Research roundup: October 2019 edition

The CDC’s yearly STD report, potential for a trivalent vaccine for genital herpes in the future, hormonal contraceptive use among women with opioid use disorder, improved patient bleeding patters with correct fundal placement of IUDs, and more.

by Colleen Denny, MD and Emma Gilmore, MD

published 10/31/19

The Research Roundup is posted at the end of each month with the top research and guidelines on birth control methods and services, sexual health, abortion, STIs, and more!

1. Relationship Between Etonogestrel Concentrations and Bleeding Patterns in Contraceptive Implant Users

2. Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use?

Unpredictable bleeding patterns, typically defined as prolonged or frequent bleeding, are common for users of the etonogestrel implant (Nexplanon) and are a frequently cited reason for discontinuation of this method. This month brought us two studies investigating these bleeding patterns, one on the possible reasons for this side effect and a second on anticipatory counseling for patients based on initial bleeding patterns.

The first of these two studies, published in Obstetrics & Gynecology in September 2019, investigated the relationship between serum etonogestrel and abnormal bleeding with a prospective cross-sectional study of 350 patients. This study found that almost 60% of patients using an implant for at least one year reported abnormal bleeding. Increased serum etonogestrel levels were associated with increased risk of abnormal bleeding—for every 100pg/ml increase in serum etonogestrel, users had 1.6 times the odds of reporting abnormal bleeding. Additionally, those with higher levels of serum etonogestrel had increased odds of receiving a combined oral contraceptive pill prescription to improve abnormal bleeding.

In Contraception, researchers reexamined etonogestrel implant Phase 3 clinical trial data to determine if initial bleeding patterns for implant users could predict future bleeding patterns and guide anticipatory counseling. Users were categorized as having “favorable” bleeding patterns if they had amenorrhea, infrequent bleeding, or normal frequency bleeding or “unfavorable” bleeding patterns, if they had prolonged and/or frequent bleeding in the first four months of use. For users with favorable patterns, 60-80% continued to report these bleeding patterns through the next two years of use. For users with unfavorable bleeding patterns in the first four months, 40-50% reported a change to favorable bleeding patterns at later assessments. Favorable bleeding patterns in the initial four months of use were associated with lower discontinuation rates. Providers can use these findings to counsel implant users with initially unfavorable bleeding patterns that bleeding patterns improve for approximately half of users.

3. Safety and effectiveness of hormonal contraception for women who use opioids: a systematic review

Caring for women with opioid use disorder (OUD) requires specific knowledge with regard to the reproductive health needs and preferences of this vulnerable population, but little has been published in this area. This systematic review found no high-quality studies about the use of hormonal contraception by women with OUD. The study authors therefore considered theoretical concerns about the use and safety of concurrent use of opiates and hormonal contraception. While there have been some findings of decreased contraception adherence by opioid users, this is common across many user groups and should not be a reason to withhold access to these methods. Since ethinyl estradiol weakly inhibits the liver enzymes that break down opioids, there is some theoretical concern that the use of estrogen-containing contraception could lead to higher opiate serum levels, but there is limited data available. Overall, the authors encourage further research but recommend utilizing evidence-based guidelines and eliminating unnecessary barriers for patients who use opioids.

4. The influence of the levonorgestrel‐releasing intrauterine system position on bleeding patterns in reproductive age women

Irregular bleeding patterns can be a barrier to patient acceptance and continued use of the levonorgestrel IUD. This prospective cohort study examined the effects of fundal versus non-fundal placement of levonorgestrel IUDs on bleeding patterns in women using the IUD for contraception. Users with non-fundal placement of IUDs were significantly more likely to report sustained bleeding and greater blood loss, with 83% reporting this abnormal bleeding at 3 months and 58% at 6 months. For users with fundal IUD placement, 55% reported abnormal bleeding at 3 months and only 31% at 6 months. Providers may be able to improve patient bleeding patterns by ensuring correct fundal placement of their IUDs at time of insertion.

5. Nucleoside-modified mRNA encoding HSV-2 glycoproteins C, D, and E prevents clinical and subclinical genital herpes

Despite the prevalence of genital herpes, the discomfort of outbreaks, and the risks of newborn transmission, no vaccine has yet been developed for this virus. Developing a genital herpes vaccine to prevent infection is difficult, as subclinical viral shedding is a known route of transmission and can be a challenging target for vaccine development. Researchers at the University of Pennsylvania evaluated a trivalent vaccine in order to see if it could prevent both genital lesions and subclinical infection. In mice and guinea pigs, it entirely prevented genital lesions in 100% and it showed promise in preventing subclinical infection, as it stopped viral shedding in 80%. These results indicate that a trivalent vaccine for genital herpes in humans may be a possibility in the future, and this formulation could be a candidate for future human trials.

