Cost-effectiveness analysis of levonorgestrel-releasing intrauterine system (LNG-IUS) 52 mg versus other long-acting reversible contraceptives for contraception in Spain.

INTRODUCTION: Condoms and combined oral contraceptive pills are widely used in Spain with high failure rates. Long-Acting Reversible Contraceptive (LARC) methods offer better efficacy and adherence and reduce unintended pregnancies (UP) compared with short-acting reversible contraceptive (SARC) methods. OBJECTIVE: To assess the cost-effectiveness of LNG-IUS 52 mg (Mirena®) versus other LARC for contraception in Spain. MATERIALS AND METHODS: A Markov model with annual cycles and an eight-year time horizon was developed from the Spanish national healthcare system (NHS) perspective, considering costs for contraceptive method acquisition, health care resources (HCR) and UP. Effectiveness was based on failure and discontinuation rates. Sensitivity analyses were performed to test the model's robustness. RESULTS: LNG-IUS 52 mg (Mirena®) resulted in lower costs and fewer UP versus LNG-IUS 13.5 mg (Jaydess®), Implant (Implanon®) and Copper IUD. LNG-IUS 52 mg (Levosert®) prevented the same UP events at a higher cost. LNG-IUS 19.5 mg (Kyleena®) was the most effective option, due to a lower discontinuation rate. CONCLUSIONS: LNG-IUS 52 mg (Mirena®) is the least costly LARC, driven by lower acquisition costs and reduced HCR utilisation. Increasing LNG-IUS 52 mg (Mirena®) uptake in contraception could generate further cost savings for the Spanish NHS and reduce economic burden of UP.

Levonorgestrel-releasing intrauterine system (LNG-IUS; Mirena^®) is an effective and cost-saving long-acting reversible contraceptive (LARC) method compared with other similar methods in Spain over an eight-year time horizon, and Kyleena^® was the most effective option.

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.

Postnatal catch-up growth in term newborns with altered fetal weight patterns. The GROWIN study.

BACKGROUND: Small for gestational age (SGA) perform a postnatal catch-up growth to recover their genetic trajectory. We studied the postnatal catch-up growth pattern of fetuses born with an appropriate-for-gestational-age (AGA) weight but with fetal growth deceleration (FGD) to explore whether they catch up. METHODS: Nine hundred and sixty-six newborns at Villalba University General Hospital (HUGV), were followed from 34 to 37 weeks to birth. Z-scores, adjusted for sex and age, of weight, length, and BMI at 3, 6, 9, and 12 months were calculated. We define catch-up as an increase in z-score greater than 0.67 SD in the growth curves. RESULTS: AGA FGD had lower mean weight and length than AGA non-FGD at all time points; BMI was lower until 3 months. AGA FGD had a lower weight, length, and BMI z-score (until 9, 6 months, and at birth, respectively) than AGA non-FGD. AGA FGD newborns had a significantly increased likelihood of weight catch-up at 3 months (OR 1.79; 95% CI: 1.16, 2.78; p = 0.009) and BMI in all investigated periods (OR 1.90; 95% CI 1.30, 2.78; p < 0.001 at 3 months), compared to AGA non-FGD newborns. CONCLUSIONS: AGA FGD newborns perform catch-up growth, especially in weight and BMI, in the first year of life, compared to AGA non-FGD. IMPACT: Appropriate-for-gestational-age (AGA) newborns with fetal growth deceleration (FGD), between the third trimester of pregnancy and delivery, present a lower weight and height, during the first year of life, compared to AGA non-FGD. Appropriate-for-gestational-age (AGA) newborns with fetal growth deceleration (FGD), between the third trimester of pregnancy and delivery, present a higher likelihood of weight catch-up in the first 3 months of life and of BMI in the first year compared to AGA non-FGD. AGA FGD experienced early weight and BMI catch-up, especially in the first 3 months of life, like SGA. This finding should be considered in the future follow-up.

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.

Diagnostic capacity and interobserver variability in FIGO, ACOG, NICE and Chandraharan cardiotocographic guidelines to predict neonatal acidemia.

OBJECTIVE: Despite its routine use in intrapartum care, the technique of fetal cardiotocography has some limitations. The aim of this study is to analyze the predictive capacity and interobserver agreement in the latest versions of four international cardiotocography guidelines: Federation of Gynecology and Obstetrics (FIGO), American College of Obstetrics and Gynecology (ACOG), the National Institute for Health and Care Excellence (NICE) and Chandraharan, used to predict neonatal acidemia. STUDY DESIGN: The last 30 min of 150 cardiotocographic records were analyzed over all the pH ranges and were blindly evaluated by three independent reviewers. The sensitivity, specificity, positive predictive value, negative predictive value, and area under the receiver operating characteristic curve (AUC) were calculated to assess the predictive capacity of each fetal cardiotocographic guideline. The degree of interobserver agreement was evaluated with the Fleiss Kappa coefficient. RESULTS: Observers found fetal cardiotocography guidelines to have a variable sensitivity and specificity. The Chandraharan classification reached the highest sensitivity (78.79%), while ACOG had the highest specificity (95.73%). On average for the three observers, Chandraharan had the highest discrimination capacity for neonatal acidemia, although this was only moderate (AUC 0.66; 95%CI, 0.55-0.77) and did not differ significantly from the remaining guidelines. The degree of agreement among the three observers, assessed according to the Fleiss Kappa coefficient, was generally acceptable or moderate for all items and classifications, being highest with the FIGO classification (ĸ = 0.35; 95%CI, 0.28-0.41) and lowest with the ACOG (ĸ = 0.23; 95%CI, 0.16-0.30). CONCLUSION: Although all the guidelines have a moderate capacity to predict neonatal acidemia, the Chandraharan guideline has the highest capacity. This follows a different approach from the others in that it relies on interpretations of cardiotocographic traces based on fetal physiology. The degree of interobserver agreement is, in general, acceptable for the four guidelines, and is the highest for FIGO.

