Volume 66 No 01: Recurrent Pregnancy Loss, January 2021

In response to the coronavirus disease 2019 pandemic, many U.S. family planning providers have started offering telemedicine services.

COVID-19 in pregnancy: What ob/gyns should know about the vaccines

In this video, Senior Editor Angie DeRosa interviews Emily Adhikari, MD, on questions or concerns she and colleagues are hearing from patients surrounding the COVID-19 vaccine.

Cognitive changes in menopause: with and without HIV

Women with HIV are no more vulnerable to menopause-related cognitive declines compared to other women, according to a longitudinal cohort study in the journal 

Cannabis use may reduce conception efforts

Marijuana use may make conception more difficult for women who smoke than those who don’t, according to a prospective cohort study from the National Institutes of Health (NIH).

Articles

It was a very busy week for the Contemporary OB/GYN® team.

In case you missed it: Jan. 18 to Jan. 22

The prospective cohort study focused on cannabis use via urinary metabolites and self-reporting during preconception, and whether it was associated with fecundability, live birth, and pregnancy loss. The findings, published in 

, linked preconception cannabis use with reduced fecundability despite increased frequency of intercourse.

The study evaluated 1,228 women aged 18 to 40 years with a history of pregnancy loss. The women were followed up with from 2006 to 2012 for up to 6 cycles while attempting pregnancy, and throughout pregnancy if they conceived. Self-reported preconception cannabis use and urinary tetrahydrocannabinol metabolites were recorded at baseline, after 6 months of follow-up or at the beginning of the conception cycle, and weeks 4 and 8 of pregnancy.

Researchers concluded that women with preconception cannabis use did have reduced fecundability (FOR 0.59; 95% CI 0.38, 0.92). They also found associations, although imprecise, with anovulation (RR 1.92, 95% CI 0.88, 4.18) and live birth (42% (19/45) cannabis users versus 55% (578/1043) nonusers; RR 0.80, 95% CI 0.57, 1.12). They did not find any association with preconception cannabis use and pregnancy loss (RR 0.81, 95% CI 0.46, 1.42).

S L Mumford, K S Flannagan, J G Radoc, L A Sjaarda, et al, Cannabis use while trying to conceive: a prospective cohort study evaluating associations with fecundability, live birth and pregnancy loss, 

Marijuana use may make conception more difficult for women who smoke than those who don’t, according to a prospective cohort study from the National Institutes of Health (NIH). 

Cannabis use may hinder conception efforts

Cervical Cancer Awareness

Slideshows

In honor of Cervical Cancer Awareness month, Contemporary OB/GYN® will publish weekly slideshows with factual information, statistics, and more.

Cervical Cancer Awareness Statistics

Emily Adhikari, MD is the medical director of Perinatal Infectious Diseases, and assistant professor of Obstetrics and Gynecology in the division of Maternal-Fetal Medicine at the University of Texas Southwestern Medical Center in Dallas.

Podcasts

On this episode of Pap Talk, Emily Adhikari, MD answers frequently asked questions about the COVID-19 vaccine.

COVID-19 in pregnancy: Q&A with Emily Adhikari, MD

“We were curious if we could augment the breadth and depth of contraceptive counseling available to patients seen in our resident continuity clinic,” said co-principal investigator Mary Tschann, PhD, MPH, who at the time of the research was an adjunct assistant research professor of ob/gyn and women’s health at the University of Hawaii in Honolulu. 

“Recognizing that clinicians are always pressed for time, and aware of the benefits of a team-based approach to healthcare, we wanted to know if a well-trained group of volunteers, who we dubbed reproductive health educators (RHEs), could complement the clinicians’ work and provide more comprehensive and tailored counseling to patients than the clinicians could afford to do with their busy schedules.”

RHEs were undergraduate and graduate students from the University of Hawaii at Mānoa who were pursuing degrees and/or careers in the health sciences.

The observational study compared baseline chart review data (all patients, aged 14 to 25, seen in the clinic from January to December 2015, representing 726 visits among 248 patients) to data collected during the RHE intervention (75 patients, each with a single visit from January to July 2016).

RHE educational sessions with the intervention group added a mean 15 minutes to the visit, ranging from an additional 5 to 60 minutes.

