David K. Turok

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. LEVEL OF EVIDENCE: I

Vasectomy: the other (better) form of sterilization.

Male sterilization (vasectomy) is the most effective form and only long-acting form of contraception available to men in the United States. Compared to female sterilization, it is more efficacious, more cost-effective, and has lower rates of complications. Despite these advantages, in the United States, vasectomy is utilized at less than half the rate of female sterilization. In addition, vasectomy is least utilized among black and Latino populations, groups with the highest rates of female sterilization. This review provides an overview of vasectomy use and techniques, and explores reasons for the disparity in vasectomy utilization in the United States.

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

Copper T380 intrauterine device for emergency contraception: highly effective at any time in the menstrual cycle

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.

Three-year efficacy and safety of a new 52-mg levonorgestrel-releasing intrauterine system

STUDY QUESTION Does the efficacy of placing a copper intrauterine device (IUD) for emergency contraception (EC) to prevent pregnancy depend on menstrual cycle timing and timing of unprotected intercourse (UPI)? SUMMARY ANSWER If the urine pregnancy test is negative prior to IUD placement, the copper IUD is highly effective for EC at any point in the menstrual cycle. WHAT IS KNOWN ALREADY The use of the Copper T380A for EC has been encouraged by the failure of oral EC methods to decrease rates of unintended pregnancy and the documented success of the IUD in reducing unintended pregnancies. However scant data exist regarding the efficacy and safety of IUD insertion for EC when accounting for menstrual cycle timing and time since UPI. STUDY DESIGN, SIZE, DURATION This is a secondary analysis of data obtained from a previously published prospective cohort study of women who received the Copper T380A IUD for EC between July 1997 and January 2000. We included 1840 participants according to the study inclusion criteria of a known last menstrual period (LMP) and cycle lengths of 25-35 days. PARTICIPANTS/MATERIALS, SETTING, METHODS The original study included women aged between 18 and 44 years who presented for EC at 18 sites throughout China and who had regular menstrual cycles between 24 and 42 days, a known LMP, UPI within 120 h (5 days) and a negative urine pregnancy test (cutoff <25 IU/ml). Women with uncertain LMP dates were excluded. This study included only participants with cycle lengths of 25-35 days. MAIN RESULTS AND THE ROLE OF CHANCE Among the 1840 participants with usual cycle lengths of 25-35 days, 850 (46.2%) had their IUD inserted following UPI in the expected fertile window and 84 (4.6%) had the insertion >5 days after the predicted ovulation day and 52 (2.8%) had the insertion >5 days after UPI. There were no pregnancies in the first month among the 1771 women who had information available regarding their 1-month follow-up pregnancy test. LIMITATIONS, REASONS FOR CAUTION This was a secondary analysis of an observational study, and thus participants were not randomized to an alternative postcoital method. There were a small number of women who had UPI >5 days after their predicted ovulation day thus limiting the confidence of assuring a low risk of pregnancy in this situation. The ovulation day was calculated based on the LMP prior to IUD insertion and not on the subsequent first day of menses following IUD insertion. WIDER IMPLICATIONS OF THE FINDINGS If the urine pregnancy test is negative prior to IUD placement, the copper IUD is likely to be effective for EC at almost any point in the menstrual cycle. STUDY FUNDING/COMPETING INTEREST(S) The original study was funded by the UNDP/UNPFA/WHO/World Bank Special Programme of Research, Development and Research Training in Human Reproduction. The donors and sponsors of the study had no role in the study design, data collection, data analysis, data interpretation, writing of the report or the decision to submit the paper for publication.

Array Comparative Genomic Hybridization for Genetic Evaluation of Fetal Loss Between 10 and 20 Weeks of Gestation

