Development and initial validation of a fertility experiences questionnaire.

BACKGROUND: Many women throughout the world have history of subfertility (resolved or unresolved), but much remains unknown about services and treatments chosen. METHODS: We developed a mixed-mode fertility experiences questionnaire (FEQ) in 2009 through literature review and iterative pilot work to optimize question format and mode of administration. The focus of the FEQ is to collect data retrospectively on time at risk for pregnancy, fertility treatments received and declined, pregnancy, time to pregnancy and pregnancy outcomes. We conducted a validation of key elements of the FEQ with comparison to medical records in 2009 and 2010. The validation sample was selected from women initially seen at a specialized fertility treatment center in Utah in 2004. RESULTS: The FEQ was optimized with two components: 1) written (paper or web-based), self-administered, followed by 2) telephone- administered questions. In 63 patients analyzed, high levels of correlation were identified between patient self-report and medical records for the use of intrauterine insemination and assisted reproductive technology, pregnancy and live birth histories, time at risk for pregnancy and time to pregnancy. There was low correlation between medical records and self-report for the use of oral ovulation drugs and injectable ovulation drugs. Compared to the medical record, the FEQ was over 90% sensitive for all elements, except injectable ovulation drugs (70% sensitivity). CONCLUSIONS: The FEQ accurately captured elements of fertility treatment history at 5-6 years after the first visit to a specialty clinic.

Diminished ovarian reserve and infertility.

Over the past several decades, social and demographic trends have led to an increased tendency for women to delay childbearing. Owing primarily to abnormalities in the oocyte and resulting embryonic aneuploidy, implantation, clinical pregnancy, and live birth rates decline sharply by the end of the fourth decade. As a result, the incidence of age-related infertility has increased. Improved awareness of the effects of aging on fertility combined with ovarian reserve assessment, patient education, and early infertility evaluation and intervention are important elements in appropriate family planning and prevention of age-related infertility.

A survey of women obtaining emergency contraception: are they interested in using the copper IUD?

BACKGROUND: This study aims to determine if women presenting for emergency contraception (EC) at family planning clinics may be interested in using the copper intrauterine device (IUD) for EC. STUDY DESIGN: This convenience sample survey was offered to women who presented for EC at four participating clinics in urban Utah. Anonymous written questionnaires were distributed. The outcome variable of interest was interest in using the copper IUD for EC. RESULTS: Of survey respondents, 320 (34.0%) of 941 said they would be interested in an EC method that was long term, highly effective and reversible. Interested women were not significantly different from noninterested women in relation to age, marital status, education, household income, gravidity, previous abortions, previous sexually transmitted infections (STIs) or relationship status. One hundred twenty women (37.5% of those interested or 12.8% of all those surveyed) would wait an hour, undergo a pelvic exam to get the method and would still want the method knowing it was an IUD. However, only 12.3% of these women could also pay $350 or more for the device. Multivariable regression found the following predictors of interest in the IUD among EC users: non-Hispanic minorities (OR=2.12, 95% CI=1.14-3.93), desire to never be pregnant in the future (OR=2.87, 95% CI=1.38-5.66) and interest in adoption (OR=1.96, 95% CI=1.00-5.73) or abortion (OR=2.68, 95% CI=1.24-4.14) if pregnant when presenting for EC. CONCLUSION: While one third of EC users surveyed at family planning clinics were interested in a long-term, highly effective method of contraception, only a small portion of all EC users may be interested in the copper IUD for EC. Cost is a potential barrier.

Lactogenesis after early postpartum use of the contraceptive implant: a randomized controlled trial.

OBJECTIVE: To evaluate lactogenesis after early postpartum insertion of the etonogestrel contraceptive implant. METHODS: Healthy peripartum women with healthy, term newborns who desired the etonogestrel implant for contraception were randomly assigned to early (1-3 days) or standard (4-8 weeks) postpartum insertion. The primary outcomes, time to lactogenesis stage II and lactation failure, were documented by a validated measure. The noninferiority margin for the mean difference in time to lactogenesis stage II was defined as 8 additional hours. Secondary data (device continuation and contraceptive use, breast milk analysis, supplementation rates, side effects, and bleeding patterns) were collected at periodic intervals for 6 months. RESULTS: Sixty-nine women were enrolled. Thirty-five were randomly assigned to early insertion and 34 to standard insertion. There were no statistically significant differences between the groups in age, race, parity, mode of delivery, use of anesthesia, or prior breastfeeding experience. Early insertion was demonstrated to be noninferior to standard insertion in time to lactogenesis stage II (early: [mean±standard deviation] 64.3±19.6 hours; standard: 65.2±18.5 hours, mean difference, -1.4 hours, 95% confidence interval [CI] -10.6 to 7.7 hours). Early insertion was also demonstrated to be noninferior to standard insertion in incidence of lactation failure (1/34 [3%] in the early insertion group, 0/35 [0%] in the standard insertion group [risk difference, 0.03, 95% CI -0.02 to 0.08]). Use of formula supplementation was not significantly different between the groups. Milk composition at 6 weeks was not significantly different between the groups. CONCLUSION: Breastfeeding outcomes were similar in women who underwent early compared with standard postpartum insertion of the etonogestrel implant. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, www.clinicaltrials.gov, NCT00847587.

