Sandra Fyfe

Danielle Mazza, MD, MBBS, FRACGP, DRANZCOG, department head of the Monash University Department of General Practice in Notting Hill, Victoria, Australia, and colleagues conducted the study. The research focused on Australian community pharmacies to find how contraceptive care is practiced and how it might be improved. 

“We examined community pharmacists’ contraceptive knowledge and their attitudes, practices and perceived barriers to and benefits of contraceptive counselling provision,” Mazza and colleagues said.

Researchers noted how community pharmacies in Europe and North America have increased access to sexual and reproductive health due to task-sharing. 

“These community pharmacy task-sharing initiatives include pregnancy options counselling, interventions integrating contraceptive care across community and clinic-based services, and legislative amendments providing pharmacists with practice licensing authority to dispense hormonal contraception without a physician's prescription,” the authors wrote.

Between September and December 2020, study authors conducted a nationwide survey by mail. They contacted 2149 community pharmacies and requested a response from a single pharmacist from each location. Nineteen percent (366) of requests were answered, with a median respondent age of 34 years old. 

Outcomes from the survey included practices, reported and tested knowledge, attitudes, confidence, benefits, and barriers.

Most pharmacists (85%), “agreed that contraceptive counselling fits within their current professional activities and emphasized benefits to their patients, including improved access to contraceptive decision support (80%), as being key motivators of counselling,” Mazza and colleagues reported.

Researchers said the most important barriers included lack of assistance tools (54%), lack of training opportunities (5%), and lack of payment mechanisms (66%).

Pharmacists rated their self-knowledge and confidence as highest with combined oral contraceptives and lowest with copper intrauterine devices. 

“When tested, pharmacists were very knowledgeable about method, dosage, frequencies and costs, and relatively less knowledgeable about side-effects and IUD suitability for adolescents,” Mazza and colleagues said. 

They added that Australian pharmacists have limited opportunities after undergraduate degrees for contraceptive knowledge, which is similar to findings in the United States, where “most pharmacists described contraceptive education in the pharmacy curricula as being inadequate to prepare them for contraception prescribing.”

In areas where general practitioners were scarce, pharmacies were most likely to have a private consultation room and advanced accreditation, according to study authors. They said this provides an opportunity for pharmacists to increase access to contraception methods and counselling in communities that lack these services, and that most pharmacists felt positive about these services.

To decrease barriers reported by pharmacists, researchers recommended policy level changes such as medicine rebates and federal pharmacy funding agreements. In addition, they said pharmacy curricula changes and professional development opportunities would also decrease these barriers.

For study limitations, researchers said that 2/3 of pharmacists who responded to the survey self-identified as innovators or early adopters, and so this may have resulted in sampling bias. 

In addition, while the sample size of 366 responses was adequate, it was a relatively small number compared with the initial 2149 survey requests and may not provide a full picture.

Researchers said that Australian community pharmacists know contraceptive counseling is good for both public health and for patients. They said pharmacists reported being enthusiastic about expanding their scope of practice for contraceptive care.

“Community pharmacists provide contraceptive information and counselling but lack the necessary resources and support to be able to consistently provide quality, person-centered care,” researchers concluded. 

They said that payment mechanisms, pharmacy-specific professional resources, and training opportunities need additional exploration to provide support for pharmacists to offer high quality, patient-centered contraceptive care.

Buckingham PLM, Hussainy S, Soon J, Norman WV, Bateson D, Mazza D. Improving access to quality contraceptive counselling in community pharmacy: examining the knowledge, attitudes and practices of community pharmacists in Australia. 

. 2022 Nov 21:bmjsrh-2022-201623. doi: 10.1136/bmjsrh-2022-201623. Epub ahead of print. PMID: 36410765.

Rebic N, Gilbert K, Soon JA "Now what?!" A practice tool for pharmacist-driven options counselling for unintended pregnancy. 

Cameron ST, Glasier A, McDaid L, et al. Use of effective contraception following provision of the progestogen-only pill for women presenting to community pharmacies for emergency contraception (Bridge-It): a pragmatic cluster­randomised crossover trial. 

Rodriguez MI, Skye M, Edelman AB, et al. Association of pharmacist prescription and 12-month contraceptive continuation rates. 

