outcome was the proportion of intrauterine devices expelled at 6 months. RESULTS: We enrolled 200 women. Of 162 participants with follow-up data at 6 months, 13 (8.0%; 95% confidence interval, 4.7-13.4%) experienced complete expulsion and 26 (16.0%; 95% confidence interval, 11.1-22.6%) partial expulsion. Of 25 malpositioned intrauterine devices (15.4%; 95% confidence interval, 10.2-21.9%), 14 were not at the fundus (8.6%; 95% confidence interval, 5.2-14.1%) and 11 were rotated within the uterus (6.8%; 95% confidence interval, 3.8-11.9%). Multinomial logistic regression modeling indicated that higher parity (odds ratio, 2.05; 95% confidence interval, 1.21-3.50; P = .008) was associated with expulsion. Provider specialty (obstetrics vs family medicine; odds ratio, 5.31; 95% confidence interval, 1.20-23.59; P = .03) and gestational weight gain (normal vs excess; odds ratio, 9.12; 95% confidence interval, 1.90-43.82; P = .004) were associated with partial expulsion. Long-acting reversible contraceptive method use at 6 months was 80.9% (95% confidence interval, 74.0-86.6%). At 6 weeks postpartum, 35 of 149 (23.5%; 95% confidence interval, 16.9-31.1%) participants had no intrauterine device strings visible. Sensitivity of a string check to detect an incorrectly positioned intrauterine device was 36.2%, and specificity of the string check to predict a correctly positioned intrauterine device was 84.5%. This corresponds to an area under the receiver operating characteristics curve of 0.5. CONCLUSION: This prospective assessment of postplacental TCu380A intrauterine device placement, with ultrasound to confirm device position, finds a complete intrauterine device expulsion proportion of 8.0% at 6 months. The association of increasing parity with expulsion is consistent with prior research. The clinical significance of covariates associated with partial expulsion (provider specialty and gestational weight gain) is unclear. Due to the observational study design, any associations cannot imply causality. The proportion of partially expelled and malpositioned intrauterine devices was high, and the area under the receiver operating characteristics curve of 0.5 indicates that a string check is a poor test for assessing device position. Women considering a postplacental intrauterine device should be counseled about the risk of position abnormalities, as well as the possibility of nonvisible strings, which may complicate clinical follow-up. The clinical significance of intrauterine device position abnormalities is unknown; future research should evaluate the influence of malposition and partial expulsion on contraceptive effectiveness and side effects.


Subject(s)
Delivery, Obstetric , Gestational Weight Gain , Intrauterine Device Expulsion , Intrauterine Device Migration , Intrauterine Devices, Copper , Postnatal Care , Adult , Area Under Curve , Contraceptive Agents/therapeutic use , Female , Humans , Logistic Models , Longitudinal Studies , Obstetrics , Patient Satisfaction , Physicians, Family , Pregnancy , Prospective Studies , Risk Factors , Young Adult
16.
Eur J Contracept Reprod Health Care ; 20(1): 4-18, 2015 Feb.
Article in English | MEDLINE | ID: mdl-25397890

ABSTRACT

OBJECTIVES: Given new research on postpartum placement of levonorgestrel and copper intrauterine devices (IUDs), our objective was to update a prior systematic review of the safety and expulsion rates of postpartum IUDs. METHODS: We searched MEDLINE, CENTRAL, LILACS, POPLINE, Web of Science, and ClinicalTrials.gov databases for articles between the database inception until July 2013. We included studies that compared IUD insertion time intervals and routes during the postpartum period. We used standard abstract forms and the United States Preventive Services Task Force grading system to summarise and assess the quality of the evidence. RESULTS: We included 18 articles. New evidence suggests that a levonorgestrel releasing-intrauterine system (LNG-IUS) insertion within 48 hours of delivery is safe. Postplacental insertion and insertion between 10 minutes and 48 hours after delivery result in higher expulsion rates than insertion 4 to 6 weeks postpartum, or non-postpartum insertion. Insertion at the time of caesarean section is associated with lower expulsion rates than postplacental insertion at the time of vaginal delivery. CONCLUSIONS: This review supports the evidence that insertion of an intrauterine contraceptive within the first 48 hours of vaginal or caesarean delivery is safe. Expulsion rates should be further studied in larger randomised controlled trials.


Subject(s)
Intrauterine Device Expulsion/etiology , Intrauterine Devices/adverse effects , Female , Humans , Postpartum Period , Time Factors
17.
Womens Health Issues ; 34(2): 148-155, 2024.
Article in English | MEDLINE | ID: mdl-38246793

ABSTRACT

BACKGROUND: Women 18-24 years of age have the highest proportion of unintended pregnancies of any age group, and thus represent a significant population in need of abortion services. Prior research indicated that only half of college student health centers provide appropriate abortion referrals. Our objective was to better understand the referral experience and barriers to abortion referral at college student health centers. PROCEDURES: We conducted a "secret caller" study at all 4-year colleges in Pennsylvania between June 2017 and April 2018, using a structured script requesting abortion referral. Calls were transcribed, coded using an iteratively developed codebook, and analyzed for themes related to barriers and facilitators of abortion referral. MAIN FINDINGS: A total of 202 completed transcripts were reviewed. Themes that emerged were knowledge, experience, and comfort with abortion referral; support, empathy, and reassurance; coercion; misleading language; questioning the caller's autonomy; and institutional policy against referral. Most staff lacked knowledge and comfort with abortion referral. Although some staff members made supportive statements toward the caller, others used coercive language to try to dissuade the caller from an abortion. Many staff cited religious institutional policies against abortion referral and expressed a range of feelings about such policies. CONCLUSIONS: Abortion referrals at student health centers lack consistency. Staff members frequently did not have the knowledge needed to provide appropriate abortion referrals, used coercive language in responding to requests for referrals, and perpetuated abortion stigma. Some health staff used coercive or evasive language that further stigmatized the caller's request for an abortion referral. College health centers should improve training and resources around abortion referral to ensure they are delivering appropriate, high-quality care.