OBJECTIVE To assess 3-year data on the efficacy and safety of a new 52-mg levonorgestrel intrauterine contraceptive (LNG20) designed for up to 7 years use. STUDY DESIGN Nulliparous and parous women aged 16-45 years at enrollment with regular menstrual cycles and requesting contraception were enrolled in an open-label, partially randomized trial to evaluate LNG20. The primary outcome was pregnancy rate for women aged 16-35 years calculated as the Pearl Index. Women aged 36-45 years received LNG20 for safety evaluation only. All participants had in-person or phone follow-up approximately every 3 months during the study. RESULTS A total of 1600 women aged 16-35 years and 151 women aged 36-45 years agreed to LNG20 placement, including 1011 (57.7%) nulliparous and 438 (25.1%) obese women. Successful placement occurred in 1714 (97.9%) women. Six pregnancies occurred, four of which were ectopic. The Pearl Index for LNG20 was 0.15 (95% CI 0.02-0.55) through Year 1, 0.26 (95% CI 0.10-0.57) through Year 2, and 0.22 (95% CI 0.08-0.49) through Year 3. The cumulative life-table pregnancy rate was 0.55 (95% CI 0.24-1.23) through 3 years. Expulsion was reported in 62 (3.5%) participants, most (50 [80.6%]) during the first year of use. Of women who discontinued LNG20 and desired pregnancy, 86.8% conceived spontaneously within 12 months. Pelvic infection was diagnosed in 10 (0.6%) women. Only 26 (1.5%) LNG20 users discontinued due to bleeding complaints. CONCLUSION The LNG20 intrauterine system is highly effective and safe over 3 years of use in nulliparous and parous women. IMPLICATIONS STATEMENT A new 52-mg levonorgestrel-releasing intrauterine system is effective and safe for nulliparous and parous women for at least 3 years.

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

OBJECTIVE: To estimate genomic copy number changes in fetal loss between 10 and 20 weeks of gestation using array comparative genomic hybridization. METHODS: This was a prospective series of 35 women who experienced pregnancy loss between 10–20 weeks of gestation with either normal karyotype (n=9) or no conventional cytogenetic testing (n=26). DNA was isolated from fetal tissue and parental blood. Array comparative genomic hybridization was performed on DNA from fetal tissue using a whole genome BAC array chip. Copy number changes in fetal tissue were then compared against databases of benign copy number changes. Parental DNA was analyzed using the same BAC array in cases that contained suspected pathogenic copy number changes. In cases where de novo copy number changes were detected in fetal DNA, further characterization was performed using a 244K oligonucleotide microarray. RESULTS: DNA was successfully isolated in 30 of 35 (86%) of cases. Array comparative genomic hybridization was performed in all of these. De novo copy number changes were detected in six (20%) cases using the Spectral chip and confirmed in four (13%) cases using the Agilent chip. These ranged in size from 93–289 Kb and mapped on 5p, 13q and Xq22. In the cases with de novo copy number changes, the higher-density Agilent array detected additional changes (20–1,310 Kb). CONCLUSION: Array comparative genomic hybridization detected de novo copy number changes in 13% of cases where routine cytogenetic testing was normal or not performed. These involved large regions of DNA and may provide novel explanations for some cases of otherwise unexplained pregnancy loss. LEVEL OF EVIDENCE: III

Intrauterine device insertion after medical abortion

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

A qualitative exploration of emergency contraception users' willingness to select the copper IUD

BACKGROUND Studies comparing immediate intrauterine device (IUD) insertion after first-trimester surgical abortion with interval insertion show similar efficacy and expulsion rates. However, women randomized to interval insertion of an IUD are less likely to return for device placement. An ideal time to insert intrauterine contraception may be the day a woman presents for verification of a completed medical abortion. We examined immediate insertion of IUDs after completed first-trimester medical abortion. STUDY DESIGN This is a prospective, observational clinical study to determine expulsion rates of intrauterine contraception placed immediately after confirmed, completed first-trimester medical abortion. RESULTS Of 118 subjects, 78 women had levonorgestrel IUDs placed, whereas 41 women received copper IUDs. Of 97 subjects who completed the study, there were 4 clinical expulsions (4.1%) during 3 months of follow-up. There were no diagnosed pelvic infections, pregnancies, or uterine perforations. The continuation rate at 3 months was 80%. CONCLUSION Intrauterine devices inserted at the time of completed, confirmed first-trimester medical abortion have low rates of expulsion.

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

BACKGROUND The copper T intrauterine device (IUD) is an effective but underutilized method of emergency contraception (EC). This study investigates the factors influencing a womans decision around which method of EC to select. STUDY DESIGN In-depth interviews with 14 IUD and 14 oral EC users aged 18-30 years accessing public health clinics. RESULTS Emergency contraception users associated long-term methods of contraception with long-term sexual relationships. Women were not aware of the possibility of using the copper IUD for EC. Cost was identified as a major barrier to accessing IUDs. Perceived side effects and impact on future pregnancies further influenced the EC method a participant selected. CONCLUSIONS Women think about contraception in the context of each separate relationship and not as a long-term individual plan. Most women were unaware of the copper IUD for EC. Furthermore, there is little discussion between women and their health-care providers around EC.