The effect of SARS-CoV-2 BNT162b2 vaccine on the symptoms of women with endometriosis.

PURPOSE: As the use of the messenger RNA (mRNA) BNT162b2 (Pfizer-BioNTech) Coronavirus disease 2019 vaccine has grown, reports on menstrual changes have arisen. We aimed to examine menstrual bleeding patterns and endometriosis-associated symptoms after receiving the mRNA BNT162b2 SARS-CoV-2 vaccine in women with endometriosis, as compared to the control group. METHODS: This is a questionnaire-based cross-sectional study including a total of 174 women. The study group included 86 women with a confirmed diagnosis of endometriosis and the control group included 88 women with no diagnosis or suspected diagnosis of endometriosis. Each woman completed a questionnaire on menstrual bleeding patterns and endometriosis-associated symptoms before and after receiving two doses of the BNT162b2 vaccine. Primary outcomes were changes in amount or length of menstrual bleeding, rates of intermenstrual bleeding and worsening in dysmenorrhea in the endometriosis patient group, as compared to the control group. Secondary outcomes included changes in all endometriosis-associated symptoms. RESULTS: In our cohort, women with endometriosis were more likely to experience changes in bleeding patterns (women with endometriosis: 39.5%, control group: 31.0%, p = 0.02), and a significant worsening in endometriosis-associated symptoms with an almost 4.3-fold worsening in dysmenorrhea [95% CI 1.9-9.9, p < 0.01] and 5.5-fold odds for any worsening in symptoms in endometriosis patients, as compared to the control group [95% CI 2.7-11.1, p < 0.01]. CONCLUSION: In our cohort, endometriosis was shown to be a significant risk factor for worsening of menstrual symptoms, after receiving the SARS-CoV-2 BNT162b2 mRNA vaccine. Further research is needed to confirm these findings.

Pregnancy outcomes following gestational exposure to papaverine: An observational comparative study.

AIMS: Papaverine is indicated for abdominal pain of various aetiologies. However, data on maternal and foetal safety following gestational exposure are lacking. The aim was to examine whether first trimester exposure to papaverine is associated with increased risk for major malformation and whether gestational exposure at any stage is associated with increased risk for preterm delivery, lower birthweight, small for gestational age, caesarean section (CS), lower Apgar score and perinatal death. METHODS: A retrospective comparative study consisted of pregnant women treated with papaverine between February 2010 and October 2019 at a large tertiary center. The control group comprised of livebirth deliveries randomly selected from the institutional obstetric database. RESULTS: The study group consisted of 498 pregnancies, which resulted in 537/544 (98.7%) live births, of whom 46/537 (8.6%) were exposed during the first trimester. The control group consisted of 498 pregnancies and 514 live births. Rate of major malformations did not differ between study group (2/46, 4.3%) and control (25/315, 4.9%, P = .67). Papaverine exposure was associated with higher rate of preterm delivery (22.3 vs. 10.3%, P < .001), CS (35.9 vs. 24.1%, P < .001) and lower birth weight (3207 vs. 3246 g, P = .02). Adjustment for treatment indication demonstrated that these remained significant only when given for obstetrical/surgical aetiologies. Comparable rates were observed for the remaining outcomes. CONCLUSIONS: Short-term gestational exposure to papaverine adjusted for indication was not associated with preterm deliveries, CS, lower birthweight, small for gestational age or perinatal death. Rate of major malformations among 46 first trimester exposures was comparable to controls.

Ovarian reserve markers of women with superficial endometriosis.

OBJECTIVE: Endometriosis affects up to 10% of reproductive age women and is associated with pelvic pain and subfertility. While previous studies have shown an association between deep and ovarian endometriosis to reduced ovarian reserve, there is no data on the effect of superficial endometriosis on ovarian reserve markers. Hence, we aimed to compare ovarian reserve markers of women with superficial endometriosis to that of women without endometriosis. METHODS: This was a case control study in a tertiary medical center. The study group included women aged 18-40 with surgically and histopathology-proven superficial endometriosis with no deep lesions or ovarian involvement. The control group included women with no known or suspected endometriosis and was matched to the study group by age, BMI and parity. We excluded women with other known risk factors for ovarian failure and with other gynecological disorders. Participants completed a questionnaire with demographic, medical and gynecological data. Each patient underwent anti-Mullerian hormone (AMH) testing and an ultrasound to assess their antral follicular count (AFC). AMH and AFC were then compared between groups. RESULTS: A total of 124 women participated in the study. Of these, 50% (n = 62) had surgically proven superficial endometriosis and 50% (n = 62) were without known or suspected endometriosis. Mean AMH levels of women with and without superficial endometriosis was 3.0 ± 2.8 ng/mL and 2.8 ± 1.9 ng/mL, respectively (P = 0.71). AFC also did not differ between groups (women with superficial endometriosis: 12.0 ± 6.6; women without endometriosis: 10.2 ± 5.0, P = 0.15). CONCLUSIONS: In our cohort, superficial endometriosis was not associated with diminished ovarian reserve. While further studies are needed, to date, it does not appear to be justified to assess ovarian reserve for patients with superficial endometriosis.

The procoagulant potential before and after surgery for endometriosis and its association with disease severity.

