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Santacruz Martín, Belén

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Belén

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Santacruz Martín

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    Physical exercise programme during pregnancy decreases perinatal depression risk: a randomised controlled trial.
    (British Journal of Sports Medicine, 2018) Vargas Terrones, Marina; Barakat, Rubén; Santacruz Martín, Belén; Fernández Buhigas, Irene; Mottola, Michelle F
    Introduction The incidence of depression is high during the perinatal period. This mood disorder can have a significant impact on the mother, the child and the family. Objective To examine the effect of an exercise programme during pregnancy on the risk of perinatal depression. Methods Healthy women who were <16 weeks pregnant were randomly assigned to two different groups. Women in the intervention group participated in a 60 min exercise programme throughout pregnancy, 3 days per week, which was conducted from October 2014 to December 2016. The Center for Epidemiological Studies-Depression Scale was used to measure the risk of depression at the beginning of the study (12–16 weeks), at gestational week 38 and at 6 weeks postpartum. Results One hundred and twenty-four pregnant women were allocated to either the intervention (IG=70) or the control (CG=54) group. No differences were found in the percentage of depressed women at baseline (20% vs 18.5%) (χ2=0.043; p=0.836). A smaller percentage of depressed women were identified in the IG compared with the CG at 38 gestational weeks (18.6% vs 35.6%) (χ2=4.190; p=0.041) and at 6 weeks postpartum (14.5% vs 29.8%) (χ2=3.985; p=0.046) using the per-protocol analysis. No significant differences were found using the intention-to-treat analyses, except in the multiple imputation analysis at week 38 (18.6% vs 34.4%) (χ2=4.085; p=0.049). Conclusion An exercise programme performed during pregnancy may reduce the prevalence of depression in late pregnancy and postpartum.
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    Level of agreement between midwives and obstetricians performing ultrasound examination during labor.
    (International Journal of Gynecology & Obstetrics, 2024) Fidalgo, Ana M.; Miguel, Raquel; Fernández-Buhigas, Irene; Aguado, Asunción; Cuerva, Marcos J.; Corrales, Elisa; Rolle, Valeria; Santacruz Martín, Belén; Gil Mira, María del Mar; Poon, Liona C.
    Objective To evaluate the level of agreement between ultrasound measurements to evaluate fetal head position and progress of labor by attending midwives and obstetricians after appropriate training. Methods In this prospective study, women in the first stage of labor giving birth to a single baby in cephalic presentation at our Obstetric Unit between March 2018 and December 2019 were invited to participate; 109 women agreed. Transperineal and transabdominal ultrasound was independently performed by a trained midwife and an obstetrician. Two paired measurements were available for comparisons in 107 cases for the angle of progression (AoP), in 106 cases for the head-to-perineum distance (HPD), in 97 cases for the cervical dilatation (CD), and in 79 cases for the fetal head position. Results We found a good correlation between the AoP measured by obstetricians and midwives (intra-class correlation coefficient [ICC] = 0.85; 95% confidence interval [CI] 0.80–0.89). There was a moderate correlation between the HPD (ICC = 0.75; 95% CI 0.68–0.82). There was a very good correlation between the CD measured (ICC = 0.94; 95% CI 0.91–0.96). There was a very good level of agreement in the classification of the fetal head position (Cohen's κ = 0.89; 95% CI 0.80–0.98). Conclusions Ultrasound assessment of fetal head position and progress of labor can effectively be performed by attending midwives without previous experience in ultrasound.
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    Does exercise during pregnancy impact on maternal weight gain and fetal cardiac function? A Randomized controlled study.
