Pregnancy Intention Screening in Patients With Systemic Rheumatic Diseases: Pilot Testing a Standardized Assessment Tool.

OBJECTIVE: Systemic rheumatic conditions affect reproductive-aged patients and often require potentially teratogenic medications. We assessed the feasibility and impact of a standardized pregnancy intention screening question (One Key Question [OKQ]) in a large academic rheumatology practice. METHODS: This 6-month pilot quality improvement initiative prompted rheumatologists to ask female patients aged 18 to 49 years about their pregnancy intentions using OKQ. We administered surveys to assess rheumatologists' barriers to and comfort with reproductive health issues. We performed chart reviews to assess uptake and impact on documentation, comparing charts with OKQ documented with 100 randomly selected charts eligible for pregnancy intention screening but without OKQ documented. RESULTS: When we compared 32 of 43 preimplementation responses with 29 of 41 postimplementation responses, the proportion of rheumatologists who reported they were very comfortable with assessing their patients' reproductive goals increased (31%-38%) and the proportion reporting obstetrics and gynecology (OB/GYN) referral challenges as barriers to discussing reproductive goals decreased (41%-21%). During the implementation period, 83 of 957 (9%) eligible patients had OKQ documented in their chart. Female providers were more likely to screen than male providers (odds ratio 2.42, 95% confidence interval 1.21-4.85). Screened patients were more likely to have their contraceptive method documented (P < 0.001) and more likely to have been referred to OB/GYN for follow-up (P = 0.003) compared with patients who were not screened with OKQ. CONCLUSION: Although uptake was low, this tool improved provider comfort with assessing reproductive goals, the quality of documentation, and the likelihood of OB/GYN referral. Future studies should examine whether automated medical record alerts to prompt screening increase uptake.

Prescription opioid fills following surgical abortion.

OBJECTIVE: To characterize opioid fills after surgical abortion among US commercially-insured women. STUDY DESIGN: We identified women aged 15-50 years with an outpatient claim for dilation and curettage or evacuation surgical abortion (D&C/D&E) in IBM MarketScan 2015-2018 and excluded patients with > 1 opioid fill in the prior 90 days, evidence of opioid dependence or abuse in the prior 180 days (baseline), miscarriage in 7 days prior, or mifepristone use in 3 to 7 days prior. We describe the frequency of an oral opioid fill within 7 days after abortion, refill within 42 days of initial fill, and chronic use (≥ 6 fills) in 1 year after abortion. We used multivariable logistic regression to evaluate predictors of opioid fill including patient and procedure characteristics. RESULTS: Among 28,252 patients who underwent induced surgical abortion, 2,340 (8.3%) filled an opioid prescription within 7 days. The strongest predictors of opioid fill were non-Northeast region, use of moderate sedation for the procedure, and baseline depression. Among 2,250 patients with an initial fill and sufficient follow-up, 10.0% had a refill within 42 days of initial fill. Among 15,353 patients with sufficient follow-up, patients with an opioid fill after abortion had a higher percentage of subsequent chronic use than those without (2.1% and 0.4%, respectively). CONCLUSION: The frequency of an opioid fill after surgical abortion among commercially-insured women was notable given it is not recommended for post-procedural analgesia. Opioid prescribing contrary to recommendations may be associated with subsequent chronic use or abuse. IMPLICATIONS STATEMENT: Despite public health efforts to decrease opioid prescribing, these findings suggest opioid prescribing after surgical abortion as a potential source of overprescribing among commercially insured patients in the United States. As surgical abortion is a minimally-invasive procedure, prescribing opioids for use in this setting may contribute to chronic use.

Gender diversity among aspiration-abortion patients.

OBJECTIVE: Describe the array of gender identities among procedural abortion patients. STUDY DESIGN: Cross-sectional survey of abortion patients in three clinics in Massachusetts. Following aspiration abortion procedures and prior to discharge, patients self-administered a survey on a tablet. RESULTS: From November 2017 through July 2018, 1,553 aspiration abortion patients completed the survey (participation rate: 82%). Patients reported several gender identities. Non-binary (0.4%) and agender (0.4%) were the most common identities after female (91.1%) and woman (6.0%). Overall, 2.7% of patients identified as a gender other than female or woman. CONCLUSION: Aspiration abortion patients have a variety of gender identities. To promote quality of care for all patients, abortion providers can ensure their names, marketing materials, patient forms, and clinical environments are gender inclusive rather than focusing on women's health.

A randomized comparison of intravenous sedation using a dosing algorithm compared to standard care during first-trimester surgical abortion.

