Intranasal fentanyl for first-trimester uterine aspiration pain: A randomized controlled trial.

OBJECTIVE: To evaluate whether administration of intranasal fentanyl reduces reported pain during first-trimester uterine aspiration. STUDY DESIGN: We conducted a multicenter, randomized, double-blind, placebo-controlled trial of patients with pregnancies less than or equal to 14 weeks gestation seeking uterine aspiration for induced abortion, early pregnancy loss, or failed medication abortion. We randomized participants 1:1 to either intranasal fentanyl 100 mcg or intranasal placebo. All participants received ibuprofen and a standardized paracervical block. The primary outcome was pain indicated at the time of uterine aspiration on a 100 mm visual analog scale (VAS). We designed the study to detect a 15 mm difference in mean pain scores, which required 53 people in each arm for a total of 106 participants. Secondary outcomes included postprocedure pain and patient satisfaction with pain control. RESULTS: From March 2017 through June 2018, we screened 355 people for eligibility and enrolled 107 participants. Those who received intranasal fentanyl reported similar uterine aspiration pain to participants who received placebo (58.4 ± 28.0 fentanyl vs 58.6 ± 24.5 placebo, p = 0.97). Participants who received intranasal fentanyl also reported similar postprocedure pain scores compared to participants who received placebo (19.1 ± 19.4 fentanyl vs 17.2 ± 19 placebo, p = 0.63), and were equally satisfied with procedure pain control (66.8 ± 31.2 fentanyl vs 63.3 ± 29.2 placebo, p = 0.57). CONCLUSION: Intranasal fentanyl did not decrease reported pain with first-trimester uterine aspiration, nor did it decrease postprocedure pain compared to placebo. As an adjunct to ibuprofen and paracervical block, intranasal fentanyl did not improve patient satisfaction with pain control. IMPLICATIONS: Intranasal fentanyl does not reduce reported pain with first-trimester uterine aspiration, however abortion-seeking patients are amenable to receiving intranasal medications for pain management.

Expansion of a direct-to-patient telemedicine abortion service in the United States and experience during the COVID-19 pandemic.

OBJECTIVE: To present updated evidence on the safety, efficacy and acceptability of a direct-to-patient telemedicine abortion service and describe how the service functioned during the COVID-19 pandemic. STUDY DESIGN: We offered the study at 10 sites that provided the service in 13 states and Washington DC. Interested individuals obtained any needed preabortion tests locally and had a videoconference with a study clinician. Sites sent study packages containing mifepristone and misoprostol by mail and had remote follow-up consultations within one month by telephone (or by online survey, if the participant could not be reached) to evaluate abortion completeness. The analysis was descriptive. RESULTS: We mailed 1390 packages between May 2016 and September 2020. Of the 83% (1157/1390) of abortions for which we obtained outcome information, 95% (1103/1157) were completed without a procedure. Participants made 70 unplanned visits to emergency rooms or urgent care centers for reasons related to the abortion (6%), and 10 serious adverse events occurred, including 5 transfusions (0.4%). Enrollment increased substantially with the onset of COVID-19. Although a screening ultrasound was required, sites determined in 52% (346/669) of abortions that occurred during COVID that those participants should not get the test to protect their health. Use of urine pregnancy test to confirm abortion completion increased from 67% (144/214) in the 6 months prior to COVID to 90% (602/669) in the 6 months during COVID. Nearly all satisfaction questionnaires (99%, 1013/1022) recorded that participants were satisfied with the service. CONCLUSIONS: This direct-to-patient telemedicine service was safe, effective, and acceptable, and supports the claim that there is no medical reason for mifepristone to be dispensed in clinics as required by the Food and Drug Administration. In some cases, participants did not need to visit any facilities to obtain the service, which was critical to protecting patient safety during the COVID-19 pandemic. IMPLICATIONS: Medical abortion using telemedicine and mail is effective and can be safely provided without a pretreatment ultrasound. This method of service delivery has the potential to greatly improve access to abortion care in the United States.

"False positive" urine pregnancy test results after successful medication abortion.