In the intervention group, 64% of patients arriving with no method elected to initiate a short-acting reversible contraceptive (SARC) or long-acting reversible contraception (LARC) method during their visit, compared to 48% of patients in the baseline group.

“We anticipated that counseling would be more thorough with dedicated counseling from the RHEs, but we were uncertain if it would change contraceptive prescribing or initiation,” Tschann told 

RHEs were a cost-effective and beneficial addition to the care team, according to Tschann. “Adding dedicated contraceptive counseling staff or volunteers to a generalist ob/gyn clinical practice could give patients more tailored support, while also freeing up clinicians to meet their clinical load,” she said.

The study authors are now analyzing qualitative feedback from the residents, attendings and RHEs to better understand how to optimize this kind of intervention. “We expect our findings will help us refine the scope of content the RHEs are responsible for, which could reduce the time and costs associated with their training,” said Tschann, who is currently senior clinical affairs manager at the Society of Family Planning.

Integrating RHEs into clinic flow was critical to the success of the intervention, as was flexibility in the design. “RHEs could see patients at any point during their visit, and worked in close contact with the medical assistants, residents and attendings to ensure they were an asset to the patient’s visit,” Tschann said.

Careful planning with the clinic leadership and practice runs with the staff can help identify potential barriers before RHEs are formally introduced.

Tschann reports no relevant financial disclosures.

Tschann MS. Elia J. Salcedo JL. Achieving comprehensive contraceptive counseling for young women and improved contraceptive uptake through the implementation of a reproductive health educator program. Matern Child Health J. Published online November 13, 2020. doi:

Initiation of more effective contraception occurred more often among patients who were seen by a volunteer reproductive health educator during routine visits at a resident obstetrics and gynecology clinic, according to a study published in Maternal and Child Health Journal.

Contraceptive counseling via volunteer reproductive health educators

The odds of impairment in learning, memory and attention/working memory were all significantly increased during the menopause transition.

Senior author Pauline Maki, PhD, a professor of psychiatry, psychology and ob/gyn at the University of Illinois at Chicago, was inspired to undertake the study because she desired to know if low-income women of color and/or women with cognitive vulnerabilities, such as those with HIV, experience higher-than-expected cognitive difficulties during menopause.

“More generally, I wanted to understand the magnitude of cognitive declines associated with the menopause transition, and to quantify the percentage of women whose cognitive declines reach the level of cognitive impairment,” Maki told 

The study analyzed 443 women (median age 42 years) from the Women’s Interagency HIV Study, of whom 34% were women without HIV, 69% African American and 18% Hispanic.

All the women completed baseline testing of verbal learning and memory, attention/working memory, processing speed, verbal fluency, motor skills and executive function on or after Oct. 1, 2008, then had two or more follow-up office visits spaced 2 years apart (mean follow-up 5.7 years). All women were premenopausal at the baseline assessment.

“For memory, there was a two-fold increased odds of impairment during the transition from pre- to early menopause transition, but that resolved in the postmenopausal stage,” Maki said. “For learning, there was a two- to three-fold increased odds of impairment that was sustained across the menopause transition into the postmenopause.”

A similar pattern was observed for attention/working memory.

Effects on the same domains were also evident in categorical scores of cognitive impairment, with the increased odds of impairment ranging from 41% to 215% (

The increase in predicted probability of impairment by menopausal stage – from premenopause to the menopause transition or postmenopause – ranged from 4% to 13%.

“While the majority of women did not experience a clinically significant menopause-related decline in learning and memory, up to 11% of women showed a clinically significant worsening of cognitive performance associated with the menopause transition,” Maki said.

Despite other studies showing that the average performance on cognitive tests of learning and memory worsen as women transition through menopause, “we are the first to determine what percent of women showed worsening of cognitive performance that reached the threshold of impairment,” Maki said. “I was surprised that this was observed for about one in 10 women. I was also surprised that there was no difference between women with HIV and those without HIV in cognition changes across the menopause.”

Many women fear that the memory changes they experience are an early sign of Alzheimer’s disease or HIV-related cognitive impairment, according to Maki. “But our research shows that they are related to a different cause: the menopause transition,” she said.

