Buccal Misoprostol Research Articles

Buccal versus Vaginal Misoprostol Combined with a Foley Catheter among Individuals with Obesity Undergoing Induction.

Combining pharmacologic agents with mechanical ripening achieves the shortest labor duration, yet there is no clear evidence on route of drug administration in obese individuals. The use of buccal misoprostol has shown greater patient acceptance but remains understudied. Our objective was to evaluate the difference in time to delivery of buccal compared with vaginal misoprostol in combination with a Foley catheter (FC) for induction of labor (IOL) in the obese population. This was a secondary analysis of a randomized controlled trial comparing identical dosages (25 μg) of buccal and vaginal misoprostol in combination with a FC. The parent trial was an institutional review board-approved, randomized clinical trial conducted from June 2019 through January 2020. Labor management was standardized among participants. Women undergoing IOL at ≥37 weeks with a singleton gestation and cervical dilation ≤2 cm were included. Body mass index (BMI, kg/m2) was stratified. The primary outcome was time to delivery. A total of 215 participants were included. Demographic characteristics were similar between the three groups. Vaginal drug administration achieved a faster median time to delivery than the buccal route among patients with a body mass index greater than or equal to 30 kg/m2 (vaginal misoprostol-FC: 21.3 hours vs. buccal misoprostol-FC: 25.2 hours, p = 0.006). There was no difference in the cesarean delivery rate between the two groups. Furthermore, patients with a BMI greater than or equal to 30 kg/m2 receiving vaginal misoprostol delivered 1.2 times faster than women who received buccal misoprostol after censoring for cesarean delivery and adjusting for parity (hazard ratio: 1.2, 95% confidence interval: 1.1-1.7). There were no significant differences in maternal and neonatal outcomes. We found that vaginal misoprostol was superior to buccal misoprostol when combined with a FC among individuals with a BMI greater than or equal to 30 kg/m2. Vaginal misoprostol should be the preferred route of drug administration for term IOL in this population. · Vaginal misoprostol was superior to buccal route among patients with obesity.. · There was no difference in the cesarean delivery rate between the two groups.. · Vaginal misoprostol should be the preferred route of administration among patients with obesity..

A Comparative Study of Vaginal, Sublingual, and Buccal Misoprostol in Induction of Labor in Term Pregnancy

A Comparative Study of Vaginal, Sublingual, and Buccal Misoprostol in Induction of Labor in Term Pregnancy

Adjuvant misoprostol or mifepristone for cervical preparation with osmotic dilators before dilation and evacuation

ObjectivesThis study aimed to compare effectiveness and safety of cervical preparation with osmotic dilators plus same-day misoprostol or overnight mifepristone prior to dilation and evacuation (D&E). Study designWe conducted a retrospective cohort analysis of 664 patients initiating abortion between 18 and 22 weeks at an ambulatory health center. We abstracted medical record data from two consecutive 12-month periods in 2017 to 2019. All patients received overnight dilators plus: 600 mcg buccal misoprostol 90 minutes before D&E (period 1); 200 mg oral mifepristone at time of dilators (period 2). Our primary outcome was procedure time. We report frequency of patients experiencing any acute complication, defined as unplanned procedure (i.e., reaspiration, cervical laceration repair, uterine balloon tamponade) or hospital transfer and bleeding complications. ResultsWe observed higher mean procedure time in the mifepristone group (9.7 ± 5.3 minutes vs 7.9 ± 4.4, p = 0.004). After adjusting for race, ethnicity, insurance, body mass index, parity, prior cesarean, prior uterine surgery, gestational age, provider, trainee participation, and long-acting reversible contraception initiation, the difference remained statistically significant (relative change 1.09, 95% CI 1.01, 1.17) but failed to reach our threshold for clinical significance. The use of additional misoprostol was more common in the mifepristone group, but the use of an additional set of dilators was not different between groups. Acute complications occurred at a frequency of 4.1% in misoprostol group and 4.3% in mifepristone group (p = 0.90). ConclusionsWe found procedure time to be longer with adjunctive mifepristone compared to misoprostol; however, this difference is unlikely to be clinically meaningful. Furthermore, the frequency of acute complications was similar between groups. ImplicationsOvernight mifepristone at the time of cervical dilator placement is a safe and effective alternative to adjuvant same-day misoprostol for cervical preparation prior to D&E and may offer benefits for clinic flow and patient experience.

