Comparing Transcervical Balloon with Osmotic Dilators for Cervical Preparation Prior to Procedural Abortion: a Non-Inferiority Randomized Trial.

OBJECTIVE: To compare cervical preparation with transcervical balloon to osmotic dilators for second-trimester procedural abortions. STUDY DESIGN: We performed an unblinded, randomized, non-inferiority trial of people undergoing second-trimester procedural abortion at 18+0 to 23+6 weeks gestation. We randomized participants to either overnight osmotic dilators (Dilapan-S) or transcervical balloon (Foley). Both groups received overnight mifepristone and pre-procedural misoprostol. We powered the study on mean difference in procedure duration; non-inferiority limit 5 minutes. We compared pre-procedure cervical dilation; need for additional dilation; and, using 100-point visual analogue scale, measured physician satisfaction and ease of procedure, and participant pain and satisfaction. RESULTS: We recruited 32 participants at a single academic center. Although procedure time (minutes) was similar (balloon: 22.6+8.9 vs Dilapan-S: 22.4+12.8, p=0.96), non-inferiority was not met (mean difference, 0.2 minutes; 95% confidence interval, -7.8 to 8.2). Cervical dilation >2cm was more likely after Dilapan-S (100% vs 62.5%, p=0.02). Placement was well tolerated with similar time (minutes) for insertion (balloon: 4.8+1.0, Dilapan-S: 5.1+2.3, p=0.64) and maximum pain (median) with insertion (balloon 39 (5-78), Dilapan-S: 39 (0-100), p=0.92). Pain immediately post-insertion was higher for Dilapan-S (33 (0-100) vs 18 (0-50), p=0.046), and similar for maximum pain overnight, participant satisfaction, and likelihood to recommend. Complications were minor and similar between groups (p=0.60). CONCLUSION: While significantly more people with transcervical balloon required mechanical dilation, the difference in operative time was clinically negligible. The transcervical balloon was well tolerated and acceptable by participants. IMPLICATIONS: Clinicians experienced in mechanical dilation may consider a transcervical balloon as a lower-cost tool for second-trimester abortion cervical preparation. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov: NCT05099991.

Acute complications with same-day versus overnight cervical preparation before dilation and evacuation at 14 to 16 weeks.

OBJECTIVE: Evaluate if same-day cervical preparation is associated with a clinically acceptable complication rate compared with overnight osmotic dilators for dilation and evacuation (D&E). STUDY DESIGN: This retrospective, noninferiority, cohort study compared complication rates for same-day versus overnight cervical preparation with D&E between 14 and 16 weeks gestation. Cervical preparation was achieved with misoprostol, osmotic dilators, or both. Our primary outcome was the acute complication rate, defined as: hemorrhage (≥500 mL); hospitalization or hospital transfer; transfusion; or unplanned procedure occurring within 24 hours of the index procedure. Secondarily we evaluated nonmajor (re-aspiration, suture repair of cervical laceration, uterine tamponade, or emergency department only transfer) and major (transfusion, uterine artery embolization, abdominal surgery, or hospital admission) complications separately. Inverse probability of treatment weighting using the propensity score was used to perform an adjusted analysis, taking into account age, ethnicity, clinic location, insurance, gestational age, gravidity, and prior pregnancy outcomes. RESULTS: We analyzed 1,319 subjects (n = 864 same-day, n = 455 overnight). Same-day cervical preparation patients were more likely to have Medicaid and a prior vaginal delivery. In both unadjusted and adjusted analyses, acute complication rates for same-day were noninferior to overnight preparation (unadjusted 0.93% vs 1.98%, difference of -1.05%, CI: -2.48% to 0.38%; adjusted difference -0.50%, CI: -1.45 to 0.44%). Only one major complication in the same-day group, a cervical laceration resulting in hemorrhage requiring transfusion, occurred in the entire sample. CONCLUSIONS: In this retrospective review, same-day cervical preparation was noninferior to overnight preparation for D&E between 14 and 16 weeks gestation, both with low complication rates. IMPLICATIONS: For early second trimester dilation and evacuation, same-day cervical preparation should be considered a safe alternative to overnight cervical preparation.

Foley catheter for cervical preparation prior to second trimester dilation and evacuation: A supply-based alternative for surgical abortion: A case series.

