Concordance of hemoglobin A1c and reproductive hormone levels in menstrual and venous blood.

Objective: To explore whether menstrual blood collected via a modified menstrual pad is a surrogate for venous blood drawn in analyzing hemoglobin A1c (HbA1c) and fertility-associated hormones. Design: Cross-sectional study. Setting: Clinical testing laboratory. Patients: This study included 152 female participants who have regular menses, aged 19-50 years old. Interventions: Participants collected menstrual effluent using a menstrual pad modified with a removable dried blood spot (DBS) strip. Peripheral blood samples were collected via venipuncture within 60 hours of menstrual pad use. Main Outcome Measures: Menstrual pad and venous blood drawn samples were analyzed for levels of HbA1c, thyroid stimulating hormone (TSH), follicle-stimulating hormone (FSH), anti-müllerian hormone (AMH), and luteinizing hormone (LH). Correlation between menstrual pad and venipuncture samples was performed using Deming linear regression, and r coefficients were measured using Pearson correlation. Results: The interassay variability of menstrual pad DBS sample measurements was <6%. Menstrual HbA1c values were stabilized in the DBS strips through 53 days, and menstrual hormone levels remained stable through 15 days. Menstrual HbA1c levels were highly correlated with venipuncture samples (r = 0.96). The levels of TSH (r = 0.94), AMH (r = 0.94), FSH (r = 0.91), and LH (r = 0.91) also showed a high correlation between menstrual strip and venipuncture samples. Conclusions: The levels of HbA1c, TSH, AMH, FSH, and LH measurements in menstrual effluent showed a high correlation to venous blood samples, supporting the use of menstrual effluent as a surrogate sample for hormone testing.

Evaluation of a "smart" screening tool for asynchronous assessment of medication abortion eligibility: A pilot study.

OBJECTIVES: This study aimed to assess the feasibility, safety, and acceptability of asynchronous screening for medication abortion eligibility using a programmed questionnaire. STUDY DESIGN: For this study, we developed an informational website about medication abortion with a linked questionnaire programmed to produce a conclusion regarding eligibility according to standard criteria. We enrolled people in Colorado and Minnesota who submitted questionnaires indicating eligibility. A study physician reviewed each questionnaire and medical records if available and determined whether the responses warranted treatment without a synchronous clinical consultation or ultrasound. If so, the physician prescribed a standard regimen of mifepristone and misoprostol. We collected posttreatment data on abortion outcome, adverse events, and satisfaction. RESULTS: We received questionnaires from 197 individuals, of whom 160 remained in the study until the physician made a final treatment decision. Physicians prescribed medication abortion to 156 (97.5%) individuals based on the questionnaire responses, whereas four needed further assessment to confirm eligibility. Of the 156 individuals, 130 had sufficient follow-up to assess abortion outcome, and 123 (95%) had complete medication abortions without additional treatment. One participant was hospitalized for bleeding, and one expelled a 15-week fetus; however, it is not clear that conventional synchronous history-based screening would have averted these events. Of the 197 questionnaires, 42% were submitted outside business hours. On satisfaction questionnaires, 134 (96%) of 144 participants said they would recommend the study to a friend who needed an abortion. CONCLUSIONS: Data from this pilot project suggest that providing medication abortion based only on a self-administered, programmed questionnaire is likely to be effective, safe, efficient, and acceptable. IMPLICATIONS: A programmed self-administered patient questionnaire to assess eligibility for medication abortion could reduce the cost of the service, augment clinic efficiency, improve quality of care, and enhance access to abortion.

Management of missing intrauterine device strings and migrated intrauterine devices.

PURPOSE OF REVIEW: The purpose of this review is to review the recent literature with respect to the management of missing intrauterine device (IUD) strings. As IUD use has increased over time, it is important to review management options for this uncommon but possible complication. RECENT FINDINGS: This article will cover stepwise approaches to management of missing IUD strings based on the most recent literature. Initial steps include obtaining history and using in office tools to reveal IUD strings. Subsequent steps focus on imaging guidelines including obtaining transvaginal ultrasound when available. Finally, IUD removal with tools for uterine instrumentation are discussed, focusing on using tools that do not require cervical dilation and allow for grasping of the device. SUMMARY: This paper details a stepwise approach to the management of missing IUD strings which, as discussed in the article, may become more frequent given the rise of IUD use in general and postpartum placement in specific.