Efficacy and safety of medical termination of pregnancy in a regional primary care setting.

Australia has demonstrated high efficacy and safety of medical termination of pregnancy (MToP) using a mifepristone-buccal misoprostol regime. The provision of medical termination services in primary care has the potential to alleviate access barriers, particularly in rural and regional populations. Large-scale data are needed to support the expansion of this model. The aim was to determine the efficacy and safety of nurse-led MToP within a regional general practice clinic. A retrospective cohort study of patients prescribed MToP from October 2014 to April 2020. Clinic nurses assessed patient eligibility and provided information, non-directive counselling and instructions. The general practitioner then confirmed eligibility, obtained informed consent and prescribed. Patients were administered 200 mg of mifepristone orally in a pharmacy and then self-administered 800-μg buccal misoprostol 36-48 h later at home. A total of 998 patients were included in this study, with the median patient age being 27.3 years and 30.3% of patients travelling over 100 km to access the service. MToP was successful in 965 (96.7%) patients. There were 36 (3.6%) complications, of which 33 were incomplete MToP. Haemorrhage requiring transfusion, pain requiring hospital treatment and suspected infection were rare, each having a frequency of one (0.1%). Our follow-up rate was 74.8%, with a strong correlation identified between increased gestational age and decreased follow-up (P < 0.001). This study is a large Australian example demonstrating high efficacy and safety of nurse-led MToP within regional general practice. The establishment of similar services in rural and regional Australia may address geographical and financial barriers to termination access.

Buccal Versus Vaginal Misoprostol Combined with a Foley Catheter Among Individuals with Obesity Undergoing Induction

Combining pharmacologic agents with mechanical ripening achieves the shortest labor, yet there is no clear evidence on route of drug administration in patients with obesity. Our objective was to evaluate the difference in time to delivery of buccal compared to vaginal misoprostol in combination with a Foley catheter (FC) for labor induction (IOL) in the obese population. This was a planned secondary analysis of a randomized controlled trial comparing identical dosages (25μg) of buccal and vaginal misoprostol in combination with a FC. Labor management was standardized among participants. Women undergoing IOL at ≥37 weeks with a singleton gestation and cervical dilation ≤2cm were included. Body mass index (BMI, kg/m2) was stratified. Our primary outcome was time to delivery. Kruskal-Wallis, Pearson chi-square and Cox survival analyses with intent-to-treat principles were performed. 215 participants were included with the following weight stratifications: 55 (25.6%) BMI < 30; 110 (51.2%) BMI 30-39.9; 50 (23.3%) BMI ≥40. Demographic characteristics were similar between the three groups. Vaginal drug administration achieved a faster median time to delivery than the buccal route among patients with a BMI range of 30-39.9, (vaginal miso–FC: 21.3hrs vs. buccal miso–FC: 23.6hrs, p=0.04). There was no difference in the cesarean delivery rate between the various groups. Furthermore, patients with a BMI range of 30-39.9 receiving vaginal misoprostol delivered 1.2 times faster than women who received buccal misoprostol after censoring for Cesarean delivery and adjusting for parity, (Hazard Ratio [HR] 1.2, 95% confidence interval [CI] 1.1-1.7). There were no significant differences in maternal and neonatal outcomes. We found that vaginal misoprostol was superior to buccal misoprostol when combined with a FC among individuals with a BMI range of 30-39.9. Therefore, vaginal misoprostol should be the preferred route of drug administration for term IOL in this population.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Short-term efficacy and safety of early medical abortion in Japan: A multicenter prospective study.