Objective: To document the use of Foley catheter as an alternative to osmotic dilators for cervical preparation before second trimester dilation and evacuation at a tertiary setting in Ethiopia. Methods: This is a retrospective case series conducted at St. Paul's Hospital Millennium Medical College (Ethiopia) from April 1, 2021 to August 30, 2021. Forty-three cases of dilation and evacuation (D&E) in which overnight intra-cervical Foley catheter placement was used to prepare the cervix were reviewed. Data were analysed using SPSS version 23 and simple descriptive statistics were applied to analyze the clinical characteristics of study subjects and procedure outcomes. Percentages and frequencies were used to present the findings. Results: The calculated median gestational age was 21.4(17-24.2) weeks. Around 40%(17/43) of cases had cervical dilation of 3 to 4 cm, with another 33% (14/43) achieving cervical dilation of 1.5 to 2.5 cm. Additional dilation during the procedure was required only in 12 cases (28%) prior to D&E procedure. In 36 cases (84%), the procedure was attended by family planning fellow. Conclusion: Cervical preparation using overnight Foley catheter before second-trimester D&E resulted in majority of the cases requiring no additional dilation immediately prior to D&E procedure. Where osmotic dilators are not available, Foley catheter can be an alternative method to prepare the cervix prior to D&E procedures. Implications: In the absence of osmotic dilators, Foley catheter can be used as an alternate, and readily available means of cervical preparation for second trimester D&E procedures.

Sonoelastography for the comparative assessment of cervical maturation after different approaches to cervical preparation ahead of labor induction.

AIM: To compare the efficacy of different approaches to cervical preparation to labor induction using the ultrasound cervical elastography. MATERIALS AND METHODS: This prospective open-label study included 200 pregnant women aged between 23 and 38 years eligible for labor pre-induction. Patients were divided into four groups (n = 50 per group). In Group I, four osmotic Dilapan-S cervical dilators combined with two doses of oral mifepristone (200 mg each) 24 h apart were used. The dilators were inserted for up to 12 h. In Group II, only the Dipalan-S dilators were used. In Group III, a Foley catheter was positioned intracervically for 12 h. In Group IV, we used two doses of intracervical prostaglandin E2 gel (0.5 mg each) 6 h apart. Cervical maturation was assessed using the Bishop scoring system and the ultrasound cervicometry with the color mapping and calculation of SR ratio. At baseline, all participants were also divided into three subgroups depending on the Bishop score before the pre-induction. Subgroup А (n = 66) included patients with the Bishop score between 0‒2 points, subgroup B (n = 69) between 3-4 points, and subgroup С (n = 65) between 4-6 points. RESULTS: Our study showed that the efficacy of Dilapan-S combined with mifepristone for cervical preparation to labor induction was higher than Dilapan-S, Foley catheter and intracervical prostaglandin E2 gel. In this group, the Bishop score after the pre-induction was the highest (11.4 (0.21) points versus 10.2 (0.2), 9.4 (0.3) и 9.67 (0.25) in Groups II, III and IV respectively (p < .05 for all). The lowest SR values were also observed among the patients receiving the combination of Dilapan-S and mifepristone: 1.23 (0.04) versus 1.63 (0.07), 1.7 (0.08) and 1.83 (0.1) in Groups II, III and IV respectively (p < .05 for all). The sonoelastographic SR values in subgroups B and C were statistically lower compared with subgroup A across all groups studied. Ultrasound elastography of the cervix allowed to perform a more objective assessment of cervical maturation compared with the Bishop scoring. CONCLUSION: Dilapan-S combined with mifepristone had higher efficacy for cervical preparation to labor induction compared with other approaches investigated.

Use of low dose vaginal misoprostol in office hysteroscopy: a pre-post interventional study.

