Offering extended use of the contraceptive implant via an implementation science framework: a qualitative study of clinicians' perceived barriers and facilitators.

BACKGROUND: The etonogestrel contraceptive implant is currently approved by the United States Food and Drug Administration (FDA) for the prevention of pregnancy up to 3 years. However, studies that suggest efficacy up to 5 years. There is little information on the prevalence of extended use and the factors that influence clinicians in offering extended use. We investigated clinician perspectives on the barriers and facilitators to offering extended use of the contraceptive implant. METHODS: Using the Consolidated Framework for Implementation Research (CFIR), we conducted semi-structured qualitative interviews. Participants were recruited from a nationwide survey study of reproductive health clinicians on their knowledge and perspective of extended use of the contraceptive implant. To optimize the diversity of perspectives, we purposefully sampled participants from this study. We used content analysis and consensual qualitative research methods to inform our coding and data analysis. Themes arose deductively and inductively. RESULTS: We interviewed 20 clinicians including advance practice clinicians, family medicine physicians, obstetrician/gynecologist and complex family planning sub-specialists. Themes regarding barriers and facilitators to extended use of the contraceptive implant emerged. Barriers included the FDA approval for 3 years and clinician concern about liability in the context of off-label use of the contraceptive implant. Educational materials and a champion of extended use were facilitators. CONCLUSIONS: There is opportunity to expand access to extended use of the contraceptive implant by developing educational materials for clinicians and patients, identifying a champion of extended use, and providing information on extended use prior to replacement appointments at 3 years.

Understanding feasibility and acceptability of implementation of linking delivery of family planning and infant vaccination care in rural Maharashtra, India: a qualitative study.

BACKGROUND: Linking family planning with infant vaccination care has the potential to increase contraceptive use among postpartum women in rural settings. We explored the multilevel factors that can facilitate or impede uptake of contraception at the time of infant vaccination among postpartum women and couples in rural Maharashtra, India. METHODS: We conducted 60 semi-structured interviews with key stakeholders including: postpartum married women (n = 20), husbands (n = 10), and mothers-in-law (n = 10) of postpartum women, frontline healthcare workers (auxiliary nurse midwives (ANMs) and Accredited Social Health Activists (ASHAs), (n = 10), and community leaders (physician medical officers and village panchayat leaders) (n = 10). We sought to assess the feasibility and acceptability of delivering community-based postpartum family planning care in rural India at the time of infant vaccination. The Consolidated Framework for Implementation Research (CFIR) was used to design a structured interview guide and codebook. Data were analyzed via directed content analysis. RESULTS: Three major themes emerged: (1) Social fertility and gender norms including son preference and male control over contraceptive decision-making influence postpartum contraceptive access and choice. (2) Linking contraceptive care and infant vaccination is perceived as potentially feasible and acceptable to implement by families, health workers, and community leaders. The intervention provides care to women and families in a convenient way where they are in their community. (3) Barriers and facilitators to linked infant postpartum contraception and infant vaccination were identified across the five CFIR domains. Key barriers included limited staff and space (inner setting), and contraceptive method targets for clinics and financial incentives for clinicians who provide specific methods (outer setting). Key facilitators included convenience of timing and location for families (intervention characteristics), the opportunity to engage husbands in decision-making when they attend infant vaccination visits (participant characteristics), and programmatic support from governmental and community leaders (process of implementation). CONCLUSIONS: Linked provision of family planning and infant vaccination care may be feasible and accessible in rural India utilizing strategies identified to reduce barriers and facilitate provision of care. A gender-transformative intervention that addresses gender and social norms has greater potential to impact reproductive autonomy and couples' contraceptive decision-making.

A qualitative analysis of pharmacists' attitudes towards provision of medication abortion.

BACKGROUND: 90% of United States' counties do not have a single clinic offering abortion care, and barriers to care disproportionately affect low-income families. Novel models of abortion care delivery, including provision of medication abortion in pharmacies, with pharmacists prescribing medication, have the potential to expand access to abortion care. Pharmacists are well-positioned to independently provide abortion care and are highly accessible to patients, however medication abortion provision by pharmacists is not currently legal or available in the United States. To assess the potential acceptability of pharmacist provision of medication abortion and to identify anticipated barriers and facilitators to this model of care, we explored pharmacists' attitudes towards providing medication abortion, inclusive of patient selection, counseling, and medication prescribing. METHODS: From May to October 2021, we conducted 20 semi-structured qualitative interviews with pharmacists across the United States, guided by the domains of the Consolidated Framework for Implementation Science Research. RESULTS: Major themes included there is a need for pharmacist provision of medication abortion and pharmacists perceive provision of medication abortion to be potentially acceptable if anticipated barriers are addressed. Anticipated barriers identified included personal, religious, and political beliefs of pharmacists and lack of space and systems to support the model. Ensuring adequate staffing with pharmacists willing to participate, private space, time for counseling, safe follow-up, training, and reimbursement mechanisms were perceived strategies to facilitate successful implementation. CONCLUSIONS: Pharmacist identified implementation strategies are needed to reduce anticipated barriers to pharmacist provision of medication abortion.