Stone RH, Rafie S, Griffin B, et al. Pharmacist self­perception of readiness to prescribe hormonal contraception and additional training needs. 

Articles

Community pharmacists need more support and resources to provide quality contraceptive counseling and care, according to a study published in BMJ Sexual and Reproductive Health.

Pharmacy’s role in contraceptive counseling and care

Nathorn Chaiyakunapruk, PhD, of the department of pharmacotherapy at the College of Pharmacy, University of Utah, Salt Lake City, Utah and of the School of Pharmacy, University of Wisconsin, Madison, Utah and colleagues conducted the umbrella review.

Researchers reported contraceptive use is increasing worldwide, with about 1.1 billion women in need of services.1 Fifty percent of those women use hormonal contraceptives, which include skin patches, intravaginal rings, intramuscular injections, IUDs, implants, and tablets.

These methods use either progesterone alone or a combination of estrogen and progesterone and are available in different doses. Are there risks involved for women who choose this family planning method?

Some meta-analyses have found major adverse health effects for women on hormonal contraceptives, including cancer, cardiovascular, gastrointestinal, and metabolic issues, as well as fractures, while others report hormonal contraceptives reduce certain risks.

 Study authors sought to evaluate the quality of evidence in meta-analysis studies to clarify this conflicting information.

Researchers collected cohort studies and randomized clinical trials (RCTs) that looked at adverse health outcomes from hormonal contraceptives in women. The authors used the Cochrane Database of Systematic Reviews, Medline, and Embase, from inception through August 2020. They searched for terms such as meta-analysis and systematic review with terms including “hormonal contraception, contraceptive agents, progesterone, desogestrel, norethindrone, megestrol, algestone, norprogesterones, and levonorgestrel.”

After screening 2996 studies, researchers evaluated 310 full-text articles. Of these, 58 were selected for evidence analysis: 45 meta-analyses of cohort studies and 13 of RCTs. The authors used the Assessment of Multiple Systematic Reviews, version 2, to grade studies’ methodologies; results were categorized as high, moderate, low, and critically low.

 “The Grading of Recommendation, Assessment, Development and Evaluations approach was used to assess the certainty of evidence in meta-analyses of RCTs, with evidence graded as very low, low, moderate, or high,” researchers reported.1 Cohort study evidence association quality evaluated criteria as being convincing, highly suggestive, suggestive, weak, and nonsignificant.

Researchers found 60 associations between hormonal contraceptive use and adverse outcomes described in meta-analyses of RCTs, and 96 associations described in meta-analyses of cohort studies.

 They reported that none of the associations were supported by high-quality evidence. Out of the 60 associations described in RCTs, researchers said only 14 were nominally statistically significant, but none of these were supported by strong evidence.

“The association between the use of a levonorgestrel-releasing intrauterine system and reductions in endometrial polyps associated with tamoxifen use (odds ratio [OR], 0.22; 95% CI, 0.13-0.38) was graded as having high-quality evidence, and this evidence ranking was retained in the subgroup analysis,” study authors reported.

 Of the 96 associations described in cohort studies, 40 were nominally statistically significant, but none were supported by convincing evidence in the primary or subgroup analyses, researchers said.

The risk of venous thromboembolism among those using oral contraceptives was initially supported by highly suggestive evidence. However, this was downgraded to weak in the sensitivity analysis, researchers said.

Study authors reported several limitations. First, the quality of the primary studies used in each meta-analysis depended on the assessment reported by the meta-analysis.

 Next, most reviews focused on estrogen-containing combined oral contraceptives. Researchers said progestin-only methods, such as tablets, depot medroxyprogesterone acetate injections, progesterone implants, and levonorgestrel-releasing intrauterine systems did not have meaningful clinical representation.

“The results of this umbrella review supported preexisting understandings of the risks and benefits associated with hormonal contraceptive use,” researchers said. They concluded that meta-analysis studies associating major adverse health outcomes such as cancer and increased cardiovascular events linked to hormonal contraceptives did not have high-quality evidence.

Brabaharan S, Veettil SK, Kaiser JE, et al. Association of hormonal contraceptive use with adverse health outcomes: an umbrella review of meta-analyses of randomized clinical trials and cohort studies. 