To evaluate the short-term efficacy and safety of a combined mifepristone-misoprostol regimen in individuals seeking medical abortion at up to 63 days of gestational age. This open-label, multicenter, prospective study evaluated the short-term efficacy and safety of medical abortion, with the primary outcome being the abortion success rate 24 h after misoprostol administration. The participants received 200 mg of mifepristone orally and 800 μg of misoprostol buccally in the hospital/clinic 36-48 h later. Bleeding and lower abdominal pain, which are the main symptoms associated with medical abortion, were recorded. The abortion success rate was 93.3% (95% confidence interval [CI]: 87.3-97.1%) within 24 h of misoprostol administration, 63.3% (95% CI: 54.05-71.94%) within 4h, and 90.0% (95% CI: 83.18-94.73%) within 8h. The median time from misoprostol administration to a successful abortion was 3.93 h. Bleeding was most commonly observed 0-4h prior to the confirmation of gestational sac (GS) expulsion. The most intense lower abdominal pain occurred 0-1h before the confirmation of GS expulsion. The combined regimen of mifepristone and buccal misoprostol for medical abortion showed short-term efficacy and a favorable safety profile.

Cervical change times during induction in nulliparas using vaginal or buccal misoprostol

Aim To determine if the time to cervical change and time to active labor were different when misoprostol was administered by a vaginal or buccal route for cervical ripening in nulliparas undergoing labor induction at term. Methods This was a secondary analysis of nulliparous participants in the IMPROVE Study—A comparison of vaginal versus buccal misoprostol for cervical ripening for labor induction at term: a triple-masked randomized controlled trial (NCT 02408315). The parent study was a non-inferiority randomized controlled trial in which patients beginning induction with a modified Bishop score ≤6 received either vaginal or buccal misoprostol and simultaneous placebo via the opposite route. The primary outcome of the parent study was time to delivery. Primary outcomes for this secondary analysis were the time to active labor (at least 6 cm dilated) and time to change in cervical dilation. Kaplan–Meier analysis was used to compare routes for time to active labor and multistate Markov modeling was used to compare sojourn times at each cervical dilation. Results Of the 300 participants enrolled in the parent trial, 124 (41.3%) were nulliparous; 59 (47.6%) nulliparous participants underwent induction with vaginal misoprostol and 65 (52.4%) received buccal dosing. Nulliparas receiving vaginal dosing required fewer doses of misoprostol to reach active labor (median 2 vs 3, p = .003). However, this did not result in shorter time to active labor (median vaginal 23.1 h, 95% CI = [21.6, 27.2 h]; buccal 25.6 h [21.5, 29.3 h], p = .45) or higher rate of vaginal delivery within 24 h; (33.9% vs 35.4%, p = .86). There was also no significant difference in time to active labor after adjusting for covariates (adjusted HR for dose route (buccal vs vaginal) = 0.91 [0.61, 1.36], p = .649). Among people that delivered vaginally, the mean sojourn times, measuring cervical dilation state change, were not significantly different, with mean duration to active labor of 20.5 [17.6, 24.5] h for buccal and 21.8 [17.7, 28.2] h for vaginal dosing (p = .092). Satisfaction and preference for dosing routes were not different between groups. Conclusion Buccal and vaginal dosing of misoprostol for cervical ripening in nulliparas appear to have similar times to active labor and progression of cervical change during ripening.

How much will it hurt? Factors associated with pain experience in women undergoing medication abortion during the first trimester

ObjectivesFew studies have investigated the features associated with pain levels during abortion. We aimed to investigate the risk factors for experiencing pain during medication abortion, focusing on women's psychological distress and anxiety levels. Study designWe carried out this observational study at two centers in Bologna, Italy. We included women aged 18 years or more with a viable intrauterine pregnancy of up to 63 days of amenorrhea, who chose medication abortion. Women received 600 mg of Mifepristone orally and after 48 hours 400 mcg of buccal misoprostol, repeated after 3 hours according to local and regional medication abortion guidelines, as well as prophylactic analgesia. We evaluated the clinical characteristics which may represent risk factors for severe pain (Visual Analogue Scale ≥ 70) through a multivariate model. ResultsTwo hundred forty-two patients were included in our analysis; 92 (38.0%) reported severe pain during medication abortion. Women with higher baseline anxiety levels (General Health Questionnaire 12 score ≥ 6 and General Anxiety Disorder 7 score ≥ 10) had a higher probability of experiencing pain with a Visual Analogue Scale ≥70 (OR = 3.33, 95% CI 1.43–7.76), as well as those who reported dysmenorrhea in the past year (OR = 6.30, 95% CI 2.66–14.91). Previous vaginal deliveries were inversely correlated with pain intensity (OR 0.26, 95% CI 0.14 – 0.50). ConclusionsIncreased baseline anxiety levels, dysmenorrhea and no previous vaginal deliveries are associated with severe pain in women undergoing medication abortion. ImplicationsThe identification of women at risk for severe pain based on clinical and historical factors as well as the definition of an adequate analgesic regimen may help to improve women's care and pain management during medication abortion.