    (Ultrasound in Obstetrics and Gynecology, 2018) Brik, Maia; Fernández Buhigas, Irene; Martín Arias, Aránzazu; Vargas Terrones, Marina; Barakat, Rubén; Santacruz Martín, Belén
    OBJECTIVE: To evaluate the association between physical exercise during pregnancy and maternal gestational weight gain and fetal cardiac function. METHODS: This was a randomized controlled trial of women with a singleton pregnancy managed from the first trimester at the Hospital de Torrejón, Madrid, between November 2014 and June 2015. Women were randomized to either follow a supervised physical conditioning program, consisting of a 60-min session 3 days per week for the duration of pregnancy, or not attend any exercise program (controls). The primary outcome was maternal weight gain during pregnancy. Secondary outcomes included fetal cardiac function parameters evaluated at 20, 28 and 36 weeks' gestation, Cesarean section, preterm delivery, induction of labor and birth weight. A sample size of 45 in each group was planned to detect differences in maternal weight gain of at least 1 kg, with a power of > 80% and α of 0.05. RESULTS: During the study period, 120 women were randomized into the exercise (n = 75) and control (n = 45) groups. Following exclusions, the final cohort consisted of 42 women in the exercise group and 43 in the control group. Baseline characteristics (maternal age, prepregnancy body mass index, parity, conception by in-vitro fertilization, Caucasian ethnicity, physical exercise prior to pregnancy and smoker) were similar between the two groups. No differences were found between the groups in maternal weight at 20, 28, 36 and 38 weeks' gestation or in weight gain at 38 weeks. However, the proportion of women with weight loss ≥ 9 kg at 6 weeks postpartum was higher in the exercise compared with the control group (68.2% vs 42.8%; relative risk 1.593; P = 0.02). The ductus arteriosus pulsatility index (DA-PI) at 20 weeks (2.43 ± 0.40 vs 2.26 ± 0.33, P < 0.05) and the ejection fraction (EF) at 36 weeks (0.85 ± 0.13 vs 0.81 ± 0.11, P < 0.05) were higher in the exercise compared with the control group. All other evaluated fetal cardiac function parameters were similar between the two groups. CONCLUSIONS: Performing exercise during pregnancy is not associated with a reduction in maternal weight gain but increases weight loss at 6 weeks postpartum. Physical exercise during pregnancy is associated with increased fetal DA-PI at 20 weeks and EF at 36 weeks, which could reflect adaptive mechanisms
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    Efficacy and safety of hydroxychloroquine for treatment of mild SARS-CoV-2 infection and prevention of COVID-19 severity in pregnant and postpartum women: A randomized, double-blind, placebo-controlled trial.
    (Acta Obstetricia et Gynecologica Scandinavica, 2023) González, Raquel; Goncé, Anna; Gil Mira, María del Mar; Mazarico, Edurne; Ferriols-Pérez, Elena; Toro, Paloma; Llurba, Elisa; Saéz, Elisa; Rodríguez-Zambrano, Miguel Ángel; García-Otero, Laura; López, Marta; Santacruz Martín, Belén; Román, Mª. Ángeles; Payà, Antoni; Alonso, Sofia; Cruz-Lemini, Mónica; Pons-Duran, Clara; Bernardo Herrera, Luis; Chen, Haily; Bardají, Azucena; Quintó, Llorenç; Menendez, Clara
    Introduction Pregnant women have an increased risk of severe COVID-19. Evaluation of drugs with a safety reproductive toxicity profile is a priority. At the beginning of the pandemic, hydroxychloroquine (HCQ) was recommended for COVID-19 treatment. Material and methods A randomized, double-blind, placebo-controlled clinical trial was conducted in eight teaching hospitals in Spain to evaluate the safety and efficacy of HCQ in reducing viral shedding and preventing COVID-19 progression. Pregnant and postpartum women with a positive SARS-CoV-2 PCR (with or without mild COVID-19 signs/symptoms) and a normal electrocardiogram were randomized to receive either HCQ orally (400 mg/day for 3 days and 200 mg/day for 11 days) or placebo. PCR and electrocardiogram were repeated at day 21 after treatment start. Enrollment was stopped before reaching the target sample due to low recruitment rate. Trial registration EudraCT #: 2020-001587-29, on April 2, 2020. Clinical trials.gov # NCT04410562, registered on June 1, 2020. Results A total of 116 women (75 pregnant and 41 post-partum) were enrolled from May 2020 to June 2021. The proportion of women with a positive SARS-CoV-2 PCR at day 21 was lower in the HCQ group (21.8%, 12/55) than in the placebo group (31.6%, 18/57), although the difference was not statistically significant (P = 0.499). No differences were observed in COVID-19 progression, adverse events, median change in QTc, hospital admissions, preeclampsia or poor pregnancy and perinatal outcomes between groups. Conclusions HCQ was found to be safe in pregnant and postpartum women with asymptomatic or mild SARS-CoV-2 infection. Although the prevalence of infection was decreased in the HCQ group, the statistical power was insufficient to confirm the potential beneficial effect of HCQ for COVID-19 treatment.
