Janet C. Jacobson

Self-administered misoprostol or placebo before intrauterine device insertion in nulliparous women: A randomized controlled trial

OBJECTIVES: To estimate the effects of self-administered misoprostol compared with placebo before intrauterine device (IUD) insertion in nulliparous women. METHOD: Nulliparous women requesting either the copper T380A or levonorgestrel IUD were randomized to self-administer either 400 &mgr;g of misoprostol or placebo (vaginally or buccally) 3–4 hours before the IUD insertion appointment. The primary outcome was health care provider–perceived ease of insertion recorded on a visual analog scale (anchors: 0 extremely easy, 100 impossible). Patients completed questionnaires addressing pain using a validated visual analog scale (anchors: 0 none, 100 worst imaginable) before insertion, immediately postinsertion, and before clinic discharge. RESULTS: Of the 108 women enrolled in the study, 54 received misoprostol and 54 received placebo. There was no significant difference in perceived ease of insertion between the two groups (25.0 mm [standard error 3.5] compared with 27.4 mm [standard error 3.5], P=.64). Patients who received misoprostol before IUD insertion had significantly higher pain scores before placement (17.1 mm [standard error 3.5] compared with 4.7 mm [standard error 2.0], P=.003). Groups did not differ in perception of pain during IUD insertion (58.4 mm [standard error 3.3] compared with 56.9 mm [standard error 3.0], P=.74). There were two expulsions in the misoprostol group and none in the placebo group. Failed insertions, need for adjuvant pain medication, and need for cervical dilation or ultrasonographic guidance did not differ between the two groups. CONCLUSION: Self-administered misoprostol before IUD insertion does not ease IUD insertion or reduce patient-perceived pain in nulliparous women. These data do not support the routine use of misoprostol before IUD insertion in nulliparous women. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00886834. LEVEL OF EVIDENCE: I

Emergency contraception with a copper IUD or oral levonorgestrel: an observational study of 1-year pregnancy rates.

OBJECTIVE We investigated the 1-year pregnancy rates for emergency contraception (EC) users who selected the copper T380 intrauterine device (IUD) or oral levonorgestrel (LNG) for EC. STUDY DESIGN This prospective study followed women for 1 year after choosing either the copper T380 IUD or oral LNG for EC. The study was powered to detect a 6% difference in pregnancy rates within the year after presenting for EC. RESULTS Of the 542 women who presented for EC, agreed to participate in the trial and met the inclusion criteria, 215 (40%) chose the copper IUD and 327 (60%) chose oral LNG. In the IUD group, 127 (59%) were nulligravid. IUD insertion failed in 42 women (19%). The 1-year follow-up rate was 443/542 (82%); 64% of IUD users contacted at 1 year still had their IUDs in place. The 1-year cumulative pregnancy rate in women choosing the IUD was 6.5% vs. 12.2% in those choosing oral LNG [hazard ratio (HR) 0.53, 95% confidence interval (CI): 0.29-0.97, p=.041]. By type of EC method actually received, corresponding values were 5.2% for copper IUD users vs. 12.3% for oral LNG users (HR 0.42, 95% CI: 0.20-0.85, p=.017). A multivariable logistic regression model controlling for demographic variables demonstrates that women who chose the IUD for EC had fewer pregnancies in the following year than those who chose oral LNG (HR 0.50, 95% CI: 0.26-0.96, p=.037). CONCLUSION One year after presenting for EC, women choosing the copper IUD for EC were half as likely to have a pregnancy compared to those choosing oral LNG. IMPLICATIONS Compared to EC users who choose oral levonorgestrel, those who select the copper IUD have lower rates of pregnancy in the next year. Greater use of the copper IUD for EC may lower rates of unintended pregnancy in high-risk women.

A survey of provider experience with misoprostol to facilitate intrauterine device insertion in nulliparous women.