. 2022;5(1):e2143730. Published 2022 Jan 4. doi:10.1001/jamanetworkopen.2021.43730

Roe A﻿, Bartz DA﻿, DouglasPS﻿. Combined estrogen-progestin contraception: side effects and health concerns. UpToDate. Updated October 20, 2021. Accessed August 7, 2020. 

https://www.uptodate.com/contents/combined-estrogen-progestin-contraception-side-effects-and-health-concerns

Lopez LM﻿, GrimesDA﻿, GalloMF﻿, StocktonLL﻿, SchulzKF﻿.Skin patch and vaginal ring versus combined oral contraceptives for contraception. 

. 2013;2013(4):CD003552. doi:10.1002/14651858.CD003552.pub4

An umbrella review of meta-analysis studies on hormonal contraceptives published in JAMA Network Open finds no high-quality evidence that they cause major adverse health outcomes such as stroke or cancer.

Hormonal contraceptives and adverse effects: What’s the evidence?

Li Hong, MD, of the reproductive genetic center at the Suzhou Affiliated Hospital of Nanjing Medical University in the Suzhou Municipal Hospital in China and colleagues performed the study. Researchers recruited 1344 women from 2 hospitals in Suzhou and Nanjing who were planning to use in-vitro fertilization (IVF). The average age of study participants was 31.3 years. Participants in the study were selected if they had not yet IVF at the time of enrollment, subsequently became pregnant with only 1 child, received prenatal and birth care from the study hospital, and provided written informed consent.

 Women who miscarried or experienced stillbirth were excluded from the study.

Researchers conducted a prospective cohort study and used the Pittsburgh Sleep Quality Index (PSQI) to assess sleep before oocytes were obtained, and then during each pregnancy trimester. According to the authors, the PSQI includes 18 questions about subjective sleep quality, the time it takes to fall asleep, sleep duration, length of actual sleep, sleep disturbances, use of sleep medication, and daytime dysfunction.

 Participants self-report questions from a scale of 0 (no difficulty) to 3 (severe). PSQI is scored between 0-21, and the authors said scores of 5 and above showed poor sleep.

Hong and colleagues obtained information on premature birth, normal birth, and birth weight from electronic medical records. Researchers then used a generalized estimating equation model to measure the associations between newborn weight and sleep quality.

 They used a general linear model to find which sleep issues most affected birth weight.

Researchers reported that women reported poor sleep quality before oocytes were obtained and through all 3 trimesters. Hong and colleagues said that “19.3%, 29.9%, 16.2%, and 14.4% reported poor sleep quality before oocyte retrieval, in the first trimester, in the second trimester, and in the third trimester, respectively, and the mean PSQI score in the first trimester was the highest (4.6±2.5).”

Hong and colleagues reported that while two studies found mothers of naturally conceived pregnancies have the worst sleep quality during the third trimester, mothers using IVF conception had the worst sleep quality in the first trimester

 “This difference is not surprising given that a previous study showed a relationship between socio-psychological pressure and poor sleep, and women with IVF conception showed more anxiety than women with natural conception in the first trimester,” the authors wrote.

Researchers said many studies have previously shown that poor sleep quality can impact both the mother’s health and fetal growth, and that birth weight is a strong predictor of newborn health. “Birth weight can reflect growth and development in the uterus; it has been widely reported that low birth weight may lead to complications such as infection and necrotizing enterocolitis,” Hong and colleagues said.

The study results found poor sleep quality during the first and second trimesters for IVF pregnancies had the most impact on reducing birth weight, but only in female infants (OR=3.03, 95% CI=1.04to 9.71, P=0.044).1 Researchers did not find a correlation in male infants (OR=1.64, 95% CI=0.68 to 3.99, P=0.271).

 Hong and colleagues noted that sex preferences for male babies in China may have influenced the anxiety of mothers pregnant with girls, and thus had a negative effect on their sleep quality.

“The results of the study suggest that early screening and interventions focused on improving sleep quality may be useful to reduce adverse outcomes related to poor sleep. Sleep intervention or psychological counseling during pregnancy may be of benefit to fetal well-being,” Hong and colleagues concluded.

