Naomi K. Tepper

U.S. Medical Eligibility Criteria for Contraceptive Use, 2016

The 2016 U.S. Medical Eligibility Criteria for Contraceptive Use (U.S. MEC) comprises recommendations for the use of specific contraceptive methods by women and men who have certain characteristics or medical conditions. These recommendations for health care providers were updated by CDC after review of the scientific evidence and consultation with national experts who met in Atlanta, Georgia, during August 26-28, 2015. The information in this report updates the 2010 U.S. MEC (CDC. U.S. medical eligibility criteria for contraceptive use, 2010. MMWR 2010:59 [No. RR-4]). Notable updates include the addition of recommendations for women with cystic fibrosis, women with multiple sclerosis, and women receiving certain psychotropic drugs or St. Johns wort; revisions to the recommendations for emergency contraception, including the addition of ulipristal acetate; and revisions to the recommendations for postpartum women; women who are breastfeeding; women with known dyslipidemias, migraine headaches, superficial venous disease, gestational trophoblastic disease, sexually transmitted diseases, and human immunodeficiency virus; and women who are receiving antiretroviral therapy. The recommendations in this report are intended to assist health care providers when they counsel women, men, and couples about contraceptive method choice. Although these recommendations are meant to serve as a source of clinical guidance, health care providers should always consider the individual clinical circumstances of each person seeking family planning services. This report is not intended to be a substitute for professional medical advice for individual patients. Persons should seek advice from their health care providers when considering family planning options.

Adverse event reports after tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccines in pregnant women

OBJECTIVE We sought to characterize reports to the Vaccine Adverse Event Reporting System (VAERS) of pregnant women who received tetanus toxoid, reduced diphtheria toxoid, and acellular pertussis vaccine (Tdap). STUDY DESIGN We searched VAERS for reports of pregnant women who received Tdap from Jan. 1, 2005, through June 30, 2010. We conducted a clinical review of reports and available medical records. RESULTS We identified 132 reports of Tdap administered to pregnant women; 55 (42%) described no adverse event (AE). No maternal or infant deaths were reported. The most frequent pregnancy-specific AE was spontaneous abortion in 22 (16.7%) reports. Injection site reactions were the most frequent non-pregnancy-specific AE found in 6 (4.5%) reports. One report with a major congenital anomaly (gastroschisis) was identified. CONCLUSION During a time when Tdap was not routinely recommended in pregnancy, review of reports to VAERS in pregnant women after Tdap did not identify any concerning patterns in maternal, infant, or fetal outcomes.

Adverse events following administration to pregnant women of influenza A (H1N1) 2009 monovalent vaccine reported to the Vaccine Adverse Event Reporting System

OBJECTIVE The objective of the study was to evaluate and summarize reports to the Vaccine Adverse Event Reporting System (VAERS), a spontaneous reporting system, in pregnant women who received influenza A (H1N1) 2009 monovalent vaccine to assess for potential vaccine safety problems. STUDY DESIGN We reviewed reports of adverse events (AEs) in pregnant women who received 2009-H1N1 vaccines from Oct. 1, 2009, through Feb. 28, 2010. RESULTS VAERS received 294 reports of AEs in pregnant women who received 2009-H1N1 vaccine: 288 after inactivated and 6 after the live attenuated vaccines. Two maternal deaths were reported. Fifty-nine women (20.1%) were hospitalized. We verified 131 pregnancy-specific outcomes: 95 spontaneous abortions (<20 weeks); 18 stillbirths (≥20 weeks); 7 preterm deliveries (<37 weeks); 3 threatened abortions; 2 preterm labor; 2 preeclampsia; and 1 each of fetal hydronephrosis, fetal tachycardia, intrauterine growth retardation, and cleft lip. CONCLUSION Review of reports to VAERS following H1N1 vaccination in pregnant women did not identify any concerning patterns of maternal or fetal outcomes.