BACKGROUND There is a significant need for research on treatments that provide pain relief during intrauterine device (IUD) insertion. Misoprostol is frequently used before IUD insertion but is not always necessary and its use may increase pain and side effects. This survey evaluated how providers who perform IUD insertion in nulliparous women report using misoprostol to facilitate the procedure. STUDY DESIGN An anonymous Internet-based survey was distributed to members of three professional organizations with family planning providers. RESULTS Of 2211 survey respondents, 1905 (86%) reported providing IUDs to nulliparous women. Of those providing IUDs to nulliparous women, 947/1905 (49.7%) reported using misoprostol, and 380 (40%) of 947 of misoprostol users reported using the treatment empirically with all nulliparous IUD insertions. There was wide variation reported in dose, route and timing of misoprostol administration. Providers most commonly reported learning of misoprostol use for IUD insertion by word of mouth rather than through the literature. CONCLUSIONS Despite conflicting published data, nearly half of survey respondents use misoprostol before IUD insertion. Considerable variation in the timing of misoprostol use may explain differences in perception of its effectiveness. Evidence-based information about misoprostol for IUD insertion in nulliparous women, including pharmacokinetics, efficacy and optimal dosing, is needed.

Vaginal microbiome changes with levonorgestrel intrauterine system placement

OBJECTIVE To investigate changes in female genital tract bacterial ecology associated with levonorgestrel intrauterine system (LNG IUS) use. STUDY DESIGN Study participants were regularly cycling Caucasian women without recent history of pregnancy or exogenous hormone use. Vaginal, cervical and uterine samples were obtained at nine time intervals, from 1 week before to 12 weeks after LNG IUS placement. Replicate paired vaginal and cervical specimens were collected to determine the consistency of specimen collection and processing. RESULTS A total of 406 samples from 11 women were available for analysis after DNA extraction, amplification and species identification. Of the 355 bacterial species or genera detected, Lactobacillus crispatus was most prevalent representing 48.9% of over 6 million total reads. L. crispatus reads of replicate vaginal samples were not significantly different [odds ratio (OR) 0.79, 0.36-1.73]. In addition, L. crispatus reads of vaginal and cervical samples from the same visit were not significantly different (OR 0.69, 0.31-1.51). Compared to sampling visits prior to LNG IUS placement, sampling visits after LNG IUS insertion were more likely to have L. crispatus reads greater than 50% of total reads (OR 2.13, 1.01-4.48). Of the 63 uterine samples demonstrating bacteria, Burkholderia genus proteobacteria, a common environmental contaminant, were most prevalent both before and after LNG IUS insertion accounting for 48.0% of all uterine sample reads. CONCLUSION The vaginal microbiome changes very little in response to LNG IUS placement. Further study is needed to place this finding in context with clinical outcomes. IMPLICATIONS There do not appear to be any clinically important differences in the vaginal microbiome in response to insertion of the LNG IUS.

Failed IUD insertions in community practice: an under-recognized problem?

BACKGROUND The data analysis was conducted to describe the rate of unsuccessful copper T380A intrauterine device (IUD) insertions among women using the IUD for emergency contraception (EC) at community family planning clinics in Utah. METHODS These data were obtained from a prospective observational trial of women choosing the copper T380A IUD for EC. Insertions were performed by nurse practitioners at two family planning clinics in order to generalize findings to the type of service setting most likely to employ this intervention. Adjuvant measures to facilitate difficult IUD insertions (cervical anesthesia, dilation, pain medication, and use of ultrasound guidance) were not utilized. The effect of parity on IUD insertion success was determined using exact logistic regression models adjusted for individual practitioner failure rates. RESULTS Six providers performed 197 IUD insertion attempts. These providers had a mean of 14.1 years of experience (range 1-27, S.D. ±12.5). Among nulliparous women, 27 of 138 (19.6%) IUD insertions were unsuccessful. In parous women, 8 of 59 IUD insertions were unsuccessful (13.6%). The adjusted odds ratio (aOR) showed that IUD insertion failure was more likely in nulliparous women compared to parous women (aOR=2.31, 95% CI 0.90-6.52, p=.09). CONCLUSION The high rate of unsuccessful IUD insertions reported here, particularly for nulliparous women, suggests that the true insertion failure rate of providers who are not employing additional tools for difficult insertions may be much higher than reported in clinical trials. Further investigation is necessary to determine if this is a common problem and, if so, to assess if the use of adjuvant measures will reduce the number of unsuccessful IUD insertions.