A pilot study of the Copper T380A IUD and oral levonorgestrel for emergency contraception.

BACKGROUND: This study evaluates the willingness of women presenting for emergency contraception (EC) to enroll in a study offering the copper intrauterine device (IUD) or oral levonorgestrel (LNG) and follows up the two groups for 6 months after EC administration to compare use of an effective method of contraception. STUDY DESIGN: This prospective observational study offered these two methods to women presenting for EC. The primary outcome was use of an effective method of contraception 6 months after presenting for EC. RESULTS: Thirty-four women (60%) chose oral LNG and 23 (40%) chose the copper IUD. One month after presenting for EC, 21 (96%) of 22 in the IUD group were still using the IUD and all 22 were using an effective method of contraception (efficacy ≥92%). In the LNG group, 13 (52%) of 25 were using an effective method of contraception (p<.001). At 6 months, 9 (69%) of 13 IUD users and 11 (52%) of 21 oral LNG EC users were using an effective method (p=NS). CONCLUSION: Women presenting for EC were willing to enroll in a study offering the copper IUD or oral LNG.

Operative management of intrauterine device complications: a case series report.

BACKGROUND: There is limited information about the number of intrauterine device (IUD) users requiring operative intervention for device-related complications. This is an evaluation of cases requiring in-hospital operative intervention for IUD perforations, removals and pregnancy-related complications. STUDY DESIGN: Large retrospective case series of patients who received operative management of IUD complications. RESULTS: Charts of patients from 15 hospitals in two health care systems from 2000 to 2007 were reviewed and outcomes of 276 women are reported. There were 95 operative IUD removals for perforations (including 60 levonorgestrel-releasing intrauterine systems), 157 operative procedures for inability to remove an IUD in the office, and 42 pregnancy-related complications that were managed in the operating room. Ectopic pregnancy was the most common diagnosis among pregnant women (23 of 42 pregnant women, 54.8%). CONCLUSION: The majority of operative procedures were performed for intrauterine IUDs, most of which were appropriately positioned IUDs with missing or short strings. In-office techniques for obtaining analgesia and dilation as well as appropriate devices for removal of T-shaped IUDs should make this practice rare.

Introduction to the MAUDE database.

The Manufacturer and User Facility Device Experience (MAUDE) database represents a reporting system mandated by the Food and Drug Administration for postmarket surveillance. MAUDE has been made into a searchable online database that includes all reported events in which medical devices may have malfunctioned or caused a death or serious injury. For the clinician considering the use of a new medical device, searching the MAUDE database is useful to search for complications not yet reported in the medical literature.

Second trimester termination of pregnancy: a review by site and procedure type.

BACKGROUND: We hypothesized that complications for second trimester terminations are higher in a low-volume residency training program than in a high-volume private practice. STUDY DESIGN: Complications and cost were compared between three groups undergoing second trimester terminations: patients undergoing dilation and evacuation (D&E) at a university hospital (Hospital D&E, n=83) or medical pregnancy termination at a university hospital (Hospital Induction, n=89) and D&E at a private outpatient facility (Clinic D&E, n=253). RESULTS: Major complications occurred in 11% of the Hospital D&E, 10% of the Hospital Induction, and 1% of the Clinic D&E patients (p=.0019). Complication rates remained statistically significant when a logistic regression model was applied to the data. The mean total charge for the three respective groups was US$4625, US$5029 and US$1105 (p<.001). CONCLUSION: Second trimester terminations of pregnancy by D&E in well-selected patients in a dedicated outpatient facility can be safer and less expensive than hospital-based D&E or induction of labor.

Complications associated with global endometrial ablation: the utility of the MAUDE database.

OBJECTIVE: To investigate the number and type of complications associated with global endometrial ablation using public-access governmental databanks. METHODS: MEDLINE (PubMed) and the US Food and Drug Administration Manufacturer and User Facility Device Experience (MAUDE) databases were searched for entries for the four US Food and Drug Administration-approved global endometrial ablation devices. RESULTS: Traditional MEDLINE and bibliography searches yielded reports of two cases of hemorrhage, one case of pelvic inflammatory disease, 20 cases of endometritis, two cases of first-degree skin burns, nine cases of hematometra, and 16 cases of vaginitis and/or cystitis. A search of the US Food and Drug Administration MAUDE database yielded reports of 85 complications in 62 patients. These included major complications: eight cases of thermal bowel injury, 30 cases of uterine perforation, 12 cases in which emergent laparotomy was required, and three intensive care unit admissions. One patient developed necrotizing fasciitis and eventually underwent vulvectomy, ureterocutaneous ostomy, and bilateral below-the-knee amputations. One of the patients with thermal injury to the bowel died. CONCLUSION: Use of the US Food and Drug Administration MAUDE database is helpful in identifying serious complications associated with global endometrial ablation not yet reported in the medical literature.