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.

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.

Postpartum contraception: An exploratory study of lactation consultants' knowledge and practices.

OBJECTIVE: Lactation consultants interact with women during the postpartum period; however, they may not have comprehensive education on postpartum contraception and the impact on breastfeeding. The aims of this study were to assess lactation consultants' knowledge and practices about postpartum contraception and assess whether lactation consultants are interested in more education on postpartum contraception. STUDY DESIGN: We distributed a 30-question survey to self-identified lactation consultants and recruited participants via email, social media and at the 2015 California Breastfeeding Summit. RESULTS: We surveyed a total of 194 lactation consultants. Seventy-seven percent (137/177) stated they offer advice about postpartum contraception and its impact on breastfeeding. The majority of lactation consultants felt the theoretical or proven risks outweighed the benefits or there was an unacceptable health risk for the progestin-only pill 76.3% (100/131), progestin injection 90.1% (118/131) and progestin implant 93.1% (122/131) if used within 21days of delivery. Although 68.7% (92/134) reported prior education on postpartum contraception, 82.1% (110/134) reported wanting more education on this topic, specifically in the form of a webinar 61.9% (83/134). Only 29.9% (40/134) reported knowledge of the United States Centers for Disease Control and Prevention 2011 Medical Eligibility Criteria for Contraceptive Use (USMEC) guidance for postpartum contraception. CONCLUSION: There is a disconnect between the USMEC guidance and lactation consultants' knowledge regarding the safety of immediate postpartum contraception. IMPLICATIONS: This study explores lactation consultants' knowledge and practices about postpartum contraception, demonstrating that more evidence-based education is needed on this topic.

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.

ACIDFORM: a review of the evidence.

OBJECTIVE: ACIDFORM is a candidate microbicide with spermicidal properties. A large Phase 3 trial is underway, and it is anticipated that this product will be approved for contraceptive use and marketed soon in the United States. The goal of this article is to critically review the evidence supporting the properties, safety profile and different uses of ACIDFORM gel. STUDY DESIGN: We searched PubMed and Medline for any published literature on ACIDFORM. RESULTS: ACIDFORM is an acidifying agent that works by lowering the vaginal pH to enhance the normal vaginal defenses. In addition to strong acid-buffering properties, ACIDFORM has high bioadhesive and viscosity-retaining properties. Several Phase 1 clinical trials have demonstrated the vaginal safety of ACIDFORM used alone or in combination with a diaphragm, although dose-dependent side effects appear to be present. Studies investigating the efficacy of ACIDFORM against sexually transmitted infections (STIs) are promising, but further trials are needed. CONCLUSIONS: The properties of ACIDFORM offer many advantages for use, either alone or in combination with another active ingredient, such as Tenofovir. Potential applications for ACIDFORM include use as a personal lubricant, a vaginal contraceptive (alone or with a barrier method) and a microbicidal product or as a formulation vehicle for an active ingredient. IMPLICATIONS: ACIDFORM is a candidate female-controlled vaginal preparation with microbicidal and spermicidal properties. A dual protection method could prevent unwanted pregnancies and reduce the risk of STI acquisition.

Use of levonorgestrel intrauterine system for medical indications in adolescents.

The levonorgestrel intrauterine system (LNG-IUS) is an underused contraceptive method in adolescent populations. In addition to being a highly effective, reversible, long-acting contraception, the LNG-IUS has many noncontraceptive health benefits including reduced menstrual bleeding, decreased dysmenorrhea and pelvic pain related to endometriosis, and menstruation suppression in teens with physical or developmental disabilities. The LNG-IUS can also provide endometrial protection in teens with chronic anovulation, and may be used to treat endometrial hyperplasia and cancer. This review examines the evidence supporting the use of the LNG-IUS in adolescents for these noncontraceptive benefits.

The price of emergency contraception in the United States: what is the cost-effectiveness of ulipristal acetate versus single-dose levonorgestrel?

BACKGROUND: Ulipristal acetate (UPA) is a novel form of emergency contraception (EC) that appears to be more effective than the prevailing method, single-dose levonorgestrel (LNG). This study examines the cost-efficacy of UPA compared with LNG. STUDY DESIGN: A decision-analytic model was developed to compare the cost-effectiveness of UPA versus LNG in preventing unintended pregnancy when taken within 120 h of unprotected intercourse. Univariate and bivariate sensitivity analyses, as well as Monte Carlo simulation and threshold analyses, were performed. RESULTS: Utilizing UPA instead of LNG would result in 37,589 fewer unintended pregnancies per 4,176,572 estimated US annual EC uses (UPA 54,295 pregnancies; LNG 91,884 pregnancies) and a societal savings of $116.3 million annually. Cost-effectiveness acceptability curve analyses suggest a 96% probability that UPA is more cost-effective at a willingness to pay $100,000 per quality-adjusted life year. CONCLUSIONS: UPA is cost-effective in preventing unintended pregnancy after unprotected intercourse. Efforts should be promoted to increase access to UPA.

Adolescent experience with intrauterine device insertion and use: a retrospective cohort study.

BACKGROUND: Adolescents contribute disproportionately to the epidemic level of unintended pregnancy in the USA. Intrauterine devices (IUDs) are highly effective but underutilized in this age group. STUDY DESIGN: We searched our electronic clinic database to identify females ≤ 19 years old who underwent attempted IUD insertion between January 2007 and June 2009. This retrospective cohort study primarily compared the insertion and postinsertion experiences between nulliparous and parous teens. RESULTS: Of the 307 charts reviewed, the majority of subjects were white (73.4%) and nulliparous (77.5%), with a median age of 18 years (range 15-19). The vast majority (96.4%, 296/307) had a successful IUD insertion upon first attempt; all of the 11 unsuccessful IUD insertion attempts were among nulliparous teens. Follow-up was available for 56% (172/307). During the first 12 months of use, there were 2.9% (5/172) IUD expulsions and 24.4% (42/172) removals, with no differences between nulliparous and parous teens. IUD continuation at 6 months was 83.3%. Pelvic inflammatory disease was diagnosed in 4.6% (8/172) of post-IUD insertions. There were no pregnancies reported in those teens with IUD continuation, while six were reported in subjects who underwent IUD removal. Independent predictors of IUD discontinuation were a history of chronic pelvic pain or dysmenorrhea, and bleeding and/or pain complaints at any post-IUD visit. CONCLUSIONS: Overall, adolescents experience minimal complications with IUD use, with similar rates of successful insertion as adults. IUD discontinuation rates were not significantly different between nulliparous and parous teens. While discontinuation was higher than reported in adults, it was lower than reported among teens using other forms of contraception.