A pre-post interventional study of patients undergoing office hysteroscopy alone and in combination with endometrial biopsy was performed during October 2015-March 2018 to evaluate the effect of low dose vaginal misoprostol on patient's pain. Pain scores were assessed using the visual analog scale at the completion of the procedure. There were 646 patients included in the study. Of these, 462 had office hysteroscopy alone; 206 (44.6%) received 50 mcg of vaginal misoprostol the night prior to the procedure and the remaining 256 (55.4%) patients had no cervical ripening. The reported pain score following hysteroscopy was significantly lower among patients who received misoprostol [4(0-10) vs. 5(0-10); p=.001]. Most patients (78.2%) did not report any misoprostol related side effects. Of the 184 patients who underwent a combination of office hysteroscopy and endometrial biopsy, 97 (52.7%) received pre-procedure vaginal misoprostol while 87 (47.3%) did not. Post procedure pain was independent of pre-treatment with vaginal misoprostol (6.3 ± 2.7 vs. 6.6 ± 2.7; p = .54).Impact statementWhat is already known on this subject? Office hysteroscopy and endometrial biopsy is increasingly performed for evaluation of various gynaecologic conditions, however, patients' perceived pain at the time of procedure may lead to incomplete procedures. Various doses of misoprostol have been tested to reduce patients' pain, however none lower than 200 mcg vaginally, and at these doses, side effects are reported.What the results of this study add? To date, there is a scarcity of published data on the use of low dose misoprostol (50 mcg) in gynaecologic procedures. Our study found that the use of low dose vaginal misoprostol prior to office hysteroscopy is associated with lower reported pain and tenaculum utilisation during the procedure. However, vaginal misoprostol prior to successive office hysteroscopy and endometrial biopsy failed to decrease the reported pain, and the overall pain score was higher than hysteroscopy alone.What the implications are of these findings for clinical practice and/or further research? The use of low dose vaginal misoprostol (50 mcg) the evening prior to office hysteroscopy is associated with lower reported pain and tenaculum utilisation and is not associated with significant side effects. Therefore, 50 mcg of misoprostol could be used in clinical practice as a method to reduce patients' reported pain during office hysteroscopy.

Opioid prescription for pain after osmotic dilator placement in abortion care: A randomized controlled trial.

OBJECTIVE: To compare the overnight maximum pain scores after osmotic dilator placement prior to a dilation and evacuation (D&E) procedure in participants assigned to a prescription for ibuprofen alone or to ibuprofen plus oxycodone. STUDY DESIGN: We conducted a nonblinded pragmatic, randomized controlled trial to evaluate pain management among women undergoing osmotic dilator placement prior to D&E. We randomly assigned 70 participants at 12 weeks 6 days to 23 weeks 6 days gestation to receive a prescription for ibuprofen alone, or ibuprofen plus oxycodone. We assessed pain using a numeric rating scale (NRS; scale 0-10) at the following time points: Baseline, dilator placement, 2 and 6 hours, and preoperatively, where we also asked participants their maximum pain score. The primary outcome was mean individual NRS pain score change from baseline to maximum pain score. RESULTS: Maximum mean pain score (change from baseline) was 4.7 ± 2.9 in the ibuprofen group, and 6.5 ± 2.5 in the ibuprofen plus oxycodone group (p < 0.01). Participants in both groups reported highest NRS pain scores 2 hours after dilator placement, 3.9 ± 2.5 and 5.3 ± 2.6 respectively (p = 0.02). Average ibuprofen use in both arms was similar, and 81% of participants used at least 1 dose of ibuprofen after dilator placement. Of those randomized to prescription to ibuprofen plus oxycodone, only 51% used a dose of oxycodone. CONCLUSIONS: Compared to participants randomized to receive a prescription for ibuprofen, those randomized to receive a prescription for ibuprofen plus oxycodone reported higher maximum overnight pain scores. IMPLICATIONS: Participants receiving a prescription for ibuprofen alone had lower maximum overnight pain scores following osmotic dilator placement. Given that opioid prescriptions did not appear to reduce overnight pain, minimizing these prescriptions would avoid opioid exposure for patients undergoing D&E.

Society of Family Planning clinical recommendations: Cervical preparation for dilation and evacuation at 20-24 weeks' gestation.

Although only 1.3% of abortions in the United States are between 20 and 24 weeks' gestation, these procedures are associated with elevated risks of morbidity and mortality. Adequate cervical preparation before dilation and evacuation (D&E) at 20-24 weeks' gestation reduces procedural risk. For this gestational range, at least one day of cervical preparation with osmotic dilators is recommended before D&E. The use of overnight osmotic dilators alone is sufficient for most D&Es at 20-24 weeks' gestation. Dilapan-S® dilators require a shorter time to achieve maximum dilation, may be more effective than laminaria and may increase the likelihood of success on the first D&E attempt. The use of adjunctive mifepristone administered one-day pre-operatively at the time of osmotic dilator placement, should be considered because evidence demonstrates that it makes D&E subjectively easier at 20-24 weeks without increasing side effects. While older studies suggest that two-days of serial osmotic dilators provide greater dilation than one day of dilators, adjunctive mifepristone may be comparable to a second day of dilators. Adjunctive misoprostol administered on the day of D&E does not appear to affect initial cervical dilation and procedure time and compared with mifepristone is associated with more side effects, such as pain and nausea. Using overnight mifepristone and same-day misoprostol without osmotic dilators at 20-24 weeks' gestation lengthens D&E procedure time and appears to increase immediate complications, at least among less experienced providers. Some evidence shows the feasibility of same-day cervical preparation before D&E at 20-24 weeks using Dilapan-S® with adjunctive misoprostol or serial repeat dosing of misoprostol, but same-day preparation should be limited to providers with significant experience with these regimens. The Society of Family Planning recommends preoperative cervical preparation before D&E at 20-24 weeks' gestation. Further studies are needed to clarify the best means of preparing the cervix in order to minimize abortion complications and improve outcomes in this gestational range.

