Liletta: New IUD approved by the FDA

The U.S. Food and Drug Administration (FDA) recently approved Liletta™, a new hormonal intrauterine device (IUD). This levonorgestrel-releasing IUD inhibits uterine lining from thickening and has been FDA approved for up to three years to prevent pregnancy. Liletta, found to be more than 99 percent effective, is already available in Europe and should arrive in the USA within the next few months.

Liletta was developed by Actavis and the non-profit Medicines360. Given the current high cost of IUDs, Medicines360 has focused on making Liletta affordable and accessible to all women. FDA approval was based on results from the largest hormonal IUD trial conducted in the U.S. The Section of Family Planning has been proud to participate in this study since 2010, as part of our broader commitment to research that improves contraceptive access for women.

Our previous research revealed various barriers in accessing the most effective methods, including cost. One recent study, conducted with support from the Office of Population Affairs, explored systems-level barriers to IUD provision. This research led to the development of a toolkit for clinical staff and health care providers to use in identifying and addressing barriers in their own clinics. We are also currently researching the feasibility and effectiveness of using mobile applications for contraceptive counseling in clinic waiting rooms. Our current studies follow previous research on an initial application, available here as an iOS app.

The Section supports the FDA’s approval of Liletta given its effectiveness at preventing pregnancy and ease of use for most women.

“Increasing the array of available and affordable contraceptive methods helps women find a method that best helps them achieve their reproductive health goals”, said Dr. Melissa Gilliam, Chief of the Section of Family Planning and lead investigator for the Section’s study site.

 

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New Section publication discusses reproductive counseling and weight-loss surgery

Women of reproductive age often pursue weight-loss surgery; in fact, they account for nearly half of all bariatric surgery patients. The relationship between reproduction and rapid weight loss has been well documented and includes an increased risk of infertility, menstrual irregularities, and changing sexual function. Women who receive bariatric surgery are also more likely to have an unplanned pregnancy. Because of these reproductive risks, the American Society for Metabolic and Bariatric Surgery recommends using effective birth control methods when experiencing rapid weight loss and the American College of Obstetricians and Gynecologists recommends delaying pregnancy one to two years after bariatric surgery.

Yet, according to one survey, 31 percent of female bariatric surgery patients planned to become pregnant after obtaining surgery, and nearly one-third planned to do so within two years. These intentions, as well as contraceptive efficacy following weight loss, warrant close collaboration between bariatric surgeons and women’s health providers.

Section faculty Dr. Julie Chor conducted a national survey of bariatric surgeons to assess perioperative reproductive counseling and contraceptive provision. Her findings were published in Surgery for Obesity and Related Diseases.

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Image courtesy of http://www.soard.org

The study found that 74% of bariatric surgeons preoperatively screen patients regarding contraceptive use more than 50% of the time. The most common method prescribed, however, were oral contraceptive pills, which may have decreased efficacy in the obese and in the postoperative state, depending on the type of surgery.

Most respondents (90 percent) recommended delaying pregnancy 12 to 24 months, yet 84% did not require a gynecologic consultation for female patients of reproductive age and 35% further stated that they did not know how their patients obtained contraception.

One-fifth of respondents did not assess their patients’ pregnancy intentions. This disparity suggests that practitioners should counsel patients preoperatively about reproductive changes that can occur after weight loss from bariatric surgery as well as discuss contraception with all women of reproductive age, whether or not they desire a future pregnancy.

Dr. Chor’s findings suggest implementing a routine gynecology consultation for female bariatric surgery patients prior to an operation. These women would greatly benefit from increased education on fertility changes associated with weight loss and on highly effective methods of contraception, such as intrauterine devices and contraceptive implants.

Read the full article here.

2014 North American Forum on Family Planning

Last month, several of our Section faculty and staff traveled to Miami for the 2014 North American Forum on Family Planning.

The Forum gathered nearly 700 clinicians, researchers, and clinical staff to present, discuss, and learn the latest on family planning and how evidence can inform both policy and practice.

The agenda included daily panels covering sexual and reproductive health and justice issues. Section Chief Dr. Melissa Gilliam served on the panel, Addressing disparities in Family Planning: Why provider diversity matters. Dr. Gilliam also moderated a panel that covered Reproductive Justice, health disparities, and incarcerated women in the U.S  This session echoed our policy brief on this topic — that a right to abortion while behind bars is meaningless without access. As a panelist said, “What happens to women behind bars is a microcosm of the politicization of reproduction in our society.”

