Carme Merced

Cervical pessary in pregnant women with a short cervix (PECEP): an open-label randomised controlled trial

BACKGROUND Most previous studies of the use of cervical pessaries were either retrospective or case controlled and their results showed that this intervention might be a preventive strategy for women at risk of preterm birth; no randomised controlled trials have been undertaken. We therefore undertook a randomised, controlled trial to investigate whether the insertion of a cervical pessary in women with a short cervix identified by use of routine transvaginal scanning at 20-23 weeks of gestation reduces the rate of early preterm delivery. METHODS The Pesario Cervical para Evitar Prematuridad (PECEP) trial was undertaken in five hospitals in Spain. Pregnant women (aged 18-43 years) with a cervical length of 25 mm or less were randomly assigned according to a computer-generated allocation sequence by use of central telephone in a 1:1 ratio to the cervical pessary or expectant management (without a cervical pessary) group. Because of the nature of the intervention, this study was not masked. The primary outcome was spontaneous delivery before 34 weeks of gestation. Analysis was by intention to treat. This study is registered with ClinicalTrials.gov, number NCT00706264. FINDINGS 385 pregnant women with a short cervix were assigned to the pessary (n=192) and expectant management groups (n=193), and 190 were analysed in each group. Spontaneous delivery before 34 weeks of gestation was significantly less frequent in the pessary group than in the expectant management group (12 [6%] vs 51 [27%], odds ratio 0·18, 95% CI 0·08-0·37; p<0·0001). No serious adverse effects associated with the use of a cervical pessary were reported. INTERPRETATION Cervical pessary use could prevent preterm birth in a population of appropriately selected at-risk women previously screened for cervical length assessment at the midtrimester scan. FUNDING Instituto Carlos III.

Cardiac complications during pregnancy are better predicted with the modified WHO risk score

BACKGROUND/OBJECTIVE Several risk scores (RSs) have been used to stratify risk of cardiac complications (CCs) in pregnant patients with heart disease. We aimed to compare and contrast the accuracy of several RSs for predicting CC in this population. METHODS Prospective inclusion of all consecutive pregnant patients with heart disease, and follow-up until 6 months postpartum. CCs were defined as primary if admission was required due to heart failure, arrhythmia or thromboembolic events, and secondary if the decline in NYHA class compared with baseline was >2 or urgent invasive cardiac procedures were needed. The discriminatory power of each RS was assessed by the area-under-the receiver-operating characteristic (ROC) curve (AUC). RESULTS 179 patients, mean age: 32 years, accounted for 13.4% of CC (primary 11.7%, secondary 1.7%); the main diagnosis was congenital heart disease (CHD) in 68% followed by valvulopathies in 16%, arrhythmia in 7% and myocardiopathies in 5%. 22% (n=40) were classified as mWHO=1, 59% (n=105) mWHO=2 including subgroup 2-3, 14% (n=26) mWHO=3 and 4%(n=7) mWHO=4; 1 patient was unclassifiable. mWHO showed a better AUC (0.763) than CARPREG (0.67). For the CHD population, ZAHARA RS showed an AUC of 0.74, and Khairy an AUC of 0.632. CONCLUSIONS mWHO was better at predicting CC than CARPREG; mWHO was also better at predicting CC than the specific CHD RS in the CHD subgroup. PRACTICE There are an increasing number of pregnant women with HD. IMPLICATIONS Improved prediction of CC risk during pregnancy can provide better preconception assessment in women with HD.

Premature rupture of membranes before 34 weeks managed expectantly: maternal and perinatal outcomes in singletons

Objectives: To ascertain the risk factors for imminent delivery and infection in pregnant women with premature rupture of membranes (PPROM) before 34 weeks of gestation, evaluate maternal and fetal outcomes and identify obstetric factors for determining which patients meet the criteria for home follow-up. Methods: Medical charts of all women with PPROM admitted to the Vall d’Hebron Hospital (HVH) between January 2006 and December 2010 were retrospectively reviewed. Results: During the study period, 216 women were admitted with a diagnosis of PPROM <34 weeks of gestation with a singleton, live, structurally-normal fetus. Mean gestational age at delivery was 31 weeks. Sixty-two patients (28.7%) delivered before 28 weeks and 76 of the infants (35.2%) had birth weight <1,500 g. Overall, 202 infants (93.5%) survived to be discharged home. On stratifying by gestational age at PPROM diagnosis, prognosis was better when PPROM occurred near to term. Gestational age at delivery was increased in pregnant women with no oligohydramnios, no shortened cervix and with negative endocervical and vaginal cultures at PPROM diagnosis (33 weeks of gestation) vs. pregnant women with positive cultures at admission (27 weeks), oligohydramnios at admission (28 weeks) and shortened cervix (26 weeks). This difference was statistically significant (p = 0.005). Conclusions: Protective factors for PPROM could be normal AFI, cervical length >25 mm and negative cultures at PPROM diagnosis. These factors could permit home follow-up of this group of patients.