Misoprostol as an adjunct to overnight osmotic dilators prior to second trimester dilation and evacuation: A systematic review and meta-analysis.

OBJECTIVE: To understand effect of adjunct misoprostol on cervical preparation with overnight osmotic dilators for dilation and evacuation after 16 weeks gestation. METHODS: We searched on-line reference databases using search terms for second trimester, abortion, misoprostol, and dilators. Randomized controlled trials of cervical preparation for second trimester D&E using overnight osmotic dilators comparing adjunct misoprostol to placebo were included. Weighted mean with standard deviation (SD) and pooled binary outcomes were compared. RESULTS: Among 84 articles identified, three met inclusion criteria (n = 457 subjects) adjunct misoprostol did not significantly decrease mean procedure times (8.5 ±â€¯4.6 vs 9.6 ±â€¯5.8 min, p = 0.78) or manual dilation (18% vs 28%, p = 0.23) when compared to placebo. There was no difference in total complications (p = 0.61), major complications (p = 0.44), or cervical lacerations (p = 0.87). CONCLUSION: Current limited evidence suggests adjunct misoprostol with osmotic dilators after 16 weeks does not affect procedure time or need for manual dilation. IMPLICATIONS: Further research is needed to determine the effect of adjunct misoprostol on major complications and blood loss.

Mifepristone and misoprostol compared to osmotic dilators for cervical preparation prior to surgical abortion at 15-18 weeks' gestation: a randomised controlled non-inferiority trial.

OBJECTIVE: Cervical preparation is recommended prior to second-trimester surgical abortion. Osmotic dilators are an effective means to prepare the cervix, but require an additional procedure and may cause discomfort. We compared cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators. STUDY DESIGN: A randomised, controlled, non-inferiority trial was performed to compare cervical preparation with mifepristone and misoprostol to preparation with osmotic dilators in women undergoing surgical abortion between 15 and 18 weeks gestation. The medication group (n=29) received mifepristone 200 mg orally 24 hours prior to uterine evacuation and misoprostol 400 µg buccally 2 hours before the procedure. The dilator group (n=20) underwent osmotic dilator insertion 24 hours prior to the procedure. The primary outcome was total procedure time, from insertion to removal of the speculum. Secondary outcomes included operative time (from intrauterine instrumentation to speculum removal), initial cervical dilation, nausea, pain, ease of procedure, and whether participants would choose the same modality in the future. RESULTS: For mean total procedure time, medication preparation (14.0 min, 95% CI 12.0-16.1) was not inferior to dilators (14.3 min, 95% CI 11.7 to 16.8, p<0.001). Mean operative time and ease of procedure were also similar between groups. More women in the medication group than the dilator group would prefer to use the same method in the future (86% vs 30%, p=0.003). CONCLUSION: Prior to surgical abortion at 15-18 weeks, use of mifepristone and misoprostol did not result in longer procedure times than overnight osmotic dilators. TRIAL REGISTRATION NUMBER: NCT01462.

A factorial-design randomized controlled trial comparing misoprostol alone to Dilapan with misoprostol and comparing buccal to vaginal misoprostol for same-day cervical preparation prior to dilation & evacuation at 14 weeks 0 days-19 weeks 6 days gestation.