OBJECTIVE: To examine the proportion of high-sensitivity urine pregnancy test (HSPT) results that were positive by time after successful medication abortion. STUDY DESIGN: We used data from an ongoing study that provides mifepristone and misoprostol for medication abortion by direct-to-patient telemedicine and mail. Providers evaluated abortion outcomes by patient interview and clinical tests per clinical judgment and participant preference. We identified all participants enrolled July 2016 to September, 2020 who had an HSPT result and no indication of viable pregnancy after treatment. We used logistic regression to examine the association between the timing of the initial post-treatment HSPT, gestational age, and the proportion of HSPTs that gave a positive result. RESULTS: Of the 472 participants in our analysis, 88 (19%) had positive initial HSPTs. The proportions that were positive at ≤20 days, 21 to 27 days, 28 to 34 days, and ≥35 days after mifepristone ingestion was 14 of 29 (48%), 15 of 58 (26%), 49 of 258 (19%), and 10 of 127 (8%), respectively (p < 0.001). Gestational age at mifepristone ingestion was not significantly related to positive HSPT results (p = 0.28). Multivariable logistic regression confirmed both findings and did not identify a statistically significant interaction between these variables. In the 67 participants who relied solely on further HSPTs to confirm abortion outcome, the median interval between the initial positive test and first negative test was 14 days. CONCLUSIONS: The proportion of participants with positive HSPTs declined with time after successful medication abortion. However, nearly one-fifth of participants with complete abortion had positive tests 4 weeks after treatment. IMPLICATIONS: HSPTs provide an inexpensive, convenient option for confirming success of medication abortion at home. However, a substantial minority of patients without ongoing pregnancy have positive HSPT results. Development of a symptom-based strategy for medication abortion outcome assessment without any confirmatory tests should be a priority.

Serum human chorionic gonadotropin decline following aspiration abortion in early pregnancy less than 42 days gestation.

OBJECTIVE: To define serum human chorionic gonadotropin (hCG) decline following complete aspiration abortion. STUDY DESIGN: We performed a secondary analysis of 86 patients who underwent uncomplicated aspiration abortion for ultrasound-confirmed pregnancy ≤42 days gestation and had serum hCG at the time of aspiration and within 3 days postprocedure. RESULTS: Median hCG declines were 72.9% by day 1 (n = 14), 87.6% by day 2 (n = 50), and 92.8% by day 3 (n = 22). Ninetieth percentile declines were 67.8%, 81.5%, and 90.8%. Minimum hCG declines were 56.2%, 77.3%, and 83.2%. Trends did not vary by gestational age or by initial hCG <3000 mIU/mL. CONCLUSION: Postprocedure hCG trend varies over the first few days in early gestation. At ≤42 days gestation, serial hCG decline at 1 day after completed aspiration abortion is greater than 50%, consistent with the decline observed in medication abortion. IMPLICATIONS: This study confirms previously estimated human chorionic gonadotropin decline after aspiration abortion of at least 50% at 24 hours for completed procedure in very early gestations. Minimum declines on days 2 and 3 are approximately 70% and 80%.

Cannabinoids for Pain Control During Medical Abortion: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether prophylactic dronabinol, a synthetic tetrahydrocannabinol, reduces pain during medical abortion. METHODS: We conducted a randomized, double-blind, placebo-controlled trial of women undergoing medical abortion with mifepristone and misoprostol up through 70 days of gestation. All participants received 800 mg of ibuprofen and were randomized to either 5 mg of oral dronabinol or a placebo 30 minutes before misoprostol administration. Participants used a text messaging service to report pain on a numeric rating scale from 0 to 10 (0=no pain, 10=worst pain). The primary outcome was maximum pain experienced during the 24 hours after misoprostol administration. Secondary outcomes were pain scores at 0, 6, and 24 hours after misoprostol administration; maximum anxiety and nausea scores; use of additional pain medication; reported side effects; and satisfaction (yes or no). We needed 68 participants (34 per group) to have 80% power to detect a 2-point difference in maximum pain on a numeric rating scale. RESULTS: From November 2018 to May 2019, we randomized 70 women (dronabinol=35, placebo=35). Participants in the study arms had comparable baseline characteristics. We found no difference between groups in the median maximum pain score reported (dronabinol 7 [interquartile range 6-8], placebo 7 [interquartile range 5-8], P=.82) or median pain scores at any timepoint. Groups were also no different in mean maximum anxiety (dronabinol 3.33 [SD 3.06], placebo 3.23 [SD 2.53], P=.88) or nausea scores (dronabinol 2.21 [SD 2.32], placebo 2.72 [SD 2.64], P=.41). Most women were satisfied with their pain management (76% dronabinol, 82% placebo, P=.51). CONCLUSION: Dronabinol does not reduce the maximum level of pain experienced by women undergoing medical abortion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03604341.