Association of traditional marital practices with contraceptive decision-making, couple communication, and method use among couples in rural Maharashtra, India.

In India, traditional social practices around marriage, such as non-involvement of prospective brides in choice of partner and timing of marriage, child/early marriage, dowry and purdah, compromise women's agency at the time of marriage and may also affect contraceptive practices in marriage. This paper examines the associations between traditional marital practices and contraceptive behaviours, including women's control over contraceptive decision-making, couples' communication about contraception, and ever use of contraceptives, among married women aged 18-29 years (N = 1,200) and their husbands in rural Maharashtra, India. Multivariable logistic regression was used to examine the association between these marginalising social practices and family planning behavioural outcomes, adjusting for demographic and parity confounders. Wives who were the primary decision-makers on who to marry had higher odds of ever having communicated with their husband on pregnancy prevention (AOR 1.76, 95% CI 1.16-2.68), and ever using modern contraceptives (AOR 2.19, 95% CI 1.52-3.16). Wives who were the primary decision-makers on when to marry also had higher odds of ever having used modern contraceptives (AOR 1.86, 95% CI 1.21-2.93). Women's involvement in marital choice may facilitate couples' engagement related to family planning, possibly via the establishment of better communication between partners.

Early vs Interval Postpartum Intrauterine Device Placement: A Randomized Clinical Trial.

Importance: The early postpartum period, 2 to 4 weeks after birth, may be a convenient time for intrauterine device (IUD) placement; the placement could then coincide with early postpartum or well-baby visits. Objective: To determine expulsion rates for IUDs placed early postpartum compared with those placed at the standard interval 6-week visit. Design, Setting, and Participants: In this randomized noninferiority trial, people who had a vaginal or cesarean birth were randomly assigned to undergo early (14-28 days) or interval (42-56 days) postpartum IUD placement. Clinicians blinded to participant study group used transvaginal ultrasonography to confirm IUD presence and position at the 6-month postpartum follow-up. The study assessed 642 postpartum people from 4 US medical centers, enrolled a consecutive sample of 404 participants from March 2018 to July 2021, and followed up each participant for 6 months postpartum. Interventions: Early postpartum IUD placement, at 2 to 4 weeks postpartum, vs standard interval placement 6 to 8 weeks postpartum. Main Outcomes and Measures: The primary outcome was complete IUD expulsion by 6 months postpartum; the prespecified noninferiority margin was 6%. Secondary outcomes were partial IUD expulsion, IUD removal, pelvic infection, patient satisfaction, uterine perforation, pregnancy, and IUD use at 6 months postpartum. IUD malposition was an exploratory outcome. Results: Among 404 enrolled participants, 203 participants were randomly assigned to undergo early IUD placement and 201 to undergo interval IUD placement (mean [SD] age, 29.9 [5.4] years; 46 [11.4%] were Black, 228 [56.4%] were White, and 175 [43.3%] were Hispanic). By 6 months postpartum, 53 participants (13%) never had an IUD placed and 57 (14%) were lost to follow-up. Among the 294 participants (73%) who received an IUD and completed 6-month follow-up, complete expulsion rates were 3 of 149 (2.0% [95% CI, 0.4%-5.8%]) in the early placement group and 0 of 145 (0% [95% CI, 0.0%-2.5%]) in the interval placement group (between-group difference, 2.0 [95% CI, -0.5 to 5.7] percentage points). Partial expulsion occurred in 14 (9.4% [95% CI, 5.2%-15.3%]) participants in the early placement group and 11 (7.6% [95% CI, 3.9%-13.2%]) participants in the interval placement group (between-group difference, 1.8 [95% CI, -4.8 to 8.6] percentage points). IUD use at 6 months was similar between the groups: 141 (69.5% [95% CI, 62.6%-75.7%]) participants in the early group vs 139 (67.2% [95% CI, 60.2%-73.6%]) in the interval group. Conclusions and Relevance: Early IUD placement at 2 to 4 weeks postpartum compared with 6 to 8 weeks postpartum was noninferior for complete expulsion, but not partial expulsion. Understanding the risk of expulsion at these time points may help patients and clinicians make informed choices about the timing of IUD placement. Trial Registration: ClinicalTrials.gov Identifier: NCT03462758.