Clinicians should help to normalize the cognitive complaints of women. “Evidence-based approaches for sustaining brain health include exercise, Mediterranean diet, sleep hygiene and novel cognitive activities,” Maki said. “We also need to know who is most vulnerable to cognitive impairment associated with menopause.”

Maki has served as a consultant to AbbVie, Astellas, Balchem and Pfizer.

Maki PM, Springer G, Anastos K, et al. Cognitive changes during the menopausal transition: a longitudinal study in women with and without HIV. 

. Published online Jan 13, 2021. doi:10.1097/GME.0000000000001725

Women with HIV are no more vulnerable to menopause-related cognitive declines compared to other women, according to a longitudinal cohort study in the journal Menopause.

However, the study found that performing TLreH on a large, immobile uterus is more difficult, in part because of the limited surgical field of view.

The operation time and blood loss were also significantly increased in uteri weighing 600 g or more (

The case-control observational study was performed at the Yokohama Municipal Citizen's Hospital in Japan between January 2014 and December 2019.

All the enrolled 92 women underwent TLreH and had uterine fibroids or adenomyosis, or both, with obliterated cul-de-sac due to severe endometriosis.

The median operation time was 122 minutes (ranging from 54 to 312 minutes) and the median blood loss was 150 mL (ranging from 0 to 1420 mL).

Perioperative complications occurred in 3.3% (n = 3) of cases, defined as Clavien-Dindo classification ≥Ⅲ. There were no cases of transition to open surgery, and only one case of blood transfusion.

Patients were also divided into two groups: uteri weighing ≥600 g (n = 25) and those weighing <600 g (n = 67). In the heavier weight uteri group, the median operation time and median estimated blood loss volume were 130 minutes (ranging from 81 to 312 minutes) and 265 mL (ranging from 70 to 420) mL), respectively.

This compared to a median operation time and median estimated blood loss volume of 99 minutes (ranging from 54 to 219 minutes) and 100 mL (ranging from 0 to 1160 mL), respectively, in the lighter weight uteri group.

“Regardless of endometriosis, carrying the large uterus out of the vagina takes longer, which also contributes to a longer surgery time,” wrote the authors.

No differences were found in the frequency of perioperative complications or blood transfusions between the two groups.

Age, body mass index (BMI) and the rate of prior treatment of gonadotropin hormone-releasing hormone agonist or dienogest were also not significantly different between the two groups.

However, gravida and parity numbers were significantly lower in the heavier weight uteri group than the lighter weight uteri group(

With TLreH, it is conceivable that hysterectomy can be safely performed by a routine surgical procedure, regardless of the severity of endometriosis. But for the study, TLreH did not actively remove deep endometriosis lesions. “Even if no endometriotic lesions remain macroscopically, they might remain at the microscopic level,” wrote the authors.

Similarly, laparoscopic modified radical hysterectomy (TLmRH) does not provide relief from rectal adhesions; for example, it would be difficult for a rectal probe to reach adhesions between the upper rectum or sigmoid colon and the uterus.

On the other hand, the risk of bowel damage and lower abdominal nerve damage can be avoided with TLreH, although chronic pelvic pain due to deep endometriosis may persist.

Besides being a retrospective study at a single institution, the study was not comparative; hence it is difficult to ascertain the usefulness of TLreH, according to the authors, adding that the procedure needs to be investigated as a curative treatment for endometriosis in the long term.

 M, Yoshida H. Feasibility and safety of total laparoscopic retrograde hysterectomy in a large uterus with obliterated cul-de-sac due to severe endometriosis. 

. 2020 Dec 29;258:43-47. doi:10.1016/j.ejogrb.2020.12.042

A retrospective study in the journal Obstetrics & Gynecology and Reproductive Health has concluded that total laparoscopic retrograde hysterectomy (TLreH) for severe endometriosis with obliterated cul-de-sac is both feasible and safe. 

Laparoscopic retrograde hysterectomy in a large uterus

Medical director of Perinatal Infectious Diseases, Parkland Hospital, and assistant professor of Obstetrics and Gynecology in the division of Maternal-Fetal Medicine at the University of Texas Southwestern Medical Center in Dallas.