Cabergoline for Lactation Inhibition After Second-Trimester Abortion or Pregnancy Loss: A Randomized Controlled Trial.

OBJECTIVE: To assess cabergoline's efficacy at decreasing breast symptoms after second-trimester abortion or pregnancy loss. METHODS: This was a double-blinded, block-randomized superiority trial comparing cabergoline 1 mg once to placebo for preventing bothersome breast engorgement after second-trimester uterine evacuation. We enrolled pregnant people at 18-28 weeks of gestation who were English- or Spanish-speaking and without contraindication to the study drug. Participants completed a validated, piloted, electronic survey at baseline and at multiple timepoints through 2 weeks postprocedure to assess breast symptoms, side effects, and bother. Our primary outcome was any breast symptoms (a composite of engorgement, milk leakage, tenderness, and need for pain relief) on day 4; we planned to enroll 80 patients to show a 30% difference in breast symptoms (80% power, α=0.049). A subgroup of participants returned for serum prolactin levels. RESULTS: After screening 150 patients from April 2021 to June 2022, we enrolled 73 participants. Baseline demographics were balanced between groups: median gestational age was 21 weeks (range 18-26 weeks), 56.2% of participants were nulliparous, 34.2% self-identified as Hispanic, and 37.0% had public insurance. At baseline, reported breast symptoms were similar between groups. Among 69 participants who returned surveys on day 4, significantly fewer participants receiving cabergoline reported any breast symptoms compared with placebo (27.8% vs 97.0%, P<.001) (primary outcome) and fewer reported significant bother (2.8% vs 33.3%, P=.001) (secondary outcome). These differences persisted through day 14. Reported incidence and severity of bother from side effects were similar between groups: most common were constipation, fatigue, and headache. Serum prolactin levels were similar at baseline. On day 4, mean serum prolactin level was 6.5 ng/mL (SD 2.2) for those who received cabergoline and 18.0 ng/mL (SD 5.9) for placebo (P=.049). CONCLUSION: Cabergoline is an effective and well-tolerated strategy to prevent breast symptoms after second-trimester abortion or pregnancy loss. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT04701333.

Interest in advance provision of abortion pills: a national survey of potential users in the USA.

OBJECTIVE: To assess interest in clinician-administered advance provision of abortion pills among potential users in the USA. METHODS: Using social media advertisements, we recruited people living in the USA who were aged 18-45 years and assigned female at birth, who were not pregnant or planning pregnancy, for an online survey on reproductive health experiences and attitudes. We explored interest in advance provision of abortion pills, participant characteristics, including demographics and pregnancy history, contraceptive use, abortion knowledge and comfort, and healthcare system distrust. We used descriptive statistics to assess interest in advance provision, and ordinal regression modelling to evaluate differences in interest controlling for age, pregnancy history, contraceptive use, familiarity and comfort with medication abortion, and healthcare system distrust, reporting adjusted odds ratios (aORs) and 95% confidence intervals (95% CIs). RESULTS: From January-February 2022, we recruited 634 diverse respondents from 48 states, among whom 65% were interested, 12% neutral, and 23% disinterested in advance provision. There were no differences among interest groups by US region, race/ethnicity, or income. In the model, variables associated with interest included being aged 18-24 years (aOR 1.9, 95% CI 1.0 to 3.4) versus 35-45 years, using a tier 1 (permanent or long-acting reversible) or tier 2 (short-acting hormonal) contraceptive method (aOR 2.3, 95% CI 1.2 to 4.1, and aOR 2.2, 95% CI 1.2 to 3.9, respectively) versus no contraception, being familiar or comfortable with the medication abortion process (aOR 4.2, 95% CI 2.8 to 6.2, and aOR 17.1, 95% CI 10.0 to 29.0, respectively), and having high healthcare system distrust (aOR 2.2, 95% CI 1.0 to 4.4) versus low distrust. CONCLUSION: As abortion access becomes more constrained, strategies are needed to ensure timely access. Advance provision is of interest to the majority of those surveyed and warrants further policy and logistical exploration.

A cross-sectional study comparing the inflammatory profile of menstrual effluent vs. peripheral blood.

