Contraception: X最新文献

Developing new long-acting products of well-characterized contraceptive drugs is one way to address some of the reasons for unmet need for modern methods of family planning among women in low- and middle-income countries. Development and approval of such products traditionally follow a conventional paradigm that includes large Phase 3 clinical trials to evaluate efficacy (pregnancy prevention) and safety of the investigational product. Exposure-bracketing is a concept that applies known pharmacokinetics and pharmacodynamics of a drug substance to inform its safe and efficacious use in humans. Several therapeutic areas have applied this concept by leveraging established drug concentration-response relationships for approved products to expedite development and shorten the timeline for the approval of an investigational product containing the same drug substance. Based on discussions at a workshop hosted by the Bill & Melinda Gates Foundation in December 2020, it appears feasible to apply exposure-bracketing to develop novel contraceptive products using well-characterized drugs.

Objective

To document the use of Foley catheter as an alternative to osmotic dilators for cervical preparation before second trimester dilation and evacuation at a tertiary setting in Ethiopia

Methods

This is a retrospective case series conducted at St. Paul's Hospital Millennium Medical College (Ethiopia) from April 1, 2021 to August 30, 2021. Forty-three cases of dilation and evacuation (D&E) in which overnight intra-cervical Foley catheter placement was used to prepare the cervix were reviewed. Data were analysed using SPSS version 23 and simple descriptive statistics were applied to analyze the clinical characteristics of study subjects and procedure outcomes. Percentages and frequencies were used to present the findings.

Results

The calculated median gestational age was 21.4(17–24.2) weeks. Around 40%(17/43) of cases had cervical dilation of 3 to 4 cm, with another 33% (14/43) achieving cervical dilation of 1.5 to 2.5 cm. Additional dilation during the procedure was required only in 12 cases (28%) prior to D&E procedure. In 36 cases (84%), the procedure was attended by family planning fellow.

Conclusion

Cervical preparation using overnight Foley catheter before second-trimester D&E resulted in majority of the cases requiring no additional dilation immediately prior to D&E procedure. Where osmotic dilators are not available, Foley catheter can be an alternative method to prepare the cervix prior to D&E procedures.

Implications

In the absence of osmotic dilators, Foley catheter can be used as an alternate, and readily available means of cervical preparation for second trimester D&E procedures

The majority of United States (US) women age 15–49 have employer-sponsored health insurance, but these insurance plans fall short if employees cannot find providers who meet reproductive health needs. Employers could and should do more to facilitate and advocate for their employees through the insurance plans they sponsor. We conducted interviews with 14 key informants to understand how large United States employers see their role in health insurance benefits, especially when it comes to reproductive health care access and restrictions in religious health systems. Our findings suggest that large employers wish to be responsive to their employees’ health insurance priorities and have leverage to improve access to reproductive health services, but they do not take sufficient action toward this end. In particular, we argue that large employers could pressure insurance carriers to address network gaps in care resulting from religious restrictions and require insurers to treat out-of-network providers like in-network providers when reproductive care is restricted.

Objective

To identify prevalence of unfulfilled contraceptive preferences due to cost among low-income United States female contraceptive method users and nonusers, and associations between access to, and experience with, contraceptive care and this outcome.

Methods

We drew on data from the 2015–2019 National Surveys of Family Growth to conduct simple and multivariable logistic regression analyses on unfulfilled contraceptive preferences due to cost among nationally representative samples of low-income women ages 15 to 49 who were current contraceptive users (N = 3178) and nonusers (N = 1073).

Results

Overall, 23% of female contraceptive users reported they would use a different method, and 39% of nonusers reported they would start using a method, if cost were not an issue. Controlling for user characteristics, low-income contraceptive users who received recent publicly supported contraceptive care reported significantly higher levels of unfulfilled contraceptive preferences due to cost than those without any access to SRH care (aOR = 1.6, CI 1.0–2.5), while having private (aOR = 0.6, CI 0.4–0.9) or public (aOR = 0.7, CI 0.5–1.0) health insurance was associated with significantly lower levels of this outcome. Nonusers of contraception who had recently received publicly supported contraceptive care also reported marginally higher levels of this outcome (aOR = 2.2, CI 1.0–5.1). Contraceptive users who received recent person-centered contraceptive counseling had marginally lower odds of unfulfilled contraceptive preferences due to cost (aOR = 0.6, CI 0.4–1.0).