Buccal versus Intravaginal Administration of Misoprostol for Labor Induction

Objective: The purpose of this study is to compare the efficacy of misoprostol that is administrated in the buccal pouch with the intravaginal route.&#x0D; Study design: Ninety eight pregnant women with a singleton live gestation. Bishop score of &lt; 5, gestational ages of &gt; 37 wks were randomized receives misoprostol that would be placed either in the buccal pouch or vagina. In the oral group were initially given 100 μg of misoprostol orally this was repeated every 3-4 hours until occurrence of active and progressive labor while in vaginal group we insert 25 μg in the vagina using a water as a lubricant and the labor and fetal outcome was compared in both groups.&#x0D; Results: The hours from drug administration to vaginal delivery were significantly not different between the buccal and vaginal group (1120 ± 128) versus (1412 ± 140) respectively, 28 patient in buccal group versus 35 delivered vaginally in vaginal group. The neonatal outcomes between the two groups were similar and there were no statistical difference between the two groups. (P = not significant). So, buccal misoprostol is effective for cervical ripening as dose the vaginal administration.

Comparison of vaginal and buccal misoprostol after mifepristone for medication abortion through 70 days of gestation: A retrospective chart review

ObjectiveTo determine the proportion of complete abortion without surgical intervention for patients who chose medication abortion with vaginal compared to buccal misoprostol following oral mifepristone through 70 days of gestation. MethodsWe performed a retrospective cohort study. We reviewed charts via electronic medical record data abstraction of patients receiving medication abortion with mifepristone and buccal or vaginal misoprostol between September 1, 2017 and August 1, 2019. Primary outcome was complete abortion without surgical intervention for any indication. Secondary outcomes were ongoing pregnancy and uterine aspiration for indications other than ongoing pregnancy. ResultsThere were 14,504 encounters included in the data set. Of the 4814 patients who took vaginal misoprostol and the 4011 patients who took buccal misoprostol for whom follow up data is available, 4640 (96.4%) and 3917 (97.7%) had a complete abortion without surgical intervention, respectively (p = 0.002). At <64 days of gestation, complete abortion was 96.6% for vaginal administration compared to 98.0% for buccal (p = 0.001). At 64 to 70 days of gestation, complete abortion was 92.7% for vaginal administration compared to 93.2% for buccal (p = 0.08). Of the 1128 patients who took vaginal misoprostol at less than 6 hours after mifepristone, 95.3% experienced a complete abortion. ConclusionBuccal administration of misoprostol is associated with a higher proportion of complete abortion before 64 days of gestation compared to vaginal misoprostol. Clinically, vaginal misoprostol is an effective route of administration through 70 days of gestation. ImplicationsMedication abortion with vaginal misoprostol is effective when administered through 70 days of gestation and with shorter intervals between mifepristone and misoprostol. Prospective research to better estimate effectiveness is warranted. Expanding medication abortion options promotes patient autonomy amid increasing restrictions and bans on abortion.

Pharmacokinetics of vaginal versus buccal misoprostol for labor induction at term.

