Lindsey Carr

Dextromethorphan was not a successful adjunctive pain management option for medication abortion, according to research results published in 

Through a randomized, double-blinded, placebo-controlled trial, investigators used data from 156 women who were eligible for medication abortion at Planned Parenthood of Western Pennsylvania to evaluate dextromethorphan (DXM) as a non-narcotic option for post-abortion pain management.

Investigators randomized 156 women to adjunctively take DXM—loading dose 60 mg and 2 subsequent 30 mg doses at 2 and 5 hours after misoprostol administration—or placebo combined with nonsteroidal anti-inflammatory medications (NSAIDS) and/or opioids for pain. Patients reported pain scores and satisfaction 2, 5, 8, and 24 hours after misoprostol administration via a secure texting application. The study’s primary outcomes were worst pain score and total analgesic use.

Patients were able to opt for a printed oxycodone prescription—10 tabs of 5 mg—to fill at their pharmacy. All patients received routine counseling to take ibuprofen—600 mg orally every 6 hours as needed and/or acetaminophen for pain control during the medication abortion process and to secondarily use the prescribed opioid as needed.

Results showed no difference in worst pain scores for patients receiving DXM versus placebo (8.0 vs 7.0 

 0.06), or in total milligram usage of ibuprofen (800 mg vs 610 mg, 

 = .62), acetaminophen (10000 mg vs 1300 mg, 

 = 0.51). Patients randomized to placebo were significantly more likely to be satisfied with their pain control (91% vs 75%, p = 0.02).

Patients receiving placebo were significantly more likely to rate their pain control as good or very good, compared to the DXM group (91% vs 75%, 

 = 0.02). While patient age was a differing factor between groups (25.8 vs 27.4, 

 < 0.05), dissatisfaction scores did not differ by patient age after adjustments (95% vs 71%, 

Of total patients, 124 (79%) opted to receive oxycodone prescriptions. Of those, 78 (63%) filled their prescriptions, and 6 of/156 (40%) reported taking any oxycodone during their medication abortion.

Patients who opted for an opioid prescription but did not get it filled reported lower rates of satisfaction in the DXM arm compared to placebo (70% vs 95% 

Investigators found worse pain scores and significantly less satisfaction in the DXM group overall, contrary to previous research that found DXM beneficial as an adjunctive option for gynecologic surgery.

“Given that patients do experience severe pain during this process, we should seek to improve patient use of ibuprofen, which is effective, and counsel patients on safe disposal of unused opioids,” the investigators concluded.

This article originally appeared on Contemporary OB/GYN.

1. Ferguson GP, Achilles SL, Meyn LA, et al. Dextromethorphan as a novel nonopioid adjunctive agent for pain control with medication abortion: A randomized controlled trial. 

. Published online November 2022. doi:10.1016/j.contraception.2022.10.010

Articles

Results from a randomized controlled trial study suggest dextromethorphan may even worsen patient pain experience.

Dextromethorphan Found Ineffective for Medication Abortion Pain Management

Research from the North American Menopause Society (NAMS) suggests that many women are using medical cannabis as an adjunctive treatment for menopause-related symptoms, with the most common being sleep disturbances and mood/anxiety.

Researchers conducted a survey of 258 women—131 perimenopausal and 127 postmenopausal—to learn more about their patterns of medical cannabis use. The survey results provided information about patients’ modes and types of use, as well as the specific menopause-related symptoms they were using medical cannabis to alleviate.

Most women reported current cannabis use (86%) and endorsed it to help with menopause-related symptoms (79%). Smoking was the most common method of use (84%), followed by edibles (78%). Researchers found that women were primarily using cannabis to address sleep disturbances (67%) and mood/anxiety (46%).

The greatest percentage of users—perimenopausal women—had worse menopause-related symptomology, including more anxiety (

=0.04), than postmenopausal women. They also had higher rates of depression (

<0.01) and used cannabis more often for treatment than postmenopausal women (

While previous research suggests that cannabis use can improve anxiety, mood, sleep, pain, and even cognition after certain treatments, more research is necessary to determine its potential benefits for women with menopause-related symptoms.

“More research is needed before this treatment is recommended in clinical practice,” said Stephanie Faubion, MD, MBA, medical director of NAMS. “Health care professionals should query their patients about medical cannabis for menopause symptoms and provide evidence-based recommendations for management.”

Future research should investigate the impacts of different medical cannabis characteristics—or cannabinoid profiles—on the efficacy of use for menopause-related symptoms, the authors wrote.

With perimenopausal women experiencing higher rates and prevalence of mood/anxiety symptoms, the study authors think they may be promising targets for future clinical trials of cannabinoid-based therapies.

Dahlgren MK, El-Abboud C, Lambros AM, Sagar KA, Smith RT, Gruber SA. A survey of medical cannabis use during perimenopause and postmenopause [published online ahead of print, 2022 Aug 2]. 