Background and Aims: Cytokine profiles of peripheral blood and other bodily fluids provide diagnostic indicators for assessing inflammatory processes. Menstrual effluent may provide a noninvasive source of biological material for monitoring cytokine levels in blood and in endometrial tissues. This pilot study investigated the potential of measuring cytokines in menstrual effluent, and compared the cytokine profiles of menstrual versus peripheral blood. Methods: Seven healthy donors (aged ≥18 and ≤45 years) collected menstrual effluent on day 2 of menses. Matched peripheral blood samples were collected by venous blood draw on the same day. Levels of 62 cytokines were measured in all samples by 62-plex Luminex assay. Results: Peripheral blood and menstrual effluent cytokine profiles were tenuously correlated (r 2 = 0.26, p < 0.0001), with higher levels detected in menstrual effluent for 48/62 cytokines. Thirty five cytokines were significantly elevated in menstrual effluent compared to peripheral blood samples (IL-8, CCL2, CCL4, LIF, IL-1RA, IL-6, IL-1ß, HGF, CCL3, FGF-2, TNF-α, VEGF-A, IL-1α, CXCL1, IL-9, IL-10, EGF, CXCL5, CSF3, EOTAXIN, TGF-α, TRAIL, CXCL10, VEGF-D, IL-12P40, CXCL9, IL-18 RESISTIN, IL-22, IL-21, CSF1, IFN-γ, IL-17A, CXCL12, IL-12p70). Two cytokines (LEPTIN, CSF2) were expressed at significantly lower levels in menstrual effluent compared to peripheral blood. Linear regression of individual cytokines found low predictive power (linear regression p > 0.05) for 53/62 cytokines in menstrual effluent versus peripheral blood. Levels of TGF-ß (r 2 = 0.87, p = 0.002) and CCL7 (r 2 = 0.63, p = 0.033) were significantly positively correlated between matched menstrual and peripheral blood samples. Conclusion: In this group of study participants, the cytokine profile of menstrual effluent was quantitatively distinct from peripheral blood, and also characterized by higher levels of inflammatory signaling. This pattern of comparative menstrual blood cytokine profiles points to a need for further studies to evaluate the relationship between peripheral and menstrual blood cytokines in broader populations including both healthy and diseased states.

Screening for High-Risk Human Papillomavirus Using Passive, Self-Collected Menstrual Blood.

OBJECTIVE: To assess concordance and acceptability of a modified menstrual pad compared with a clinician-collected high-risk human papillomavirus (HPV) sample. METHODS: This was a prospective observational study. Women presenting for either cervical cancer screening or with a history of high-risk HPV positivity were eligible. Three samples were requested from participants: 1) clinician-collected cervical specimens; 2) self-collected vaginal swabs; and 3) a modified menstrual pad, which was taken home for use during the next menstruation. All samples were processed using the Cobas HPV test. Menstrual pad dried blood spots were eluted, then similarly processed. RESULTS: Of 153 women enrolled in the study, 106 provided menstrual pad samples and clinician-collected cervical specimens for high-risk HPV analysis. For samples in which the interval between the clinician-collected specimen and the menstrual pad sample was less than 2 months, the concordance was 94% (95% CI 83-98). For women who tested positive for high-risk HPV who presented for general screening and those with more than cervical intraepithelial neoplasia 2, menstrual pad and clinician-collected specimen agreement was 100% (95% CI 32.5-100). Among participants, 22.9% expressed discomfort with the self-collected vaginal swabs and opted out of collection. Overall, 94.0% of participants preferred the menstrual pad over clinician-collected sampling. Twelve patients were found to be positive for HPV on the menstrual pad sample but negative on the clinician-collected specimen. CONCLUSION: Among women who tested positive for HPV, the menstrual pad showed highly concordant results compared with clinician-collected sampling. This collection approach shows promise for integration into cervical cancer prevention programs.

Second-trimester abortion care for those with complex medical conditions.

PURPOSE OF THE REVIEW: This review focuses on patients who are most likely to experience morbidity associated with second trimester abortion care and risk mitigation strategies. RECENT FINDINGS: Prior cesarean birth, particularly multiple prior cesarean births, is the most significant risk factor associated with complications during second trimester abortion because of increased risks of hemorrhage, with or without placenta accreta spectrum (PAS), and distorted anatomy, which increases the risk of uterine perforation. Recent data suggests that first trimester ultrasound findings may be predictive of PAS, including multiple lacunae, abnormal uteroplacental interface, and hypervascularity. Multiple common medications interact with mifepristone and are therefore contraindicated; ulipristal shares mifepristone's selective progesterone receptor modulator activity but does not share the same metabolic pathway. Recent data suggests ulipristal may be an effective adjunct for cervical preparation, avoiding potentially mifepristone's drug-drug interactions. Those ending a pregnancy due to severe early-onset hypertensive disorders have a high rate of clinically significant thrombocytopenia: platelet transfusion is recommended for those with platelets <50 000 per cubic millimeter. SUMMARY: Pregnant people presenting for care in the second trimester may have conditions that make an abortion more technically or medically complex. Clinicians can mitigate much of this increased risk with preprocedural planning, and appropriate intra-operative preparedness.

