bluuebunny/crossref_metadata_2025_split huggingface dataset:
Genitourinary Side Effects With the Vaginal pH Regulator: Results From AMPOWER [19I]
Authors: Maximos Bassem , Culwell Kelly , Dart Clint , Howard Brandon 
Published: April 2020

INTRODUCTION:
The investigational vaginal pH regulator (VPRTM) is a non-hormonal, woman-controlled contraceptive vaginal gel. The objectives of the current analysis are to report on genitourinary (GU) side effects with VPR based on the phase 3 AMPOWER trial.

METHODS:
AMPOWER was a single-arm, open-label, IRB-approved, multi-center trial based in the United States (NCT03243305). Women, aged 18-35 years, administered VPR intravaginally up to 1 hour before each episode of vaginal intercourse. The primary study objective was contraceptive efficacy over 7 cycles of use. Safety was assessed through adverse event reporting.

RESULTS:
In 1,330 women included in the safety analysis, the most common adverse events (10% or greater) were vaginal burning (20.0%) and itching (11.2%). Rates of vaginal burning and itching generally decreased over time (burning: Cycle 0=11.2%, Cycle 3=4.2%, Cycle 7=1.4%; itching: 4.5%, 1.1%, and 0.3%, respectively). Rates of burning and itching by act of intercourse were lower when VPR was used once/day (2.1% and 0.7%, respectively) compared to 2 or more times/day (4.6% and 1.0%, respectively). In women who had GU infections on-study (n=77), rates of burning (32.5%) and itching (22.1%) were higher than in the general study population. Women with a history of bacterial vaginosis (n=245) had similar rates of burning (21.6%) and itching (12.7%) compared to the general study population. Overall, 1% [13/1330] of women discontinued due to GU symptoms.

CONCLUSION:
In the phase 3 AMPOWER trial, rates of GU symptoms with VPR decreased substantially over time, with higher rates reported in women with existing GU infections compared to the general study population.
Innovative Trial Design Using Digital Approaches: An Example From Reproductive Medicine [21I]
Authors: Hamvas Györgyi , Hofmann Anja , Sakalidis Vanessa , Goodale Brianna , Shilaih Mohaned , Leeners Brigitte 
Published: April 2020

INTRODUCTION:
Loss to follow-up and missing data are common reasons why clinical studies fail. In a site-less digital clinical trial we assessed the accuracy of a wearable fertility tracker, where we examined participants’ retention, compliance, and satisfaction with the site-less design.

METHODS:
In this IRB approved study, participants were recruited remotely through social media, online platforms, and email invitations. Participants wore the Ava Fertility Tracker for up to 6 menstrual cycles, took body temperature and urinary luteinizing hormone tests. We collected all self-reported outcomes and wearable device data via a mobile app, wherein the study coordinator could monitor compliance and send participation reminders. An independent customer support team provided technical support. Participants gave input on the site-less study design via an online survey.

RESULTS:
Fifty-six Swiss women completed the satisfaction survey (85% of the 66 enrolled study participants), rating their experience with social media recruitment (83%), online registration (98%) and online invitations (98%) as good or very good. Almost two-thirds of respondents considered the trial design easy to integrate into their everyday life. Most participants were highly satisfied with the technical support (78%), while 98% reported the study coordinator’s remote support as very helpful.

CONCLUSION:
Our predominantly digital approach resulted in high rates of completion (92%) and procedural compliance (87%), while maintaining participant satisfaction. This suggests site-less designs in reproductive health research could increase the quality and quantity of clinical data collected while minimizing participation burden. Future replication studies with longer follow-up times should consider whether the sampled population is biased towards digital natives.
Is There Sperm in Pre-ejaculate? How to Study Pre-ejaculate to Determine Contraceptive Efficacy for Withdrawal [23I]
Authors: Patel Jasmine , Nelson Anita L. , Nguyen Brian T. 
Published: April 2020

INTRODUCTION:
The perfect-use failure rate of withdrawal for contraception is not informed by controlled clinical trials, but rather inferred by the presumption of sperm in the pre-ejaculate. Several studies comprising a range of collection and examination methods provide contradictory data, highlighting the importance of a review that summarizes previous evaluation methods and defines optimized research methods.

METHODS:
We included peer-reviewed literature indexed in PubMed, EMBASE, and Web of Science that evaluated the sperm content of pre-ejaculatory fluid as a defined outcome. Pre-ejaculate collection and evaluation methods were identified for each study, assessing strengths, limitations, and the validity of conclusions drawn from the findings. These findings were synthesized to provide optimal guidelines for evaluating the contributory risk of pre-ejaculate in contraceptive failure.