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    Risk Factors for Preeclampsia: Results from a Cohort of Over 5000 Pregnancies in Spain.
    (Maternal-Fetal Medicine, 2021) Cuenca, Diana; Rolle, Valeria; De Paco Matallana, Katy; Valiño, Nuria; Revello, Rocio; Adiego, Begoña; Mendoza, Manel; Santacruz Martín, Belén; Gil Mira, María del Mar
    Objective: To determine the incidence of preeclampsia (PE) and preterm PE in Spain and to identify the risk factors for developing the disease. Methods: This is a multicenter prospective cohort study performed at six maternity units across Spain. Women with singleton pregnancies attending their first-trimester routine visit at the hospital were offered participation. Maternal and pregnancy characteristics, including mean arterial pressure, as well as ultrasound findings were recorded. Univariate and multivariate logistic regression analyses were performed to identify independent risk factors for subsequent development of PE. Results:A total of 5868 pregnancies were recruited for this study, including 174 (3.0%) cases of PE, 47 (0.8%) cases of preterm PE and 127 (2.2%) cases of term PE. Median maternal age was 33.9 years (interquartile range: 30.1 to 36.9) and median gestational age at the routine visit was 12.7 weeks (interquartile range: 12.3 to 13.0). However, 293 (5.0%) of the women were on aspirin treatment during pregnancy, likely reducing the true incidence of the disease. As expected, increasing body mass index (P<0.001), uterine artery pulsatility index (P=0.011) and mean arterial pressure (P<0.001), assisted conception (P=0.013), previous personal (P<0.001) or family history of PE (P=0.024) and chronic hypertension (P=0.001) were identified as independent risk factors for developing subsequent PE during pregnancy. Screening for PE by maternal factors alone leads to a detection rate of 36.8% (64/174) at 10.0% (587/5868) screen positive rate. Conclusion: In Spain, 3.0% of singleton pregnancies are complicated by PE and 0.8% require delivery before term due to its severity. Screening of PE by risk factors alone is only able to detect about 40% of total PE at 10% screen-positive rate.
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    Fetal and maternal Doppler adaptation to maternal exercise during pregnancy: a randomized controlled trial.
    (The Journal of Maternal-Fetal and Neonatal Medicine, 2023) Fernández Buhigas, Irene; Martin Arias, Aranzazu; Vargas-Terrones, Marina; Brik, Maia; Rolle, Valeria; Barakat, Rubén; Muñoz Gonzalez, María; Refoyo, Ignacio; Gil Mira, María del Mar; Santacruz Martín, Belén
    Background Regular and supervised exercise during pregnancy is worldwide recommended due to its proven benefits, but, during exercise, maternal blood flow is redirected from the viscera to the muscles and how fetal wellbeing may be affected by this redistribution is still not well known. Objective To analyze the longitudinal effect of a supervised moderate physical exercise program during pregnancy on uteroplacental and fetal Doppler parameters. Methods This is a planned secondary analysis of an randomized controlled trial (RCT), performed at Hospital Universitario de Torrejón, Madrid, Spain, including 124 women randomized from 12+0 to 15+6 weeks of gestation to exercise vs. control group. Fetal umbilical artery (UA), middle cerebral artery, and uterine artery pulsatility index (PI), were longitudinally collected by Doppler ultrasound assessment throughout gestation, and derived cerebroplacental ratio (normalized by z-score), and maternal mean PI in the uterine arteries (normalized by multiplies of the median). Obstetric appointments were scheduled at 12 (baseline, 12+0 to 13+5), 20 (19+0 to 24+2), 28 (26+3 to 31+3) and 35 weeks (32+6 to 38+6) of gestation. Generalized estimating equations were adjusted to assess longitudinal changes in the Doppler measurements according to the randomization group. Results No significant differences in the fetal or maternal Doppler measurements were found at any of the different checkup time points studied. The only variable that consistently affected the Doppler standardized values was gestational age at the time of assessment. The evolution of the UA PI z-score during the pregnancy was different in the two study groups, with a higher z-score in the exercise group at 20 weeks and a subsequent decrease until delivery while in the control group it remained stable at around zero. Conclusions A regular supervised moderate exercise program during pregnancy does not deteriorate fetal or maternal ultrasound Doppler parameters along the pregnancy, suggesting that the fetal well-being is not compromised by the exercise intervention. Fetal UA PI z-score decreases during pregnancy to lower levels in the exercise group compared with the control group
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    Maternal COVID-19 Serological Changes—Comparison between Seroconversion Rate in First and Third Trimesters of Pregnancy and Subsequent Obstetric Complications: A Cohort Study.
