Health-related quality of life and satisfaction associated with 3-year use of a levonorgestrel 13.5 mg intrauterine device vs Nova T copper 380 mm2 intrauterine device: Results of a phase 4 randomized controlled trial.

OBJECTIVES: This study aimed to investigate the impact of levonorgestrel 13.5 mg and Nova T copper 380 mm2 intrauterine devices (LNG13.5-IUD and Cu380-IUD, respectively) on health-related quality of life (HRQoL) and the satisfaction with the method throughout 3 years of use. STUDY DESIGN: We conducted a single-center, evaluator-masked, randomized controlled trial to compare the bleeding profile of LNG13.5-IUD and Cu380-IUD users. Secondary objectives included HRQoL and satisfaction throughout the study. We used the validated questionnaire of the Spanish Society of Contraception (SEC-QoL), which evaluates social, sexual/psychological well-being, and menstrual/breast symptoms, to assess HRQoL and a 5-point Likert scale for satisfaction. RESULTS: These secondary outcomes were assessed in the whole population included in the study: 55 LNG13.5-IUD and 51 Cu380-IUD users. The mean overall SEC-QoL scores were similar at baseline (61.5 and 59.6, respectively; p = 0.570) and greater for LNG13.5-IUD after 3 years (69.2 vs 52.5, respectively; p = 0.002). All SEC-QoL domains scored also higher (p < 0.05 vs Cu380-IUD for all). At month 36, 20/30 (67%) and 8/28 (29%) users, respectively, had reached the MID (a 3.4-point increase) in SEC-QoL score (p = 0.004). At this time, 24/29 (82%) and 9/28 (32%) users, respectively, were "very satisfied" (p < 0.001). Willingness to continue the method was similar (22/28 [79%] vs 17/28 [61%] users, respectively; p = 0.170). CONCLUSIONS: Among the use of LNG13.5-IUD was associated with better HRQoL vs Cu380-IUD throughout the 3 years. Satisfaction with the method was higher with LNG13.5-IUD. IMPLICATIONS: People considering having an LNG13.5-IUD or a Cu380-IUD inserted may now benefit from the information regarding the impact of these devices on HRQoL and satisfaction with the method as reported in our study conducted in Spain.

Use of Contraceptive Methods Among Women in the General Population and Female Gynecologists in Spain: the ELEGIAN Survey.

Background: The contraceptive preferences of obstetricians and gynecologists (OB/GYNs) are thought to influence the contraceptive counseling they provide. The purpose of this study was to assess contraceptive preferences of OB/GYNs and women in the general population (WGP) in the current Spanish contraceptive scenario. Materials and Methods: Anonymous online survey of 100 OB/GYNs and 1,217 WGP aged 23-49 years. Results: WGP were younger (35.3 ± 7.3 vs. 37.9 ± 6.2 years, respectively) and less likely to have stable partners (64.7% vs. 84.0%) and children (49.1% vs. 62.0%) (all p < 0.05 vs. OB/GYNs). Seventy-nine percent versus 82%, respectively, used contraceptive methods, with condoms used most frequently by WGP (37% vs. 22% by OB/GYNs; p < 0.05) and pills by OB/GYNs (26% vs. 21% by WGP; p > 0.05). Intrauterine devices (IUDs) were more frequently used by OB/GYNs (20% vs. 5%; p < 0.05), especially the levonorgestrel-releasing intrauterine devices (LNG-IUDs) (18% vs. 2.6%; p < 0.05). The highest-rated methods were condoms among WGP and LNG-IUDs among OB/GYNs. Effectiveness was the most valued attribute of contraceptive methods for both. Reasons related to convenience were the main reason for choosing IUDs. OB/GYNs prescribed the contraceptive method in 40% of cases. Conclusions: Our study reveals differences between female OB/GYNs and WGP in contraceptive methods use and rating. The use of LNG-IUDs was much higher among OB/GYNs.

Bleeding profile and safety of a levonorgestrel 13.5 mg intrauterine device versus Nova T copper 380 mm2 intrauterine device: Results of a 3-year, single-center, randomized phase 4 study.