Dr. Gilliam also contributed to a timely and important discussion, The continuing debate on the Medicaid sterilization policy: The advocacy community’s perspective. This session took into account the full, diverse experiences of women seeking to end fertility and reminders to support reproductive autonomy.

Other Forum sessions from Section faculty included a presentation by Dr. Amy Whitaker called Postpartum IUD insertion: From research to reality.

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Dr. Sabrina Holmquist and Clinic Administrator Brie Anderson presented at the Ryan Program meeting.

 

Many of our faculty and staff had posters accepted at the Forum as well.

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Dr. Whitaker’s poster presented her research on motivational interviewing to improve post-abortive uptake of LARC methods. Dr. Whitaker’s research shows that motivational interviewing is a promising approach to address health behavior issues, including repeat abortion and contraceptive counseling, as it is theory based, directive, and patient centered. Click here to view a PDF of the poster.

 

Section faculty Dr. Julie Chor’s poster discussed her research on the prevalence and correlates of women presenting for abortion having a regular provider. julieforumDr. Chor’s study found that a history of abortion did not increase the likelihood of a woman having a regular  provider, and so an abortion visit is a good opportunity to engage women in the healthcare system. Click here to view a PDF of the poster.

 

Other posters presented at the Forum included:

  • Shared negative experiences with long-acting reversible contraception and their impact on contraception counseling: A mixed methods study (Authors include OBGYN resident Dr. Benjamin Brown and Dr. Amy Whitaker). Click here for PDF.
  • Risk Factors for Feelings of Shame and Guilt at the Time of Abortion (Authors include Dr. Julie Chor, Dr. Amy Whitaker, and Policy Coordinator Lee Hasselbacher). Click here for PDF.
  • Reproductive health characteristics associated with unwanted or ambivalent first sexual experience among reproductive-aged men in the United States: An analysis of the National Survey of Family Growth, 2006-2010 (Authors include Dr. Melissa Gilliam, Dr. Amy Whitaker, and former fellow Dr. Elisabeth Woodhams). Click here for PDF.
  • Also spotted: Is LARC for everyone? Socio-cultural perceptions and barriers to contraception among refugees in Ethiopia.  Dr. AuTumn Davidson conducted this research during her fellowship in family planning. Authors include Dr. Gilliam and Research Specialists Dr. Camille Fabiyi, Dr. Brandon Hill, and Erin Jaworski.

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Section/Ci3 Study Featured in IUD Community Newsletter

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A research study co-authored by Section staff, Ci3 Founder and Director Dr. Melissa Gilliam and Ci3 Executive Director Dr. Brandon Hill was recently featured in the IUD Community Newsletter. “Impact of a theory-based video on initiation of long-action reversible contraception after abortion” was published online ahead of print in the American Journal of Obstetrics & Gynecology and presented at the 2014 Annual Meeting of the Fellowship of Family Planning in April 2014. Read the abstract here.

Former Family Planning Fellow Publishes Chapter in New Book

Dr. AuTumn Davidson, 2014 graduating fellow from the Section of Family Planning and now an Assistant Professor of Obstetrics and Gynecology at the University of Illinois College of Medicine at Chicago, contributed a chapter to the new book Contraception for the Medically Challenging Patient. Co-authored by Section faculty Dr. Julie Chor, “Contraceptive Management of Women with Cardiac Disease” addresses how to best care for the rising number of women of reproductive age who present with cardiac conditions that impact pregnancy risks and contraceptive efficacy.

Contraception for the Medically Challenging Patient offers advice on meeting the contraceptive needs of women with chronic medical problems. Family planning physicians, fellows, and women’s health care providers at any level can utilize this resource as both a literature review and a complementary guide to decrease barriers to safe contraceptive use. The authors address how common misconceptions and lack of knowledge can put patients at risk.

More from the Springer website:

Contraception for the Medically Challenging Patient fills the gap that currently exists in the knowledge of correct contraceptive prescribing practice and shows that inappropriate contraindications can easily become a barrier to effective contraception use among women. Chapters highlight obsolete views about appropriate candidates for contraception and address the complex contraceptive needs of today’s medically challenging patients with HIV/AIDS, uterine fibroids, or cardiac, neurologic or thyroid disease. The book gives attention to recommendations on the use of contraception in women with medical problems such as diabetes, obesity, epilepsy, and lupus, among others, and provides comprehensive information regarding the effects that certain drugs may have on contraceptive hormone levels. While national guidelines do exist for contraceptive eligibility, this book discusses in more detail the evidence behind the guideline recommendations and the nuances that clinicians confront in daily practice.

