Browsing by Author "De Paco Matallana, Catalina"
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Item Early vaginal progesterone versus placebo in twin pregnancies for the prevention of spontaneous preterm birth: a randomized, double-blind trial.(American Journal of Obstetrics and Gynecology, 2021) Rehal, Anoop; Benkő, Zsófia; De Paco Matallana, Catalina; Gil Mira, María del Mar; Nicolaides, Kypros H.Background: In women with a singleton pregnancy and sonographic short cervix in midgestation, vaginal administration of progesterone reduces the risk of early preterm birth and improves neonatal outcomes, without any demonstrable deleterious effects on childhood neurodevelopment. In women with twin pregnancies the rate of spontaneous early preterm birth is 10-times higher than in singletons and in this respect all twins are at increased risk of preterm birth. However, six trials in unselected twin pregnancies reported that vaginal progesterone from mid-gestation had no significant effect on the incidence of early preterm birth. Such apparent lack of effectiveness of progesterone in twins may be due to inadequate dosage or treatment which is started too late in pregnancy. Objective: The Early vaginal progesterone for the preVention of spontaneous prEterm birth iN TwinS: A randomized, placebo controlled, double-blinded trial (EVENTS) was designed to test the hypothesis that, among women with twin pregnancies, vaginal progesterone at a dose of 600 mg per day from 11-14 until 34 weeks’ gestation, as compared with placebo, would result in a significant reduction in the incidence of spontaneous preterm birth between 24+0 and 33+6 weeks. Methods: The trial was conducted at 22 hospitals in England, Spain, Bulgaria, Italy, Belgium and France. Women were randomly assigned in a 1:1 ratio, to receive either progesterone or placebo and in the random-sequence generation there was stratification according to participating center. Primary outcome was spontaneous birth between 24 +0 and 33+6 weeks’ gestation. Statistical analyses were performed on an intention-to-treat basis. Logistic regression analysis was used to determine the significance of difference in incidence of spontaneous birth between 24+0 and 33+6 weeks’ gestation between the progesterone and placebo groups, adjusting for the effect of participating centre, chrorionicity, parity and method of conception. Prespecified tests of treatment interaction effects with chrorionicity, parity, method of conception, compliance and cervical length at recruitment were performed. A post hoc analysis using mixed effects Cox regression was used for further exploration of the effect of progesterone on preterm birth. Results: We recruited 1,194 women between May 2017 and April 2019; 21 withdrew consent and 4 were lost to follow up, which left 582 in the progesterone group and 587 in the placebo group. Adherence was good, with reported intake of ≥80% of the required number of capsules in 81.4% of the participants. After excluding births before 24 weeks and indicated deliveries before 34 weeks, spontaneous birth between 24+0 and 33+6 weeks occurred in 10.4% (56/541) participants in the progesterone group and in 8.2% (44/538) in the placebo group (odds ratio in the progesterone group, adjusting for the effect of participating center, chrorionicity, parity and method of conception, 1.35; 95% CI 0.88 - 2.05; p=0.17). There was no evidence of interaction between the effects of treatment and chorionicity (p=0.28), parity (p=0.35) method of conception (p=0.56) and adherence (p=0.34); however, there was weak evidence of an interaction with cervical length (p=0.08) suggestive of harm to those with cervical length ≥30 mm (odds ratio 1.61, 95% CI 1.01-2.59) and potential benefit for those with cervical length <30 mm (odds ratio 0.56; 95% CI 0.20-1.60). There was no evidence of difference between the two treatment groups for stillbirth or neonatal death; neonatal complications; neonatal therapy; and poor fetal growth. In the progesterone group there were 1.4% (8/582) women and 1.9% (22/1,164) fetuses with at least one serious adverse event; the respective numbers for the placebo group were 1.2% (7/587) and 3.2% (37/1,174) (p=0.80 and p=0.06, respectively). In the post hoc time to event analysis, miscarriage or spontaneous preterm birth between randomization and 31 +6 weeks’ gestation was reduced in the progesterone group relative to the placebo group (hazard ratio 0.23, 95% CI 0.08 - 0.69). Conclusions: In women with twin pregnancies universal treatment with vaginal progesterone did not reduce the incidence of spontaneous birth between 24+0 and 33+6 weeks’ gestation. Post hoc time to event analysis led to the suggestion that progesterone may reduce the risk of spontaneous birth <32 weeks in women with cervical length <30 mm and it may increase the risk for those with cervical length ≥30 mm.Item Efficiency of the Cerebroplacental Ratio in Identifying High-Risk Late-Term Pregnancies.