Complications after interval postpartum intrauterine device insertion.

BACKGROUND: In the United States, up to 57% of women report resumption of sexual activity by the 6 week postpartum visit. Effective contraception should be addressed and provided at that time, to avoid unintended pregnancies and optimize interpregnancy intervals. Long-acting reversible contraceptives are the most effective forms of reversible contraception and are increasingly popular during the postpartum period. However, timing of postpartum intrauterine device (IUD) placement varies among providers and many delay insertion due to concerns for uterine perforation or expulsion of the IUD. OBJECTIVE: This study aimed to evaluate uterine perforation and expulsion rates with IUD insertion at 4-8 weeks postpartum vs 9-36 weeks postpartum. STUDY DESIGN: We performed a retrospective cohort study using the Kaiser Permanente Southern California electronic medical record from 2010 to 2016. We calculated the proportion of perforations and expulsions with IUD insertion at 4-8 weeks vs 9-36 weeks postpartum. Our primary outcome was the perforation rate. Secondarily, we evaluated the expulsion rate. For our minimum sample size calculation, to detect a difference of 0.5% in the perforation rate, with a baseline perforation rate of 0.5% for the 9-36 week postpartum IUD placement group, 80% power, and 5% alpha error rate, we would need at least 4221 participants per group, 8442 in total. RESULTS: A total of 24,959 patients met inclusion criteria (n=13,180 in the 4-8 week group, n=11,777 in the 9-36 week group). Of 430 patients with a confirmed complication, 157 uterine perforations and 273 IUD expulsions were identified. Perforation rates were significantly higher with placement at 4-8 weeks than at 9-36 weeks (0.78% vs 0.46%; P=.001). After adjusting for race and ethnicity, breastfeeding, IUD type, provider type, parity, most recent delivery, and body mass index, the odds of perforation remained higher with placement at 4-8 weeks than at 9-36 weeks (adjusted odds ratio, 1.92; 95% confidence interval, 1.28-2.89). Our Kaplan-Meier survival curve showed that the risk of uterine perforation remained elevated until approximately 22-23 weeks postpartum. Expulsion rates were similar between the 2 groups (1.02 vs 1.17; P=.52). CONCLUSION: Uterine perforation after interval postpartum IUD insertion is greater at 4-8 weeks than at 9-36 weeks, although perforation rates remain low at <1%. Expulsion rates did not differ between the groups. Because overall rates of uterine perforation are low, women can safely be offered IUDs at any interval beyond 4 weeks with minimal concern for perforation.

Associations between Contraceptive Decision-Making and Marital Contraceptive Communication and use in Rural Maharashtra, India.

Women's contraceptive decision-making control is crucial for reproductive autonomy, but research largely relies on the Demographic and Health Survey (DHS) measure which asks who is involved with decision-making. In India, this typically assesses joint decision-making or male engagement. Newer measures emphasize female agency. We examined three measures of contraceptive decision-making, the DHS and two agency-focused measures, to assess their associations with marital contraceptive communication and use in rural Maharashtra, India. We analyzed follow-up survey data from women participating in the CHARM2 study (n = 1088), collected in June-December 2020. The survey included the DHS (measure 1), Reproductive Decision-Making Agency (measure 2), and Contraceptive Final Decision-Maker measures (measure 3). Only Measure 1 was significantly associated with contraceptive communication (adjusted odds ratio [AOR]: 2.75, 95 percent confidence interval [CI]: 1.69-4.49) and use (AOR: 1.73, 95 percent CI: 1.14-2.63). However, each measure was associated with different types of contraceptive use: Measure 1 with condom (adjusted relative risk ratio [aRRR]: 1.99, 95 percent CI: 1.12-3.51) and intrauterine device (IUD) (aRRR: 4.76, 95 percent CI: 1.80-12.59), Measure 2 with IUD (aRRR: 1.64, 95 percent CI: 1.04-2.60), and Measure 3 with pill (aRRR: 2.00, 95 percent CI: 1.14-3.52). Among married women in Maharashtra, India, male engagement in decision-making may be a stronger predictor of contraceptive communication and use than women's agency, but agency may be predictive of types of contraceptives used.

Immediate versus delayed postpartum insertion of contraceptive implant and IUD for contraception.