Safety and effectiveness of medication and aspiration abortion before or during the sixth week of pregnancy: A retrospective multicenter study.

OBJECTIVE: To compare adverse outcomes of medication and aspiration abortion among those with intrauterine pregnancy <43 days gestation versus abortions performed at 43-48 days. STUDY DESIGN: We conducted a multicenter retrospective chart review study to review all medication and aspiration abortion of visualized pregnancy <49 days gestation at Planned Parenthood Columbia Willamette (Oregon) and Planned Parenthood of Orange and San Bernardino Counties (California) in 2014-2015. We identified incident cases by billing codes and performed chart review for adverse outcomes (ED visits, incomplete abortion), need for further interventions, or complications (hemorrhage, infection, and uterine perforation), captured up to 90 days post-abortion. RESULTS: The 3930 abortions during the study period at the two sites included 2914 medication abortions and 1016 aspiration abortions, with 1470 medication abortions and 469 aspiration abortions at <43 days gestation. Composite adverse outcomes did not vary by gestation, for either medication abortion (75/1470; 5.1% for <43 days versus 94/1444; 6.5% at 43-48 days, p = 0.10) or aspiration (12/469; 2.6% for <43 days versus 16/547; 2.9% at 43-48 days, p = 0.72). Fewer incomplete abortions (ongoing pregnancy, symptomatic retained tissue, or retained gestational sac) occurred in the earlier gestational group (3.1% for <43 days versus 4.3% at 43-48 days, p = 0.04). Composite adverse outcomes were higher after medication versus aspiration abortion (169/2914; 5.8% versus 28/1016; 2.7%, p < 0.01). CONCLUSION: Medication and aspiration abortion performed either before or during the sixth week of ultrasound-confirmed intrauterine pregnancy have low rates of composite adverse outcomes, including complications or incomplete abortion. However, unplanned interventions are more common after medication compared to aspiration abortions. IMPLICATIONS: Very early medication and aspiration abortion are similarly safe and effective before or during the sixth week of ultrasound-confirmed pregnancy, though subsequent interventions are more likely after medication abortion. Patients with early pregnancy can safely initiate abortion with follow-up to ensure complete abortion.

Opioid Analgesia for Medical Abortion: A Randomized Controlled Trial.

OBJECTIVE: To estimate the effect of oral opioids on patient pain during first-trimester medical abortion. METHODS: We conducted a randomized, double-blind, placebo-controlled trial where patients up to 10 0/7 weeks of gestation undergoing a medical abortion with mifepristone and misoprostol took 10 mg oral oxycodone or placebo at onset of painful cramping. Additionally, all patients received 800-mg ibuprofen tablets, 4-mg ondansetron oral dissolving tablets, and a written prescription for adjunctive pain medication (six tablets oxycodone 5 mg). Participants used a text-messaging service to report pain scores on a numerical rating scale from 0 to 10 (0 being no pain, 10 being worst pain) for 24 hours at start of misoprostol dosing. The primary outcome was maximum pain experienced within 24 hours postmisoprostol. Our secondary outcomes were maximum pain stratified by gestational age (less than 7 weeks of gestation, 7-10 weeks of gestation), duration of maximum pain, use of adjunctive medication, presence of nausea or vomiting, and satisfaction. We needed at least 76 participants per group to differentiate a clinically important pain difference of 2 points on the numerical rating scale. RESULTS: From May 2017 to May 2018, we randomized 172 participants (placebo group with 86, oxycodone group with 86). The study groups had comparable baseline characteristics. We found no difference between groups in median maximum pain scores (placebo 8 [range 1-10], oxycodone 8 [range 2-10], P=.92) and the median duration of maximum pain (placebo 0.75 hours range 0.01-15 vs oxycodone 1 hour range 0.02-10, P=.39). Groups were also similar in the proportion obtaining (placebo 62%, oxycodone 49%, P=.09) and using (placebo 48%, oxycodone 40%, P=.28) adjunctive medication, experiencing nausea or vomiting (placebo 59%, oxycodone 65%, P=.43) and reported satisfaction with pain medications (placebo 62%, oxycodone 65%, P=.63). CONCLUSION: Oxycodone does not reduce the maximum level of pain experienced by women undergoing medical abortion up to 10 0/7 weeks of gestation or improve satisfaction. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03139240.