OBJECTIVE: To assess the bleeding profiles of the levonorgestrel 13.5 mg intrauterine device (LNG13.5-IUD) and Nova T copper 380 mm2 IUD (Cu380-IUD). STUDY DESIGN: Single-center, evaluator-masked, randomized study conducted in women aged 18-45 years starting these methods. Primary outcomes were number of bleeding days, self-reported bleeding intensity, Pictorial Blood Assessment Chart (PBAC) score, and blood biochemical values at baseline, months 3, 6, 12, 24, and 36 per 90-day reference periods except for PBAC (months). Secondary objectives were presence/duration/intensity of dysmenorrhea and tolerability. RESULTS: We included 106 women aged 32.5 ± 6.7 years: 55 with LNG13.5-IUD and 51 with Cu380-IUD. Data for LNG13.5-IUD versus Cu380-IUD at baseline and month 36 (both respectively) were as follows: (1) median (25th; 75th percentile) number of bleeding days: 12 (9.0; 15.0) versus 12 (9.0; 15.0), p = 0.82, and 4 (0; 13.7) versus 15 (14.2; 20.0), p < 0.001; (2) mean bleeding intensity: 1.7 for both, p = 0.66, and 0.7 and 2.2, p < 0.001. Forty percent versus 0% presented with amenorrhea at month 36; (3) mean PBAC score (95% Confidence interval (CI): 50.7 (16.6; 84.7) versus 130.4 (95.7; 165.0) at month 1, and 7.9 (-26.7; 42.6) versus 126 (90.7; 161.2), p < 0.001; (4) median (25th; 75th percentile) ferritin levels (Ug/L) 33 (19; 53) versus 30 (19; 45), p = 0.70, and 59 (42; 84) versus 21 (8; 39). We did not observe changes or differences between groups in hemoglobin and hematocrit. The duration and intensity of dysmenorrhea were significantly lower with LNG13.5-IUD versus Cu380-IUD. Adverse events were those expected. CONCLUSIONS: LNG13.5-IUD is associated with a significant reduction in blood loss and dysmenorrhea compared with Cu380-IUD. IMPLICATIONS: Women eligible for a levonorgestrel 13.5 mg intrauterine device (IUD) or a copper 380 mm2 IUD should be informed of the differences in bleeding profiles-one of the main causes for IUD discontinuation-so they can compare this information against their bleeding expectations.

Sensitivity to Change of the SAMANTA Questionnaire, a Heavy Menstrual Bleeding Diagnostic Tool, After 1 Year of Hormonal Treatment.

Background: The validated SAMANTA questionnaire allows identification of women with heavy menstrual bleeding (HMB); that is, with excessive menstrual bleeding that interferes with quality of life (QoL). We assessed its value for monitoring HMB treatment in clinical practice. Material and Methods: This is a prospective observational study conducted between December 2018 and March 2021 in consecutively recruited women with HMB attending gynecologists' offices who started a hormonal treatment. Sociodemographic characteristics were recorded at enrollment. At baseline and month 12, we assessed the HMB (SAMANTA questionnaire), the global impression of menstrual bleeding severity in patients (PGI-S) and clinicians (CGI-S), and the QoL (SF36). At month 12, we assessed the global impression of menstrual bleeding change in patients (PGI-C) and clinicians (CGI-C). Changes in SAMANTA questionnaire score at month 12 were compared with the presence of amenorrhea and changes in blood loss, menstrual period duration, and PGI-S, PGI-C, CGI-S, and CGI-C. Results: The study included 371 women aged 41.2 ± 6.5 years, 87% of whom were using the levonorgestrel intrauterine system. The SAMANTA questionnaire score significantly decreased in 97.3% of women. The decrease was greater in women reporting a reduction in blood loss, shorter menstrual bleeding duration, or a strong improvement in menstrual bleeding severity (PGI-S and CGI-S) or amount (PGI-C and CGI-C) (p < 0.001 for all), but not amenorrhea. SF-36 domains improved significantly; changes being inversely associated with changes in the SAMANTA questionnaire score. Conclusions: The SAMANTA questionnaire seems a valuable tool for monitoring hormonal treatment for HMB. ClinicalTrials.gov identifier NCT03751800.

Real-world satisfaction and menstrual bleeding pattern with available LNG-IUD among Spanish young women.

OBJECTIVE: The aim of this study was to evaluate the satisfaction and menstrual bleeding pattern with levonorgestrel-releasing intrauterine systems (LNG-IUD) in young women. METHODS: A prospective, multicentre, non-interventional study with 1-year follow-up was conducted in Spain. Participants were women between 18 and 30 years old who freely choose any available LNG-IUD for contraception. Satisfaction with LNG-IUD was measured with a 5-point Likert scale. Type of LNG-IUD, menstrual bleeding pattern and satisfaction with it, easiness of insertion and pain during procedure were collected. RESULTS: A total of 555 women (37.3% parous, 62.7% nulliparous) (mean age 25.8 ± 3.5) completed the study. After 12 months, 92.4% of women were satisfied or very satisfied with the LNG-IUD, with no differences by parity status, type of IUD or baseline menstrual bleeding pattern. Satisfaction with the LNG-IUD correlated with satisfaction with menstrual bleeding pattern at 12 months. Up to 88.7% of women were satisfied or very satisfied with their menstrual bleeding pattern at 12 months in comparison to 41.5% at baseline (p < 0.001). Adverse events (AE)-related discontinuation rate was low (2.2%). CONCLUSIONS: Satisfaction with LNG-IUD is very high among young Spanish women, regardless of parity and menstrual bleeding pattern at baseline.