Mengye Y, Fangfang N, Qingxia M, Yan Z, Yangqian J, Hong L. Sleep quality is associated with the weight of newborns after in vitro fertilization (IVF)/intra-cytoplasmic sperm injection (ICSI). 

. 2022;26(4):2059-2068. doi:10.1007/s11325-021-02498-7

Conlon RPK, Wang B, Germeroth LJ, Cheng Y, Buysse DJ, Levine MD. Demographic, pregnancy-related, and health-related factors in association with changes in sleep among pregnant women with overweight or obesity. 

. 2021;28(2):200-206. doi:10.1007/s12529-020-09887-4

Sedov ID, Cameron EE, Madigan S, Tomfohr-Madsen LM. Sleep quality during pregnancy: A meta-analysis. Sleep Med Rev. 2018;38:168-176. doi:10.1016/j.smrv.2017.06.005

Kirca N, Ongen M. Perceived stress and sleep quality before oocyte pick-up, embryo transfer, and pregnancy test in women receiving in vitro fertilization treatment. 

. 2021;25(4):1977-1985. doi:10.1007/s11325-021-02328-w

A study published in the journal Sleep and Breathing found sleep quality influenced newborn weight in a gender-specific and trimester-specific way.

Sleep quality affects newborns’ weight in women with IVF pregnancies

Patients can face obstacles if they wish to remove their IUDs, including cost, scheduling, and even resistance from clinicians.1 During the Covid-19 pandemic, patients faced issues with access to healthcare as another barrier. Some patients want to remove their own IUDs, and this may be an important choice for reproductive autonomy.

 How often were IUD users removing their own IUDs before the pandemic? What about after?Kathryn E Fay, MD, of the department of obstetrics, gynecology, and reproductive biology at Harvard Medical School in Boston, Massachusetts and colleagues conducted a study to find out.

Researchers analyzed secondary data from research previously performed between April and October 2020 by the Society of Family Planning (SFP) Abortion Clinical Research Network on clinic sites throughout the United States. SFP’s longitudinal survey recruited family planning clinics online through Qualtrics. Researchers said community-based and academic clinics were equally represented in the sample, and noted greater participation in the West and Northeast. “Approximately half of clinics provided 26 to 250 unique contraceptive encounters per month at baseline and a remaining quarter provided 251 to 1000 encounters,” researchers reported.1 Providers were asked about contraception and abortion clinical practices before and during the pandemic for survey 1 (66 sites), while surveys 2 and 3 concentrated on the ways clinics adapted to Covid-19 in these areas. Researchers said 53 sites participated in all 3 surveys.

Fay and colleagues used data from 63 of the respondents. They reported three clinics were excluded because they only provided abortion services. Of those that provided contraceptive services, 7.9% (5) said they provided information on the self-removal of IUDS before Covid-19.1 By the end of the study, which was 8 months into the pandemic, 25.4% (16) gave guidance to patients about IUD removal.

 “Self-removal counseling was associated with being an academic center and reporting a median lower number of monthly contraceptive encounters,” researchers said.1 Fay and colleagues noted that the increase was 3 times higher than before the pandemic.

Researchers reported that a “qualitative study that examined clinician opinion of self-removal highlighted that…clinicians were not concerned about the safety of self-removal and may plan to remove their own IUDs.”1,2 However, they also noted that the study found that clinicians prefer to be involved in the decision to remove IUDs.

Generally, women who have selected IUD for contraception are urged to have removal performed by a professional. However, researchers said that, “self-removal guidance may be an important practice for patient autonomy, and, during a pandemic, a means of reducing exposure risk. In the context of public health demand to innovate remote contraceptive care delivery, family planning clinics demonstrated increasing endorsement of IUD self-removal.”

Fay and colleagues noted that contraception care is changing to include patients getting services outside of traditional healthcare settings. They said that this trend may increase, “particularly now that SFP's pandemic-responsive clinical recommendations endorse IUD self-removal counseling.”

Study limitations included small sample size and wording of certain questions that may not have captured the full the full picture of how many patients requested guidance for self-removal. Of particular concern was the reference specifically to the pandemic, when patients may have removed their IUDs for other reasons, researchers noted.