Intrauterine device use among women with uterine fibroids: a systematic review ☆

BACKGROUND There are concerns that intrauterine device (IUD) use by women with uterine fibroids might increase their uterine bleeding or risk for device expulsion. The objective of this systematic review was to evaluate evidence concerning the safety and effectiveness of IUD use among women with uterine fibroids. Key questions included whether IUD use is associated with increased risk for uterine bleeding among women with uterine fibroids and whether the presence of uterine fibroids is associated with an increased risk for device expulsion among IUD users. STUDY DESIGN We searched the PubMed database for peer-reviewed articles relevant to IUD (copper or levonorgestrel-releasing) use and uterine fibroids published in any language from database inception through June 2009. We used standard abstract forms and a grading system to summarize and assess the quality of the evidence. RESULTS From 202 articles found in the database search, we identified 11 studies that met our inclusion criteria, all of which examined outcomes among users of the levonorgestrel-releasing IUD (LNG-IUD). Evidence from 10 of 11 noncomparative studies (Level II-3, fair) suggests that LNG-IUD use among women with fibroids does not increase menstrual bleeding, and results from all 11 showed that menstrual blood loss decreased among women who continued to use the LNG-IUD through the end of the study period. Overall, serum levels of hemoglobin, hematocrit and ferritin increased among LNG-IUD users in studies that assessed these outcomes. Several studies reported some occurrences of irregular bleeding. Findings from two cohort studies (Level II-2, fair to poor) showed rates of LNG-IUD expulsion to be higher among women with uterine fibroids (11% in each) than among women without uterine fibroids (0% and 3%); however, in one study the difference was not statistically significant, and in the other significance testing was not conducted. Six prospective noncomparative studies reported expulsion rates of 0-20% among women with uterine fibroids. CONCLUSIONS Most women with uterine fibroids are likely to have less menstrual blood loss and higher serum levels of hemoglobin, hematocrit and ferritin after insertion of an LNG-IUD, despite some occurrences of irregular bleeding. LNG-IUD users with uterine fibroids may have higher rates of expulsion than those without fibroids.

Pregnancies after hysteroscopic sterilization: a systematic review.

BACKGROUND Female sterilization is the second most commonly used form of contraception in the United States. Newer approaches to female sterilization, including hysteroscopic methods, have been approved for use in the United States since 2002. Little is known about the occurrence and timing of pregnancies after these procedures. STUDY DESIGN The objective of this systematic review was to identify evidence that assesses when and how often pregnancies occur following hysteroscopic sterilization. The PubMed database was searched for all studies published from database inception through March 2012 that reported whether or not pregnancies occurred following hysteroscopic sterilization. RESULTS Twenty-four original research articles of fair quality met the inclusion criteria: 22 studies of women who underwent Essure® placement and 2 studies of women who underwent Adiana® placement. Eleven articles that documented bilateral tubal occlusion with hysterosalpingogram (HSG) or placement with X-ray or ultrasound following Essure® placement did not report any pregnancies with follow-up ranging from 7 months to 7 years. The remaining 11 articles identified 102 reported pregnancies. Eighteen of these pregnancies occurred prior to the 3-month period required before imaging for contraceptive reliability. Two articles did not report what follow-up imaging was performed among women after Essure® placement; one of these articles reported three pregnancies. Two reports from the same study of women who underwent Adiana® placement reported six pregnancies during the first year of follow-up, three pregnancies during the second year of follow-up and no pregnancies during the third year of follow-up. CONCLUSIONS Fair-quality evidence suggests that among women who were followed beyond 3 months after hysteroscopic sterilization, pregnancies were rare and generally occurred among women who had no imaging follow-up or had inadequate confirmation of placement or occlusion. Few pregnancies occurred in women with documented bilateral tubal occlusion by HSG or correct placement at 3 months by ultrasound or X-ray. Only one study reported follow-up past 5 years. Further studies are needed to address the long-term effectiveness of hysteroscopic sterilization.