BACKGROUND: Long-acting reversible contraception (LARC), including intrauterine devices (IUDs) and contraceptive implants, are highly effective, reversible methods of contraception. Providing LARC methods during the postpartum period is important to support contraceptive choice, and to prevent unintended pregnancy and short interpregnancy intervals. Delaying offering contraception to postpartum people until the first comprehensive postpartum visit, traditionally at around six weeks postpartum, may put some postpartum people at risk of unintended pregnancy, either due to loss to follow-up or because of initiation of sexual intercourse prior to receiving contraception. Therefore, immediate provision of highly effective contraception, prior to discharge from hospital, has the potential to improve contraceptive use and prevent unintended pregnancies and short interpregnancy intervals. OBJECTIVES: To compare the initiation rate, utilization rates (at six months and 12 months after delivery), effectiveness, and adverse effects of immediate versus delayed postpartum insertion of implants and IUDs for contraception. SEARCH METHODS: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase, and POPLINE for eligible studies up to December 2020. We examined review articles and contacted investigators. We checked registers of ongoing clinical trials, citation lists of included studies, key textbooks, grey literature, and previous systematic reviews for potentially relevant studies. SELECTION CRITERIA: We sought randomized controlled trials (RCTs) that compared immediate postpartum versus delayed insertion of contraceptive implant and IUDs for contraception. DATA COLLECTION AND ANALYSIS: Two review authors (JS, SK) independently screened titles and abstracts of the search results, and assessed the full-text articles of potentially relevant studies for inclusion. They extracted data from the included studies, assessed risk of bias, compared results, and resolved disagreements by consulting a third review author (PL, SA or PP). We contacted investigators for additional data, where possible. We computed the Mantel-Haenszel or inverse variance risk ratio (RR) with 95% confidence interval (CI) for binary outcomes and the mean difference (MD) with 95% CI for continuous variables. MAIN RESULTS: In this updated review, 16 studies met the inclusion criteria; five were studies of contraceptive implants (715 participants) and 11 were studies of IUDs (1894 participants). We identified 12 ongoing studies. We applied GRADE judgements to our results; the overall certainty of the evidence for each outcome ranged from moderate to very low, with the main limitations being risk of bias, inconsistency, and imprecision. Contraceptive implants Immediate insertion probably improves the initiation rate for contraceptive implants compared with delayed insertion (RR 1.48, 95% CI 1.11 to 1.98; 5 studies, 715 participants; I2 = 95%; moderate-certainty evidence). We are uncertain if there was a difference between the two groups for the utilization rate of contraceptive implants at six months after delivery (RR 1.16, 95% CI 0.90 to 1.50; 3 studies, 330 participants; I2 = 89%; very low-certainty evidence) or at 12 months after insertion (RR 0.98, 95% CI 0.93 to 1.04; 2 studies, 164 participants; I2 = 0%; very low-certainty evidence). People who received an immediate postpartum contraceptive implant insertion may have had a higher mean number of days of prolonged vaginal bleeding within six weeks postpartum (mean difference (MD) 2.98 days, 95% CI -2.71 to 8.66; 2 studies, 420 participants; I2 = 91%; low-certainty evidence) and a higher rate of other adverse effects in the first six weeks after birth (RR 2.06, 95% CI 1.38 to 3.06; 1 study, 215 participants; low-certainty evidence) than those who received a delayed postpartum insertion. We are uncertain if there was a difference between the two groups for prolonged bleeding at six months after delivery (RR 1.19, 95% CI 0.29 to 4.94; 2 studies, 252 participants; I2 = 0%; very low-certainty evidence). There may be little or no difference between the two groups for rates of unintended pregnancy at six months (RR 0.20, 95% CI 0.01 to 4.08; one study, 205 participants; low-certainty evidence). We are uncertain whether there was a difference in rates of unintended pregnancy at 12 months postpartum (RR 1.82, 95% CI 0.38 to 8.71; 1 study, 64 participants; very low-certainty evidence). There may be little or no difference between the two groups for any breastfeeding rates at six months (RR 0.97, 95% CI 0.92 to 1.01; 2 studies, 225 participants; I2 = 48%; low-certainty evidence). IUDs Immediate insertion of IUDs probably improves the initiation rate compared with delayed insertion, regardless of type of IUD (RR 1.27, 95% CI 1.07 to 1.51; 10 studies, 1894 participants; I2 = 98%; moderate-certainty evidence). However, people who received an immediate postpartum IUD insertion may have had a higher expulsion rate at six months after delivery (RR 4.55, 95% CI 2.52 to 8.19; 8 studies, 1206 participants; I2 = 31%; low-certainty evidence) than those who received a delayed postpartum insertion. We are uncertain if there was a difference between the two groups in the utilization of IUDs at six months after insertion (RR 1.02, 95% CI 0.65 to 1.62; 6 studies, 971 participants; I2 = 96%; very low-certainty evidence) or at 12 months after insertion (RR 0.86, 95% CI 0.5 to 1.47; 3 studies, 796 participants; I2 = 92%; very low-certainty evidence). Immediate IUDs insertion may reduce unintended pregnancy at 12 months (RR 0.26, 95% CI 0.17 to 0.41; 1 study, 1000 participants; low-certainty evidence). We are uncertain whether there was difference in any breastfeeding rates at six months in people receiving progestin-releasing IUDs (RR 0.90, 95% CI 0.63 to 1.30; 5 studies, 435 participants; I2 = 54%; very low-certainty evidence). AUTHORS' CONCLUSIONS: Evidence from this updated review indicates that immediate postpartum insertion improves the initiation rate of both contraceptive implants and IUDs by the first postpartum visit compared to delayed insertion. However, it is not clear whether that there are differences in utilization rates at six and 12 months postpartum. We are uncertain whether there is any difference in the unintended pregnancy rate at 12 months. Provision of progestin-releasing implants and IUDs immediately postpartum may have little or no negative impact on breastfeeding. However, the expulsion rate of IUDs and prolonged vaginal bleeding associated with immediate implants appears to be higher.