TelAbortion: evaluation of a direct to patient telemedicine abortion service in the United States.

OBJECTIVES: To evaluate the safety, feasibility, and acceptability of a direct-to-patient telemedicine service that enabled people to obtain medical abortion without visiting an abortion provider in person. STUDY DESIGN: We offered the service in five states. Each participant had a videoconference with a study clinician and had pre-treatment laboratory tests and ultrasound at facilities of her choice. If the participant was eligible for medical abortion, the clinician sent a package containing mifepristone, misoprostol, and instructions to her by mail. After taking the medications, the participant obtained follow-up tests and had a follow-up consultation with the clinician by telephone or videoconference to evaluate abortion completeness. The analysis was descriptive. RESULTS: Over 32 months, we conducted 433 study screenings and shipped 248 packages. The median interval between screening and mailing was 7 days (91st percentile 17 days), and no participant took the mifepristone at ≫71 days of gestation. We ascertained abortion outcomes of 190/248 package recipients (77%): 177/190 (93%) had complete abortion without a procedure. Of the 217/248 package recipients who provided meaningful follow-up data (88%), one was hospitalized for postoperative seizure and another for excessive bleeding, and 27 had other unscheduled clinical encounters, 12 of which resulted in no treatment. A total of 159/248 participants who received packages (64%) completed satisfaction questionnaires at study exit; all were satisfied with the service. CONCLUSIONS: This direct-to-patient telemedicine abortion service was safe, effective, efficient, and satisfactory. The model has the potential to increase abortion access by enhancing the reach of providers and by offering people a new option for obtaining care conveniently and privately. IMPLICATIONS: Provision of medical abortion by direct-to-patient telemedicine and mail has the potential to increase abortion access by increasing the reach of providers and by offering people the option of obtaining abortion care without an in-person visit to an abortion provider.

Blood loss at the time of dilation and evacuation at 16 to 22 weeks of gestation in women using low molecular weight heparin: a case series.

OBJECTIVE: Describe blood loss with surgical abortion ≥16weeks of gestation in anticoagulated patients. STUDY DESIGN: Clinicians involved in a professional listserv (2011-2013) reported cases of abortion ≥16weeks of gestation in anticoagulated women. RESULTS: All 7 patients were using or had recently discontinued low molecular weight heparin (LMWH). One patient was reported to have greater than anticipated blood loss for gestational age. No patients required transfusion and no complications were reported. CONCLUSIONS: Our limited case series suggests D&E may not always be contraindicated in women with recent or current LMWH use.

Blood loss at the time of surgical abortion up to 14 weeks in anticoagulated patients: a case series.

OBJECTIVE: To describe estimated blood loss (EBL) with surgical abortion ≤14 weeks' gestation in anticoagulated patients. STUDY DESIGN: We invited 170 clinicians involved in a professional listserv to report cases when they performed a surgical abortion on a patient ≤14 weeks' gestation taking an anticoagulant. Clinicians reported EBL and bleeding-related complications (need for a blood transfusion, additional surgical procedures to treat bleeding). We contacted clinicians 30 days postprocedure to capture postoperative complications. RESULTS: Clinicians reported 52 cases between February 2011 and October 2013. Thirty percent of patients (16/52) stopped the anticoagulant with adequate time for the effects to abate prior to surgery (6 h for heparin, 24 h for low-molecular-weight heparin, International Normalized Ratio ≤1.7 the day prior to surgery for warfarin), while 69% (36/52) continued the anticoagulant either at therapeutic (25/36) or subtherapeutic (16/36) doses. Seventy-eight percent (28/36) of patients who continued the anticoagulant had an EBL of 50 mL or less compared to 88% (14/16) of those who stopped the anticoagulant with adequate time for its effects to abate (p=.73). Bleeding-related complications occurred in four anticoagulated patients and none of the patients who discontinued anticoagulant therapy. CONCLUSION: Continuation of anticoagulation for planned surgical abortion under 84 days does not appear to be associated with heavy bleeding.

Long-Acting Reversible Contraception Counseling and Use for Older Adolescents and Nulliparous Women.

