Medical management of ectopic pregnancy in a family planning clinic: A case series.

OBJECTIVE: To evaluate safety of medical management of ectopic pregnancy in a free-standing family planning clinic setting. STUDY DESIGN: We retrospectively reviewed cases of ectopic pregnancy between January 2014 and December 2018 which were identified using a "Beta Board" tracking system. Planned Parenthood of Orange and San Bernardino Counties staff added patients the "Beta Board" if they had a positive urine pregnancy test without definitive ultrasound diagnosis of intrauterine pregnancy and/or symptoms suggestive of ectopic pregnancy, such as vaginal bleeding, and cramping. Patients were included in the study if they had received a final diagnosis of ectopic pregnancy. RESULTS: Of 5083 patients tracked via the Beta Board, 260 patients presented to a Planned Parenthood free-standing, family planning clinic with ectopic pregnancy. Ninety-five patients were treated with methotrexate entirely at the clinic. There were no deaths. Four ectopic pregnancies ruptured and 8 required surgery. CONCLUSION: Treatment of ectopic pregnancy with methotrexate in the family planning clinic setting can be safe and effective with reassuring outcomes that are similar to the hospital setting.

We should really keep in touch: predictors of the ability to maintain contact with contraception clinical trial participants over 12 months.

OBJECTIVES: This study assesses the ability to maintain contact with participants enrolled in an emergency contraception (EC) trial with 12 months of follow-up based on the modes of contact they provided at enrollment. STUDY DESIGN: Data came from a clinical trial offering women the copper intrauterine device or oral levonorgestrel for EC. A modified Poisson regression was used to assess predictors associated with the ability to contact study participants 12 months after enrollment. RESULTS: Data were available for 542 participants; 443 (82%) could be contacted at 12 months. Contact at 12 months was greatest for those whose preferred the method of contact was text messaging, e-mail or any (62/68; 91% contacted) and worst for the 18 who had a landline phone (only 7 contacted; 39%). After controlling for age, having an e-mail address, text messaging, language preference, type of EC chosen and insurance, preferred contact other than phone increased the likelihood of follow-up by 10% [risk ratio (RR) 1.1 95% confidence interval (CI) 1.0-1.2], while having a landline reduced a woman's likelihood of being contacted at 12 months by 50% compared to women with a contract cell (RR 0.5, 95% CI 0.3-1.0). CONCLUSION: The few women with a landline for contact had poor follow-up at 1 year, while women who preferred e-mail or text had the highest rate of follow-up. IMPLICATIONS: Understanding how best to reduce loss to follow-up is an essential component of conducting a contraceptive clinical trial. Improved participant retention maximizes internal validity and allows for important clinical outcomes, such as pregnancy, to be assessed.

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.

Removal of the LNG IUD when strings are not visible: a case series.

OBJECTIVES: To report length of intrauterine device (IUD) and strings as well as technique for extraction when IUD removal occurs without visible strings. STUDY DESIGN: A prospective case series of 29 women who had IUDs removed in-office when strings were not visible at the external cervical os. RESULTS: One third (n=11) were found to have a total length of IUD and strings <7.5 cm. All IUD removals were successfully performed as outpatient procedures. CONCLUSION: Removal of IUDs without visible strings can be successfully done as an in-office procedure. IMPLICATIONS: In-office removal of IUDs without visible strings is effective, safe and economically sound.

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.

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 women's 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.

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.

Extended and continuous combined contraceptive regimens for menstrual suppression.

Many women have medical indications for menstrual suppression or a personal preference to reduce or eliminate monthly bleeding, which can be achieved with extended and continuous regimens of combined estrogen and progestin contraceptives. Combined contraceptives are traditionally administered in a 28-day cycle, with 21 days of a contraceptive pill, vaginal ring, or transdermal patch followed by a hormone-free interval that is usually 7 days. During the hormone-free interval, women either take a placebo pill or do not use their combined contraceptive method. Hormone-related symptoms are significantly worse during the hormone-free interval than the days when the contraceptive is used. Alterations of the standard 28-day cyclic regimen for menstrual suppression include decreasing the frequency of the hormone-free interval, thus extending the time between withdrawal bleeding episodes (extended use), and eliminating the hormone-free interval altogether (continuous use). This article reviews menstrual suppression indications and physiology. Research demonstrating that the effectiveness, safety, and side effects of oral, vaginal, and transdermal extended and continuous regimens are comparable to cyclic regimens is summarized. Findings from studies of women's and health care providers' attitudes toward menstrual suppression also are reviewed. Important topics to include in evidence-based counseling for extended and continuous combined contraceptive use are presented.

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 µg 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.

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.

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.

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

BACKGROUND: Prospective meta-analysis (PMA) is a collaborative research design in which individual sites perform randomized controlled trials (RCTs) and pool the data for meta-analysis. Members of the PMA collaboration agree upon specific research interventions and outcome measures, ideally before initiation but at least prior to any individual trial publishing results. This allows for uniform reporting of primary and secondary outcomes. With this approach, heterogeneity among trials contributing data for the final meta-analysis is minimized while each site maintains the freedom to design a specific trial. This paper describes the process of creating a PMA collaboration to evaluate the impact of misoprostol on ease of intrauterine device (IUD) insertion in nulliparous women. METHODS: After the principal investigator developed a preliminary PMA protocol, he identified potential collaborating investigators at other sites. One site already had a trial underway and another site was in the planning stages of a trial meeting PMA requirements. Investigators at six sites joined the PMA collaborative. Each site committed to enroll subjects to meet a pre-determined total sample size. A final common research plan and site responsibilities were developed and agreed upon through email and face-to-face meetings. Each site committed to contribute individual patient data to the PMA collaboration, and these data will be analyzed and prepared as a multi-site publication. Individual sites retain the ability to analyze and publish their site's independent findings. RESULTS: All six sites have obtained Institutional Review Board approval and each has obtained individual funding to meet the needs of that site's study. Sites have shared resources including study protocols and consents to decrease costs and improve study flow. This PMA protocol is registered with the Cochrane Collaboration and data will be analyzed according to Cochrane standards for meta-analysis. CONCLUSIONS: PMA is a novel research method that improves meta-analysis by including several study sites, establishing uniform reporting of specific outcomes, and yet allowing some independence on the part of individual sites with respect to the conduct of research. The inclusion of several sites increases statistical power to address important clinical questions. Compared to multi-center trials, PMA methodology encourages collaboration, aids in the development of new investigators, decreases study costs, and decreases time to publication. TRIAL REGISTRATION: ClinicalTrials.gov: NCT00613366, NCT00886834, NCT01001897, NCT01147497 and NCT01307111.