The book is available now in print as well as electronically. Order here.

New Section research assesses systematic barriers to IUD care

iudAt the Section of Family Planning & Contraceptive Research, we are committed to conducting quality research about the effectiveness of IUDs as birth control, especially for young women.

IUDs require little user maintenance, last between 7 and 12 years, and are highly effective at preventing pregnancy. As our earlier research has shown, in order to reduce undesired pregnancy amongst young women, it is critical to remove unnecessary barriers to choosing the IUD. One way to improve the quality of IUD services and the number of women receiving this contraceptive method is to assess the underlying problems that prevent women from receiving an IUD at their scheduled appointment.

Section Chief Dr. Melissa Gilliam’s research on these systematic barriers to IUD care was published in the July 2014 online edition of Contraception.

This article describes the novel use of a systematic approach to evaluating clinical care, called Failure Modes Effects and Criticality Analysis (FMECA). This step-by-step approach was originally developed by engineers to evaluate high-risk industries such as nuclear power and commercial aviation in order to identify practices that contribute to poor quality, unsafe, or unreliable inefficiencies. When adapted to healthcare, team members use FMECA to evaluate the systems and processes of a specific type of clinic care (eg IUD care). “Failures” are identified from qualitative and quantitative data, determining the frequency and impact in order to prioritize redesign and improvements.

For example, a failure in IUD delivery would be a patient calling and cancelling an appointment, but the cancellation is not entered into the scheduling system.

Dr. Gilliam’s study used the FMECA process to evaluate IUD services at three Title X clinics and identified three main failures during the scheduling and intake processes: 1) The patient does not show up for appointment or cancels; 2) The patient recently had unprotected intercourse; and 3) Limited time for counseling, informing, and placing IUDs. This FMECA drew upon interviews with IUD clients, the clinical care team, and reviewed administrative data at all three clinics.

After reviewing the failures, the researchers and clinical care team created solutions to the identified failures: implementing a revised scheduling call script and developing an app to be used in the waiting room. To address cancellations and no-shows, the new call center script reminded patients to keep their appointment or call to cancel beforehand. The script also addressed the need to abstain from unprotected intercourse prior to the appointment. The third failure, limited time, was also addressed by this revision, which identified potentially eligible IUD patients beforehand and saved time at the actual appointment. The barrier of limited time was also addressed with the waiting room “app”, which maximized the wait time by counseling women about contraceptive options.

After the completion of this study, the research team developed an online toolkit describing processes, procedures, and tools for an FMECA and shared with Title X clinics nationally.

To read our published research on the impact of the revised call script and the waiting room app, click here and here.

New study recommends doula support during abortion procedures

image from exhaleprovoice.orgMany women choose to have a doula–a lay support person–present during their labor process. A doula’s support has been connected to maternal and child health benefits such as pain control, shorter labor, decreased rates of cesarean delivery, and breastfeeding assistance. In full-spectrum reproductive health care, doulas can provide support for women during not only labor and delivery, but also for a variety of reproductive experiences, including miscarriage, adoption, and abortion.

While each of these reproductive experiences has unique physical and emotional challenges, a doula’s role is consistent: be a source of emotional, physical, and social support.

Section faculty Dr. Julie Chor researches the effect and role of doulas in abortion care. Her most recent publication, co-authored with Dr. Melissa Gilliam and Dr. Brandon Hill, appeared in the June 2014 online edition of the American Journal of Obstetrics and Gynecology.

In this study, Dr. Chor hypothesized that women having a first trimester abortion with doula support would have significantly less pain than women randomized to usual care.

She found that the although the majority of women who had an abortion were satisfied with the procedure, doula support did not statistically impact recalled pain. However, 96.2% of women who received doula support recommended that doula support be routinely used during procedures and 60.4% expressed interest in training to become a doula. Additionally, more than 70% of women who did not receive doula support said they would have wanted someone present to provide support during their procedure.

Furthermore, women receiving doula support were less likely to require additional clinic support resources. Doula support, Chor suggests, may address patient psychosocial needs.

Dr. Chor’s findings are relevant and timely, as volunteer abortion doula groups are organizing across the country and increasingly being used in clinics.

Click here to read more of Dr. Chor’s research on expanding the role of doulas into abortion care.

Clear communication during appointment scheduling can increase LARC uptake

Portrait of a female doctor using a computer while being on the phone

UPDATE: the final version of this article is now online. Read the abstract and download the full article in PDF format.