As with other vaccine trials, pregnant women were not included in the trials for the two vaccines that have been approved for COVID-19.

“I suspect follow-up studies will involve the surveillance of side effects from the 

 program as well as other studies (including our own group) who look to evaluate pregnancies in women who received the vaccine,” she said. 

“I suspect there will not be large clinical trials now that the vaccines are made available to pregnant women but there will be follow-up studies of antibody titers, etc., in pregnancy/lactation following vaccination. (It) might be hard to do a placebo-controlled trial at this point.”

As the United States rolls out its program to vaccinate the population, myths persist for the safety and efficacy of the vaccine for pregnant and lactating women, including the notion that the vaccine can cause infertility or the belief that Bell’s palsy can be a side effect. 

, which also will appear in the February print issue of 

She elaborates on the points included in that FAQ in this video interview.

The American College of Obstetricians and Gynecologists (ACOG) last updated its practice advisory on Dec. 21 for “Vaccinating Pregnant and Lactating Patients Against COVID-19,” the link for which can be found 

. In that advisory, ACOG recommended that vaccines not be withheld from pregnant individuals who meet the criteria for vaccination based on the priority groups established by the Advisory Committee on Immunization Practices (ACIP).

Videos

In this video, Senior Editor Angie DeRosa interviews Emily Adhikari, MD, on questions or concerns she and colleagues are hearing from patients surrounding the COVID-19 vaccine. 

COVID-19 Vaccine: Questions and answers for practicing ob/gyns and their patients

The pandemic took what was mostly niche telehealth technology and brought it to a much larger patient population. Without it, many primary care practices wouldn’t have been able to see enough patients to stay open. But as the novelty has worn off and people have regained confidence in going to in-person appointments, both the government and private payers have begun making moves that will impact the technology’s long-term viability.

Medical Economics spoke with Thomas Conroy, CEO, MedSign, about how telehealth is viewed and what its future might look like.

(Editor’s note: The transcript has been edited for brevity and clarity.)

Medical Economics: With the massive expansion of telehealth during the pandemic, how well has it worked out for both doctors and patients?

 When we talk about telehealth, thank goodness that the government sort of got it right by expanding the use of telehealth across the board here. As you know, in the beginning, telehealth was positioned for rural areas and now it's across the nation. I think it's a learning process. Because of COVID and the inability to get the physician's office, telehealth has opened up the door, but we have got to do a lot more than that. We need to make some technology changes to enable those who are, let's say technology averse, to access telehealth, in the comfort of their home, and I'm talking about seniors. So I think overall, for doctors, you'll find that the younger doctors are totally open minded and want to embrace telehealth and maybe the older doctors are the type that would like to see the patient in the home. And they're going to learn over time that this is an incredible tool that they'll have in their war chest to help to keep people healthy and well in the home.

Medical Economics: Getting telehealth to this point required a lot of changes from the government. The Trump administration announced several changes to telehealth recently; what did they get right and what did they get wrong about it?

 I think they really got it right. Early on, they decided to allow telehealth especially because of the fact that the COVID-mandated isolation and confinement forced millions of Americans in the home. I think just allowing telehealth to expand across the country was an incredible mark for the administration. They also got it right by paying providers the same reimbursement rates as if they were giving care in the office. And that was critical at the time. I think that over time, we're going to see a change and telehealth is here to stay, and it's going to change the way healthcare is provided in the future. But more so, I think it's going to reduce costs in a hospital.

Medical Economics: In the past, Medicare primarily focused telehealth benefits on rural areas where care could often be hard to access. Is that the right approach?

 CMS took what they were doing in the rural areas and applied it to a nationwide program. Absolutely, it was a great way to start, and they understood some of the shortfalls there. What we need to do though, and being a technologist, we need to make sure that the information that's provided and the connectivity that is provided is for all Americans, and not just the young people today. They all understand just having happiness in your hand in the form of a cell phone is the way to go, because that's what they live by. We're going to see more and more of that as we progress in the telehealth arena. But we have to embrace those people and get others to adopt the system, and I think CMS has done that in the beginning here very well.

Medical Economics: Many patients that used telehealth have since returned to in-office visits, and doctors that reported a lot of telehealth usage in early 2020 now say it's declined. What does that say about the long-term future for telehealth in medicine?

