Bob Kronemyer

However, the authors noted that that inappropriate use of over-the-counter (OTC) drugs like clotrimazole causes drug resistance, leading to greater prevalence of the infection.

The study comprised 84 married, nonpregnant women, between the ages of 18 and 49, who were referred for VVC to the Baharloo Hospital of Tehran University of Medical Sciences, in Iran, from August 2019 to February 2020.

Patients with positive yeast cultures were randomly divided into two main groups: 

-honey vaginal cream (the intervention group; n = 42) and 1% clotrimazole vaginal cream (the control group; n = 42).

 and 30% honey were used to formulate the former vaginal cream.

Clinical signs and symptoms and lab tests were recorded at baseline and 6 through 10 days after treatment. Patients applied an applicator (5 grams) of the designated cream before going to the bed for seven consecutive nights.

At the start of the study, 100% of the participants in both groups reported discharge, redness and itching.

After completing treatment, secretion, redness, itching and fungal culture significantly improved in both groups (

But itching and discharge were statistically better in the 

-honey group than in the clotrimazole group.

Conversely, pruritus and secretion significantly improved in the clotrimazole group compared to the 

Vaginal cultures of Candida became negative in 67.5% of patients in the intervention group and in 74.4% of patients in the control group.

The difference in outcomes between the two therapies may be due to the additional benefit of combining 

 and honey, according to the authors, who noted that “

, which might be attributed in part to honey’s low pH, the osmotic pressure of honey and honey’s production of hydrogen peroxide.

“Most of the biological and medicinal effects of 

 on the prevention of fungal growth and the effective antiinflammatory and analgesic may be due to the presence of thymoquinone,” wrote the authors.

There was no statistically significant difference between the two therapies for fungal culture results, satisfaction with the method of drug prescribed and satisfaction with the drug itself.

No study patient showed drug-specific side effects either.

“The results of this study show that the 

-honey significantly improves the symptoms of VVC; thus, the application of 

-honey can be considered as a complementary therapy in the treatment of VVC,” wrote the authors. “The complementary medicine appears to be safe, effective, and tolerable.”

However, due to the high cost, the investigators did not employ chromium agar medium to identify the type of 

 species. Additional studies are also needed to demonstrate the safety and the mechanism of action for 

Korabi MNA, Mirmolaei ST, Tabarrai M, et al. Comparison between the efficacy of 

-honey and clotrimazole on vulvovaginal candidiasis: a randomized clinical trial. 

. Published online October 14, 2022. doi:

Articles

A study published in the journal Evidence-Based Complementary and Alternative Medicine found that both Nigella sativa (N. sativa) (black seed and black cumin)-honey vaginal cream and the antifungal medication clotrimazole significantly improve the symptoms of vulvovaginal candidiasis (VVC).

Efficacy of N. sativa-honey vs. clotrimazole for VVC

“Previous models had attempted to estimate the potential impact of a prescription (Rx)-to-OTC switch of an oral contraceptive on the number of unintended pregnancies in the U.S.,” said co-author Helene Guillard, PharmD, global Rx-to-OTC switch director at HRA Pharma, headquartered in Paris, France, which is the company that sponsored the clinical study on which the model is based, as well as the sponsor of an application that was submitted earlier this year to the U.S. Food and Drug Administration (FDA) to request a change of its POP minipill Opill from Rx to OTC.

“Our model is unique because it uses data on the contraceptive method mix used by women who chose to purchase and use a POP in a simulated OTC setting in an actual-use trial2 at the time they agreed to participate in our study,” Guillard told 

. “This population likely best represents the potential actual users of an OTC POP. By using this data and varying the inputs, our model demonstrates the magnitude of the potential impact for the population who would choose to use an OTC POP.”

Employing standard typical use failure rates, including 7% for POPs, the investigators compared the expected number of unintended pregnancies for two theoretical cohorts of 100,000 women. The first cohort used an OTC POP exclusively for contraception, whereas the second cohort used contraceptive methods at the same percentages obtained from the actual-use clinical trial simulating OTC use of norgestrel 0.075 mg.

Overall, 35% of individuals in the latter cohort used no method, compared to only 19% using hormonal contraception or long-acting contraceptives.

Sensitivity analyses were conducted using alternative model inputs, like different failure rates for OTC POPs and an alternative contraceptive method mix.

An estimated 37,624 unintended pregnancies would occur annually if 100,000 women continued their usual contraceptive method.

However, this estimate would be reduced by 81%, or to 7,000 pregnancies total, by solely using an OTC POP, for a net reduction of 30,624 unintended pregnancies annually.