Potential candidate for oral pericoital contraception: evaluating ulipristal acetate plus cyclo-oxygenase-2 inhibitor for ovulation disruption.

BACKGROUND: There remains considerable global unmet contraceptive need, with almost 200 million women reporting desire to limit or space childbearing without contraceptive use. Researchers have documented worldwide interest in an oral, on-demand contraceptive option were it available. Candidates for use include ulipristal acetate (UA), levonorgestrel and cyclo-oxygenase-2 (COX-2) inhibitors alone or in combination. METHODS: We performed an exploratory, prospective study of matched menstrual cycles: one baseline cycle and one treatment cycle of UA 30 mg plus meloxicam 30 mg just prior to ovulation. The primary outcome was ovulation disruption, defined as unruptured dominant follicle for 5 days. Secondary outcomes included comparing cycle length, endometrial stripe thickness, and side effects. RESULTS: Nine participants completed all study procedures in both cycles. Ovulatory disruption occurred in 66.7% (n=6) of treatment cycles and all but one demonstrated features of ovulatory dysfunction. Cycle length (mean±SD) was longer in the treatment cycle (31.9±4.0 vs 28.6±3.5 days, p<0.01). Secondary outcomes did not differ between the two cycles. CONCLUSIONS: UA plus the COX-2 inhibitor meloxicam disrupts ovulation at peak luteal surge and is a promising candidate for evaluation as a pericoital oral contraceptive. TRIAL REGISTRATION NUMBER: NCT03354117.

Novel use of menstrual blood for monitoring glycaemic control in patients with diabetes: a proof-of-concept study.

BACKGROUND: Glycated haemoglobin (HbA1c) is the diagnostic and prognostic standard for clinical management of diabetes mellitus (DM). Unfortunately, patient adherence to guidelines for routine testing can be poor and there are significant gender-based disparities in DM management and outcomes. Recent evidence suggests that menstrual blood may be comparable to systemic blood for monitoring of common biomarkers. The objective of the present study was to assess the concordance of HbA1c levels between menstrual and systemic blood in healthy women and women with diabetes of reproductive age. METHODS: In this prospective, observational cohort study, we enrolled healthy and diabetic (type 1 and type 2 DM) reproductive-age women (aged ≥18 and ≤45 years). Menstrual blood and venous systemic blood specimens were simultaneously obtained at time of menstruation, and analysed for HbA1c levels. Participants self-collected menstrual blood using a QPad, a novel, modified menstrual pad with an embedded dried blood spot strip. RESULTS: Among 172 participants, 57.6% were healthy and 42.4% had a diagnosis of either type 1 or type 2 DM. There were no significant differences in mean HbA1c values in menstrual and systemic blood across the overall cohort or within the diabetic subgroup. Furthermore, HbA1c levels between blood sources were robustly correlated and demonstrated a significant linear relationship. CONCLUSIONS: There is a strong concordance in HbA1c levels between menstrual and systemic blood. Empowered by self-collection technologies, these findings suggest that menstrual blood may serve as a reliable, non-invasive and potentially cost-effective alternative to serum for HbA1c monitoring among reproductive-age women with DM.

Global myth busting in family planning.

PURPOSE OF REVIEW: Myths and misconceptions about family planning are pervasive around the world and can adversely affect both initiation and continuation of family planning services. Here, we review the current literature and identify major themes among them to better understand these myths and misconceptions. RECENT FINDINGS: Myths and misconceptions regarding family planning are a global phenomenon with the most recent studies focused on sub-Saharan Africa and West Africa.The belief that family planning negatively impacts future fertility was mentioned in all studies reviewed.Other major themes include misconceptions about the adverse effects, complications, mechanisms of action, and reproductive health. SUMMARY: Myths and misconceptions regarding family planning are widespread. Current literature suggests that there is a globally prevalent belief that family planning negatively impacts future fertility. Misconceptions related to adverse effects and mechanism of action were also identified. There is overall poor knowledge of sexual and reproductive health in the populations studied. Recent studies focus primarily on sub-Saharan Africa and West Africa. These findings and lessons learned may be helpful in customizing contraceptive counseling and increasing both global access to family planning and satisfied clients.