6. Immunogenicity of 2 and 3 doses of the quadrivalent HPV vaccine up to 120 months post-vaccination; follow-up of a randomized clinical trial

Use of the HPV vaccine series has led to significant decreases in precancerous cervical lesions and cancers and has been historically given over a 3-dose schedule. However, some young people are unable to return to their provider on multiple occasions for the pre-determined doses. Data has shown that the 2-dose HPV vaccine schedule is non-inferior for women up to age 26, and some countries have changed their vaccine recommendation based on this information. This article describes a post-hoc analysis after 120 months of a non-inferiority immunogenicity trial that compares girls who received the HPV vaccine over 2 versus 3 doses. Girls were monitored on Day 1 and Months 7, 24, and 120 post-vaccination. Findings confirmed immunogenicity of the 2-dose quadrivalent HPV schedule over this 10-year span, further highlighting its utility for vaccine recipients. The CDC currently recommends the 2-dose schedule for recipients up to 14 years of age.

7. Sexually Transmitted Disease Surveillance 2018

The CDC releases yearly statistics on reportable sexually transmitted infections (STIs)—chlamydia, syphilis, and gonorrhea—along with information on other STIs. This information is compiled from state-based health reporting agencies and surveys. The report also provides updated information on special groups such as women, infants, racial/ethnic minorities, and men who have sex with men. The 2018 edition is notable for increases in cases of chlamydia, gonorrhea, and syphilis (primary, secondary, and congenital) in the United States, along with ongoing health care disparities across differing groups. This report provides useful graphics that can be customized and used for educational purposes and can guide providers when counseling and discussing STI testing with patients.

8. Intrauterine Devices: Effective Contraception with Noncontraceptive Benefits for Adolescents

This review in the Journal of Pediatric and Adolescent Gynecology discusses the role of IUDs specifically for an adolescent patient population. The authors note that adolescents are the age group at the highest risk of unintended pregnancy, and thus stand to benefit from the high effectiveness of methods such as IUDs. IUDs are not contraindicated in nulliparous women, including teens, and teens do not appear to have higher complication rates. The authors also note potential non-contraceptive benefits of IUDs for adolescents, including improvements in dysmenorrhea and heavy menstrual bleeding as well as endometrial protection for obese adolescents. This review and discussion help to reassure providers about the appropriateness of IUDs as a choice for adolescents.

9. Effectiveness, safety, and acceptability of self‐assessment of the outcome of first‐trimester medical abortion: a systematic review and meta‐analysis

Many clinics require a second in-clinic visit to confirm a complete abortion after medication abortion, limiting access to this type of abortion for people who are unable to return to the clinic. In this systematic review and meta-analysis, the authors chose four RCTs, combining nearly 5500 patients, to assess the safety and outcomes of medical abortion follow up done at home to in-clinic follow-up visit. The included trials each had a group of patients who assessed the success of their medication abortion using a home pregnancy test and communication with the clinic via phone, text, or email. The authors found no difference in complete abortion rates, rates of ongoing pregnancies, or various important safety outcomes between the two groups. This suggests that allowing medication abortion users to self-assess at home with a urine pregnancy test and remote communication with the clinic staff may increase access to medication abortion by avoiding an extra visit while not compromising efficacy or safety.

Colleen Denny, MD, is an attending ObGyn at Bellevue Hospital in New York City, where she is the Medical Director of the Women's Clinic, and a clinical assistant professor with the NYU School of Medicine. She enjoys providing care for patients in all phases of life and is especially interested in issues related to contraception access and public health. Outside of work, she’s a runner, a dancer, and a bit of a crossword puzzle nerd.
Emma Gilmore is a fellow in Complex Family Planning at the University of Pennsylvania. She completed her residency in Obstetrics and Gynecology at New York University. She's passionate about reproductive rights, medical education, and combating health care disparities, particularly in sexual and reproductive health. In her free time, she can be found taking her dog on walks around the beautiful parks in and around Philadelphia.
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