“It may surprise some clinicians that even with the most conservative model inputs, there is still a demonstrated benefit of a reduced number of unintended pregnancies with the use of an OTC POP, compared to what women currently use,” Guillard said. “Clinicians also need to realize that 90% of the pregnancies prevented by the use of an OTC POP in the model occurred among women previously using either no contraception or one of the least effective methods.”

The study’s main outcome – a reduction in the overall number of unintended pregnancies – remains true across a wide range of modeled scenarios, including with the most conservative inputs, according to Guillard.

The number of unintended pregnancies prevented varied from 1,461 to 34,124 yearly as the model parameters were modified.

“The potential benefit to individuals and overall public health by a reduction in unintended pregnancies, as suggested by the estimates in our model, supports an OTC switch for a POP,” Guillard said.

1. Guillard H, Laurora I, Sober S, et al. Modeling the potential benefit of an over-the-counter progestin-only pill in preventing unintended pregnancies in the U.S. 

. Published online October 15, 2022. doi:org/10.1016/j.contraception.2022.10.006

2. ClinicalTrials.gov [Internet]. Bethesda (MD): National Library of Medicine (US). Identifier NCT04112095, Adherence With Continuous-dose Oral Contraceptive: Evaluation of Self-Selection and Use (ACCESS); https://clinicaltrials.gov/ct2/ show/NCT04112095

An over-the-counter (OTC) progestin only pill (POP) could potentially reduce the overall number of unintended pregnancies in the United States, according to a modeling study published in the journal Contraception.

Preventing unintended pregnancies with an OTC progestin-only pill

“This is because the study has shown that when women make decisions with others, they are more likely to opt for the use of modern contraceptives and so a well-informed society will most likely have increased prevalence of modern contraceptive use,” wrote the authors.

Results of the 2014-2018 survey were published in the journal 

Chad has a modern contraceptive prevalence of only 7.7%. probably due to social, cultural and religious norms.

The country’s estimated population growth of 3.5% per year is relatively fast-paced, thus perhaps attributing to the region’s high fertility and low use of contraceptives.

Survey data was gleaned from 4,113 women, aged 15 to 49, who were in sexual union. Overall, 91% of respondents were married and 73.3% have partners who were sole decision-makers for health issues.

A mere 5.7% of respondents used a modern contraceptive method, which included female sterilization, an intrauterine contraceptive device (IUD), contraceptive injection, contraceptive implants (Norplant), contraceptive pill, condoms, emergency contraception, standard day method (SDM), vaginal methods (foam, jelly, suppository), lactational amenorrhea method (LAM) and country-specific modern methods, as well as a cervical cap or contraceptive sponge.

Traditional methods of proven effectiveness were periodic abstinence (rhythm, calendar method), withdrawal (coitus interruptus) and country-specific traditional techniques.

Folkloric methods of unproven effectiveness included herbs and amulets (including the Voodoo amulet gris-gris).

Women who collaborated on health decisions with another person were nearly three time as likely to use modern contraceptives than those who decided alone: adjusted odds ratio (aOR) = 2.71; 95% confidence interval (CI) =1.41 to 5.21. 

Education, ability to refuse sex and employment were also linked to the use of modern contraceptives.

Women with at least a primary education were more than twice as likely to use modern contraceptives, while those with secondary or higher education were four times as likely.

Compared to their nonworking peers, the working class seeks to maintain its employment and devote more time to occupations than having children. “Also, working women are expected to have the financial backing to be able to make health decisions concerning their reproductive health,” wrote the authors.

Conversely, women who resided in rural settings were 53% less likely to use modern contraceptives than those in urban areas, perhaps because women in urban areas may have easier access to information and more interest in education. Other potential barriers for rural dwellers are poor transportation access, long distances to health facilities and shortage of contraceptives.

The survey also revealed that women who gave birth at least four times were 61% more likely to use modern contraceptives than those without birth experience.

In addition, women who could refuse sex were at least 50% more likely to use modern contraceptives than their counterparts who were unable to refuse sex.

But age, marital status or first age at sex were not associated with the use of modern contraceptives.

Adde KS, Ameyaw EK, Mottey BE, et al. Health decision-making capacity and modern contraceptive utilization among sexually active women: evidence from the 2014–2015 Chad Demographic and Health Survey. 

The major conclusion of a demographic and health survey of sexually active women from the sub-Saharan African country Chad is that education is key for adopting modern contraceptive methods.

Health decision-making ability and modern contraceptive use

, noted that despite limited historical evidence on whether fetal red blood cell (RBC) exposure during early spontaneous or induced abortion can cause maternal Rh sensitization, “Forgoing Rh immunoglobulin administration before 12 weeks gestation is highly unlikely to increase risk of Rh (D) antibody development.”

