Kari P. Braaten

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. LEVEL OF EVIDENCE: II

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.

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.

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 (&agr;=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.

Screening pregnant young adults for alcohol and drug use: a pilot study.

This study ascertained the feasibility of offering a self-report alcohol and drug screen embedded in a general health habits survey to patients attending the Young Adult Reproductive Medicine Clinic and compared those who screened positive for a substance use problem with those who did not. An anonymous convenience sample of 100 young adults completed the Health Habits Survey, which included the CRAFFT screening test, designed specifically to identify substance-related problems in adolescent populations and recently recommended as a potential tool to reduce adverse outcomes from prenatal alcohol exposure. Eighty of the 100 respondents were pregnant and younger than aged 25 years, and they are the focus of the study. With a mean age of 18.2 years and 23.5 weeks gestation, most were single (75%) and had a high school education or less (75%). The majority (81%) was CRAFFT screen negative, but 15 answered yes to at least 1 CRAFFT question. There were no systematic differences between those with positive or negative CRAFFT screens. The CRAFFT, when embedded in a general health habits survey, seems to be a feasible option for pregnant young adults, but further studies to assess reliability, sensitivity, and specificity are recommended.

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.

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.