 I think this is a generation issue. The old generation wants to be able to go into the doctor's office, look them in the whites of their eyes, and get the people to care for them personally. The young people, they're used to the use of technology that exists today, and it's just only going to grow. We're not really seeing a real reduction, but an increase in in-home and in-office care. But what we are seeing is that the seniors would like to actually talk and see the doctors themselves. Well, that will change over time as telehealth becomes commonplace. And what you really have to consider is, there's another area of seniors that is really important: those who have chronic diseases. They don't want to go to the hospitals, they don't want to see their doctors, they want to sit and stay in the comfort of their home, but you have to provide technology that enables them to do that. And there's technology out there, like the one that I'm working on, that enables the seniors to talk to the physician or their nurse, or even their loved one, through the comfort of their home using a home television set. And I think that if we can apply that common technology that is in 120 million homes, we get to sell a winner here. When we talk about the seniors, you have to provide them what they know best, and that’s access to a product that they use every day in their home, and it's a television set. So that will be the embracement part. The adoption part that telehealth needs is you have to bring in those people that are pretty much using most of the Medicare and Medicaid dollars. It's the seniors over 75 years of age especially. And here's the other thing, that population is growing. Think about it: Because of all the health care that they're receiving, they are living longer. We have to make sure that we can embrace those folks, and the way you do it is providing technology so that they can adopt it with ease.

Medical Economics: How have private insurers approached telehealth and have they gotten it right?

 Yes, and no. There's still a weeding-out factor, and the government and the private insurers really have to get together on this. Let's face it, COVID forced us into this new arena called telehealth across the country. Before, telehealth was rural. I think on the private insurers’ side, there's a real lack of understanding on the potential of telehealth right now. They understand it, but I think over time they will start seeing the analytics or statistics showing that it's better to have telehealth to reduce the cost of a hospital stay than it is not to have it. Now, I will say that one of the things that's a problem right now that companies have to explore and they have to include is you have to build controls into the telehealth sessions. And, if you may recall, early in 2020, there was a telehealth fraud in Florida to the order of $1.2 billion. They were having cases made up and they were caught. There are roughly 300 people involved in this, because there were no control mechanisms built in. It’s the wild west of telehealth right now, and it is “get a session-get paid.” But if you can build controls that enables even Medicare to look in, even with using HIPAA as a baseline, look in and make sure that it's a true telehealth session, you'll see that the economics will be a lot better with telehealth built into the system. It’s still a learning process for these folks, but it will change over time. It's going to be a common item just like going into your doctor's office, getting your blood pressure, getting your weight and temperature—this will be commonplace.

Medical Economics: Some experts have indicated that if you make telehealth too easy to use, it will lead to an explosion in unnecessary costs because people will use the service just because of the convenience factor. Is this a valid argument?

 It is, but again, it's sort of a learning process for everybody. I think the young adults are going to use this when they need it. What you have to build in, as I said before, you have to build in controls in this whole process. And that's where I would focus my attention on, and we have focused our attention on, how do you control the system so that you have true telehealth sessions that are approved?

Medical Economics: Are there still technological challenges with telehealth, and if so, how can they be fixed?

 Yes, the technological challenges are the fact that you're not reaching 35 million people who are senior citizens. And every day, it grows by 10,000—every day for the next 15 years. Some of those people are ready. They understand the iPhone, smartphones, tablets, but 35 million people out there do not. And so they're technologically a challenge. There are 260 telehealth companies out there, and they're all vying for the same space and use smartphones and tablets. Seniors don't use those things. So, you have to develop a develop a technology that seniors will adopt. So that's the challenge. How do you get into that senior home? How do you get them to adopt it? But the second challenge is how can you go and perform an examination in a home? And that would be to me is very critical and in providing a better health and wellness system for a person, especially the elderly, many of whom are disabled. You have to take that technology aversion away, and you have to gain adoption.

Medical Economics: What will ultimately drive greater telehealth adoption: reimbursement that's on par with in-office visits or just patient demand for it?