The IMPROVE study (NCT02408315) compared the efficacy and safety of vaginal and buccal administration of misoprostol for full‐term, uncomplicated labor induction. This report compares the pharmacokinetics of misoprostol between vaginal and buccal routes. Women greater than or equal to 14 years of age undergoing induction of labor greater than or equal to 37 weeks gestation without significant complications were randomized to vaginal or buccal misoprostol 25 μg followed by 50 μg doses every 4 h. Misoprostol acid concentrations were determined using liquid chromatography‐tandem mass spectrometry for the first 8 h in a subgroup of participants. A population pharmacokinetic model was developed using NONMEM. Plasma concentrations (n = 469) from 47 women were fit to a one‐compartment nonlinear clearance model. The absorption rate constant (ka) was dependent on both route and dose of administration: buccal 25 μg 0.724 (95% confidence interval, 0.54–0.92) h−1; 50 μg 0.531 (0.37–0.63) h−1; vaginal 25 μg 0.507 (0. 2–1. 4) h−1; and 50 μg 0.246 (0.103–0.453) h−1. Relative bioavailability for vaginal compared to buccal route was 2.4 (1.63–4.77). There was no effect of body mass index or age on apparent clearance 705 (431–1099) L/h or apparent volume of distribution 632 (343–1008) L. The area under the concentration–time curve to 4 h following the first 25 μg dose of misoprostol was 16.5 (15.4–17.5) pg h/ml for buccal and 34.3 (32.5–36.1) pg h/ml for vaginal administration. The rate of buccal absorption was two times faster than that of vaginal, whereas bioavailability of vaginal administration was 2.4 times higher than that of buccal. Decreased time to delivery observed with vaginal dosing may be due to higher exposure to misoprostol acid compared to buccal.

The experience of pain in real-time during medication abortion

ObjectiveWe aimed to characterize the current pain experience of patients completing an evidence-based mifepristone-misoprostol medication abortion regimen using real-time pain scores. Study DesignWe collected real-time data on pain experienced by 54 women undergoing medication abortion using an evidence-based regimen of 200 mg mifepristone and 800 mcg buccal misoprostol. These women were enrolled in the placebo arm of a study on the effect of pregabalin for pain during medication abortion. All participants were dispensed ibuprofen and oxycodone/acetaminophen for analgesia. We assessed maximum pain experienced by participants on an 11-point numerical rating scale (NRS), duration of pain, and analgesic usage. Data was collected through electronic surveys sent via text message link at 6 specified points over 72 hours. ResultsOf the 54 women randomized to the placebo group, 2 were lost to follow-up. Participants experienced a mean maximum pain score of 5.5 ± 2.2. The mean time to maximum pain was 3.7 ± 2.4 hours after misoprostol. By hour 12 after misoprostol, 60.8% of participants reported no pain, which increased to 76.9% at 24 hours and 82.0% at 72 hours. Participants reported median ibuprofen usage of 2 800 mg tablets and median oxycodone/acetaminophen usage of one-half of a 5/325mg tablet. Approximately 12.0% of participants reported taking zero ibuprofen tablets, and 50.0% reported no opioid usage during the study period. ConclusionsOur real-time data collection demonstrated lower mean maximum experienced pain scores and shorter duration of pain than previously reported for medication abortion. Analgesic use was lower than previously described. ImplicationsThis updated characterization of pain experienced during an evidence-based medication abortion regimen may allow for better pain-related counseling, tailoring of opioid prescription practices, and improvement in patient satisfaction.

The effect of intravenous (IV) tranexamic acid plus buccal misoprostol on blood loss during and after cesarean delivery: a randomized double-blind study

The effect of intravenous (IV) tranexamic acid plus buccal misoprostol on blood loss during and after cesarean delivery: a randomized double-blind study

A novel method for office aspiration curettage in cases of retained products of conception: A randomized controlled trial.