For spontaneous or induced abortion care in the first two trimesters of pregnancy, in which the fetus is reasonably certain to be Rh negative, the prescription medicine RhoGAM is not necessary in any scenario or at any gestational age.

The risk of maternal Rh isoimmunization before 12 weeks gestation in patients undergoing spontaneous, medication or uterine aspiration abortion is minimal, according to the consensus statement, due to emerging evidence and improved techniques with greater sensitivity and specificity to quantify fetal red blood cells(RBCs) in maternal blood after abortion.

The costs incurred with routine Rh screening and testing and Rh immunoglobulin administration of pregnant patients before 12 weeks gestation also likely outweigh the benefits, particularly with evolving clinical abortion practices.

Uterine aspiration is the standard of care for uterine evacuation. But sharp curettage is not recommended. In cases where sharp curettage is judged clinically necessary, it is unclear how the procedure might influence the need for Rh immunoglobulin.

Although dissuaded, Rh testing and Rh immunoglobulin administration may be considered for patients less than 12 weeks gestation, at the request of the patient as part of shared decision-making about the patient’s future fertility desires in light of existing data.

For Rh immunoglobulin prior to 12 weeks gestation, a 50 mcg (250 IU) dose of Rh immunoglobulin is recommended.

A 100 mcg dose (500IU) at 12 to 18 weeks gestation is considered safe and effective, which may be available in international settings or can be achieved by giving two 50 mcg (250IU) doses.

The amount of fetomaternal hemorrhage during dilation and evacuation procedures up to 18 weeks gestation is adequately treated with 100 mcg of Rh immunoglobulin.

Continued administration of a 300 mcg (1500IU) dose for patients undergoing abortion after 18 weeks gestation is also encouraged.

However, all patients have the right to decline recommended Rh immunoglobulin testing and administration. Common reasons include no desire for future pregnancy, relative certainty that the patient is Rh-positive, relative certainty that the pregnancy is Rh-negative and the wish to avoid administration of human blood product.

“It is important to document the counseling, recommendation, and declination,” wrote the authors.

Due to the consequences of undertreatment, the recommendations are intentionally conservative, according to the authors, adding that the guidelines will be updated as new evidence surfaces. “As clinics adopt these new guidelines, longitudinal cohort studies should be undertaken to evaluate their uptake and efficacy,” they wrote.

Meanwhile, clinical studies are ongoing to investigate fetal RBC concentration after abortion through 10 weeks in larger populations. The authors advocate similar studies in patients throughout the first and second trimesters.

Horvath S, Goyal V, Traxler S, et al. Society of Family Planning committee consensus on Rh testing in early pregnancy. 

. Published online July 21, 2022. doi:org/10.1016/j.contraception.2022.07.002

Rhesus (Rh) immunoglobulin should be given only after 12 weeks gestation for spontaneous abortion, or for medication or uterine aspiration abortion, according to a new consensus statement from the Society of Family Planning (SFP). 

Consensus statement on Rh pregnancy testing

“There is a gap in our knowledge about population-level racial disparities in birth outcomes among women who use assisted reproduction,”

said principal investigator Sarka Lisonkova, MD, PhD, an associate professor of ob/gyn at the University of British Columbia (BC), Vancouver, BC, Canada.

The retrospective cohort study comprised data on all singleton births in the United States in 2016 and 2017 (n=7,545, 805). The authors used publicly available information from birth and death certificates and fetal death certificates obtained from the National Center for Health Statistics.

Overall, 1.3% of singletons were conceived by MAR.

Non-Hispanic Black, American Indian and Alaska Native (AIAN) and Hispanic mothers were on average younger and more likely to be obese, use Medicaid, unmarried and less educated than non-Hispanic White mothers.

AIAN mothers had the highest prevalence of smoking during pregnancy, obesity, and prepregnancy diabetes, whereas Asians and Pacific Islanders had the highest percentage of underweight mothers in all mode-of-conception groups.

The study’s primary outcome was neonatal death, defined as death within 28 days after birth.

In the spontaneous-conception group, neonatal mortality was twice as high among infants of non-Hispanic Black compared to non-Hispanic White women.

More starkly, among women who conceived by assisted reproductive technology (ART), including in-vitro-fertilization, neonatal mortality was roughly fourfold higher in infants of non-Hispanic Black women than in non-Hispanic White women.

Racial and ethnic disparities between Hispanic versus non-Hispanic White women were also significantly greater for preterm birth (<34 weeks) and perinatal mortality in women who conceived via MAR.