. 2022;10.1097/GME.0000000000002018. doi:10.1097/GME.0000000000002018

https://www.menopause.org/docs/default-source/press-release/cannabis-use-increasing-for-meno-symptoms.pdf

More women are using medical cannabis for menopause-related symptoms.

Patients Turning to Medical Cannabis for Menopause Relief

Monkeypox can be transmitted to the fetus during pregnancy or to the newborn through close contact during and after birth. Spontaneous pregnancy loss and stillbirth, and preterm delivery, have been reported in confirmed cases.

Monkeypox is similar to smallpox (Variola virus) but seems to be less severe in its manifestations and resulting illnesses during pregnancy, including hemorrhagic complications and death. Variola virus infection during pregnancy has been reported to cause pregnancy loss, stillbirth, preterm birth, and congenital infection.

The signs and symptoms of monkeypox infection in pregnancy appear like those of nonpregnant people, including prodromal symptoms such as fever, headache, lymphadenopathy, malaise, sore throat and cough, and rash.

The cause of fever may be difficult to identify until the rash appears.

It is important to differentiate a monkeypox diagnosis from dermatoses of pregnancy, including pruritic urticarial papules and plaques of pregnancy.

Monkeypox lesions can mimic the appearance of other infections. Patients with rashes that appear to be more common infections, such as varicella zoster or sexually transmitted infections (STIs), need to be evaluated for a characteristic monkeypox rash (IMAGES). Providers should also consider diagnostic testing, especially if epidemiologic risk factors for monkeypox virus infection are present. The Centers for Disease Control and Prevention (CDC) recommends a broad approach to testing as simultaneous infections of monkeypox virus and STIs have been reported.

Providers should prioritize currently or recently pregnant and breastfeeding people with monkeypox infection for medical treatment before non-pregnant individuals, as the likely increased risk of severe disease, fetal transmission during pregnancy, and severe newborn infection via close contact during and after birth.

At the time of this article’s publication, there is not yet a treatment approved specifically for monkeypox infections. However, antivirals developed for use in patients with smallpox may be beneficial.

If treatment is indicated, tecovirimat—also known as TPOXX—should be considered as the first-line antiviral for pregnant, recently pregnant, or breastfeeding people. Tecovirimat is a US Food and Drug Administration (FDA)-approved antiviral medication for the treatment of smallpox in children and adults. It is expected to have antiviral activity against monkeypox and is FDA-authorized for this indication under an expanded access protocol.

The information regarding the effects of tecovirimat on fetal and reproductive development is limited to animal studies, in which subject animals were given a dose that was 23 times higher than the recommended human dosage. No specific fetal effects were noted, but it is unclear whether it prevents congenital monkeypox.

While tecovirimat was present in subject animals’ breast milk, it is unknown if the levels are sufficient for treating a breastfeeding child with monkeypox infection. If indicated, breastfeeding children with monkeypox infection should be treated independently.

While they are considered alternative antiviral therapies for treating monkeypox infection, animal studies have shown evidence of teratogenicity so they should not be used to treat people in their first trimester of pregnancy. Their presence in breastmilk is also unknown, so it should also be avoided in breastfeeding people in case of serious adverse reactions in the breastfeeding infant.

Vaccinia Immune Globulin Intravenous (VIVIG)

Researchers have not yet conducted animal reproduction studies with VIVIG, so there is little data on whether it can cause fetal harm during pregnancy, or on a person’s future fertility. However, immune globolins have been used during pregnancy for many years without any apparent negative reproductive side effects. Providers should evaluate the risks and benefits of VIVIG for each individual patient and exercise caution when administering to a breastfeeding person, as it may be excreted in breast milk.

Live, nonreplicating viral vaccine licensed for the prevention of smallpox and monkeypox infection.

Vaccine-associated risks in pregnancy are unknown, but animal studies indicated no evidence of harm to a developing fetus.

Due to its nonreplicating quality, it should not present a risk of transmission to breastfed infants, making it the vaccine of choice for both pregnant and breastfeeding people.

Replicating viral vaccine licensed for smallpox prevention. Contraindicated in pregnant and breastfeeding people due to risk of pregnancy loss, congenital defects, and fetal-infant vaccinia virus infection.

Pre- and post-exposure prophylaxis should be offered when indicated to pregnant or breastfeeding people.

As with any treatment, shared decision-making should be used when discussing the risks and benefits with patients.

Direct contact between a patient in isolation for monkeypox and their newborn is not advised. Separating the monkeypox-infected person from their newborn is the best way to prevent transmission, and full-time rooming-in is not recommended during the infectious period. Providers should counsel the patient on the transmission risk and potential consequences for severe disease in newborns. If the patient chooses to have infant contact during their infectious period, the following precautions should be taken:

Infant should be fully clothed or swaddled, and after contact occurs, the clothing or blanket should be replaced.