PURPOSE: The majority of pregnancies during adolescence are unintended, and few adolescents use long-acting reversible contraception (LARC) due in part to health care providers' misconceptions about nulliparous women's eligibility for the intrauterine device. We examined differences in LARC counseling, selection, and initiation by age and parity in a study with a provider's LARC training intervention. METHODS: Sexually active women aged 18-25 years receiving contraceptive counseling (n = 1,500) were enrolled at 20 interventions and 20 control clinics and followed for 12 months. We assessed LARC counseling and selection, by age and parity, with generalized estimated equations with robust standard errors. We assessed LARC use over 1 year with Cox proportional hazards models with shared frailty for clustering. RESULTS: Women in the intervention had increased LARC counseling, selection, and initiation, with similar effects among older adolescent and nulliparous women, and among young adult and parous women. Across study arms, older adolescents were as likely as young adults to receive LARC counseling (adjusted odds ratio [aOR] = .85; 95% confidence interval [CI]: .63-1.15), select LARC (aOR = .86; 95% CI: .64-1.17), and use LARC methods (adjusted hazard ratio [aHR] = .94; 95% CI: .69-1.27). Nulliparous women were less likely to receive counseling (aOR = .57; 95% CI: .42-.79) and to select LARC (aOR = .53; 95% CI: .37-.75) than parous women, and they initiated LARC methods at lower rates (aHR = .65; 95% CI: .48-.90). Nulliparous women had similar rates of implant initiation but lower rates of intrauterine device initiation (aHR = .59; 95% CI: .41-.85). CONCLUSIONS: Continued efforts should be made to improve counseling and access to LARC methods for nulliparous women of all ages.

Refining paracervical block techniques for pain control in first trimester surgical abortion: a randomized controlled noninferiority trial.

OBJECTIVES: Our objective was to evaluate two different aspects of the paracervical block (PCB) technique for first trimester surgical abortion, to compare a 3-min wait prior to cervical dilation to no wait and to compare four-site with two-site injection. STUDY DESIGN: We conducted two consecutive randomized, single-blinded noninferiority trials. In the first trial, women <11 weeks gestational age received a 20-mL 1% buffered lidocaine four-site PCB with either a 3-min wait between PCB injection and dilation or no wait. In the second trial, we compared a four-site with a two-site PCB. We evaluated dilation pain [100-mm visual analogue scale (VAS)] as the primary outcome. Secondary outcomes included pain at additional time points, anxiety, satisfaction and adverse events. RESULTS: Both trials fully enrolled (total n=332). Results were inconclusive as to whether no wait was noninferior to waiting 3-min prior to cervical dilation for dilation pain [VAS: 63 mm (SD, 24 mm) vs. 56 mm (SD, 32mm)] and as to whether a two-site PCB was noninferior to a four-site block [VAS: 68 mm (SD, 21 mm) vs. 60 mm (SD, 30 mm)]. Noninferiority analysis was inconclusive because the confidence interval of the mean pain score difference between groups included the predefined inferiority margin of 13-mm pain difference. Superiority analysis showed the four-site PCB to be superior to the two-site PCB. CONCLUSION: It remained inconclusive whether a 3-min wait time between PCB and cervical dilation provides noninferior pain control for first trimester surgical abortion. However, a four-site PCB appeared to be superior to a two-site PCB. IMPLICATIONS: It remained inconclusive whether a 3-min wait time between PCB and cervical dilation or using a two-site instead of a four-site PCB provided noninferior pain control for first trimester surgical abortion. This study did not assess whether the combination of the two separate factors provides additive benefit.

Aspiration Abortion With Immediate Intrauterine Device Insertion: Comparing Outcomes of Advanced Practice Clinicians and Physicians.

INTRODUCTION: Immediate postabortion intrauterine device (IUD) insertion is a safe, effective strategy to prevent subsequent unplanned pregnancy. Oregon is one of 5 US states where advanced practice clinicians perform aspiration abortions. This study compares outcomes of first-trimester aspiration abortion with immediate IUD insertion between advanced practice clinicians and physicians. METHODS: We conducted a historical cohort study of first-trimester aspiration abortions with immediate IUD insertion performed at our center from 2009 to 2011. We extracted demographic and clinical data from patient charts. Immediate complications including excessive blood loss, perforation, and reaspirations were recorded at the time of procedure. We used descriptive statistics and multivariable logistic regression to test for differences in outcomes by clinician type. RESULTS: Data were available on 669 of the 1134 combined procedures. Advanced practice clinicians performed 224 of these. There were no significant differences in immediate outcomes. The only immediate complications were reaspirations; 1.8% (4/224) in the advanced practice clinician group, and 2.0% (9/445) in the physician group (P = .83). DISCUSSION: We found no differences in outcomes between provider type for immediate IUD insertion after first-trimester aspiration abortion. This study helps reinforce that advanced practice clinicians can provide immediate postaspiration abortion IUD insertions with similar outcomes to those of physicians. Many countries do not allow advanced practice clinicians to perform this service, but a change in policy could help address family planning provider shortages.