Non-Hispanic Black women who conceived using non-ART MAR (including, for instance, fertility drug treatments) were three times more likely to experience a fetal death than non-Hispanic White women.

“Socioeconomic status (SES) disparity has been implicated as one of the major drivers of racial/ethnic disparity in adverse birth outcomes,” Lisonkova told 

. “The premise was that racial/ethnic-related SES disparity among women who use MAR would be less than what we observe in pregnant women in the general population, because fertility treatments require financial resources. Surprisingly, though, the opposite was true: racial disparities were larger among women who conceived using assisted reproduction.”

The study offers information to healthcare providers about potential gaps in pregnancy and neonatal care for women with assisted reproduction and their infants, including all racial/ethnic groups.

To reduce the racial and ethnic disparities found in the study, “we need to further examine racial/ethnic differences in causes of infertility, types of fertility treatments and birth outcomes in women with multiple pregnancies, such as twins and triplets, which are more common following assisted reproduction than in natural conception,” said Lisonkova. “This will provide more information about possible improvements in clinical care.”

From a public health perspective, “we need to provide high-quality obstetric and neonatal care for women who conceive using fertility treatments, plus have care that is accessible, especially among minority racial/ethnic groups,” Lisonkova said. “We need to also ensure equal access to fertility therapies.”

Lisonkova S, Ukah UV, John S, et al. Racial and ethnic disparities in the perinatal health of infants conceived by ART. 

. Published online October 19, 2022. doi:org/10.1542/peds.2021-055855

Racial and ethnic disparities in adverse perinatal outcomes were significantly greater among women who used medically assisted reproduction (MAR) than those who conceived spontaneously, according to a study published in the journal Pediatrics.

Disparities in prenatal health of infants conceived by assisted reproduction

The study conducted a longitudinal nationwide survey of 57 abortion providers (some with more than one clinical location) in 31 states.

Among the 57 clinics, 60% were classified as having low abortion restrictions, followed by 18% with extreme restrictions, 12% with high restrictions and 11% with medium restrictions.

Overall, 18% of clinics required in-person visits for medication abortions, due to state-level abortion restrictions.

Compared to clinics in states with high or extreme abortion restrictions, clinics in states with low or medium abortion restrictions were more likely to change their ultrasound policy, so that fewer patients were required to undergo the imaging in order to minimize in-person contact before the abortion (33% vs 0%); adopt low- or no-test abortion (LNTA) protocols (40% vs 18%); permit “curbside” medication abortion pick-up (13% vs 6%); offer mail delivery of medication abortion (13% vs 0%); and provide telehealth for follow-up (85% vs 47%).

Similarly, compared to clinics in states that required in-person visits for medication abortions, states without that requirements were significantly more likely to change ultrasound requirements (28% vs 0%); adopt LNTA protocols (38% vs 10%); permit curbside medication pick-up (13% vs 0%); offer mail delivery of medication abortion (11% vs 0%); and provide telehealth for follow-up (79% vs 50%).

“Clinics in more hostile states were less likely to offer patients options to mitigate their risk of acquiring SARS CoV-2 infection in healthcare settings,” wrote the authors.

They also noted that there was no state-level regulation requiring in-person dispensing of the abortion medicine mifepristone.

Although the study sheds light on legislation on the state level about adoption of public health best practices, the small sample size may underestimate the true influence of abortion restrictions on service delivery innovation during the early COVID-19 pandemic.

The survey was also limited to changes made during the pandemic from January to November 2020, not previous adoption of these innovative practices. For example, telemedicine abortion outside of a site-to-site model was not included, except as part of a research protocol prior to the pandemic. Likewise, waiving ultrasound requirements may have been adopted at some clinics before 2020.

Nonetheless, evidence of the safety and efficacy of telehealth abortion has increased during the COVID-19 pandemic, according to the authors, prompting the Food and Drug Administration (FDA) to review the risk evaluation and mitigation strategy (REMS) for mifepristone and removing the in-person dispensing requirement in December 2021.

“This change could vastly improve access to medication abortion via telehealth,” wrote the authors. “However, as our findings indicate, the positive impact of this change on abortion access may vary substantially depending on other state-level abortion restrictions.”

Janiak E, Belizaire C, Liu J, et al.The association of U.S. state-level abortion restrictions with medication abortion service delivery innovations during the early COVID-19 pandemic. 

A study in the journal Contraception found that, within the first year of the COVID-19 pandemic in the US, abortion clinics in states with low or medium hostility to abortion were significantly more likely to embrace innovative medication abortion practices such as changing ultrasound requirements, offering telehealth or dispensing medications without a physical exam, compared to abortion clinics in states with high or extreme hostility to abortion. 