FundAl Retroflexion (FAR) Angle is a Novel Sonographic Marker Associated With Cesarean Scar Pregnancies in the First Trimester: A Case-Control Study.

OBJECTIVES: Early diagnosis of Cesarean scar pregnancies (CSP) remains difficult. This study describes a novel sonographic marker, the FundAl Retroflexion (FAR) angle, that may be used in the first trimester. The objective of the study is to compare the FAR angle between CSP and normal pregnancies. METHODS: For this case-control study, we reviewed images from our institution's database that were acquired from January 2016 to December 2019. All cases of CSP and randomly selected controls, defined as patients with history of Cesarean delivery and normal implantation, that underwent ultrasound evaluation at <14 weeks were included. The FAR angle, defined as the acute angle created between the endometrial echo and cervical canal, was measured. The mean FAR angle was then compared between the two groups and a receiver operating characteristic (ROC) curve was generated. RESULTS: We identified 15 cases of CSP during the study period and were able to measure the FAR angle in 14 of the cases. The mean FAR angle was larger in CSP than in normal control pregnancies (45° versus 27°, respectively, P < 0.001). Using an ROC curve, a FAR angle cut off of 40° maximizes the ability to distinguish between CSP from normal pregnancies. CONCLUSIONS: The FAR angle provides an easily obtainable and numerical measurement. CSP have larger FAR angle compared to normal controls with a distinguishing cut off of 40°. Larger studies are needed to determine if using the FAR angle can improve first trimester diagnosis for CSP.

PrEP University: A Multi-Disciplinary University-Based HIV Prevention Education Program.

The introduction of emtricitabine/tenofovir diphosphate (FTC/TDF) as pre-exposure prophylaxis (PrEP) for HIV prevention has raised questions regarding which clinicians will serve as prescribers and how providers will be educated about this HIV prevention strategy. We piloted an HIV Prevention Education Program called PrEP University (PrEP U) to address knowledge gaps in HIV prevention among medical trainees. We examined PrEP awareness and assessed learning as a result of the program, measuring knowledge before and after the lectures with an anonymous 5-question multiple choice test. A total of 198 learners participated in PrEP University, which included 127 first year medical students, and post-graduate trainees in internal medicine (n = 23), family medicine (n = 16), OBGYN (n = 13) and pharmacy (n = 19). Prior to PrEP U, 27% of all participants were not aware of PrEP and an additional 8% were unsure if they had heard of it. Knowledge increased significantly after the education program among trainees in OBGYN (2.3 vs 3.8, p < 0.001), pharmacy (1.4 vs 2.5, p = 0.012) and school of medicine (3.3 vs 4.4, p < 0.001), with a trend seen in family medicine (2.7 vs. 3.7, p = 0.067) and internal medicine (2.7 vs 3.4, p = 0.068). Overall, an HIV Prevention Education Program was successfully administered to nearly 200 participants and resulted in improved knowledge of HIV prevention and PrEP across. Pharmacists and OBGYN physicians are two groups with an expanding role in the use of PrEP. Similar programs at other medical schools should be implemented to ensure that future physicians and pharmacists are comfortable with PrEP prescription.