Missed abortion can be treated with medication or aspiration curettage. A Karman aspiration cannula is another option. We evaluated its success in evacuating retained products of conception (RPOC) based on symptoms, endometrial thickness, endometrial irregularity, and blood flow seen on Doppler ultrasound (indicative of placenta). This prospective, randomized, nonblinded trial was conducted in a university-affiliated medical center. It included 40 women diagnosed with missed abortion and two failed courses of 600µg buccal misoprostol, one week apart, randomly assigned to treatment or controls. One week after the second misoprostol course, immediately after evaluating endometrial thickness, endometrial irregularity using Doppler ultrasound, and with blood flow indicative of RPOC, women in the aspiration group underwent endometrial suction with a Karman aspiration cannula. The 5-6mm cannula attached to a 60mL syringe was inserted into the uterus under ultrasound guidance. The contents were aspirated until the uterus was empty. Control group patients did not receive additional treatment. All were scheduled for ambulatory, operative hysteroscopy under anesthesia 1month later (departmental protocol). On that day, all women with RPOC on Doppler ultrasound underwent hysteroscopy. Bleeding days, days with pain, pain according to visual analog scale, length of hospitalization, and infection rate were recorded. NIH clinical trial registration number NCT02917785. In the study group, 90% did not need hysteroscopy, compared with 50% of controls (p=0.014). No complications were noted. At all visits, we used Doppler ultrasound to exclude or confirm RPOC. Pathology revealed RPOC in all women who underwent aspiration. Average visual analog scale score for office aspiration (n=20) was 4.9±3.6. vs. 6.3±3.4 for the first (p=0.157) and 4.7±3.3 for the second (p=0.836) misoprostol treatment cycle. The treatment group experienced 6.1days of bleeding and the control group experienced 1.4days (p=.006). Based on our criteria of diagnosing RPOC according to symptoms, endometrial thickness, endometrial irregularity, and blood flow indicative of placental tissue seen on Doppler ultrasound and histo-pathological confirmation, aspiration using Karman cannula can be an effective therapeutic approach. It may be a safe alternative for women with RPOC after misoprostol failure.

UTAH: Using Telemedicine to improve early medical Abortion at Home: a protocol for a randomised controlled trial comparing face-to-face with telephone consultations for women seeking early medical abortion

IntroductionEarly medical abortion (EMA) is a two-stage process of terminating pregnancy using oral mifepristone (a progesterone-receptor antagonist) followed usually 1–2 days later by sublingual, vaginal or buccal misoprostol (a prostaglandin...

Buccal vs vaginal misoprostol combined with Foley catheter for cervical ripening at term (the BEGIN trial): a randomized controlled trial

Combining pharmacologic agents with mechanical ripening achieves the shortest time to labor; however, there is no clear evidence on route of drug administration. Buccal administration of misoprostol has shown greater patient acceptance but remains understudied. This study aimed to evaluate the difference in time to delivery between buccal and vaginal administration of misoprostol along with a Foley catheter for induction of labor. The BEGIN trial (buccal vs vaginal misoprostol combined with Foley catheter for cervical ripening at term) was an institutional review board-approved, randomized clinical trial conducted from June 2019 to January 2020 comparing identical doses (25 μg) of buccal misoprostol and vaginal misoprostol along with a Foley catheter for induction of labor. Randomization was stratified by parity. Labor management was standardized among participants. Individuals undergoing induction of labor at ≥37 weeks with a singleton gestation and needing cervical ripening were included. Our primary outcome was time to delivery. Kruskal-Wallis, Pearson chi-squared, and Cox survival analyses with intent-to-treat principles were performed. A sample size of 216 was planned to detect a 4-hour reduction in delivery time. A total of 215 women (108 in the buccal drug administration group and 107 in the vaginal drug administration group) were randomized. The vaginal route of drug administration achieved a faster median time to delivery than the buccal route of drug administration (19.7 hours in the vaginal route vs 24.1 hours in the buccal route; P<.001). A greater percentage of women in the vaginal drug administration group delivered within 24 hours compared with the buccal drug administration group (65% vs 49%; P=.02). There was no difference in the cesarean delivery rate between the 2 groups (17% in the vaginal drug administration group vs 21% in the buccal drug administration group; P=.6). Individuals who received vaginal misoprostol with Foley catheter delivered 2 times faster than women who received buccal misoprostol with Foley catheter after censoring for cesarean delivery and adjusting for parity (hazard ratio, 2.13; 95% confidence interval, 1.44-3.17). There was no significant difference in maternal and neonatal outcomes. We found that vaginal administration of misoprostol was superior to buccal administration of misoprostol along with a Foley catheter for induction of labor. Furthermore, vaginal administration of misoprostol resulted in twice the chance of delivering earlier compared with buccal administration of misoprostol with no difference in cesarean delivery rates. Therefore, the vaginal route of administration of misoprostol should be preferred among individuals undergoing a combined pharmacologic and mechanical induction.