RESULTS:
Of six human trials examining the sperm content of pre-ejaculatory fluid, three concluded that sperm was absent from their samples, however small sample size and selection bias were present. Four studies examined dried preparations, which could not evaluate motility nor measure volume. Only two differentiated between pre-ejaculate and ejaculate. No studies reported on participant characteristics or behavioral antecedents that might influence collection of an uncontaminated sample.

CONCLUSION:
Previous pre-ejaculate research have methodological problems that limit the reliability of their findings. Future research should measure and examine wet and dry specimens, differentiate between pre-ejaculate and ejaculate, examine sperm for motility and concentration, as well as query for clinical factors associated with sperm leakage and presence in the pre-ejaculate. Findings via these methods will better inform guidance on pregnancy risk with pre-ejaculate and withdrawal.
Logistical Barriers to Obtaining a Hospital-Based Abortion in New Jersey [25I]
Authors: Unsal Aylin , Segui Morit , Vlahos Alec , Musa Tina , Barlog Lauren , Brandi Kristyn 
Published: April 2020

INTRODUCTION:
Many women face logistical obstacles delaying access to abortion. This study aimed to identify logistical barriers to care in women obtaining hospital-based abortions in New Jersey (NJ) a state with limited restrictions.

METHODS:
This prospective cross-sectional study of women seeking abortion care at University Hospital in Newark surveyed participants using questions from the Guttmacher Institute’s “National Survey of Women Having Abortions.” IRB approval and informed consent were obtained prior to patient enrollment. Cross-sectional comparisons were made using Wilcoxon rank-sum tests and likelihood ratios.

RESULTS:
Of 121 patients, 93 women (81.8%) cited yearly household income below $40,000 with 59 (51.7%) reporting a yearly household income below $20,000. Length of time to abortion is significantly longer in women with a household income <$40,000 compared to those with incomes >$40,000 (32.98+/-27.2 days vs. 17.3+/-10.3 days, P=.03). Twenty (17.1%) cite high treatment cost as a factor hindering earlier abortion. Similarly, 12 (10.3%) cite transportation issues as another barrier. Time to abortion is significantly longer for those who cited cost and transportation as barriers compared to those who did not report this (26.4+/-20.2 days vs. 47.9+/-39.8 days, P=.039; 28.4+/-25.6 days vs. 45.5+/-23.3 days, P=.006, respectively). Age, race, ethnicity, and educational status are not significantly associated with time to abortion.

CONCLUSION:
Access to abortion services in NJ are limited by logistical barriers to care, particularly for women with lower yearly household income and lack of transportation. Providing financial and transportation support for patients may improve access to abortion.
Patient-Reported Outcomes of Peripartum Contraceptive Care Quality [29I]
Authors: Peahl Alex , Bonawitz Kirsten , Owens Lauren , Dehlendorf Christine , Kolenic Giselle , Moniz Michelle 
Published: April 2020

INTRODUCTION:
Patient-reported outcomes are underutilized in peripartum populations. Little is known about the patient experience of care, and some studies raise concern that care is not always respectful nor patient-centered. We evaluated patient-reported outcomes of peripartum contraceptive care to guide future quality improvement efforts.

METHODS:
We conducted a cross-sectional, online survey at a tertiary care center in September/October 2018 using two convenience samples: pregnant women (32+ weeks gestation) and postpartum women (4-8 weeks postpartum). We evaluated patient contraceptive care experiences at prenatal visits (pregnant sample) and during childbirth hospitalizations and postpartum visits (postpartum sample). We used the validated, 4-item Patient-Centered Contraceptive Counseling [PCCC] measure (positive score, all items rated excellent), analyzing data with descriptive statistics.

RESULTS:
We included 117 pregnant patients (response rate 49.5%) and 84 postpartum patients (response rate 43.8%). Participants were largely white (87.1%), aged 25-35 years (66.7%), college graduates (77.6%), and wanting to avoid pregnancy for 2 or more years (63.2%). Positive PCCC scores varied across practice settings (prenatal visit, 66.7%, childbirth hospitalization, 45.2%, postpartum visit, 68.8%). On individual PCCC items, “Excellent” ratings were least common for “my provider gave me enough information to make the best decision about my birth control method” (prenatal visit, 68.9%, childbirth hospitalization, 50.6%, postpartum visit, 69.1%), and “my provider let me say what mattered to me about my birth control method” (prenatal visit, 78.8%, childbirth hospitalization, 63.1%, postpartum visit, 76.3%).