    (Viruses, 2023) N. Rayo, Maria; Aquise, Adriana; Fernández Buhigas, Irene; Gonzalez-Gea, Lorena; Garcia-Gonzalez, Coral; Sanchez-Tudela, Mirian; Rodriguez-Fernandez, Miguel; Tuñon-Le Poultel, Diego; Santacruz Martín, Belén; Gil Mira, María del Mar
    Pregnant women are especially vulnerable to respiratory diseases. We aimed to study seroconversion rates during pregnancy in a cohort of consecutive pregnancies tested in the first and third trimesters and to compare the maternal and obstetric complications in the women who seroconverted in the first trimester and those who did so in the third. This was an observational cohort study carried out at the Hospital Universitario de Torrejón, in Madrid, Spain, during the first peak of the COVID-19 pandemic. All consecutive singleton pregnancies with a viable fetus attending their 11–13-week scan between 1 January and 15 May 2020 were included and seropositive women for SARS-CoV2 were monthly follow up until delivery. Antibodies against SARS-CoV-2 (IgA and IgG) were analyzed on stored serum samples obtained from first- and third-trimester routine antenatal bloods in 470 pregnant women. Antibodies against SARS-CoV-2 were detected in 31 (6.6%) women in the first trimester and in 66 (14.0%) in the third trimester, including 48 (10.2%) that were negative in the first trimester (seroconversion during pregnancy). Although the rate of infection was significantly higher in the third versus the first trimester (p = 0.003), no significant differences in maternal or obstetric complications were observed in women testing positive in the first versus the third trimester.
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    New approach for estimating risk of miscarriage after chorionic villus sampling.
    (Ultrasound in Obstetrics & Gynecology, 2020) Gil Mira, María del Mar; Santacruz Martín, Belén; De Paco Matallana, C.