Perinatal Adverse Effects in Newborns with Estimated Loss of Weight Percentile between the Third Trimester Ultrasound and Delivery. The GROWIN Study.

Fetal growth restriction has been associated with an increased risk of adverse perinatal outcomes (APOs). We determined the importance of fetal growth detention (FGD) in late gestation for the occurrence of APOs in small-for-gestational-age (SGA) and appropriate-for-gestational-age (AGA) newborns. For this purpose, we analyzed a retrospective cohort study of 1067 singleton pregnancies. The newborns with higher APOs were SGA non-FGD and SGA FGD in 40.9% and 31.5% of cases, respectively, and we found an association between SGA non-FGD and any APO (OR 2.61; 95% CI: 1.35-4.99; p = 0.004). We did not find an increased APO risk in AGA FGD newborns (OR: 1.13, 95% CI: 0.80, 1.59; p = 0.483), except for cesarean delivery for non-reassuring fetal status (NRFS) with a decrease in percentile cutoff greater than 40 (RR: 2.41, 95% CI: 1.11-5.21) and 50 (RR: 2.93, 95% CI: 1.14-7.54). Conclusions: Newborns with the highest probability of APOs are SGA non-FGDs. AGA FGD newborns do not have a higher incidence of APOs than AGA non-FGDs, although with falls in percentile cutoff over 40, they have an increased risk of cesarean section due to NRFS. Further studies are warranted to detect these newborns who would benefit from close surveillance in late gestation and at delivery.

Screening of severe acute respiratory syndrome coronavirus-2 infection during labor and delivery using polymerase chain reaction and immunoglobulin testing.

AIMS: To assess severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection during labor and delivery with polymerase chain reaction (PCR) and using immunoglobulin G and M testing to correlate with maternal and perinatal outcomes. MAIN METHODS: Pregnant women admitted for labor and delivery at two Spanish hospitals were screened for SARS-CoV-2 infection by PCR test and by detection of serum immunoglobulins G and M. Maternal and perinatal outcomes were compared in women with laboratory evidence of SARS-CoV-2 infection with those with negative tests. KEY FINDINGS: Between March 31st and September 30th, 2020, 1211 pregnant women were screened for SARS-CoV-2 infection. The prevalence of laboratory evidence of SARS-CoV-2 infections was 5.4% (n = 65), corresponding to (i) 22 ongoing infections at admission, including two with mild clinical symptoms and 20 asymptomatic women; (ii) 43 cases of previous SARS-CoV-2 exposure; (iii) and 1146 women who were negative for both SARS-CoV-2 PCR and serological test. None of the screened mothers required hospital admission for coronavirus disease before or after delivery, nor were any of the newborns admitted to the intensive care unit. All newborns from mothers with positive PCR on admission were PCR negative. There were no significant differences in maternal or perinatal outcomes among the three studied groups. SIGNIFICANCE: Ongoing or previous SARS-CoV-2 infection with asymptomatic or mild clinical symptoms detected during screening in pregnant women at labor and delivery do not have a higher rate of adverse maternal or perinatal outcomes.

Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) universal screening in gravids during labor and delivery.

OBJECTIVE: To screen pregnant women at risk of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection during delivery using reverse-transcription polymerase chain reaction (RT-PCR) test and serum immunoglobulin (Ig) testing. METHOD: Between March 31 st and August 31 st of 2020, consecutive pregnant women admitted for labor and delivery in a single hospital were screened for SARS-CoV-2 with nasopharyngeal RT-PCR swab tests and detection of serum IgG and IgM. RESULTS: We studied 266 pregnant women admitted for labor and delivery. The prevalence of acute or past SARS-CoV-2 infection was 9.0 %, including (i) two cases with respiratory symptoms of SARS-Co-V-2 infection and positive RT-PCR; (ii) four asymptomatic women with positive RT-PCR without clinical symptoms and negative serological tests between two and 15 weeks later; and (iii) two women with false positive RT-PCR due to technical problems. All newborns of the 6 pregnant women with RT-PCR positive had negative RT-PCR and did not require Neonatal Intensive Care Unit admission. There were eighteen asymptomatic women with positive serological IgG tests and negative RT-PCR. CONCLUSION: In our cohort of gravids, we found 2.2 % of women with positive RT-PRC tests and 6.7 % with positive serological tests during the first wave of the SARS-CoV-2 pandemic.