Intrauterine device placement at 3 versus 6 weeks postpartum: a randomized trial.

OBJECTIVE: To investigate whether early placement of an intrauterine device (IUD) at 3 weeks after delivery, compared to placement at 6 weeks, is associated with greater use at 3 months postpartum. STUDY DESIGN: This prospective randomized, controlled trial enrolled inpatient postpartum women intending to use intrauterine contraception. Participants were assigned to an early (3 week) or standard (6 week) postpartum visit with IUD placement and were followed for 6 months. We used transvaginal ultrasonography to confirm placement and measure uterine dimensions. We measured pain with IUD insertion and satisfaction with IUD timing using 100-mm visual analog scales. Data were analyzed based on randomization and actual timing of insertion (18-24 vs. 39-45 days). RESULTS: Between February 2012 and December 2013, 201 subjects were enrolled (early=101; standard=100). Most participants returned for IUD placement as scheduled; 70.1% (53/75) in the early group, 74.3% (58/78) in the standard group (p=.06). IUD use did not differ between groups at 3 months (73/100, 73.0% and 73/97, 75.3%, respectively, p=.72) or 6 months (80.3% and 82.8%, p=.71) amongst those women for whom follow-up was available. Women randomized to 6-week insertion were more likely to have resumed intercourse prior to the IUD appointment (15/64, 23.4% vs. 5/68, 7.3%, p=.01). Pain with insertion (19.9 vs. 25.1, respectively, p=.21) and satisfaction (89.6 vs. 93.4, respectively, p=.23) did not vary based on actual timing of insertion. CONCLUSION: Offering IUD placement at 3 weeks postpartum compared to standard scheduling at 6 weeks does not result in increased use at 3 months. However, early IUD placement is acceptable to women and without increased pain. IMPLICATIONS: This study demonstrates that IUD placement as early as 3 weeks postpartum is feasible. Larger studies are needed to evaluate risks and benefits of IUD placement at this early interval. While earlier timing does not result in increased IUD uptake, early placement should be explored as an option since many women resume intercourse before 6 weeks.

Immediate Intrauterine Device Insertion Following Surgical Abortion.

Placement of an intrauterine device (IUD) immediately after a first or second trimester surgical abortion is safe and convenient and decreases the risk of repeat unintended pregnancy. Immediate postabortion IUD placement is not recommended in the setting of postprocedure hemorrhage, uterine perforation, infection, or hematometra. Otherwise, there are few contraindications to IUD placement following surgical abortion. Sexually transmitted infection screening should follow US Centers for Disease Control and Prevention guidelines. No additional antibiotics are needed beyond those used for the abortion. Placing immediate postabortion IUDs makes highly-effective long-acting reversible contraception more accessible to women.

An Evaluation of Oral Midazolam for Anxiety and Pain in First-Trimester Surgical Abortion: A Randomized Controlled Trial.

OBJECTIVE: To estimate the effect of oral midazolam on patient pain and anxiety perception during first-trimester surgical abortion. METHODS: Between May and December 2013, we conducted a randomized, double-blind, placebo-controlled trial. Patients between 6 0/7 and 10 6/7 weeks of gestation received 10 mg oral midazolam or placebo 30-60 minutes before surgical abortion. All patients received ibuprofen and a paracervical block. We powered the study (power=80%; significance level=.025) to detect a 15-mm difference in our two a priori primary outcomes of pain and anxiety with uterine aspiration on a 100-mm visual analog scale. Secondary outcomes were pain and anxiety at additional time points, memory, satisfaction, side effects, and adverse events. RESULTS: Demographics were similar between groups (placebo=62, midazolam=62). Compared with those randomized to placebo, patients who received midazolam had significantly less anxiety preoperatively (room entry: 51.4 mm compared with 34.5 mm, P<.001; positioning: 56.6 mm compared with 45.4 mm, P=.02). There was no difference in pain (P=.28) or anxiety (P=.14) during uterine aspiration or at other procedural time points. A significantly greater number of patients in the midazolam group reported partial amnesia (31/61 compared with 16/61, P=.005) and dizziness (30/61 compared with 18/61, P=.03). Controlling for baseline differences, patients who received midazolam reported more postoperative sleepiness (P<.001) and less postoperative nausea (P=.004). There was no difference in overall satisfaction (P=.88). CONCLUSION: Although oral midazolam reduces preprocedural anxiety, it does not reduce pain or anxiety with uterine aspiration during first-trimester surgical abortions. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01830881. LEVEL OF EVIDENCE: I.