AEEM-SEGO position statement on menopausal hormone therapy / Posicionamiento AEEM-SEGO sobre la terapia hormonal de la menopausia

According to the latest data from the medical literature, the Spanish Menopause Society (Asociación Española para el Estudio de la Menopausia [AEEM]) has brought together a group of experts to re-evaluate the use of menopausal hormone therapy so that women can make an informed, evidence-based decision to determine the most appropriate dose, formulation, route of administration, and duration of menopausal hormone therapy. There is some disagreement between scientific evidence on the efficacy and safety of menopausal hormone therapy and how this evidence is perceived by menopausal women and the clinicians who care for them, leading to an unnecessary loss of quality of life in those who reject it or in the unjustified fear of those who choose to use it. A critical review of the most recent available literature was conducted. The review mainly covered randomized clinical trials and epidemiological studies published since January 2015. This paper reviews clinical trials published since then, as well as new information on the potential risks and benefits of HT for the treatment of menopausal symptoms. Decisions about menopausal hormone therapy should be based on a woman’s specific health risks, age, and time since onset of the menopause, as well as on the goals of therapy. The Spanish Menopause Society (Asociación Española para el Estudio de la Menopausia) and the Spanish Society of Gynecology and Obstetrics (Sociedad Española de Ginecología y Obstetricia) updated their position statement on menopausal hormone therapy. This statement updates the clinical practice guidelines on the menopause

Conocidos los últimos datos de la literatura médica, la Asociación Española para el Estudio de la Menopausia ha reunido a un grupobde expertos para reevaluar el uso de la terapia hormonal de la menopausia con el fin de adoptar una decisión informada, basada en la evidencia que determina el tipo más apropiado de dosis, formulación, vía de administración y duración del uso de la terapia hormonal de la menopausia. Existe una discordancia entre las evidencias de carácter científico, sobre la eficacia y la seguridad de la terapia hormonal de la menopausia y la percepción que tienen de ello las mujeres que están en la menopausia y los médicos que las atienden, lo que redunda en una pérdida innecesaria de la calidad de vida en las que lo rechazan o en el temor injustificado de las que optan por su utilización. Se ha realizado una revisión crítica de la literatura disponible más reciente, fundamentalmente de ensayos clínicos aleatorizados y estudios epidemiológicos, publicados desde enero de 2015. El presente documento revisa los nuevos ensayos clínicos publicados desde entonces, así como nueva información sobre los posibles riesgos y beneficios de la terapia hormonal de la menopausia para el tratamiento de los síntomas de la menopausia. Las decisiones sobre la terapia hormonal de la menopausia deben basarse en los riesgos de salud específicos de cada mujer, la edad o el tiempo desde la menopausia y los objetivos de la terapia. La Asociación Española para el Estudio de la Menopausia y la Sociedad Española de Ginecología y Obstetricia actualizaron su posicionamiento con respecto a la terapia hormonal de la menopausia. Dicho posicionamiento de la Asociación Española para el Estudio de la Menopausia/Sociedad Española de Ginecología y Obstetricia actualiza las guías de práctica clínica de menopausia ya publicadas

Pregnancy beyond 65: report of a unique case and discussion of a controversial issue.

We present the case report of a 66-year-old woman who was attended at our gynaecology department at a tertiary university hospital in Barcelona, Spain for a high-risk pregnancy and comment on the obstetric implications and bioethical issues. We retrospectively analysed clinical data about the case and bibliographic references related to the issue. The woman underwent in vitro fertilisation of donated embryos in a private centre and came to our unit at 27 weeks of gestation for pregnancy care. At 33 weeks, she presented pre-eclampsia and a caesarean section was performed. She gave birth to healthy twin boys. Four months later, she returned to our centre with the diagnosis of ovarian cancer and died 30 months after delivery. We present the clinical course and management of this pregnancy and comment on the obstetric implications, the impact on maternal and neonatal health, and bioethical issues related to assisted reproduction techniques in pregnancies beyond the natural reproductive age.

Mode of vaginal delivery: a modifiable intrapartum risk factor for obstetric anal sphincter injury.