Conclusions

Cost is a barrier to using preferred contraception for both contraceptive users and nonusers; health insurance coverage and person-centered contraceptive counseling may help contraceptive users to overcome cost barriers and realize their contraceptive preferences.

Implications

Factors related to contraceptive access at the systems level—specifically the subsidization and experience of contraceptive care—impact whether cost serves as a barrier to individuals’ contraceptive preferences. Delivery of patient-centered care and shoring up health insurance coverage for all can help to mitigate cost barriers and enable individuals to realize their contraceptive preferences.

Objectives

A more nuanced understanding of contributors to covert contraceptive use remains critical to protecting covert users and reducing its necessity. This study aimed to examine the overall prevalence of covert use, and sociodemographic characteristics associated with covert vs overt use across multiple geographies in sub-Saharan Africa and Asia.

Study Design

Performance Monitoring for Action (PMA) is one of the few nationally representative surveys that measures covert use across socially diverse contexts via a direct question. Utilizing PMA 2019–2020 phase 1 data from Burkina Faso, Côte D'Ivoire, Kenya, Democratic Republic of Congo (DRC; Kinshasa and Kongo Central regions), Uganda, Nigeria (Kano and Lagos), Niger, and Rajasthan, we estimated overall prevalence of covert use. We conducted bivariate analyses and multivariate logistic regressions for 6 sites, comparing the odds of covert use with overt use among users of contraception by sociodemographic characteristics.

Results

Covert use ranged from 1% in Rajasthan to 16% in Burkina Faso. Marital status was the only sociodemographic characteristic consistently associated with type of use across sites. Specifically, polygynous marriage (compared to monogamous) increased odds of using covertly, ranging from adjusted odds ratio (aOR) of 1.8 [95% confidence interval (CI) 1.2–2.7] in Burkina Faso to 6.2 [95% CI 2.9–13.3] in Kinshasa. Unmarried women with partners or boyfriends were also more likely to be using covertly compared with their monogamously married counterparts in all sites (aORs ranged from 2.2 [95% CI 1.0–4.7] in Uganda to 4.4 [95% CI 1.7–11.0] in Kinshasa).

Conclusion

Understanding factors associated with covert use has programmatic and policy implications for women's reproductive autonomy.

Implications

Covert use is a common phenomenon across most sites, representing a small but programmatically important contingent of users. Family planning providers and programs must protect access to and maintain privacy of reproductive services to this population, but should also focus on creating interventions and environments that support overt use.

Objectives

In Tanzania, contraceptive use is limited, particularly in rural communities and even among women who would like to delay childbearing. This paper aims to present health providers’ perspectives on populations seeking contraception and barriers that could be addressed to increase access to and uptake of contraception, given their interface with large portions of their communities.

Study Design

We conducted 18 in-depth interviews with providers stationed at health dispensaries in six rural villages in northwest Tanzania. Two investigators independently coded interviews using a stepwise process to achieve consensus on prevalent topics.

Results

Three topics emerged from our analysis: (1) nature of clients seeking contraception; (2) barriers to uptake of contraception; and (3) the role of secrecy in obtaining and using contraception. Health providers reported that married women with children were the most frequent users of contraception, alongside some single women, men, sex workers, and students. Barriers to contraception included lack of supplies and trained staff, misconceptions and fears, stigma, and unsupportive partners. Providers observed that contraception was often used secretly. They reported surreptitious visits and described clients’ preferential use of discreet methods. Providers respected and supported clients’ desires to keep visits confidential.

Conclusion

Our data suggest maintaining high stocks of discreet contraceptive methods and deploying more trained staff to dispensaries could increase availability and access to contraceptives. At the community level, more education campaigns are warranted to address barriers, especially those related to stigma.