Patient should always wear gloves and a fresh gown, covering all visible skin below the neck.

Soiled linens should be removed from the area.

The patient should wear a medical mask or other well-fitting source control during the visit.

Discharge planning should consider a patient’s isolation period duration, ability to strictly adhere to isolation recommendations and availability of alternate caregivers.

Breastfeeding should also be delayed until the isolation period has concluded.

Updated Case-finding Guidance: Monkeypox Outbreak—United States, 2022

This article originally appeared on Contemporary Ob/Gyn.

Clinical Considerations for Monkeypox in People Who are Pregnant or Breastfeeding. CDC. Published July 18, 2022. Accessed July 26, 2022. 

https://www.cdc.gov/poxvirus/monkeypox/clinicians/pregnancy.html

What we know about monkeypox in pregnancy, including treatment recommendations, vaccination, and postpartum care.



Monkeypox in Pregnancy: Clinical Considerations

Mycovia Pharmaceuticals recently announced US availability of oteseconazole (VIVJOA; Mycovia) for the treatment recurrent vulvovaginal candidiasis (RVVC) in women with a history of the chronic infection, who are postmenopausal and/or are without reproductive potential.

Oteseconazole—an azole antifungal agent—became the first and only RVVC treatment medication approved by the US Food and Drug Administration in April 2022. The drug’s 12-week treatment course provides women with long-term relief from RVVC for up to 1 year (50 weeks).

“Through our efforts, we will help patients understand that chronic yeast infection is a distinct condition from acute yeast infection,” said Tiffany Ahlers, chief commercial officer of Mycovia in a recent 

, “and VIVJOA was designed and studied in clinical trials to reduce the incidence of recurrent vaginal yeast infection in females with a history of RVVC.”

A novel oral inhibitor of fungal CYP51, oteseconazole was studied in 3 clinical trials, including 2 global studies—VIOLET Trials 1 (NCT03562156) and 2 (NCT03561701)—and a US-based study, 

 (NCT03840616). Although clinical efficacy data included women with reproductive potential, data showed oteseconazole to be contraindicated in pregnant and lactating women due to potential risks of embryonic and fetal toxicity. The most common side effects included headaches and nausea.

There are 2 treatment regimens for providers to consider when prescribing—oteseconazole on its own, or in combination with 150 mg of fluconazole.

Day 1: single dose of 600mg oteseconazole

Day 2: single dose of 450mg oteseconazole

Day 14: take 150mg oteseconazole once per week—every 7 days—for 11 weeks.

Day 1, Day 4, Day 7: single dose of 150mg fluconazole

Days 14 to 20: 150mg oteseconazole once daily for 1 week

Day 28: 150mg oteseconazole once per week—every 7 days—for 11 weeks.

As oteseconazole is a breast cancer resistance protein (BCRP) inhibitor, its use may increase the risk of adverse reactions when taken with certain breast cancer treatment drugs—specifically BCRP substrates such as rosuvastatin.

Oteseconazole is now available in a network of pharmacies and can be ordered by mail or picked up in-person, making treatment that much more accessible for women dealing with RVVC nationwide.

Mycovia Pharmaceuticals Announces U.S. Availability of VIVJOA (oteseconazole) Capsules, the First and Only FDA-Approved Medication for Recurrent Vulvovaginal Candidiasis (Chronic Yeast Infection). Businesswire.com. July 18, 2022. Accessed July 25, 2022. 

https://www.businesswire.com/news/home/20220718005049/en/Mycovia-Pharmaceuticals-Announces-U.S.-Availability-of-VIVJOA%E2%84%A2-oteseconazole-Capsules-the-First-and-Only-FDA-Approved-Medication-for-Recurrent-Vulvovaginal-Candidiasis-Chronic-Yeast-Infection

Oteseconazole treats recurrent vulvovaginal candidiasis in women without reproductive potential.



Oteseconazole for RVVC Commercially Available in US

, outlines women’s reproductive rights and details the various reproductive health care services still available and protected by law.

The website provides helpful information about access to and coverage of various reproductive health care resources and services, including abortion care, birth control, emergency contraception, and family planning counseling.

the most comprehensive directory of trusted and verified abortion service providers in the country—where women can find verified abortion providers, resources for financial assistance, and a state-by-state guide on the current abortion laws.

This article was originally published by Contemporary OB/GYN.

The Department of Health and Human Services (HHS) launched a website Friday which offers women a comprehensive list of reproductive health care resources, services, and information.

Reproductive Health Care Website Launched by HHS

An oral presentation at the Society for Maternal-Fetal Medicine’s (SMFM) 42nd Annual Pregnancy Meeting explored possible associations with marijuana use and nausea and vomiting in early pregnancy.