OBJECTIVE: The objective was to compare the safety and efficacy of an algorithm for abortion intravenous sedation dosing (AAID) to standard dosing during first-trimester surgical abortion. STUDY DESIGN: This was a randomized, single-blinded, controlled trial in which women undergoing first-trimester surgical abortion received fentanyl and midazolam dosed per either an algorithm or clinic standard. Patient-level factors including weight, airway risk, anxiety, and drug and alcohol use determined AAID doses. The primary outcome was pain with suction curettage measured immediately on a 21-point verbal numerical rating scale ranging from 0 to 100. Secondary outcomes included pain with cervical dilation and postprocedure, intraoperative pain as recalled postprocedure, need for additional doses of medication, oxygen saturation<93%, sedation level, adverse events, side effects and patient satisfaction. RESULTS: We enrolled 196 women and randomized 98 to the AAID and 98 to standard care. Baseline factors were similar between groups. Median intraoperative pain scores did not differ between groups when measured immediately (47.5 vs. 50, p=.81) or on recall (30 in both arms, p=.68). There were no significant differences in other secondary outcomes. Women with a body mass index (BMI) 30-35 trended toward improved pain control with the algorithm (60 vs. 27.5, p=.07). CONCLUSIONS: Intravenous sedation determined by an algorithm did not produce differences in pain scores in a setting with highly experienced providers. IMPLICATIONS: An intravenous sedation algorithm did not demonstrate significant benefit for the general population of surgical abortion patients. Providers with less experience titrating intravenous sedation might find it a helpful tool to guide sedation dosing. A possible benefit in obese patients warrants further study.

Moderate intravenous sedation for first trimester surgical abortion: a comparison of adverse outcomes between obese and normal-weight women.

OBJECTIVE: To determine if obese women experience increased rates of adverse outcomes with moderate intravenous sedation during first trimester surgical abortion compared to normal weight women. STUDY DESIGN: We performed a retrospective cohort study of all first trimester surgical abortions with moderate intravenous sedation at an outpatient facility between September 2010 and June 2015. The primary outcome was supplemental oxygen administration. Secondary outcomes included reversal agent administration, anesthesia-related adverse events, and intraoperative lowest level of consciousness (LLOC). We compared three obesity groups [I (Body Mass Index, BMI=30-34.9), II (BMI=35-39.9), and III (BMI ≥40)] to normal weight women (BMI <25). We exported data from electronic medical records and reviewed adverse outcomes individually. RESULTS: Of 20,381 first trimester surgical abortion procedures, 31 (0.15%) utilized supplemental oxygen, 24 (0.12%) utilized a reversal agent, 40 (0.20%) had a presumed anesthesia-related adverse event and 184 of 19,725 (0.93%) had a documented low intraoperative LLOC. One patient (0.005%) required hospital transfer or hospitalization. Supplemental oxygen administration (obesity versus normal weight: obese I, aOR 0.52, 95% CI 0.12-2.27; II/III, aOR 1.51, 95% CI 0.50-4.54), low intraoperative LLOC, and anesthesia-related adverse events were not associated with obesity. The rate of reversal agent administration was lower among obese I, II and III women combined compared to normal weight women (aOR 0.13, 95% CI 0.02-0.96). CONCLUSIONS: Adverse outcomes were rare across all BMI categories with no detectable increased risk among obese women compared to normal weight women. IMPLICATIONS: With appropriate clinical screening, obese women can safely receive moderate intravenous sedation for first trimester surgical abortion in an outpatient clinical setting. Restrictions on moderate intravenous sedation based on BMI alone may be unnecessary.

Naproxen Sodium for Pain Control With Intrauterine Device Insertion: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether 550 mg oral naproxen sodium given 1 hour before intrauterine device (IUD) insertion is effective for pain relief as compared with placebo. METHODS: This was a randomized, double-blind, placebo-controlled trial. The primary outcome was pain with IUD insertion measured on a 100-mm visual analog scale (VAS). Our sample size was calculated to detect a 15-mm difference in VAS scores with 80% power (α=0.05). Secondary outcomes included pain with tenaculum placement, uterine sounding, and 5 and 15 minutes postinsertion. RESULTS: A total of 118 women were enrolled and analyzed (58 in the naproxen sodium arm, 60 in the placebo arm, 97% nulliparous) between May 11, 2015, and March 25, 2016. There were no differences in baseline demographics or reproductive characteristics between arms. There were no differences in median VAS pain scores for the primary outcome of pain with IUD insertion between the naproxen sodium arm compared with the placebo arm (69 compared with 66 mm, P=.89). There were no differences in the secondary outcomes of median VAS pain scores with tenaculum placement (37 compared with 32 mm, P=.97) or uterine sounding (60 compared with 58 mm, P=.66). However, median pain scores postprocedure were lower in the naproxen arm as compared with the placebo arm: 17 compared with 26 mm (P=.01) at 5 minutes and 13 compared with 24 mm (P=.01) at 15 minutes postinsertion. CONCLUSION: Oral naproxen sodium does not reduce pain with IUD insertion but does reduce pain after insertion and should be considered as a premedication. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, http://clinicaltrials.gov, NCT02388191.

Intramuscular ketorolac versus oral ibuprofen for pain relief in first-trimester surgical abortion: a randomized clinical trial.