OBJECTIVES: To compare procedure times following same-day cervical preparation using misoprostol 400 mcg alone or misoprostol 400 mcg plus hygroscopic dilators for dilation and evacuation (D&E) before 20 weeks gestation and to compare side effects of buccal and vaginal misoprostol administration. STUDY DESIGN: We randomized women undergoing D&E at 14 weeks 0 days-19 weeks 6 days gestation to receive (1) hygroscopic dilators or not and (2) buccal or vaginal misoprostol using a 2 × 2 factorial design. We assessed two primary outcomes: (1) total procedure time, defined as time to insert hygroscopic dilators plus D&E time, and (2) side effects of misoprostol 4-6 h after initiation of cervical preparation using a 5-point Likert scale assessing nausea, emesis, diarrhea, chills and cramps. RESULTS: We randomized 163 women and 161 completed the study. We completed all procedures in one day. Mean total procedure time was 14.0 and 10.8 min. with and without hygroscopic dilators (difference 3.2 minutes, 95% CI 1.7, 4.6). Mean D&E procedure time was 0.7 (95% CI -0.8, 2.1) min longer without hygroscopic dilators. Initial cervical dilation was 15.6 and 11.7 mm with and without hygroscopic dilators (difference 3.9 mm, 95% CI 3.1, 4.8). Participants receiving buccal misoprostol reported less chills (1.9) than women receiving vaginal misoprostol (2.3), p = 0.04. CONCLUSIONS: Hygroscopic dilators with misoprostol requires more time and increases cervical dilation without shortening D&E time when used for cervical preparation 4-6 h prior to D&E before 20 weeks. Women receiving vaginal misoprostol may have more chills compared to buccal misoprostol. IMPLICATIONS: Adding hygroscopic dilators to misoprostol for same day D&E procedures at less than 20 weeks gestation increases total intervention time without reducing D&E time and is less favored by patients. Clinical judgment requires balancing relative effectiveness with patient preference. Further studies should evaluate the side effect profile of vaginal misoprostol.

Adjunctive Agents for Cervical Preparation in Second Trimester Surgical Abortion.

Late second trimester dilation and evacuation is a challenging subset of surgical abortion. Among the reasons for this is the degree of cervical dilation required to safely extricate fetal parts. Cervical dilation is traditionally achieved by placing multiple sets of osmotic dilators over two or more days prior to the evacuation procedure; however, there is interest in shortening cervical preparation time. The use of adjuvant mifepristone and misoprostol in conjunction with osmotic dilators has been studied for this purpose, and their use demonstrates that adequate cervical dilation can be achieved in less time than with dilators alone. We present a review of the current evidence surrounding adjunctive agents for cervical preparation, and contend that for women presenting for surgical abortion care above 19 weeks gestation, the use of adjunctive mifepristone and/or misoprostol should be strongly considered along with osmotic dilator insertion when cervical preparation in less than 24 h is needed.

Synthetic osmotic dilators for cervical preparation prior to abortion-An international multicentre observational study.

OBJECTIVES: To evaluate the outcomes with the use of Dilapan-S for cervical preparation prior to medical or surgical abortion. STUDY DESIGN: International, multicentre, prospective observational study in women between 6 + 0-24 + 0 weeks' gestation. The study was conducted across 7 study sites in 4 countries, between 1/5/2015 to 31/12/2016. The primary outcomes studied were the number of dilators used and the duration required for cervical preparation prior to abortion. Secondary outcomes were complications of dilator use and infection. Participants were followed-up for 4 weeks post procedure to capture any delayed complications. RESULTS: A total of 483 women were enrolled with 439 women eligible for analysis. Medical abortion was performed in 38% (n = 165) women and surgical abortion in 62% (n = 274). For medical abortions and surgical abortions, an average of 3 osmotic dilators for time interval of 4-7 hours provided effective cervical preparation. Medical abortions were performed as day-case procedures (<12 h) in 81% of women. There was no difference in using either adjunctive misoprostol or Dilapan-S followed by misoprostol for cervical ripening effect to achieve complete medical abortion. Dilapan-S permitted surgical abortions to be performed as same-day procedures (<12 h), in 85% of women regardless of gestational age and without the need to use adjunctive or additional misoprostol. There were no serious adverse events reported with the use of Dilapan-S, including in women with a previous caesarean section. The overall infectious morbidity was 0.9% of cases with no causal relationship with the use of synthetic osmotic dilator use (for a length <24 h). In addition, Dilapan-S was reported as easy to insert and remove in over 90% of women. CONCLUSION: Dilapan-S is a safe and effective method for cervical preparation for medical and surgical abortions up to 24 weeks' gestation. It allows medical and surgical abortions to be performed as day case procedures and is associated with a low complication rate. Future research should aim at directly comparing Dilapan-S and preferred pharmacological agents in a randomised controlled trial.

Cervical preparation prior to surgical abortion in real-life conditions and factors driving the prescription: A national observational study.