United States Medical Eligibility Criteria for Contraceptive Use 2010: A Review of Changes

In the late 1990s, the World Health Organization (WHO) created the Medical Eligibility Criteria for Contraceptive Use (MEC), which provide evidence-based recommendations for safe and effective contraception in women with medical problems. The WHO MEC incorporate the best available evidence, are periodically updated, and are designed to be modified for specific populations. The US Centers for Disease Control and Prevention published US MEC in 2010. Changes to WHO guidelines for use in the US population include the following areas: breastfeeding, intrauterine device use, valvular heart disease, ovarian cancer, uterine fibroids, and venous thromboembolism. Medical conditions not covered by WHO recommendations but added to the US MEC include contraceptive guidance for women with inflammatory bowel disease, history of bariatric surgery, rheumatoid arthritis, endometrial hyperplasia, history of peripartum cardiomyopathy, and history of solid organ transplant. This article reviews the changes and additions to WHO MEC found in the US MEC.

Same-day cervical preparation with misoprostol prior to second-trimester D&E: a case series

BACKGROUND Traditionally, overnight cervical preparation with osmotic dilators has been used for second trimester dilation and evacuation (D&E) procedures. Misoprostol offers an alternative treatment that could shorten cervical preparation time. STUDY DESIGN This study reports on a case series of patients who received only buccal or vaginal misoprostol for cervical preparation on the same day as the D&E procedure. Data were collected from charts of women undergoing second trimester D&E at an outpatient womens health clinic. Eligible cases included procedures performed between January 2001 and December 2010 at 17 0/7 to 23 0/7 weeks of gestation. RESULTS Chart review identified 1177 cases of D&E during the study period. After deletion of 96 multiple-day cases using laminaria, 1081 misoprostol-only cases remained for analysis. Two of the cases were not able to be completed in the same day (0.2%). Ninety-eight percent of cases were 17-20 weeks of gestation. The average time from either vaginal or buccal placement of the first misoprostol dose to procedure completion was 4.9 h (SD±1.7 h). The average procedure length was 13.0 min (SD±10.2 min). Complications were reported in 21 of 1079 same-day procedures (2%) and included resuction (n=4), hemorrhage (n=5), cervical laceration (n=4), endometritis (n=5), pulmonary embolus (n=1), disseminated intravascular coagulation (n=1) and perforation (n=1). CONCLUSION Same-day cervical preparation with misoprostol for second trimester D&E is both safe and effective. With the continuing shortage of D&E providers, the resulting increase in travel distance to obtain the procedure, mandatory waiting periods and the capability of having the procedure completed in a single day may increase patient access, reduce cost and improve patient satisfaction.

A policy of discrimination: reproductive health care in the military.

In 2002, the wife of a young U.S. Navy sailor was given the news that her fetus had no brain, a birth defect known as anencephaly (Wilson, 2010). This condition is not compatible with life, and, at 16 weeks of gestation, the couple decided not to continue the pregnancy. In fiscal 1977, over 25,000 abortions were performed in military facilities (Boonstra, 2010; Burrelli, 2008). However, in 2002 federal law prohibited termination of the pregnancy at the military health care facility where they were stationed. In addition, federal funds could not be used for the abortion (10 USC 1093, 1996). This young family faced a

Criterion-based screening for sexually transmitted infection: sensitivity, specificity, and predictive values of commonly used questions.

3,000 medical bill for the abortion procedure at a local civilian clinic, or the pain of going through 5 months of carrying a fetus that would die. Service members make less than civilians in similar occupations and depend on the military for their health coverage (Wilson, 2010). The additional

The methodology for developing a prospective meta-analysis in the family planning community

3,000 was beyond the financial capability of the couple. With the help of family and friends, they were able to overcome the financial burden and obtain the abortion. Had the family been stationed overseas, finding a civilian abortion provider may not have been possible. While stationed overseas in the Philippines from 1989 to 1991, one of the authors (J.T.J.) witnessed firsthand the burden of restrictive abortion policy. Active duty women electing to terminate an unwanted pregnancy were forced to make a difficult choice: Take emergency leave and travel to Hawaii for a legal abortion (at their own expense) or obtain an illegal abortion under unsafe conditions locally. Not surprisingly, the burden of