Cannabis use is increasing as many states legalize marijuana. Despite recommendations from the American College of Obstetrics and Gynecology, pregnant individuals frequently use marijuana to alleviate stress, anxiety, nausea, vomiting, and pain.

 In a 2019 study, researchers conducted a test in which a “mystery caller” contacted 400 Colorado dispensaries to ask about morning sickness relief. Nearly 70% recommended cannabis use, despite a lack of scientific data.

To further investigate the use of marijuana for morning sickness, Torri D. Metz, MD, MSCR, associate professor at the University of Utah Health in Salt Lake City, Utah, along with her co-authors, led an ancillary study to evaluate whether marijuana use was in fact associated with early pregnancy nausea and vomiting. Secondarily, they wanted to learn more about antiemetic use in individuals with and without marijuana use.

The ancillary study used data from the prospective Nulliparous Pregnancy Outcomes Study: Monitoring Mothers-to-be (nuMoM2b), which recruited individuals from 2010 to 2013 from 8 US centers.

Metz and her team included only individuals who completed a Pregnancy-Unique Quantification of Emesis (PUQE) evaluation and consented to a frozen stored urine sample at the first study visit, which included 9,250 participants. Their primary outcome was the overall PUQE score, which involved 3 questions—how many hours in the past 12 hours have you felt nauseated? How many times in the past 12 hours have you vomited? How many times in the past 12 hours have you had retching or dry heaves?

Using the PUQE scores, they calculated nausea severity as mild, moderate, or severe—a PUQE score of 0 meant no nausea severity; A score of 1 to 6 was mild; 7 to 12 was moderate; and a score of 13 or more was qualified as severe. They also gathered antiemetic use via medical inventory that certified research staff collected at the time of the study.

Marijuana exposure was measured via biological sampling. Researchers did an immunoassay screen for 11-nor-9-carboxy-delta-9-tetrahydrocannabinol (THC), followed by confirmatory testing with liquid chromatography-mass spectrometry with a cutoff at 15 ng/mL. They then quantified the THC in the urine and normalized it with urine creatinine. The team compared those with and without urine positive for THC. Multivariable logistic regression adjusted for maternal age, body mass index, prescription antiemetic use, and gestational age (P<0.05).

Researchers ultimately included 9,250 nuMoM2b participants in their analysis, 5.8% (95% CI 5.4-6.3%) of which were THC-positive (n=540). As for nausea severity, 46% (4,257) had no nausea symptoms; 38.2% (3,531) had mild nausea; and 15.8% (1,462) had moderate-to-severe nausea. The average gestational age at the first visit was between 11- and 12-week gestation.

THC-positive participants had higher rates of nausea symptoms, episodes of vomiting, and episodes of dry heaves than those who tested negative for THC (n=8,710). THC-positive participants, Metz said, were more likely to be younger, Black, live below the poverty line, and have public insurance. Interestingly, after multivariable modeling, incrementally higher THC was not significantly associated with any level of nausea (OR 1.6). 9.6% of participants reported using antiemetics at the first visit. THC-positive participants were more likely to report use of antiemetic (18 vs 12 with P<0.01).

The investigators concluded that, though they were unable to establish cause and effect through a retrospective study, they did find marijuana use to be associated with nausea and vomiting in early pregnancy. They also found that most THC-positive participants were taking only 1 antiemetic.

“Obstetricians should query about marijuana use,” Metz said, “to understand the reasons for use, and counsel [patients on] potential adverse effects. Nausea may be undertreated in early pregnancy, and we do have the opportunity to offer safe, effective alternatives.”

Metz T, Allshouse A, McMillin G, et al. Association of Marijuana Use with Nausea and Vomiting of Pregnancy. Oral concurrent session. SMFM Annual Meeting. February 3, 2022.

Ko JY, Coy KC, Haight SC, et al. Characteristics of Marijuana Use During Pregnancy — Eight States, Pregnancy Risk Assessment Monitoring System, 2017. 

MMWR Morbidity and Mortality Weekly Report

. 2020;69(32):1058-1063. doi:10.15585/mmwr.mm6932a2

Dickson B, Mansfield C, Guiahi M, et al. Recommendations From Cannabis Dispensaries About First-Trimester Cannabis Use. 

. 2018;131(6):1031-1038. doi:10.1097/AOG.0000000000002619

Metz TD, Allshouse AA, McMillin GA, Silver RM, Jarlenski MP. Association of Marijuana Use with Nausea and Vomiting of Pregnancy. 

American Journal of Obstetrics and Gynecology

. 2022;226(1):S22-S23. doi:10.1016/j.ajog.2021.11.082

A presentation at the Society for Maternal-Fetal Medicine’s (SMFM) 42nd Annual Pregnancy Meeting explored possible associations with marijuana use and nausea and vomiting in early pregnancy.