Implications

Our work highlights the need for additional contraceptive methods that are easy to administer and discreet for women who must maintain secrecy. Future studies of the effectiveness of interventions and new contraceptives should obtain healthcare providers’ perspectives, as they can provide important insights to service provision.

Objective

To solicit Illinois staff and clinician perspectives on rapid implementation of telehealth for contraceptive counseling and recommendations to improve and sustain it in the long term.

Study design

Researchers recruited and interviewed clinicians (n = 20) in primary care and obstetrics/gynecology clinics across 13 health care systems in Illinois, as well as clinicians (n = 11), leadership (n = 6) and staff (n = 7) from Planned Parenthood of Illinois clinics. Guided by the Consolidated Framework for Implementation Research, we coded and analyzed interview transcripts in Dedoose with a focus on themes regarding steps to improve quality and sustainability of telehealth.

Results

Participants expressed generally positive attitudes towards telehealth, noting that it increased access to care and time for patient education. Still, many highlighted areas of implementation that needed improvement. Clinic operations were complicated by gaps in telehealth training and the logistical needs of balancing telehealth and in-person appointments. Clinics had difficulty ensuring patient awareness of telehealth as an option for care, in addition to deficiencies with the telehealth technology itself. Finally, innovative resources for telehealth patients, while existent, have not been evenly offered across clinics. This includes the use of self-injection birth control, as well as providing medical equipment such as blood pressure cuffs in community settings. Some themes reflect issues specific to contraceptive counseling while others reflect issues with telehealth implementation in general, including confusion about reimbursement.

Conclusion

Illinois contraceptive care providers and staff wish to sustain telehealth for the long term, while also recommending specific improvements to patient communications, clinic operations, and access to supportive resources.

Implications

Our study highlights considerations for clinics to optimize implementation of telehealth services for contraceptive care. Providers described the value of clear workflows to balance in-person and telehealth visits, streamlined communications platforms, targeted patient outreach, training on providing virtual contraceptive care, and creative approaches to ensuring patient access to resources.

Objectives

To characterize the relationship between serum medroxyprogesterone acetate (MPA) concentrations and ovulation suppression, and to estimate the risk of ovulation for investigational subcutaneous regimens of Depo-Provera CI (Depo-Provera) and Depo-subQ Provera 104 (Depo-subQ).

Study Design

We performed a secondary analysis of 2 studies that assessed the pharmacokinetics and pharmacodynamics of MPA when Depo-Provera is administered subcutaneously rather than by the labeled intramuscular route. Each woman received a single 45 mg to 300 mg subcutaneous injection of Depo-Provera, a single 104 mg subcutaneous injection of Depo-subQ, or 2 injections of Depo-subQ at 3-month intervals. We used an elevation of serum progesterone ≥4.7 ng/mL as a surrogate for ovulation and non-parametric statistical methods to assess pharmacokinetic and pharmacodynamic relationships.

Results

This analysis included 101 women with body mass index (BMI) 18 to 34 kg/m². Return of ovulation occurred at a median MPA concentration of 0.07 ng/mL (95% CI: 0.06–0.08) and the 90th percentile was 0.10 ng/mL (95% CI: 0.09–0.14). Neither age, race, nor BMI significantly influenced this relationship. The estimated probabilities of ovulation within 4 months of a 104 mg subcutaneous injection and within 7 months of a 150 mg subcutaneous injection (6 plus a 1-month grace) were each below 2.2%.

Conclusions

The typical MPA concentration associated with loss of ovulation suppression is substantially less than the commonly cited threshold of 0.2 ng/mL. Based on our results, MPA levels would rarely be low enough to permit ovulation if the Depo-subQ reinjection interval were extended to four months or if 150 mg Depo-Provera were injected subcutaneously every 6 months.

Implications

Extending the three-month Depo-subQ reinjection interval by one month would result in a 25% reduction in yearly MPA exposure, with little risk of pregnancy. Off-label subcutaneous administration of 150 mg Depo-Provera every 6 months would be a highly effective repurposing of an excellent product, with a similar reduction in cumulative exposure.