U.S. Selected Practice Recommendations for Contraceptive Use, 2016

The 2016 U.S. Selected Practice Recommendations for Contraceptive Use (U.S. SPR) addresses a select group of common, yet sometimes controversial or complex, issues regarding initiation and use of specific contraceptive methods. These recommendations for health care providers were updated by CDC after review of the scientific evidence and consultation with national experts who met in Atlanta, Georgia, during August 26-28, 2015. The information in this report updates the 2013 U.S. SPR (CDC. U.S. selected practice recommendations for contraceptive use, 2013. MMWR 2013;62[No. RR-5]). Major updates include 1) revised recommendations for starting regular contraception after the use of emergency contraceptive pills and 2) new recommendations for the use of medications to ease insertion of intrauterine devices. The recommendations in this report are intended to serve as a source of clinical guidance for health care providers and provide evidence-based guidance to reduce medical barriers to contraception access and use. Health care providers should always consider the individual clinical circumstances of each person seeking family planning services. This report is not intended to be a substitute for professional medical advice for individual patients. Persons should seek advice from their health care providers when considering family planning options.

Intrauterine contraceptive insertion postabortion: a systematic review☆

BACKGROUND This review was conducted to evaluate the evidence regarding the safety and effectiveness of intrauterine device (IUD) insertion immediately following spontaneous or induced abortion. STUDY DESIGN We searched MEDLINE databases for all articles (in all languages) published in peer-reviewed journals from January 1966 through March 2010 for evidence comparing immediate postabortion IUD insertion with either no IUD insertion, insertion at a different time, insertion following first-trimester compared with second-trimester abortion or copper IUD insertion compared with hormone-releasing IUD insertion postabortion. We used standard abstraction forms to summarize and assess the quality of the evidence. RESULTS The search strategy identified a total of 990 articles, of which 19 met our inclusion criteria for this review. Studies comparing immediate postabortion IUD insertion with no IUD insertion found that both groups experienced similar rates of pain and infection and a similar number of bleeding days, but one study reported that women with copper IUD insertion experienced a greater amount of bleeding than women without IUD insertion after abortion. Results from studies comparing immediate postabortion IUD insertion and insertion at a time not associated with pregnancy did not report differences between the two groups in the duration of bleeding, pain, expulsions or pelvic inflammatory disease (PID). One study however reported a greater amount of bleeding and another reported more removals for medical reasons among women with postabortion IUD insertion. Evidence from studies that examined immediate vs. delayed postabortion insertion reported minimal differences in bleeding, pain, expulsion and PID between groups. Studies comparing immediate IUD insertion after first- vs. second-trimester abortion reported no difference in removals for pain and bleeding, and an increased risk of expulsion among those women who had insertions after second-trimester abortion. In addition, women with insertions immediately after abortions occurring later in the first trimester had higher expulsion rates than those with insertions after early first-trimester abortions. Studies examining women using a copper IUD compared with a hormone-releasing IUD reported inconsistent results, with one paper reporting more bleeding days in the copper IUD group and another finding higher rates of removal for bleeding in the progesterone-releasing IUD group. CONCLUSION Intrauterine device insertion immediately after abortion is not associated with an increased risk of adverse outcomes compared with use of other contraceptive methods or with no IUD insertion after abortion and compared with IUD insertion at times other than immediately after abortion. Intrauterine device expulsion rates, while generally low, were higher with insertions that occurred after later first-trimester abortion compared with after early first-trimester abortion and higher with IUD insertion after second-trimester abortion compared with after first-trimester abortion.

Postpartum venous thromboembolism: incidence and risk factors.