Cervical Preparation Before Dilation and Evacuation Using Adjunctive Misoprostol or Mifepristone Compared With Overnight Osmotic Dilators Alone: A Randomized Controlled Trial.

OBJECTIVE: To evaluate operative time after adjunctive misoprostol or mifepristone compared with overnight osmotic dilators alone for cervical preparation before dilation and evacuation at 16-23 6/7 weeks of gestation. METHODS: This double-blind, three-arm, multicenter, randomized trial compared overnight osmotic dilators alone, dilators plus 400 micrograms buccal misoprostol 3 hours preoperatively, and dilators plus 200 mg oral mifepristone during dilator placement for dilation and evacuation. Our primary outcome was dilation and evacuation operative time within two cohorts: 16-18 6/7 weeks of gestation (N=150) and 19-23 6/7 weeks of gestation (N=150). Three hundred women were required for 80% power to detect a 2-minute difference in operative time. Secondary outcomes included initial cervical dilation, side effects, physician satisfaction by Likert scale, and complications. RESULTS: Between February 2013 and February 2014 we randomized 300 women evenly across treatment arms. Group demographics were similar. We found no difference in operative time in either gestational cohort (early cohort [minutes]: 5.11±3.0 dilators alone, 4.99±3.3 misoprostol, 4.33±2.0 mifepristone, P=.34; late cohort [minutes]: 7.50±3.7 dilators alone, 7.62±5.4 misoprostol, 6.74±3.2 mifepristone, P=.53). In the early cohort, initial dilation was greater with misoprostol than dilators alone (2.4 compared with 2.0 cm, P=.007). Patients given misoprostol had significantly more pain, fever, and chills. In the late cohort, dilation and evacuation procedures were less difficult after mifepristone (4.1%, 95% confidence interval [CI] 0.0-9.6) than misoprostol (18.8%, 95% CI 7.7-29.8) or dilators alone (18.8%, 95% CI 7.7-29.8; P=.04). We had inadequate power to infer differences in complications: dilators alone (10%, 95% CI 4.2-16.0) compared with misoprostol (2%, 95% CI 0-4.7) compared with mifepristone (2%, 95% CI 0-4.8). CONCLUSION: Despite no difference in operative time, adjunctive mifepristone facilitates later dilation and evacuation compared with osmotic dilators alone and is better tolerated than misoprostol. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT01751087. LEVEL OF EVIDENCE: I.

The effect of sevoflurane on interventions for blood loss during dilation and evacuation procedures at 18-24 weeks of gestation: a randomized controlled trial.

OBJECTIVE: The objective was to evaluate whether the use of sevoflurane during general anesthesia for dilation and evacuation (D&E) procedures increases the frequency of interventions to treat excess bleeding. STUDY DESIGN: A randomized, double-blinded, placebo-controlled trial of a standardized general anesthesia protocol with or without inhaled sevoflurane for D&Es between 18 and 24 weeks' gestation was performed. The primary outcome was need for any intervention to treat blood loss. Secondary outcomes included measured blood loss, procedure time, complications, side effects, patient satisfaction and provider ease of procedure. RESULTS: One hundred sixty subjects were randomized. Those in the sevoflurane group were slightly more likely to have interventions for bleeding as compared to those subjects who did not receive sevoflurane (25% versus 16.3%, p=.17) or a measured blood loss above 300 mL (15% versus 7.5%, p=.13); however, these differences could have arisen by chance. Most cases of excess bleeding required only minor interventions, including uterine massage and/or uterotonic agents. Procedure time, complications, side effects, satisfaction and ease of procedure were similar between groups. CONCLUSION: Addition of sevoflurane to general anesthesia during a D&E between 18 and 24 weeks' gestation did not increase the risk of intervention for bleeding; however, this study was underpowered to detect clinically important differences. IMPLICATIONS: In this randomized, double-blinded, placebo-controlled trial, sevoflurane did not significantly increase the risk of intervention for bleeding during D&Es. However, this agent should be used with caution as an anesthetic for surgical abortions.