 Both. Appropriate reimbursement is critical. The doctors have to get reimbursed for this, but you have to have people wanting to do this. Seniors want to stay at home. They don't want to go out on the road. I don't want my dad who is a 92-year-old World War II vet, he's got to go down to the VA to see a physician. I don't want him getting in a car traveling. They're sitting there for an hour potentially getting COVID while he's there, and then driving back and not getting in an accident. So, I think the drive here is including systems that's easy for them to use. But on the medical side, full reimbursement for a telehealth session is important. And may I also point out something that's really important I didn't mention earlier: medical equipment is reimbursed but telehealth-specific equipment is not being reimbursed at this time. I understand why the government is hesitant on reimbursing telehealth equipment, because anybody can say a computer or a laptop is reimbursable, and that's not going to happen. So, if you design telehealth specific equipment, the government should allow that to be a reimbursable event.

Medical Economics: 10 years from now, what do you think telehealth will look like? And how widespread do you think it will be?

 It's going to be universal. I think we're going to get it right. There's lots of companies working on it. I think we're going to see that it's going to go have a global impact too. I can see telehealth being provided to other countries through the United States. With the technologies that are coming down the pipe, you're into some pretty exciting things and of course on top of it, besides having telehealth, you should have a fully automated home that's fully embraces somebody that's disabled, and you should have the ability to send medical information anytime, anywhere that they need it. And I'm talking about physicians who need it. Then finally there is AI. There are not enough nurses out there, there are not enough doctors. So, what are you going to do? You should have AI be a part of your system that enables the doctors to get a full pre-evaluation before they talk to the patient. I think AI is going to be absolutely critical in anybody's roadmap.

The pandemic brought telehealth into the mainstream, but will government and private payers make the right moves to make it a standard part of medicine?

Will telehealth persist after the pandemic?

These providers find that telemedicine for contraceptive counseling during the early stage of the pandemic was a positive experience and believe that the service should be expanded, according to an exploratory survey in the journal 

First author Bianca Stifani, MD, a family planning fellow at Albert Einstein College of Medicine and Montefiore Medical Center in the Bronx, New York, and the other investigators were inspired to undertake the study based on their own experience with telemedicine at the height of the pandemic in New York City.

“We saw our own routines as physicians drastically changed by working from home,” Stifani told 

. “We also felt we were meeting many of our patients' needs efficiently.”

The authors wanted to find out if other family planning providers around the country were having similar experiences.

The cross-sectional, web-based survey was conducted in June and early July of 2020 and completed by 172 providers (34% response rate).

Overall, 91% of respondents offered telemedicine services in the 2 months prior to the survey, with 55.1% from a hospital/clinic and 42.9% from home. Most of these providers (78%) were new to telemedicine.

More than half of the cohort (54%) referred less than a quarter of their contraception patients for in-person visits. The most common in-person referral reason was long-acting reversible contraceptive (LARC) insertion (53%).

“We were surprised by the fact that many providers reported referring less than a quarter of patients for in-person visits,” Stifani said. “This could potentially mean that contraceptive counseling via telemedicine can meet many patients' needs; however, it would be important to see if these results are replicated outside the context of a pandemic, because patients may have made different contraceptive choices to avoid COVID-19 exposure.”

The survey also revealed that 80% of providers strongly agree that telemedicine visits are an effective way to provide contraceptive counseling and 84% believe this service should be expanded after the pandemic.

In addition, 64% of providers said they would be very happy if telemedicine were to become a routine part of their clinical practice after the pandemic.

Although almost half of providers used personal smartphones or laptops to conduct telemedicine visits, their ideal devices are work-issued computers, tablets or phones, and 60% prefer video over phone visits.

“We were surprised that many providers were using their personal computers or phones to conduct telemedicine visits, rather than work-issued devices,” Stifani said.

The study indicates that telemedicine may be an effective way to conduct contraceptive counseling and that it might meet many patient needs. “But it will be important to conduct more studies on telemedicine in normal times to assess the extent to which this technology can meet patients' needs outside of a pandemic,” Stifani said.

Also, technological challenges are one of the main obstacles to offering telemedicine. “Practices and hospitals should invest in telemedicine platforms that work and are easy to use for both patients and providers,” Stifani said.

Stifani reports no relevant financial disclosures.