(Medicina, 2023) Martin-Alonso, Raquel; Rolle, Valeria; Akolekar, Ranjit; De Paco Matallana, Catalina; Fernández Buhigas, Irene; Sánchez-Camps, Maria Isabel; Giacchino, TaraBackground and Objectives: Over the last few years, great interest has arisen in the role of the cerebroplacental ratio (CPR) to identify low-risk pregnancies at higher risk of adverse pregnancy outcomes. This study aimed to assess the predictive capacity of the CPR for adverse perinatal outcomes in all uncomplicated singleton pregnancies attending an appointment at 40–42 weeks. Materials and Methods: This is a retrospective cohort study including all consecutive singleton pregnancies undergoing a routine prenatal care appointment after 40 weeks in three maternity units in Spain and the United Kingdom from January 2017 to December 2019. The primary outcome was adverse perinatal outcomes defined as stillbirth or neonatal death, cesarean section or instrumental delivery due to fetal distress during labor, umbilical arterial cord blood pH < 7.0, umbilical venous cord blood pH < 7.1, Apgar score at 5 min < 7, and admission to the neonatal unit. Logistic mixed models and ROC curve analyses were used to analyze the data. Results: A total of 3143 pregnancies were analyzed, including 537 (17.1%) with an adverse perinatal outcome. Maternal age (odds ratio (OR) 1.03, 95% confidence interval (CI) 1.01 to 1.04), body mass index (OR 1.04, 95% CI 1.03 to 1.06), racial origin (OR 2.80, 95% CI 1.90 to 4.12), parity (OR 0.36, 95% CI 0.29 to 0.45), and labor induction (OR 1.79, 95% CI 1.36 to 2.35) were significant predictors of adverse perinatal outcomes with an area under the ROC curve of 0.743 (95% CI 0.720 to 0.766). The addition of the CPR to the previous model did not improve performance. Additionally, the CPR alone achieved a detection rate of only 11.9% (95% CI 9.3 to 15) when using the 10th centile as the screen-positive cutoff. Conclusions: Our data on late-term unselected pregnancies suggest that the CPR is a poor predictor of adverse perinatal outcomes.Item Pravastatin versus Placebo in Pregnancies at High Risk of Term Preeclampsia.(Circulation, 2021) Döbert, Moritz; Nektaria Varouxaki, Anna; Chi Mu, An; Syngelaki, Argyro; Ciobanu, Anca; Akolekar, Ranjit; De Paco Matallana, Catalina; Cicero, Simona; Greco, Elena; Singh, Mandeep; Janga, Deepa; Gil Mira, María del Mar; C. Jani, Jacques; Bartha, José Luis; Maclagan, Kate; Wright, David; H. Nicolaides, KyprosBACKGROUND: Effective screening for term preeclampsia is provided by a combination of maternal factors with measurements of mean arterial pressure, serum placental growth factor and serum soluble fms-like tyrosine kinase-1 at 35 to 37 weeks of gestation, with detection rate of about 75%, at screen positive rate of 10%. However, there is no known intervention to reduce the incidence of the disease. METHODS: In this multicenter, double-blind, placebo-controlled trial, we randomly assigned 1,120 women with singleton pregnancies at high-risk of term preeclampsia to receive pravastatin, at a dose of 20 mg per day, or placebo from 35 to 37 weeks of gestation until delivery or 41 weeks. The primary outcome was delivery with preeclampsia at any time after randomization. The analysis was performed according to intention-to-treat. RESULTS: A total of 29 women withdrew consent during the trial. Preeclampsia occurred in 14.6% (80/548) participants in the pravastatin group and in 13.6% (74/543) in the placebo group. Allowing for the effect of risk at the time of screening and participating centre, the mixed effects Cox regression showed no evidence of an effect of pravastatin; hazard ratio (statin/placebo) 1.08 (95% confidence interval: 0.78, 1.49; p=0.65). There was no evidence of interaction between the effect of pravastatin, estimated risk of preeclampsia, previous pregnancy history, adherence and aspirin treatment. There was no significant between-group difference in the incidence of any secondary outcomes, including gestational hypertension, stillbirth, abruption, delivery of small for gestational age neonates, neonatal death or neonatal morbidity. There was no significant between-group difference in the treatment effects on serum placental growth factor and soluble fms-like tyrosine kinase-1 concentrations 1 and 3 weeks after randomization Adherence was good, with reported intake of 80% or more of the required number of tablets in 89% of participants. There were no significant between-group differences in neonatal adverse outcomes or other adverse events.