Fay and colleagues said the study results are a launch point for more studies to examine the future of IUD self-removal, regular contraception recommendations, and implementation. “These findings suggest clinician support for patient autonomy in contraceptive self-management and limited concern for safety issues with self-removal during a public health emergency,” Fay and colleagues concluded.

Fay KE, Traore F, Amico JR. Intrauterine device self-removal practices during the COVID-19 pandemic among family planning clinics [published online ahead of print, 2022 Oct 12]. 

. 2022;S0010-7824(22)00391-2. doi:10.1016/j.contraception.2022.09.127

Amico JR, Bennett AH, Karasz A, Gold M. Taking the provider "out of the loop: "Patients' and physicians' perspectives about IUD self-removal. 

A study published in the journal Contraception shows patients sought guidance from clinics to remove their own IUDs at a much higher rate than before the pandemic.

Requests for intrauterine device self-removal guidance from clinics during COVID-19 

Women who experience poor sleep quality may have less success with IVF than women who experience higher quality sleep, according to a study conducted by Marco Reschini, MSc, of the infertility unit at Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, Via M. Fanti, in Milan, Italy.

Between September and December 2019, researchers recruited 263 women who were receiving services from the infertility unit at Fondazione IRCCS Ca’ Granda Ospedale Maggiore Policlinico. At the time of oocytes collection, study participants answered questions about sleep and psychological health on 3 surveys—the Pittsburgh Sleep Quality Index (PSQI), the Fertility Problem Inventory (FPI), and the Hospital Anxiety and Depression Scale (HADS). Researchers examined age, job status, and education, in addition to a number of health factors such as body mass index and smoking. They also looked at how long the women had been infertile, previous deliveries, serum FSH (IU/mL), serum Anti-Müllerian Hormone (AMH) (ng/mL), antral follicle count (AFC), and indication for IVF.1 This data was examined with the results of the surveys, which were given in Italian and required the women to be native speakers.

Study participants were excluded if they did not speak fluent Italian, and if they had a neurologic or severe psychiatric disorder such as bipolar disorder, schizophrenia, or major depressive disorder. Women with obstructive sleep apnea syndrome and conditions that may reduce embryo implantation such as endometrial polyps, submucosal fibroids, hydrosalpinx, and uterine formations were also excluded.

Thirty-one percent of women (81) had a successful pregnancy. Researchers noted that, in these successful pregnancies, ovarian reserve was preserved better and the women were younger. There was no difference in FPI and HADS scores.

“Conversely, a statistically significant difference emerged for the PSQI score, the median [interquartile range] in pregnant and non-pregnant women being 4 [3–5] and 5 [3–7], respectively (p = 0.004). The crude and adjusted OR of pregnancy in women with a PSQI > 5 (indicating impaired sleep quality) was 0.46 (95% CI 0.25–0.86, p = 0.02) and 0.50 (95% CI: 0.26–0.94, p = 0.03), respectively,” researchers reported. They also said that poor sleep quality was common in women seeking IVF and could affect the procedure.

“Taken together, our findings highlighted that assessing sleep quality in women undergoing IVF is clinically relevant, due to its association not only with outcome of the procedure, but also with women’s overall psychological health,” researchers concluded. Reschini and colleagues noted that poor sleep quality was also linked to poor psychological health, indicating that treating poor sleep quality could improve these outcomes as well.

Lubna Mohammed, MBBS, lecturer of research at the California Institute of Behavioral Neurosciences and Psychology in Fairfield, California, spoke with 

® as a subject-matter expert. For Mohammed, the most important information for providers to take away from this study is the recommendation to inquire about the quality of sleep of women undergoing the IVF process. Mohammed added that future research should concentrate on studying the impact of sleep improvement on the outcomes of the procedure. “It can also be targeted at studying if poor sleep is related to women having unhealthy lifestyles and how lifestyle changes precisely impact sleep,” she said. She noted an important limitation of this study—the absence of a control group, and the fact that sleep quality was measured using self-reported sleep measures. “Other options like sleep tracking devices can also be considered for future research, Mohammed said.

Reschini M, Buoli M, Facchin F, et al. Women's quality of sleep and in vitro fertilization success. 

 2022;12(1):17477. Published 2022 Oct 19. doi:10.1038/s41598-022-22534-0

A study published in the journal Scientific Reports may shed light on a potential connection between sleep quality and IVF success.