    Objective To estimate the risk of miscarriage associated with chorionic villus sampling (CVS). Methods This was a retrospective cohort study of women attending for routine ultrasound examination at 11 + 0 to 13 + 6 weeks' gestation at one of eight fetal-medicine units in Spain, Belgium and Bulgaria, between July 2007 and June 2018. Two populations were included: (1) all singleton pregnancies undergoing first-trimester assessment at Hospital Clínico Universitario Virgen de la Arrixaca in Murcia, Spain, that did not have CVS (non-CVS group); and (2) all singleton pregnancies that underwent CVS following first-trimester assessment at one of the eight participating centers (CVS group). We excluded pregnancies diagnosed with genetic anomalies or major fetal defects before or after birth, those that resulted in termination and those that underwent amniocentesis later in pregnancy. We used propensity score (PS) matching analysis to estimate the association between CVS and miscarriage. We compared the risk of miscarriage of the CVS and non-CVS groups after PS matching (1:1 ratio). This procedure creates two comparable groups balancing the maternal and pregnancy characteristics that are associated with CVS, in a similar way to that in which randomization operates in a randomized clinical trial. Results The study population consisted of 22 250 pregnancies in the non-CVS group and 3613 in the CVS group. The incidence of miscarriage in the CVS group (2.1%; 77/3613) was significantly higher than that in the non-CVS group (0.9% (207/22 250); P < 0.0001). The PS algorithm matched 2122 CVS with 2122 non-CVS cases, of which 40 (1.9%) and 55 (2.6%) pregnancies in the CVS and non-CVS groups, respectively, resulted in a miscarriage (odds ratio (OR), 0.72 (95% CI, 0.48–1.10); P = 0.146). We found a significant interaction between the risk of miscarriage following CVS and the risk of aneuploidy, suggesting that the effect of CVS on the risk of miscarriage differs depending on background characteristics. Specifically, when the risk of aneuploidy is low, the risk of miscarriage after CVS increases (OR, 2.87 (95% CI, 1.13–7.30)) and when the aneuploidy risk is high, the risk of miscarriage after CVS is paradoxically reduced (OR, 0.47 (95% CI, 0.28–0.76)), presumably owing to prenatal diagnosis and termination of pregnancies with major aneuploidies that would otherwise have resulted in spontaneous miscarriage. For example, in a patient in whom the risk of aneuploidy is 1 in 1000 (0.1%), the risk of miscarriage after CVS will increase to 0.3% (0.2 percentage points higher). Conclusions The risk of miscarriage in women undergoing CVS is about 1% higher than that in women who do not have CVS, although this excess risk is not solely attributed to the invasive procedure but, to some extent, to the demographic and pregnancy characteristics of the patients. After accounting for these risk factors and confining the analysis to low-risk pregnancies, CVS seems to increase the risk of miscarriage by about three times above the patient's background risk. Although this is a substantial increase in relative terms, in pregnancies without risk factors for miscarriage, the risk of miscarriage after CVS remains low and similar to, or slightly higher than, that in the general population. © 2020 The Authors. Ultrasound in Obstetrics & Gynecology published by John Wiley & Sons Ltd on behalf of International Society of Ultrasound in Obstetrics and Gynecology.
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    Validation of machine-learning model for first-trimester prediction of pre-eclampsia using cohort from PREVAL study.
    (Ultrasound in Obstetrics & Gynecology, 2024) Gil Mira, María del Mar; Cuenca Gómez, D.; Rolle, V.; Pertegal, M.; Valiño, N.; Revello, R.; Adiego, B.; Mendoza, M.; Molina, F. S.; Santacruz Martín, Belén; Ansbacher-Feldman, Z.; Meiri, H.; Martín Alonso, R.; Louzoun, Y.; De Paco Matallana, C.