A Comparison of Paracervical Block Volumes Before Osmotic Dilator Placement: A Randomized Controlled Trial.

OBJECTIVE: To evaluate whether a 12-mL paracervical block is noninferior to a 20-mL block in reducing pain with osmotic dilator insertion. METHODS: In this single-blinded noninferiority trial, we randomized individuals undergoing insertion of osmotic dilators before second-trimester abortion to receive either a 12-mL or 20-mL 1% lidocaine paracervical block. The primary outcome was pain immediately after insertion of osmotic dilators. Prespecified secondary outcomes included pain with paracervical block administration, overall pain, and side effects, with 88 participants being required for a noninferiority margin of 15 mm on a 100-mm visual analog scale assuming an SD of 28. We analyzed data using Wilcoxon rank sum, χ2, and t tests and performed analysis of variance to account for repeated measures. Secondary analysis included multivariable regression to explore potential confounders. RESULTS: From January 2018 to October 2020, of 232 eligible individuals, 174 were approached and 96 randomized (48 participants to each group); 91 were available for analysis (45: 12 mL, 46: 20 mL). Group demographics were similar, with a mean gestation of 21 weeks and four osmotic dilators placed. The 12-mL paracervical block was noninferior to the 20-mL paracervical block for pain with osmotic dilator insertion with a difference in means of -1.36 (95% CI -12.56 to 9.85) favoring 12 mL. Median pain scores after dilator placement were 47 mm (interquartile range 22-68) and 50 mm (interquartile range 27-67) in 12-mL compared with 20-mL paracervical block, respectively (P=.81). No difference was seen in median pain at baseline, with paracervical block administration, postprocedure or with overall pain or experience. At least one lidocaine-related side effect occurred in 4% of participants in the 12-mL group compared with 13% for those receiving 20 mL (P=.15), with metallic taste, ringing in ears, and lightheadedness being most common. CONCLUSION: A 12-mL paracervical block is noninferior to a 20-mL block for pain reduction with osmotic dilator insertion. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03356145.

Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial.

OBJECTIVE: To evaluate high-frequency, high-intensity transcutaneous electrical nerve stimulation (TENS) as an inexpensive, noninvasive pain management approach for first-trimester aspiration abortion. METHODS: We conducted a noninferiority, single-blind, randomized controlled trial of patients seeking aspiration abortion at up to 83 days of gestation. Participants received TENS (placed posteriorly, T10-L1 and S2-S4) or intravenous (IV) sedation (fentanyl, midazolam). The primary outcome was pain with aspiration, as self-reported by visual analog scale (VAS, 100 mm). To detect at least a 15 mm mean difference on the 100 mm VAS with 90% power and a significance level of .05, a total of 90 participants were required. RESULTS: Between January 2018 and October 2019, we enrolled 109 participants (55 TENS, 54 IV). Participant median gestation was 53 days (range 36-82) in the TENS group and 58 days (range 35-82) in the IV group (P=.65). Group demographics and clinical histories were similar. Intention-to-treat analysis (n=109) yielded noninferior results for the primary outcome (mean difference 4.8 mm, 95% CI -5.9 to 13.5 mm). In the per-protocol analysis, 9 (16%) in the TENS group were excluded after receiving IV sedation; 100 participants were included (46 TENS, 54 IV). Median (range) reported VAS for aspiration was 73 mm (13-97) and 66 mm (0-99) in the TENS and IV groups, respectively (P=.40). With a mean difference of 4.4 mm (95% CI -5.6 to 14.5 mm), we found TENS to be noninferior to IV. Physicians underestimated participant pain, perceiving pain to be 34 mm (6-91) in the TENS group and 25 mm (0-83) in the IV group (P=.003). CONCLUSION: We found TENS to be a noninferior alternative to IV sedation for aspiration pain during first-trimester abortion. Expanding pain management options can improve quality of and access to abortion. Transcutaneous electrical nerve stimulation could be a standalone or adjunct approach for abortion pain management for those without access to or are ineligible to receive IV sedation due to the lack of sedation practitioner, designated driver, or local restrictions. CLINICAL TRIAL REGISTRATION: ClinicalTrials.gov, NCT03187002.