OBJECTIVES: Previous studies have suggested that endometriosis is associated with increased hypercoagulable state. We aimed to determine the procoagulant potential among women with endometriosis before and after surgery. METHODS: A prospective longitudinal study performed during 2020-2021 at a university hospital. Women undergoing laparoscopic surgery for endometriosis served as the study group. Blood samples were taken preoperatively and 3 months after surgery. The degree of hypercoagulability was assessed by thrombin generation, a global marker of the activation of the coagulation system, expressed as the endogenous thrombin potential (ETP). Healthy volunteers, without any medical condition or medications use, matched for age and weight of the study group, served as a control group. RESULTS: Thirty women with histologically-proven endometriosis and thirty healthy control subjects were enrolled in this study. Median preoperative ETP was significantly higher in women with moderate-to-severe endometriosis (3313 [interquartile range, IQR 3067-3632] nM) as compared to those with minimal-to-mild disease (2368 [IQR 1850-2621] nM) and the control group (2451 [2096-2617] nM) ( P  < 0.001 for both comparisons). Following surgery, the ETP significantly decreased in those with moderate-to-severe endometriosis (postoperative: 2368 vs. preoperative: 3313 nM, P  < 0.001) and was comparable to the ETP in the control group ( P  = 0.35). In multivariate analysis, moderate-to-severe endometriosis was the only independent predictor of the preoperative ETP level ( P  < 0.001), with a direct positive correlation between disease revised American Society for Reproductive Medicine severity score and the preoperative ETP level ( rs  = 0.67; P  < 0.0001). CONCLUSION: Moderate-to-severe endometriosis is associated with enhanced hypercoagulable state, which decreases significantly after surgery. Disease severity was independently associated with the degree of hypercoagulability.

The effect of BNT162b2 SARS-CoV-2 mRNA vaccine on menstrual cycle symptoms in healthy women.

OBJECTIVE: To investigate the impact of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) mRNA BNT162b2 vaccine on women's menstrual cycle. METHODS: In this questionnaire-based cross-sectional study, we assessed menstrual pattern and changes in women who completed the SARS-CoV-2 mRNA BNT162b2 vaccine 3 months before and after receiving the vaccine. Included were women aged 18-50 years without known gynecologic comorbidities who regularly monitor their menstruation through electronic calendars. All participants competed a detailed questionnaire on their menstrual symptoms including information on any irregular bleeding. To minimize bias, each woman served as a self-control before and after vaccination. Primary outcome was rate of irregular bleeding following vaccination and secondary outcome was presence of any menstrual change, including irregular bleeding, mood changes, or dysmenorrhea following the vaccine. RESULTS: A total of 219 women met the inclusion critieria. Of them, 51 (23.3%) experienced irregular bleeding following the vaccine. Almost 40% (n = 83) of study participants reported any menstrual change following vaccination. Parity was positively asssociated with irregular bleeding with 26 (50%) of those suffering from irregular bleeding being multiparous compared with only 53 (31.5%) of women with no irregular bleeding (nulliparous 46% vs 60%, multiparous 50% vs 31%, rest 4% vs 8%, P = 0.049). The presence of medical comorbidities was also significantly higher among patients who experienced irregular bleeding (20.0% vs 6.0%, P = 0.003). CONCLUSION: Our study shows relatively high rates of irregular bleeding and menstrual changes after receiving the SARS-CoV-2 mRNA BNT162b2 vaccine. Further research is needed to confirm our findings and to better characterize the magnitude of change and any possible long-term implications.

Twenty-Four-Hour Ambulatory Blood Pressure Measurement Using a Novel Noninvasive, Cuffless, Wireless Device.

BACKGROUND: Ambulatory blood pressure monitoring (ABPM) using cuff-based devices is used for diagnosis and treatment of hypertension. Technical limitations, low compliance, and complex procedures limit their use. The aim of the present study was to test the accuracy of a new photoplethysmography-based, wearable device (Wrist-monitor) as compared with the standard cuff-based ABPM device. METHODS: Twenty-four-hour (24H) ABPM was performed in parallel for both devices on volunteers aged 18-65 years, while documenting their daily activities. Level of comfort and activity disturbance of both devices were recorded. Linear regression and Bland-Altman were used to evaluate the agreement between devices. Receiver operating characteristic (ROC) curve analysis was used to classify hypertension based on the average Wrist-monitor measurements as compared with a cuff-based ABPM device. RESULTS: The study included 28 subjects (18 men) mean age 41.5 ± 16.2 years. Bland-Altman analysis resulted in 24H bias of -1.1 mm Hg for both diastolic blood pressure (DBP) and systolic blood pressure (SBP). Mean daytime bias was -1.9 mm Hg for DBP and SBP, while nighttime bias was smaller (0.7 and 0.4 mm Hg for DBP and SBP, respectively). ROC curve analysis yielded a mean area under the curve (AUC) of 1 for SBP and 24H blood pressure measurements. AUCs of 0.994 and 0.955 were found for the daytime DBP and night DBP, respectively. 24H ABPM with the Wrist-monitor caused significantly less inconvenience compared with the cuff-based device (P < 0.001). CONCLUSIONS: The cuffless device provides comparable measurements to those obtained with the currently used cuff-based ABPM device, with significantly less inconvenience to the subject. CLINICAL TRIALS REGISTRATION: Trial Number NCT03810586.