    Objective Effective first-trimester screening for pre-eclampsia (PE) can be achieved using a competing-risks model that combines risk factors from the maternal history with multiples of the median (MoM) values of biomarkers. A new model using artificial intelligence through machine-learning methods has been shown to achieve similar screening performance without the need for conversion of raw data of biomarkers into MoM. This study aimed to investigate whether this model can be used across populations without specific adaptations. Methods Previously, a machine-learning model derived with the use of a fully connected neural network for first-trimester prediction of early (< 34 weeks), preterm (< 37 weeks) and all PE was developed and tested in a cohort of pregnant women in the UK. The model was based on maternal risk factors and mean arterial blood pressure (MAP), uterine artery pulsatility index (UtA-PI), placental growth factor (PlGF) and pregnancy-associated plasma protein-A (PAPP-A). In this study, the model was applied to a dataset of 10 110 singleton pregnancies examined in Spain who participated in the first-trimester PE validation (PREVAL) study, in which first-trimester screening for PE was carried out using the Fetal Medicine Foundation (FMF) competing-risks model. The performance of screening was assessed by examining the area under the receiver-operating-characteristics curve (AUC) and detection rate (DR) at a 10% screen-positive rate (SPR). These indices were compared with those derived from the application of the FMF competing-risks model. The performance of screening was poor if no adjustment was made for the analyzer used to measure PlGF, which was different in the UK and Spain. Therefore, adjustment for the analyzer used was performed using simple linear regression. Results The DRs at 10% SPR for early, preterm and all PE with the machine-learning model were 84.4% (95% CI, 67.2–94.7%), 77.8% (95% CI, 66.4–86.7%) and 55.7% (95% CI, 49.0–62.2%), respectively, with the corresponding AUCs of 0.920 (95% CI, 0.864–0.975), 0.913 (95% CI, 0.882–0.944) and 0.846 (95% CI, 0.820–0.872). This performance was achieved with the use of three of the biomarkers (MAP, UtA-PI and PlGF); inclusion of PAPP-A did not provide significant improvement in DR. The machine-learning model had similar performance to that achieved by the FMF competing-risks model (DR at 10% SPR, 82.7% (95% CI, 69.6–95.8%) for early PE, 72.7% (95% CI, 62.9–82.6%) for preterm PE and 55.1% (95% CI, 48.8–61.4%) for all PE) without requiring specific adaptations to the population. Conclusions A machine-learning model for first-trimester prediction of PE based on a neural network provides effective screening for PE that can be applied in different populations. However, before doing so, it is essential to make adjustments for the analyzer used for biochemical testing.
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    Maternal physiological changes at rest induced by exercise during pregnancy: A randomized controlled trial.
    (Physiology and Behavior, 2020) Fernández Buhigas, Irene; Brik, Maia; Martin Arias, Aranzazu; Vargas Terrones, Marina; Varillas Delgado, David; Barakat, Rubén; Santacruz Martín, Belén
    Objective: to analyse maternal physiological changes in several areas (cardiovascular, metabolic, renal and hepatic) related to the regular practice of a supervised exercise program. Methods: This is an unplanned secondary analysis from a randomized controlled trial carried out in a single maternity unit in Madrid, Spain (NCT 02,756,143). From November 2014 to June 2015, 92 women were randomly assigned to perform a mild-moderate supervised exercise program during pregnancy (Intervention group, IG) or to continue with their routine pregnancy care (control group, CG). For the purpose of this study we collected clinical and analytical data (heart blood pressure, weight, blood glucose, AST, ALT, blood Creatinine and blood Uric acid) available from all obstetric visits and examined the differences between groups. Results: We did not find any differences in: pregnancy weight (IG: 11.4 ± 4.4 Kg vs. CG: 10.1 ± 5.3 Kg; p = 0.173); fasting glucose at 10+0–12+6 weeks (IG: 78.48±8.34 vs. CG: 76±13.26, p = 0.305) or at 34+0–36+4 weeks (IG: 73.25±10.27 vs CG: 73.45± 8.29,p = 0.920), and 50 gs glucose tolerance at 24+4–26+6weeks (IG: 116.23±35.07 vs CG: 116.36±25.98, p = 0.984); Aspartate-amino-transferase at 10+0–12+6 weeks (IG: 15.38±4.17 vs CG: 17.33±7.05, p = 0.124) and at 34+0–36+4 weeks (IG: 21.65±5.25 vs CG: 19.53±8.32, p = 0.165) or Alanine-amino- transferase at 10+0–12+6 weeks (IG: 27.50±10.63 vs CG: 28.27±11.77, p = 0.746) or at 34+0–36+4 weeks (IG: 22.93±9.23 vs CG: 20.84±13.49, p = 0.407); blood Creatinine concentrations at 34+0–36+4 weeks (IG: 0.595±0.401 vs CG: 0.575±0.100, p = 0.757) and blood uric acid concentrations at 34+0–36+4 weeks (IG: 3.526 ± 0.787 vs CG: 3.262±0.672, p = 0.218). Heart blood pressure was similar between groups except at 27+0–28+6 weeks, where systolic blood pressure was significantly lower in the CG in comparison to the IG (116.31±10.8 mmHg vs. 120.22 ± 10.3 mmHg, p = 0.010). Conclusion: Regular supervised exercise during pregnancy does not alter normal maternal physiology