CONCLUSION:
Findings suggest opportunities to improve patient-centeredness in peripartum contraceptive care, with a goal of providing adequate information and respecting patient preferences and priorities.
Perfect-Use Pregnancy Rates With the Vaginal pH Regulator: Efficacy Results From AMPOWER [30I]
Authors: Chappell B. Todd , Culwell Kelly , Dart Clint , Howard Brandon 
Published: April 2020

INTRODUCTION:
To address women’s unmet contraceptive needs, the investigational vaginal pH regulator (VPR™) was developed as a novel, non-hormonal, woman-controlled vaginal gel. The IRB-approved, phase 3 AMPOWER study met its primary efficacy endpoint: the typical-use 7-cycle cumulative pregnancy percentage with VPR was 13.7% (95% CI 9.91%, 17.39%) (Thomas et al, ASRM 2019). Here we present perfect-use VPR efficacy results.

METHODS:
AMPOWER (NCT03243305) was a single-arm, open-label, confirmatory trial conducted at 112 U.S. sites. Women were instructed to administer a single prefilled applicator of study drug intravaginally before each episode of intercourse. For inclusion in the perfect-use analyses, study cycles met rigorous criteria including: 21 to 35-day cycle; no back-up or emergency contraception; 1 or more recorded act of intercourse; and correct use of VPR for every act of intercourse in that cycle, per eDiaries. To more accurately evaluate efficacy, the perfect-use analysis was repeated to remove factors that confounded efficacy assessment in ad hoc sensitivity analyses.

RESULTS:
AMPOWER enrolled 1,384 women; in the efficacy-evaluable population (n=1,003), the perfect-use 7-cycle cumulative pregnancy percentage was 9.99% (95% CI 7.17%, 12.81%). When including all 21 to 42-day cycles and removing subjects with incomplete washout of previous hormonal contraceptive and removing pregnancies from cycles with inconsistent eDiary reporting, the 7-cycle cumulative pregnancy percentage ranged from 6.67% (95% CI 4.61%, 8.73%) based on all evaluable cycles to 8.44% (95% CI 5.90, 10.98%) based on perfect-use cycles.

CONCLUSION:
Using multiple sensitivity analyses to determine perfect-use efficacy, women’s 7-cycle cumulative pregnancy percentage ranged from 6.67% to 9.99% with VPR.
Pulling Away From Pulling Out? A Survey of Family Planning Providers’ Perceptions of Withdrawal [31I]
Authors: Or Maya , Nelson Anita L. , Nguyen Brian T. , Patel Jasmine 
Published: April 2020

INTRODUCTION:
While more than half of women report ever using withdrawal for contraception, family planning providers have limited evidence with which to counsel patients; their attitudes may vary, leading to inconsistent patient counseling. We examined providers’ perspectives on the efficacy of withdrawal and their patients’ use of withdrawal for contraception.

METHODS:
We examined provider perspectives on withdrawal by distributing an IRB-approved close and open-ended survey to healthcare professionals attending women’s health contraception conferences in 2019. Free-response items underwent content analysis and coding for salient themes, which were modified iteratively until adequate inter-rater agreement was reached; remaining responses were coded independently. Pearson chi-square tests demonstrated associations between provider characteristics and salient themes.

RESULTS:
Nearly all (n=422/445, 95%) approached individuals participated in the survey. Providers’ positive and open-minded attitudes on withdrawal significantly differed from their perceptions of their colleagues’ negative attitudes (P<.01). Providers suggested that withdrawal might be appropriate for pregnancy ambivalent individuals (155/422, 36.8%) or those in a monogamous relationship (70/422, 16.6%). Successful use of withdrawal was thought to be linked to education on the method (119/422, 28.2%) and physiologic awareness (107/422, 25.4%). Providers linked premature ejaculation (104/422, 24.6%) to withdrawal failure.