INTRODUCTION: Few data exist to document the real-life practices regarding surgical abortion for first trimester abortion, in particular regarding the cervical preparation. Using a large national sample of French hospitals practicing surgical abortion, we explore actual practices and described drugs used for cervical preparation and factors that influence the prescription. METHODS: From December 2013 to July 2014, a longitudinal, prospective, multicenter, non-interventional study was undertaken with the main objective of assessing in real-life conditions the modalities of cervical preparation prior surgical abortion in women with less than 14 weeks of amenorrhea. RESULTS: A total of 542 patients agreed to participate and were included by 36 French private or public hospitals. Among 36 active centers, 31 (86.1%) implemented cervical preparation prior surgical abortion, in line with French and international clinical guidelines. For the 510 patients who underwent surgical abortions, the most frequent prescribed treatment was misoprostol only (224/510, 43.9% of patients), following by mifepristone only (167/510, 32.8%) and a combination of misoprostol and mifepristone (99/510, 19.4%). Finally, four factors were identified as independent contributor to guide the treatment prescribed for cervical preparation: woman work situation, gestational age intensity of center's activity regarding the number of abortions yearly and mode of anesthesia. CONCLUSIONS: Our study showed an almost systematic implementation of cervical preparation before surgical abortion in France. Misoprostol only was the most commonly prescribed treatment for the cervix preparation, followed by mifepristone only. Several factors may have a significant influence on the type of cervical preparation chosen by physicians.

Two cervical preparation regimens prior to surgical abortion at 10-14 weeks of gestation: A randomized clinical trial.

BACKGROUND: The aim of the study was to determine whether same-day cervical preparation with an osmotic dilator and misoprostol was as effective and safe as overnight cervical preparation for surgical abortions at 10-14 weeks. METHODS: Seventy women seeking surgical abortion at 10-14 weeks were allocated to receive one osmotic dilator 16-17 h or 6-7 h prior to an abortion. All women received misoprostol 400 µg orally 2 h before the abortion. RESULTS: The abortion time of the same-day group was 7.42 ± 1.73 min, and that of the overnight group was 8.00 ± 2.19 min (p = 0.23). The blood loss volume of the same-day group was 20.6 ± 10.6 mL, and that of the overnight group was 16.3 ± 7.0 mL (p = 0.55). The degree of cervical dilation for the same-day group was inferior to the overnight group (p = 0.02). CONCLUSIONS: Same-day cervical preparation with misoprostol and an osmotic dilator shortens the hospitalization days, suggesting same-day cervical preparation is safe, effective, and feasible for surgical abortion at 10-14 weeks of gestation.

Misoprostol 1 to 3 h preprocedure vs. overnight osmotic dilators prior to early second-trimester surgical abortion.

OBJECTIVES: We sought to compare the effectiveness of at least 1 h of 400 mcg of buccal misoprostol to overnight osmotic dilators for early second-trimester surgical abortion cervical preparation. DESIGN: We conducted a retrospective cohort study, reviewing 145 consecutive charts to compare procedure duration for women who received 400 mcg of buccal misoprostol at least 1 h preprocedure vs. overnight osmotic dilators before dilation and evacuation between 14 weeks, 0 days and 15 weeks, 6 days' gestation. Primary outcome was procedure duration and secondary outcomes included maximum mechanical dilator size, estimated blood loss and side effects. RESULTS: Sixty-four women (44.1%) received buccal misoprostol (mean 1.6 h), and 81 women (55.9%) received overnight osmotic dilators. Groups did not differ regarding mean gestational age or gynecologic history. All procedures in both groups were completed. Procedure duration was not significantly different between the misoprostol and osmotic dilator groups (median 11.0 min vs. 10.0 min, p=.22), even after multivariable linear regression (p=.17). The mean total cervical preparation duration was 1.6 h for women in the misoprostol group compared to 20.3 h in the osmotic dilator group (p<.001). Secondary outcomes did not differ between groups. CONCLUSIONS: We found that at least 1 h of preprocedure misoprostol decreased the duration of cervical preparation for early second-trimester procedures performed by an experienced surgeon. IMPLICATIONS: In this small, retrospective review, at least 1 h of preprocedure buccal misoprostol decreased the duration from cervical preparation initiation to procedure completion in early second-trimester procedures performed by an experienced surgeon. These results should be considered as a pilot evaluation, and further prospective study is needed to further clarify whether this short interval could be applied in general practice.

Laminaria vs. vaginal misoprostol for cervical preparation before second-trimester surgical abortion: a randomized clinical trial.