Subject(s)
Abortion, Induced , Pregnancy , Humans , Female , Pregnancy, Unplanned , Referral and Consultation , Pennsylvania , Students
18.
Article in English | MEDLINE | ID: mdl-38959113

ABSTRACT

Objective: Our objective was to evaluate the feasibility of a new protocol for telemedicine follow-up after medication management of early pregnancy loss. Study Design: The study was designed to assess the feasibility of planned telemedicine follow-up after medication management of early pregnancy loss. We compared these follow-up rates with those after planned in-person follow-up of medication management of early pregnancy loss and planned telemedicine follow-up after medication abortion. We conducted a retrospective cohort study, including patients initiating medication management of early pregnancy loss <13w0d gestation and medication abortion ≤10w0d with a combination of mifepristone and misoprostol between April 1, 2020, and March 28, 2021. As part of a new clinical protocol, patients could opt for telemedicine follow-up one week after treatment and a home urine pregnancy test 4 weeks after treatment. Our primary outcome was completed follow-up as per clinical protocol. We also examined outcomes related to complications across telemedicine and in-person follow-up groups. Results: Of patients reviewed, 181 were eligible for inclusion; 75 had medication management of early pregnancy loss, and 106 had medication abortion. Thirty-six out of 75 patients elected for telemedicine follow-up after early pregnancy loss. Of patients scheduled for telemedicine follow-up, 29/36 (81%, 95% CI: 64-92) with early pregnancy loss and 64/69 (93%, 95% CI: 84-98) undergoing medication abortion completed follow-up as per protocol (p = 0.06). Completed follow-up was also similar among patients undergoing medication management of early pregnancy loss who planned for in-person follow-up (p = 0.135). Complications were rare and did not differ across early pregnancy loss and medication abortion groups. Conclusions: Telemedicine follow-up is a feasible alternative to in-person assessment after medication management of early pregnancy loss.

19.
Obstet Gynecol ; 2024 Jun 18.
Article in English | MEDLINE | ID: mdl-38889434

ABSTRACT

OBJECTIVE: To use choice-based conjoint survey methodology to evaluate patient values and decision making regarding immediate compared with delayed placement of postpartum intrauterine devices (IUDs). METHODS: We conducted a cross-sectional study in which we surveyed 200 nonpregnant, parous patients. Participants chose between hypothetical postpartum IUDs varying in multiple attributes (hormonal or nonhormonal IUD type, placement timing, 1-year efficacy, expulsion risk, risk of lost strings, and malposition risk). The primary outcome was preference for immediate compared with delayed postpartum IUD placement and importance of placement timing relative to other attributes. Secondarily, we evaluated whether demographic and neighborhood characteristics were associated with timing preference and attribute importance. RESULTS: We included 190 participants for analysis. Most participants (62.6%) preferred delayed placement. There was no significant difference in timing preference by race (P=.28) or block-level Area Deprivation Index score (P=.27). Patients who preferred immediate placement were more likely to have public insurance than private insurance (70.4% vs 29.6%, P=.04); however, the majority of patients (55.1%) with public insurance still preferred delayed placement. Attributes of IUD type, malposition risk, 1-year efficacy, and expulsion risk all had greater effects on patient decision making than placement timing. There was no difference in attribute importance by race (P=.30), Area Deprivation Index score (P=.88), or insurance type (P=.22). CONCLUSION: Patients preferred the higher efficacy and lower complication rates of delayed postpartum IUD placement over the convenience of immediate placement. Insurance considerations may affect these timing preferences. There was no difference in attribute importance between demographic groups or based on neighborhood-level factors, indicating that, although both immediate and delayed postpartum IUD placement should be offered, counseling should not vary according to individual demographic characteristics.

20.
Obstet Gynecol ; 143(4): 550-553, 2024 Apr 01.
Article in English | MEDLINE | ID: mdl-38262065

ABSTRACT

Previable and periviable rupture of membranes is associated with significant morbidity for the pregnant patient. For those who have a choice of options and undergo active management, it is not known how the risks of induction of labor compare with those for dilation and evacuation (D&E). We performed a retrospective cohort study of patients with rupture of membranes between 14 0/7 and 23 6/7 weeks of gestation who opted for active management. Adverse events (52.2% vs 16.9%, P <.01) and time to uterine evacuation greater than 24 hours (26.7% vs 9.6%, P =.01) were more common among patients undergoing induction of labor. In a multivariable regression, induction of labor was an independent risk factor for complications (odds ratio 5.70, 95% CI, 2.35-13.82) compared with D&E. Severe complications were rare across both groups (4.4% for patients undergoing induction vs 2.6% for D&E, P =.63). Given the differing risks by termination method, access to D&E is an important treatment option for this patient population.


Subject(s)
Abortion, Induced , Pregnancy , Female , Humans , Pregnancy Trimester, Second , Abortion, Induced/methods , Retrospective Studies , Dilatation , Labor, Induced/adverse effects , Labor, Induced/methods
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