A new study from Dr. Melissa Gilliam and former Section staff discusses why some scheduled IUD appointments do not result in placement.

“Impact of a revised appointment scheduling script on IUD service delivery in three Title X family planning clinics” was published in the June 2014 online issue of Contraception.

This study began by reviewing clinic administrative data, which showed that women did not receive a desired IUD because of cancellations, no-shows, the need for an IUD-specific appointment, lack of awareness of clinic guidelines, and unknown pregnancy status.

With these systems-level barriers in mind, the researchers created a simple and scalable intervention: revising the appointment scheduling call script. The revised script used by telephone schedulers at a call center addressed these common mishaps and met national Title X guidelines. Along with the revised script, visual tools reminded schedulers to explain behavior prerequisites such as “Do not have unprotected sex at least two weeks prior to an appointment” and “Continue to use pills, patches, or rings up until the appointment”. The script also prompted schedulers to communicate logistical requirements such as bringing an ID, proof of insurance or cash to pay for the procedure, and instructions to call and cancel an appointment if necessary.

Before the new script was instituted, only 47 percent of patients at these sites successfully received an IUD at their scheduled appointment. After implementation of the revised script, 60 percent of scheduled appointments resulted in the desired IUD insertion. Additionally, the no-show rates decreased from 40 to 23 percent, and in particular, young women were more likely to keep their scheduled appointment.

This study shows that a simple IUD appointment scheduling script with clear communication improves LARC uptake. Additionally, as many clinics in the US move forward to computerized and centralized call centers, improving patient communication during the scheduling process may have a broad impact on clinical efficiency.

Related: Development and testing of an iOS waiting room “app” for contraceptive counseling in a Title X family planning clinic

 

Asking Your Doctor about Birth Control

Studies have shown using contraception consistently and correctly reduces rates of unplanned pregnancy.

For many women, that is easier said than done. Complicated lives, medical issues, and safety concerns are important factors to consider when choosing the best birth control method. And what matters in the end is having a birth control method that meets individual needs.

SHAPE Magazine interviewed Section faculty Dr. Julie Chor about “3 Birth Control Questions You Must Ask Your Doctor”. Dr. Chor is an experienced contraceptive counselor, and in the article she advises all women to talk to their doctor about birth control options. She stresses the basics, such as asking how often you need to remember to take a form of contraception and if that realistically fits into your lifestyle.

Earlier this year, FitPregnancy asked Dr. Chor about the best postpartum birth control and she gave her expert advice about how IUDs help attain a healthy pregnancy interval.

Dr. Chor can answer your questions about birth control during her clinic hours at the University of Chicago Hospitals where she provides contraceptive counseling and family planning services. Make an appointment here.

 

Use of an iOS Waiting Room “App” Improves LARC Knowledge

image from www.securedgenetworks.comSection Chief and Ci3 Founder and Director Dr. Melissa Gilliam has published a research article in the American Journal of Obstetrics and Gynecology called Development and Testing of an iOS Waiting Room “App” for Contraceptive Counseling in a Title X Family Planning Clinic.

Data shows that long-acting reversible contraception (LARC) methods (the IUD and implant) are highly effective forms of contraception, but used by less than 10 percent of US women. After talking to clinic staff and analyzing appointment data at three Title X clinics in Chicago, this study found that a lack of contraceptive counseling during a scheduled appointment contributes to the under-use of LARC methods.

This study began by identifying key failures in IUD service delivery, including inadequate counseling time, non-use of waiting room pamphlets, and failure to counsel all women on LARC methods. As a result, the research team opted to create a counseling “app” to increase women’s contraceptive knowledge and interest in the most effective methods.

Results showed that users were highly satisfied with the app and it was easy to use. A brief (<15 min) app session significantly improved women’s knowledge scores on the relative effectiveness of LARC compared with other methods—before she even met with the healthcare provider. App testers (n=17) preferred the interactive, visually appealing design and video testimonials. In the pilot RCT (n=52), app users had significantly higher knowledge of contraceptive effectiveness (p=0.0001) and increased interest in the implant (7.1% to 32.1%, p=0.02) post-intervention. While app users reported increased interest in the contraceptive implant, the app had no discernible impact on women’s interest in the IUD.

The study concluded that integrating app usage into the Title X setting is highly acceptable, informative, and easily integrated into waiting room situations or downloaded onto smartphones in advance of a visit. Thus, apps could be a mechanism for implementing timely, evidenced-based educational information to a wide network of clinics and clients.