OBJECTIVE: To compare the efficacy and tolerability of vaginal misoprostol and laminaria for cervical preparation before second-trimester surgical abortion. STUDY DESIGN: We performed a prospective, randomized trial comparing midnight administration of misoprostol 600 mcg vaginally to midnight placement of laminaria, before surgical abortions among women at 13-20 weeks of gestation. The primary outcome was preoperative cervical dilation. Secondary outcomes were the need for further dilation, procedure duration and difficulty, immediate complications and side effects. RESULTS: Eighty-four women were randomized, with a median gestational age of 16.5 weeks. The mean time interval between misoprostol and laminaria placement and dilatation and evacuation initiation was 11.0±2.9 and 11.2±2.0h, respectively (p=.17). Cervical dilation was not greater in the laminaria group as compared to the misoprostol group (12.8 vs. 12.4mm, respectively; p=.32). No difference was demonstrated regarding the need for additional dilation or the difficulty of the procedure. Procedures performed after laminaria insertion were 1 min longer (median 11 vs. 10 min, p=.04). Participants found laminaria placement more uncomfortable than vaginal misoprostol placement. Other than pain, additional side effects occurred only in the misoprostol group, primarily nausea and vomiting. One participant in the misoprostol group experienced fetal expulsion during the night before the intended procedure. CONCLUSION: Either vaginal misoprostol or laminaria provides adequate dilation for second-trimester surgical abortion. Laminaria causes more pain at insertion and misoprostol causes more side effects. IMPLICATIONS STATEMENT: We found that cervical preparation in an inpatient setting for approximately 11h with misoprostol 600 mcg vaginally is comparable to 11h of laminaria. However, given the potential for spontaneous expulsion and more side effects with misoprostol, laminaria is likely a better general option in such a setting.

Intrauterine lidocaine for pain control during laminaria insertion: a randomized controlled trial.

OBJECTIVE: To determine if intrauterine administration of 5 cc of 2% lidocaine in addition to paracervical block reduces pain during laminaria insertion, when compared with paracervical block and saline placebo. STUDY DESIGN: This was a randomized, double blind placebo-controlled trial. Women presenting for abortion by dilation and evacuation (D&E) at 14-24 weeks gestational age were randomized to receive an intrauterine instillation of either 5 mL of 2% lidocaine or 5 mL of normal saline, in addition to standard paracervical block with 20 cc of 0.25% bupivacaine. Our primary outcome was self-reported pain scores on a 100mm Visual Analogue Scale (VAS) immediately following laminaria insertion. Secondary outcome was self-reported VAS pain score indicating the maximum level of pain experienced during the 24-48-h interval between laminaria insertion and D&E procedure. RESULTS: Seventy-two women were enrolled, and data for 67 women were analyzed, only two of whom were more than 21 weeks on gestation. The range of pain scores at both time points was large (1-90 mm at laminaria insertion; 0-100mm in laminaria-D&E interval). Mean pain scores were not different between treatment groups at laminaria insertion, (33 vs. 32, p=.8) or in the laminaria - D&E interval (43 vs. 44, p=.9). CONCLUSION: Intrauterine administration of 5 cc of 2% lidocaine in addition to paracervical block did not reduce pain with laminaria insertion when compared to paracervical block with saline placebo. IMPLICATIONS: Intrauterine lidocaine combined with paracervical block does not improve pain control at laminaria insertion when compared with paracervical block and saline placebo. Wide variation in pain scores and persistent pain after laminaria insertion suggests patient would benefit from more effective methods of pain control at laminaria insertion and during the post-laminaria interval.

Comparative assessment of the effects of Gates-Glidden, Largo, LA-Axxess, and New Brazilian Drill CPdrill on coronal pre-enlargement: cone-beam computed tomographic analysis.

INTRODUCTION: The removal of dentin interferences from the cervical third of root canals is essential for their correct cleaning and shaping and to facilitate access of endodontic instruments to the critical apical region. In mandibular molars, the concavity observed in the furcation area reduces dentin thickness, making this region more susceptible to perforation. The present ex vivo study used cone-beam computed tomographic imaging to compare 3 rotary burs with a new rotary bur recently launched in Brazil (ie, CPdrill; Helse Industry and Commerce Ltda, Santa Rosa, São Paulo, Brazil) regarding the amount of dentin removal from the distal wall of the mesial root of mandibular first molars. METHODS: A total of 40 root canals were selected and randomly divided into 4 groups for cervical preparation: Gates-Glidden burs #2 and #3 (Dentsply Maillefer, Ballaigues, Switzerland), Largo burs #1 and #2 (Dentsply Maillefer), LA-Axxess burs #1 and #2 (SybronEndo, Glendora, CA), and CPdrill burs (1-size only). Dentin thickness in the distal wall of mesial canals at 2 mm from the furcation was measured using I-CATvision software before and after cervical preparation. RESULTS: There was no statistically significant difference between groups regarding residual dentin thickness after instrumentation with the drills (P = .684). CONCLUSIONS: It was concluded that CPdrill is safe for use in cervical preparation of the mesial root of mandibular first molars because it did not promote excessive dentin removal on distal walls.