48 Buccal Versus Vaginal Misoprostol Combined with a Foley Catheter (BEGIN Trial): A Randomized Controlled Trial

Combining pharmacologic agents with mechanical ripening achieves the shortest labor, yet there is no clear evidence on route of drug administration. The use of buccal misoprostol (miso) has shown greater patient acceptance but remains understudied. Our objective was to evaluate the difference in time to delivery of buccal compared to vaginal miso in combination with a Foley catheter (FC) for labor induction (IOL). A randomized clinical trial was conducted from June 2019 through January 2020 comparing identical dosages (25μg) of buccal and vaginal miso in combination with a FC. Randomization was stratified by parity. Labor management was standardized among participants. Women undergoing IOL at ≥37 weeks with a singleton gestation and cervical dilation ≤2cm were included. Our primary outcome was time to delivery. Kruskal-Wallis, Pearson chi-square and Cox survival analyses with intent-to-treat principles were performed. 215 women (108 Buccal, 107 Vaginal) were randomized. Vaginal drug administration achieved a faster median time to delivery compared to buccal miso, (vaginal miso–FC: 19.7hrs vs. buccal miso–FC: 24.1hrs, p< 0.001). A greater percentage of women in the vaginal administration group delivered within 24hrs (65% versus 49%, p=0.02). There was no difference in the cesarean delivery rate between the two groups (vaginal miso–FC: 17% vs. buccal miso–FC: 21%, p=0.6). Women receiving vaginal miso delivered 1.5 times faster than women who received buccal miso after censoring for Cesarean delivery and adjusting for parity, (Hazard Ratio [HR] 1.5, 95% confidence interval [CI] 1.1-2.0). There were no significant differences in maternal and neonatal outcomes. We found that vaginal miso was superior to buccal miso when combined with a FC. Vaginal administration of miso resulted in twice the chance of delivering before a similar dose of buccal miso with no difference in cesarean delivery rates. Therefore, vaginal miso should be the preferred route of drug administration in term IOL.View Large Image Figure ViewerDownload Hi-res image Download (PPT)

Rate of Cervical Change During Ripening in Nulliparous Women Using Vaginal or Buccal Misoprostol [38J

INTRODUCTION: Cervical ripening is frequently needed for labor induction in nulliparous women. The objective of this study was to determine if the rate of cervical change and time to active labor were different when misoprostol is administered by vaginal or buccal route. METHODS: This was a secondary analysis of nulliparous women enrolled in the IMPROVE Study- A comparison of vaginal versus buccal misoprostol for cervical ripening in women for labor induction at term: a triple-masked randomized controlled trial. Primary outcomes were time to active labor (defined as at least 6 cm cervical dilation) and rate of change of cervical dilation up to active labor. Survival analysis using Product-Limit Survival Estimate and Kaplan-Meier method was utilized for time to active labor. IRB approval was obtained. RESULTS: Of the 300 women enrolled in the trial, 124 (41.3%) were nulliparous, with 59 receiving vaginal misoprostol and 65 receiving buccal. Nulliparous women receiving vaginal dosing required fewer doses to reach active labor (2.0 vs 3.0, P=.003). However, this did not result in shorter time to active labor (median 23.1 hrs vs. 25.6, P=.49). The rate of cervical change for the vaginal misoprostol group from trial entry to ≥6 cm was 2.9 (±1.6) mm/hr compared to 2.9 (±1.6) mm/hr for buccal (P=.97). CONCLUSION: In nulliparous women undergoing cervical ripening with misoprostol, vaginal dosing may require fewer doses to achieve active labor but the time to active labor and rate of cervical change were similar between dosing groups. There may not be clinically meaningful differences between dosing routes in nulliparous women.

Commentary: No-test medication abortion: A sample protocol for increasing access during a pandemic and beyond

Author(s): Raymond, Elizabeth; Grossman, Daniel; Mark, Alice; Upadhyay, Ushma; Dean, Gillian; Creinin, Mitchell; Coplon, Leah; Perritt, Jamila; Atrio, Jessica; Taylor, DeShawn; Gold, Marji | Abstract: No abstract

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,

ObjectivesTo 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 DesignWe 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. ResultsWe 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. ConclusionsHygroscopic 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. ImplicationsAdding 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.