OBJECTIVE: To calculate incidence of postpartum venous thromboembolism by week after delivery and to examine potential risk factors for venous thromboembolism overall and at different times during the postpartum period. METHODS: A deidentified health care claims information database from employers, health plans, hospitals, and Medicaid programs across the United States was used to identify delivery hospitalizations among women aged 15–44 years during the years 2005–2011. International Classification of Diseases, 9th Revision, Clinical Modification diagnosis and procedure codes were used to identify instances of venous thromboembolism and associated characteristics and conditions among women with recent delivery. Incidence proportions of venous thromboembolism by week postpartum through week 12 were calculated per 10,000 deliveries. Logistic regression was used to calculate odds ratios for selected risk factors among women with postpartum venous thromboembolism and among women with venous thromboembolism during the early or later postpartum periods. RESULTS: The incidence proportion of postpartum venous thromboembolism was highest during the first 3 weeks after delivery, dropping from nine per 10,000 during the first week to one per 10,000 at 4 weeks after delivery and decreasing steadily through the 12th week. Certain obstetric procedures and complications such as cesarean delivery, preeclampsia, hemorrhage, and postpartum infection conferred an increased risk for venous thromboembolism (odds ratios ranging from 1.3 to 6.4), which persisted over the 12-week period compared with women without these risk factors. CONCLUSION: Risk for postpartum venous thromboembolism is highest during the first 3 weeks after delivery. Women with obstetric complications are at highest risk for postpartum venous thromboembolism, and this risk remains elevated throughout the first 12 weeks after delivery. LEVEL OF EVIDENCE: II

Trends in venous thromboembolism among pregnancy-related hospitalizations, United States, 1994-2009

OBJECTIVE The purpose of this study was to evaluate national trends in the rate of pregnancy-related hospitalizations for venous thromboembolism (VTE) from 1994-2009 and to estimate the prevalence of comorbid conditions among these hospitalizations. STUDY DESIGN An estimated 64,413,973 pregnancy-related hospitalizations among women 15-44 years old were identified in the 1994-2009 Nationwide Inpatient Sample. Trends in VTE-associated pregnancy hospitalizations were evaluated with the use of variance-weighted least squares regression. Chi-square tests were used to assess changes in prevalence of demographics and comorbid conditions, and multivariable logistic regression was used to evaluate the likelihood of VTE during the study period after adjustment for comorbid conditions. Antepartum, delivery, and postpartum hospitalizations were evaluated separately and reported in 4-year increments. RESULTS From 1994-2009, there was a 14% increase in the rate of overall VTE-associated pregnancy hospitalizations; antepartum and postpartum hospitalizations with VTE increased by 17% and 47%, respectively. Between 1994-1997 and 2006-2009, the prevalence of hypertension and obesity doubled among all VTE-associated pregnancy hospitalizations; significant increases in diabetes mellitus and heart disease were also noted. A temporal increase in the likelihood of a VTE diagnosis in pregnancy was observed for antepartum hospitalizations from 2006-2009 when compared with 1994-1997 (adjusted odds ratio, 1.62; 95% confidence interval, 1.48-1.78). CONCLUSION There has been an upward trend in VTE-associated pregnancy hospitalizations from 1994-2009 with concomitant increases in comorbid conditions. Clinicians should have a heightened awareness of the risk of VTE among pregnant women, particularly among those with comorbid conditions, and should have a low threshold for evaluation in women with symptoms or signs of VTE.

Safety of seasonal influenza and influenza A (H1N1) 2009 monovalent vaccines in pregnancy

Inactivated influenza vaccines have been given to pregnant women since 1964. Since 2004, the Advisory Committee on Immunization Practices has recommended that pregnant women receive trivalent inactivated influenza vaccine at any time during pregnancy. Studies conducted before 2009 did not identify any safety concerns after trivalent inactivated influenza vaccine in mothers or their infants. During the 2009–2010 influenza A (H1N1) influenza vaccination program, several monitoring systems were established or enhanced to assess whether adverse events were associated with H1N1 2009 monovalent vaccines (2009 H1N1 influenza vaccines). Data from these systems did not identify any safety concerns in pregnant women who received 2009 H1N1 influenza vaccines or their infants. Although live attenuated influenza vaccines are not recommended in pregnant women, a small number of studies have not shown any safety concern among pregnant women or their infants who were inadvertently exposed to these vaccines. This review summarizes US and international safety data for influenza vaccines in pregnant women with an emphasis on 2009 H1N1 influenza vaccines.