Misoprostol for intrauterine device insertion in nulliparous women: a randomized controlled trial.

OBJECTIVE: To examine the effects of preprocedure misoprostol on intrauterine device (IUD) placement in nulliparous women. STUDY DESIGN: In this randomized controlled double-blind trial at the University of New Mexico reproductive health clinic, nulliparous women requesting an IUD were randomized to 400 mcg of buccal misoprostol or placebo 2-8 hours before insertion. Primary outcomes included pain on a 10-cm visual analog scale and women's perception of the value of delaying insertion for an effective medication. Provider ease of insertion and need for adjunctive insertion measures were also assessed, on a visual analog scale. Participants indicated maximum pain after IUD insertion, pain level they would tolerate to avoid delay in IUD insertion, and preference for IUD insertion without delay if an effective medication was available. RESULTS: Of 85 women enrolled, 3 were ineligible; 42 were randomized to misoprostol and 40 to placebo. There were no differences between groups in worst insertion pain, (5.8 ± 2.0 vs 5.9 ± 2.0, P = .94), provider ease of insertion (2.2 ± 2.2 vs 2.5 ± 2.2; P = .54) or adjunctive measures (14% vs 25%; P = .27). The groups were willing to tolerate the same mean pain (4.9 ± 2.5 vs 5.7 ± 2.4, P = .18) to avoid waiting for medication. The majority of women (85%) preferred to wait for an effective medication. CONCLUSION: Misoprostol for nulliparous women did not decrease pain or improve the ease of insertion of an IUD. Most women were willing to wait for a medication that decreases pain, indicating a need to pursue alternatives for pain control with IUD insertion.

Effects of Gates-Glidden, LA Axxess and orifice shaper burs on the cervical dentin thickness and root canal area of mandibular molars

This study evaluated the increase of the instrumented area and dentin thickness in the mesial and distal aspects of mesial canals of mandibular molars after the use of Gates Glidden (GG), LA Axxess (LA) and Orifice Shaper (OS) instruments. A total of 53 canals from 27 mandibular molars were embedded in resin and divided into 3 groups. The roots were sectioned 3 mm below the cementoenamel junction and the images were captured before and after instrumentation. The increase of the instrumented area in terms of percentages and the remaining dentin thickness, in mm, at the mesial and furcal aspects were calculated using the Image tools software. Data were analyzed using the Kruskal-Wallis and Dunn's test. The significance level was set at 5 percent. All instruments promoted cervical flaring with different amounts of dentin removal at the mesial and distal aspects of the root canals. Statistically significant difference (p<0.05) was found between LA and all other instruments after using the first instrument. Regarding dentin thickness, no significant difference (p>0.05) was found between the mesial and distal walls in all groups. It may be concluded that LA 35.06 and GG 3 burs produced the thinnest dentin walls, and thus their use in mesial canals of mandibular molars should be done with caution.

Este estudo avaliou o aumento da área do canal e a espessura de dentina na parede mesial e distal dos canais mesiais de molares inferiores após o uso de Gates Glidden (GG), La Axxess (LA), Orifice Shaper (OS). Um total de 53 canais mesiais de 27 molares inferiores foram incluídos em resina e divididos em 3 grupos. As raízes foram seccionados 3 mm abaixo da junção cemento-esmalte e as imagens foram capturadas antes e depois da instrumentação. O aumento da área do canal em percentagem e a espessura da dentina remanescente nas paredes mesial e furca foram calculados utilizando o software Image Tools. Os dados foram analisados utilizando o Kruskal-Wallis e teste de Dunn. O Nível de significância foi de 5 por cento. Todos os instrumentos promoveram o aumento da área cervical, com diferentes quantidades de remoção da dentina nas paredes mesial e distal do canal radicular. Diferença estatística (p<0,05) foi encontrada entre LA e todos os outros instrumentos após o uso do primeiro instrumento. Quanto à espessura da dentina, não houve diferença significativa (p>0,05) entre as paredes mesial e distal de todos os instrumentos analisados. O LA 35.06 e GG 3 mostraram a menor espessura da parede e sua utilização em canais mesiais de molares inferiores deve ser feito com cuidado.