CONCLUSION:
While family planning providers were generally open-minded to withdrawal use, they perceived negative attitudes from their peers, which may influence their patient interactions and counseling. While education was thought to positively influence the successful use of withdrawal, it remains unclear whether providers were referring to education on efficacy versus operationalizing the method. Further research on factors associated with successful withdrawal is needed.
Sociodemographic Trends in Long Acting Reversible Contraception vs. Female Sterilization, 2006-2017 [33I]
Authors: Beshar Isabel B. , Chelvakumar Meena , So Jodi , Cahill Erica P. , Shaw Kate A. , Shaw Jonathan G. 
Published: April 2020

INTRODUCTION:
Historically, female sterilization (FS) has been disproportionately concentrated among racial minorities and women with lower education and income. Given increasing popularity of long-acting reversible contraception (LARC), we examined changing socio-demographic patterns of FS and LARC usage.

METHODS:
We used data files from the National Survey of Family Growth 2006-2010 (earlier) and 2015-2017 (later) survey waves. We analyzed all women of reproductive age not seeking pregnancy, with a sub-analysis of FS and LARC, and extracted socio-demographic information.

RESULTS:
We included 11,073 respondents. From the earlier to later cohort, the prevalence of LARC increased 3-fold (7% to 20%), while FS dropped (25% to 22%). In our sub-analysis comparing LARC vs FS users (n=3918), the adjusted likelihood of LARC use was greater in the later cohort (OR 2.3 [1.6, 3.4]). When comparing LARC to FS in both cohorts, there were non-significant trends of reduced LARC use in black women (OR 0.51 [0.3, 1.1]), while Hispanic women emerged as more likely to use LARCs in the later cohort (OR 1.5 [0.9, 2.7]). Overall, the most significant predictors of LARC use in the later cohort remained younger age (>35), higher income ($75,000), and more education (OR 3.6 [1.9, 6.6], 5.3 [1.8, 15.9], and 4.5 [2.1, 9.7], respectively). Living in a metropolitan area emerged as a new predictor of LARC use over FS in the later cohort (OR 3.0 [1.3, 7.3]).

CONCLUSION:
Although LARC use increased and FS decreased, the most significant predictors of LARC over FS include higher income, more education and metropolitan residence, suggesting inequities in access.
The Impact of Body Mass Index on Bleeding Pattern in Women Discontinuing Usage of a Subdermal Contraceptive Implant [34I]
Authors: Davis Susan , Hansen Katie , Pike Jordyn , Gabriel Kelley , Tristan Bri 
Published: April 2020

INTRODUCTION:
The etonogestrel subdermal contraceptive implant is among the most effective contraceptive methods available. The most common associated side effect is irregular menstrual bleeding. Approximately 15% of users discontinue implant usage prematurely due to unacceptable bleeding. Understanding of how obesity impacts the side effect profile of the implant is limited, since the initial clinical trials excluded obese patients. However, recent studies have suggested that obese patients are less likely report irregular or heavy bleeding than are their normal-weight counterparts, although these studies were small and examined predominately white patients. We sought to study whether BMI impacted the bleeding pattern of implant users in our large, racially diverse population.

METHODS:
This study was deemed exempt from the UT Austin IRB. We conducted a chart review of patients in Austin’s CommUnity Care clinic system who had an implant removed between 2012 and 2017. For each subject, we abstracted age, race/ethnicity, gravidity/parity, BMI, and indication for implant discontinuation. Univariate analysis was conducted to determine whether the reason for implant discontinuation varied between underweight, normal-weight, overweight, and obese patients.

RESULTS:
Data were abstracted for 636 subjects. 40% of normal-weight subjects discontinued usage of a contraceptive implant due to irregular bleeding, compared to 55% of underweight and 26% of obese subjects. Duration of implant usage did not vary between BMI classes.

CONCLUSION:
Underweight women were more likely to discontinue implant usage due to irregular bleeding than normal-weight women, and obese women were less likely to do so. This may guide counseling regarding expected bleeding pattern for prospective implant users.
Trends in Contraceptive Methods Among Substance Abusers Reveals Unmet Need [36I]
Authors: Freer Katherine , Hopper Taylor , Kruse Alexandra , Robinson William R. 
Published: April 2020

INTRODUCTION:
Female substance abusers are a vulnerable population facing numerous barriers to care, especially gynecological health. Access to contraception is a crucial part of women’s health; however, research on contraceptive use in substance abusers is limited. Our aim was to investigate contraceptive methods in a women’s substance abuse rehabilitation facility.

METHODS:
Data was taken from 697 intake surveys of reproductive-aged women between 2013 and 2019. Analysis examined contraceptive use by sociodemographic variables. Trends were compared with data from 2015-2017 National Surveys of Family Growth and 2017 state-level data from the CDC.