Objectives

The levonorgestrel-releasing intrauterine device (LNG-IUD) is a well-accepted contraceptive across developed countries, yet there is limited experience in use and acceptance amongst women living in low-resource, developing country settings. We studied the feasibility of providing the LNG-IUD through a primary care service, and its acceptability amongst women living in a low-income, rural-tribal community in India.

Study design

We conducted an observational study of feasibility and acceptability at four health facilities (three rural, and one urban) in Rajasthan, India. Women seeking contraception were offered the LNG-IUD in addition to existing contraceptive methods. We followed all those who adopted LNG-IUD from August 2015 to September 2019 (n= 1266) till discontinuation or 12 months, whichever was earlier. The primary outcome was continuation rate and acceptability, and the secondary outcome was change in hemoglobin levels, which we measured before insertion and at 12-month follow-up, using Sahli's method.

Results

Most users lived in villages, were illiterate, belonged to marginalized groups, had 2 or more children, and wished to limit births when they adopted the method. The 12-month continuation rate was 87.6%. Amongst all users, 7.4% of women sought removal for side effects and 2% for change in reproductive intention, while another 2% reported spontaneous expulsion. Most continuing users reported hypomenorrhea (54%) or amenorrhea (42%) by 12 months of use. User satisfaction was high at 91.6%, with 92% of women rating their experience as equaling or exceeding expectations. Moderate and severe anemia reduced, and mean hemoglobin levels increased by 0.7 g/dL (p < 0.01).

Conclusion

Primary care clinics can feasibly deliver LNG-IUD, with high acceptability amongst women living in low resource settings. Given the paucity of long-acting reversible contraceptive options and high prevalence of anemia among women in India and similar countries, the method should be piloted through the public health system.

Implications

Long duration of contraceptive action, ability to reduce menstrual bleeding and reduce anemia, reversibility, and easy removal, combine to make LNG-IUD acceptable to women, especially in regions with high prevalence of anemia. This study demonstrates the feasibility and acceptability of introducing LNG-IUD in a low resource, primary care setting.

Objective

To examine the relationship between pregnancy coercion and partner knowledge of contraceptive use.

Study design

Cross-sectional Performance Monitoring for Action-Ethiopia data were collected in October-November 2019 from a nationally representative sample of women ages 15 to 49. The analytical sample (n = 2,469) included partnered women using contraception in the past year. We used multinomial logistic regression to examine associations between past-year pregnancy coercion (none, less severe, more severe) and partner knowledge/couple discussion of contraceptive use (overt use with couple discussion before method initiation (reference group), overt use with discussion after method initiation, and covert use of contraception).

Results

Most women reported their partner knew they were using contraception and had discussed use prior to method initiation (1,837/2,469, 75%); 16% used overtly and discussed use after method initiation, and 7% used contraception covertly. The proportion of covert users increased with pregnancy coercion severity (4%_none, 14%_{less severe}, 31%_{more severe}), as did the proportion of overt users who delayed couple contraceptive discussions, (14%_none, 23%_{less severe}, 26% _{more severe}); however, overt use with couple discussion before method initiation decreased with pregnancy coercion severity (79%_none, 60%_{less severe}, 40%_{more severe}). The risk of covert use among women experiencing less severe pregnancy coercion was four times greater than women who experienced no pregnancy coercion (adjusted relative risk ratio, (aRRR) = 3.95, 95% confidence interval (CI) 2.20–7.09) and ten times greater for women who experienced the most severe pregnancy coercion (aRRR = 10.42, 95% CI 6.14–17.71). The risk of overt use with delayed couple discussion also increased two-fold among women who experienced pregnancy coercion compared to those who did not (less severe aRRR = 2.05, 95% CI 1.39–2.99; more severe aRRR = 2.89, 95% CI 1.76–4.73).

Conclusion

When experiencing pregnancy coercion, women may avoid or delay contraceptive conversations with their partners. Increased pregnancy coercion severity has the greatest association with covert use and couple contraceptive discussions.

Implications

The presence and timing of couple discussions about contraception are critical for ensuring safety for women experiencing pregnancy coercion. Screening for pregnancy coercion must be included within contraceptive counseling so that women can choose methods that maximize their reproductive autonomy.