OBJECTIVE: Oral nonsteroidal antiinflammatory medications (NSAIDs) have been shown to reduce pain with first-trimester surgical abortion compared to placebo, but it is unclear if one NSAID is better than another. Some providers administer intramuscular ketorolac, though data regarding its efficacy in abortion are limited. This study was designed to compare oral ibuprofen to intramuscular ketorolac for pain management during first-trimester surgical abortion. STUDY DESIGN: This was a randomized, double-blind, controlled trial. Women undergoing first-trimester surgical abortion with local anesthesia were randomized to preprocedural oral ibuprofen, 800 mg given 60-90 min preprocedure, or intramuscular ketorolac, 60 mg given 30-60 min preprocedure. The primary outcome was pain with uterine aspiration on a 21-point, 0-100, numerical rating scale. Secondary outcomes included pain with cervical dilation, postoperative pain and patient satisfaction. RESULTS: Ninety-four women were enrolled; 47 were randomized to ibuprofen and 47 to ketorolac. The groups did not differ with regards to demographics, reproductive history or Depression Anxiety Stress Scale scores. Mean pain scores for suction curettage did not differ between groups (52.3 vs. 56.2, p=.53). There was also no difference in pain with cervical dilation (41.6 vs. 45.4, p=0.48) or postoperative pain (22.3 vs. 15.0 p=.076), though patients in the ketorolac group experienced significantly greater arm pain than those who received a placebo injection (30.4 vs. 15.6, p<.001). Satisfaction with pain control did not differ significantly by group. CONCLUSIONS: Intramuscular ketorolac does not offer superior pain control compared to oral ibuprofen for first-trimester surgical abortion. IMPLICATIONS: Intramuscular ketorolac does not offer superior pain control over oral ibuprofen during first-trimester surgical abortion, is more expensive and causes patients significant arm discomfort. Its use should therefore be reserved for patients who cannot tolerate oral NSAIDs.

Malpositioned intrauterine contraceptive devices: risk factors, outcomes, and future pregnancies.

OBJECTIVE: To assess possible risk factors, management, and outcomes for women with malpositioned intrauterine contraception devices (IUDs). METHODS: This retrospective case-control study compared 182 women with malpositioned IUDs shown by ultrasonography at a single institution from 2003 to 2008 with 182 women with properly positioned IUDs. We evaluated whether insertion at 6-9 weeks postpartum, postabortion placement, breastfeeding, type of IUD, pregnancy history, leiomyomas, suspected adenomyosis, and indication for placement were associated with malpositioning. Our study had 70-99% power to detect whether postpartum placement was associated with an odds ratio (OR) of 2-3. RESULTS: Malpositioned devices were noted on 10.4% of ultrasonography scans among women with IUDs having pelvic ultrasonography for any indication. Most malpositioned devices (73.1%) were noted to be in the lower uterine segment or cervix. Insertion of IUDs at 6-9 weeks postpartum was not associated with malpositioning (OR 1.46, 95% confidence interval [CI] 0.81-2.63). Among other possible risk factors examined, suspected adenomyosis was associated with IUD malpositioning (OR 3.04, 95% CI 1.08-8.52), whereas prior vaginal delivery (OR 0.53 95% CI 0.32-0.87) and private insurance (OR 0.38, 95% CI 0.24-0.59) were protective. Approximately two-thirds (66.5%) of malpositioned devices were removed by health care providers. There were more pregnancies within 2 years among those in the case group than those in the control group (19.2% compared with 10.5%, P=.046). All pregnancies were the result of IUD expulsion or removal, and none occurred with a malpositioned IUD known to be in situ. CONCLUSION: Malpositioning of IUDs does not appear to be associated with insertion at 6-9 weeks postpartum. Women with malpositioned IUDs are more likely to become pregnant because of IUD removal without initiation of another highly effective contraceptive method.

Human Papillomavirus (HPV), HPV-Related Disease, and the HPV Vaccine.

Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States, and persistent HPV infection is strongly associated with risk of cervical cancer and genital warts. The recently approved quadrivalent HPV vaccine targets the HPV strains responsible for approximately 70% of cervical cancers and 90% of genital warts. It is also effective in reducing the incidence of HPV-related conditions, especially when given prior to exposure to HPV. The vaccine is recommended for all girls aged 11 to 12 with catch-up vaccination for women up to age 26, and most insurance plans cover the vaccine. A second bivalent HPV vaccine is currently pending approval by the US Food and Drug Administration (FDA). HPV vaccination reduces the incidence of HPV-related cancers and precancerous lesions in the United States and abroad, though decisions regarding implementation of vaccination remain.

A reliable, valid instrument to assess patient knowledge about urinary incontinence and pelvic organ prolapse.

The objective of this study is to develop a reliable, validated questionnaire to assess patient knowledge about urinary incontinence (UI) and pelvic organ prolapse (POP). We designed a written questionnaire comprised of UI and POP scales and administered it to 133 gynecologic and 61 urogynecologic patients. We performed a principal components factor analysis for UI and POP items and assessed construct validity, internal consistency, and stability of each scale. For both scales, mean total urogynecologic group scores exceeded those for gynecologic patients (P values < 0.001), suggesting construct validity. Both scales had excellent internal consistency (Cronbach's alpha > 0.8). Mean test scores were slightly higher upon retest (UI, 0.46, P = 0.046; POP, 0.33, P = 0.126). Pearson's correlation between initial and repeat scores was high for UI (0.675) and POP scales (0.940), indicating questionnaire stability. We developed a reliable, valid instrument for assessing patient knowledge about UI and POP.