RESULTS:
The majority of women did not use contraceptives (40.3%), were sterilized (22.7%) or used condoms (21.1%). Compared to national and Louisiana-specific rates, this data reveals significantly higher proportions of no contraception and sterilization; conversely, there were lower rates of hormonal and long-acting reversible contraceptive methods (6.9; 4.9%). Substance-abusing women reported sterilization at a younger age (37) compared to national averages. 64.8% reported Medicaid enrollment; education and insurance were independent of contraceptive choice (X2=5.76, P=.22; X2=3.15, P=.53; P<.05).

CONCLUSION:
Women in rehabilitation reported both a high rate of sterilization, and limited use of reversible contraceptives. Lack of variability in method could include amenorrhea from chronic substance use, mistrust of the healthcare system, and inadequate education on gynecological health. Residential rehabilitation facilities provide a unique opportunity for providers to deliver contraceptive education in a positive, encouraging environment, while women are focused on making positive lifestyle changes. Addressing this need would give these women greater autonomy over their health and fertility.
Weight Gain Associated With LARC Within a Racially Diverse Patient Population [38I]
Authors: Hattiangadi Rohan 
Published: April 2020

INTRODUCTION:
This study aims to evaluate and compare weight gain in reproductive-age women using long acting reversible contraception over 12, 36 and 60-month periods.

METHODS:
Retrospective cohort study of 36,584 female patients between 15 and 45 years old with either the LNG-IUS, ENG implant or copper IUD for at least 12 consecutive months between April 2008 and April 2017. A Kruskal-Wallis test was performed to compare the magnitude of weight gain at the specified time intervals. The influence of race and age were evaluated through multivariate linear regression. IRB approval was obtained.

RESULTS:
After 12 months, copper IUD and LNG-IUS users lost weight (0.58 and 0.08 kg, respectively), while ENG implant users gained weight 1.15 kg (P<.01). After 36 months, copper IUD users gained 0.46 kg, LNG-IUS users gained 0.72 kg and ENG implant users gained 3.84 kg (P<.01). After 60 months, LNG-IUS users gained twice as much weight as copper IUD users (1.52 and 0.87 kg, respectively). Black and Hispanic women gained more weight than white and Asian women, especially in those younger than 35 years old. (P<.01).

CONCLUSION:
At 12 and 36 months, ENG implant users demonstrated both statistically and clinically significant weight gain compared to LNG-IUS and copper IUD users. However, in the adjusted model, only ENG implant users younger than 35 demonstrated a significant weight gain. Race proved to be a predictor of weight gain. These observations may help counsel women towards an appropriate LARC method, taking into consideration age and race.
Association of Immediate Postpartum Etonogestrel Implant Insertion and Venous Thromboembolism [01J]
Authors: Floyd Jessica L. , Beasley Anitra , Swaim Laurie S. , Turrentine Mark , Nijjar J. Biba 
Published: April 2020

INTRODUCTION:
Placement of the etonogestrel contraceptive implant (ECI) during the delivery admission provides immediate, reliable and convenient contraception. The implant manufacturer recommends delaying placement until 21 days postpartum due to concern for increased risk of postpartum venous thromboembolism (VTE). This study compares the rate of VTE between women with and without delivery admission contraceptive implant insertion.

METHODS:
The Nationwide Readmissions Database from 2016 was used to identify women with a singleton delivery, immediate postpartum ECI, and readmission for VTE within 30 days of discharge. Those with a prior history of VTE or anticoagulant therapy were excluded. These women were compared to the number of women readmitted for VTE who did not have the contraceptive implant placed during delivery admission.

RESULTS:
Of 3,387,120 deliveries, 8,369 women underwent ECI placement during the delivery admission. Of women readmitted with VTE, 7 had received a postpartum ECI (0.8 per 1,000 deliveries) compared to 1,192 without an ECI (0.4 per 1,000 deliveries), Odds Ratio (OR) 2.41; 95th CI 0.58-9.89. The rates of diabetes, thrombophilia, lupus and cesarean delivery did not differ between groups. Women that underwent ECI placement were younger, on Medicaid, smoked, had hypertension, intrauterine growth restriction, peripartum infection, or postpartum hemorrhage (P<.01). Adjusting for these confounders showed no impact, adjusted OR 1.80; 95th CI 0.44-7.37.

CONCLUSION:
No significant difference was noted in the rate of VTE in women after immediate postpartum insertion of the ECI, suggesting that the implant may not be associated with VTE if placed in the immediate postpartum period.