The aim of this study was to analyze the comparative risks of this anal sphincter injury in relation to the type of intervention in vaginal delivery. We performed an observational, retrospective study of all vaginal deliveries attended at a tertiary university hospital between January 2006 and December 2009. We analyzed the incidence of obstetric anal sphincter injury for each mode of vaginal delivery: spontaneous delivery, vacuum, Thierry spatulas, and forceps. We determined the proportional incidence between methods taking spontaneous delivery as the reference. Ninety-seven of 4526 (2.14%) women included in the study presented obstetric anal sphincter injury. Instrumental deliveries showed a significantly higher risk of anal sphincter injury (2.7 to 4.9%) than spontaneous deliveries (1.1%). The highest incidence was for Thierry spatulas (OR 4.804), followed by forceps (OR 4.089) and vacuum extraction (OR 2.509). The type of intervention in a vaginal delivery is a modifiable intrapartum risk factor for obstetric anal sphincter injury. Tearing can occur in any type of delivery but proportions vary significantly. All healthcare professionals attending childbirth should be aware of the risk for each type of intervention and consider these together with the obstetric factors in each case.

Rotura prematura de membranas pretérmino: consideraciones y controversias / Preterm premature rupture of membranes: issues and controversies

Presentamos un caso de gestación gemelar bicorial biamniótica con rotura prematura de membranas al límite de la viabilidad fetal. Se adoptó una actitud expectante, produciéndose una corioamnionitis tras un periodo de 3 semanas. Se asistió al parto de 2 niñas cuya evolución al año de vida parece ser favorable. Existen múltiples controversias no resueltas sobre la mejor conducta en estos casos, particularmente con relación a cuándo finalizar la gestación. Asimismo, cabe destacar las dificultades del diagnóstico de esta complicación en las gestaciones múltiples, así como la complejidad del seguimiento en estos casos, siendo necesario definir protocolos específicos para su manejo(AU)

We report a case of preterm premature rupture of membranes in a diamniotic dichorionic twin pregnancy at the limit of fetal viability. Expectant management was adopted. After 3 weeks of latency the pregnancy ended in chorioamnionitis. The patient delivered two girls whose neurodevelopment seems to be satisfactory at 1 year of follow-up. There are several unresolved controversies about the optimal management of these cases, especially when rupture of membranes occurs at the limit of fetal viability. There is no agreement about the right time to end pregnancy. This case also highlights the complexity of the follow-up of this complication in multiple pregnancies and the need for specific protocols to be developed(AU)

Ovulation induction with a starting dose of 50 IU of recombinant follicle stimulating hormone in WHO group II anovulatory women: the IO-50 study, a prospective, observational, multicentre, open trial.

OBJECTIVE: To assess the efficacy and safety in clinical practice of a low dose regimen of 50 IU of recombinant follicle stimulating hormone in induction of ovulation. DESIGN: Prospective, observational, non-comparative, open, multicentre study. SETTING: Eighty-eight infertility clinics and teaching hospital fertility units throughout Spain. POPULATION: Women with normogonadotrophic chronic anovulation (WHO group II) with or without echographic diagnosis of polycystic ovary syndrome. METHODS: Low dose step-up protocol of recombinant follicle stimulating hormone administration (follitropin beta, Puregon) with a starting dose of 50 IU and weekly increments according to follicular response monitored prospectively by transvaginal ultrasonography. Patients were followed for a minimum of one cycle and a maximum of six. MAIN OUTCOME MEASURES: Rate and size of follicular growth, cumulative ovulation rate, follicle stimulating hormone doses and duration of treatment, pregnancy and cycle cancellation rate, ovarian hyperstimulation syndrome and multiple pregnancy. RESULTS: A total of 945 treatment cycles were evaluated. In 817 cycles, ovulation was induced with human chorionic gonadotrophin (hCG) and in 501 (61.3%) unifollicular development (a follicle of > or =18 mm) was achieved. A total of 128 cycles (13.5%) were cancelled because of ovarian hyper-responsiveness or spontaneous ovulation. The cumulative ovulation rate (confirmed by mid-luteal serum progesterone concentrations) after six treatment cycles was 84%. There were 136 clinical pregnancies (14.4% pregnancies per cycle). The cumulative pregnancy rate after six treatment cycles was 53.1%. Eight twin pregnancies occurred. Thirteen women miscarried and there were two cases of ectopic pregnancies. The median of average daily doses of follitropin beta in all cycles was 50 IU. Between 68% and 86% of patients received treatment with follitropin beta for a maximum of 14 days. Ovarian hyperstimulation syndrome occurred in 64 (6.8%) cases but no case of severe ovarian hyperstimulation developed. CONCLUSIONS: Low dose regimen of 50 IU of recombinant follicle stimulating hormone (Puregon) is efficient, safe and well tolerated for inducing follicular development in WHO group II anovulatory women.