Can sleep quality affect the results of in vitro fertilization?

Between 70-75% of women in their childbearing years face the unpleasant symptoms of candidiasis infections.

 Fillipo Murina, MD, of the lower genital tract disease unit in the obstetrics and gynecology department at the V. Buzzi Hospital-University of the Study of Milan in Milan, Italy and colleagues conducted research to discover if adding a feminine wash was more efficient in treating itching and burning symptoms associated with the infection than using an anti-fungal cream alone. The study was published in the journal 

Researchers conducted an observational, randomized, controlled, open-label trial at multiple centers at 4 private and public medical centers in Italy. They compared an acid pH thymol and zinc-containing cleansing wash with additional azole therapy to the sole use of topical azole therapy in treating itching and burning associated with yeast infections.

Researchers randomly assigned 200 women age 18-45 with vulvovaginal candidiasis (VVC) to 2 groups. One hundred ninety-two women completed the study. VVC was confirmed by a positive vaginal culture for candida or by seeing hyphae or blastospheres in a fresh sample under a microscope, and by a score ≥2 on the Sobel scale, which measures vulvar or vaginal erythema, edema, pruritis, and excoriation/fissure formation.

 “Women who were pregnant, lactating, postmenopausal, had trichomonas vaginitis, a history of repeated vaginal candidiasis, or had taken contraceptive pills, broad-spectrum antibiotics, or oral vaginal-related vaginitis drugs in the past two weeks were excluded,” Murin and colleagues reported.

Ninety-seven Group 1 participants were given 1 canister of a cleansing wash containing acid pH thymol and zinc to use twice daily for 15 days in the vulvar area and a tube of 2% clotrimazole cream to be applied once daily at bedtime for 6 days. Group 2, which had 95 participants, was just given the 2% clotrimazole cream at bedtime for 6 days.

The women completed 2 visits during the study: the first collected participants’ demographic information and screened them for VVC. Women were asked to record their symptoms of itching and burning at home through the end of the study. “During visit 2 (15 ± 3 days after visit 1), a physical examination was conducted, diaries were returned, and women were asked about adverse events (AEs) experienced during the treatment period,” the researchers reported.1 In addition, all incidences of any adverse effects were recorded on a chart.

“In both groups, pruritus and burning VAS scores improved from baseline at Days 6, 10 and 15. On Day 10 and Day 15, the pruritus score was significantly lower in Group 1 versus Group 2 (P <0.005 at both timepoints), suggesting acid pH thymol and zinc-containing cleansing wash ameliorates VVC-associated pruritus as part of a female hygiene regimen,” researchers reported.

Murin and colleagues said similar side effects were reported for both groups, and no adverse effects occurred that required participants to stop the treatment. Two patients in Group 1 did report a mild burning sensation that resolved after 2-3 days according to researchers.

“An acid pH thymol and zinc-containing cleansing wash may be an appropriate adjuvant to pharmacological therapy for the management of VVC,” researchers concluded.

Lubna Mohammed, MBBS, lecturer of research at the California Institute of Behavioral Neurosciences and Psychology in Fairfield, California spoke with 

® as researcher who is unaffiliated with the study. She said that the most important takeaway from this study for providers in practice is that a zinc and thymol containing vaginal wash could be a good adjuvant alongside clotrimazole for the treatment of vulvovaginal candidiasis (VVC). “What is most significant about this particular study is that it had relatively larger sample sizes in each of the 2 study groups that compared the results of treatment of VVC with and without the usage of the vaginal wash,” Mohammed said.

She added that a next step that can be considered in this field of research is to find out the exact effects that a vaginal wash can have on a healthy vaginal microbiome if it is considered to be used on a daily basis. “An important limitation of this study is that there was no comparable intervention in the second group, so a possibility of the placebo effect of wash usage needs to be considered,” she said.

Murina F, Lubrano C, Cappelli E, Campo M, Taraborrelli S. The role of female intimate hygiene practices in the management of vulvovaginal candidiasis: A randomized, controlled open-label trial [published online ahead of print, 2022 Jun 27]. 

. 2022;1-12. doi:10.1080/07399332.2022.2061972

A research study examined the role of a medicated feminine wash as an adjunct treatment for candidiasis.