Predictors of obstetric complications in women with heart disease

Abstract Objectives: The objective of this study is to evaluate obstetric outcomes in women with heart disease and determine whether current multidisciplinary management approaches adversely affect the mother, the neonate, or both. Also to compare the accuracy of several risk scores (RS) including the modified World Health Organization classification (mWHO) and CARPREG to predict obstetric and neonatal complications and to study the addition value of Uteroplacental-Doppler flow (UDF) parameters to predict obstetric complications. Methods: A prospective cohort study examined outcomes in women with heart disease (HD), the majority of whom had corrective surgery and delivered between January 2007 and March 2012. Results: One hundred and seventy-four patients with 179 pregnancies were included in the study. Obstetric complications, including premature labor, arose in 87 patients (48.6%). Neonatal complications were observed in 11 cases (7%). On multivariate analysis, maternal heart disease was predictive of adverse perinatal events (46 cases, 25.7%) and mode of delivery (Thierry’s spatula) of third- or fourth-degree perineal tears (six cases, 3.2%). mWHO classification predicted obstetric complications (p = 0.0001) better than the CARPREG study. Impaired UDF (uterine artery pulsatility index-20 weeks and umbilical artery pulsatility index-32 weeks in HD versus healthy women: 20w 1.12 versus 1.34, p = 0.005; 32w 0.87 versus 1.09, p = 0.008) was associated with adverse obstetric and offspring outcome in the group of HD pregnant women. Conclusions: Nearly 50% of pregnancies were associated with an adverse obstetric outcome, particularly IUGR. mWHO was better at predicting obstetric and neonatal complications that CARPREG in all cathegories. Furthermore, compromised UDF combined with mWHO improved the prediction of obstetric and offspring complications in this population.

Physical examination-indicated cerclage in singleton and twin pregnancies: maternal–fetal outcomes

Abstract Objectives: To study maternal and perinatal outcomes after physical examination-indicated cerclage in both singleton and twin pregnancies and evaluate the possible risk factors associated. Study design: Retrospective review of all women undergoing physical examination-indicated cerclage at the Hospital Vall d’Hebro, Barcelona from January 2009 to December 2012 after being diagnosed with cervical incompetence and risk of premature birth. Results: During the study period, 60 cases of women diagnosed with cervical incompetence who were carrying live and morphologically-normal fetuses (53 singleton and 7 twin pregnancies), and who had an imminent risk of premature birth were evaluated. Mean gestational age until birth was 35 weeks in singleton and 32 weeks in twin pregnancies. Four cases (7.5%) of immature births and one case (2.0%) of neonatal death were recorded in singleton pregnancies. No cases of immature births or neonatal deaths were recorded in twin pregnancies. Diagnostic amniocentesis was performed IN all cases to rule out possible chorioamnionitis. Conclusions: Physical examination-indicated cerclage for cervical incompetence in women at risk for immature or preterm birth demonstrates good perinatal prognosis without increasing maternal morbidity in either singleton or twin pregnancies. The increase in gestation time in our study may also have been due to the fact that patients with subclinical chorioamnionitis were excluded by diagnostic amniocentesis.

Modification of cervical length after cervical pessary insertion: correlation weeks of gestation.

Abstract Objectives: To observe the modifications in cervical length (CL) in patients with and without cervical pessary (Arabin® ASQ 65/25/32) and correlate these modifications with gestational age at delivery. Study design: Prospective study of asymptomatic singleton pregnancies (PECEP-Trial) between weeks 20 + 0 and 23 + 6 with maternal short cervix (<25 mm) randomised into two groups: expectant management and cervical pessary. Results: This study included 380 pregnant women: 190 with pessary and 190 without pessary. Mean CL in both groups at the time of randomisation showed no statistically-significant differences (pessary group: 19.0 mm and management group: 19.0 mm; p = 0.9). Mean CL measured after randomisation was 15.4 mm in patients of the expectant management group and 21.5 mm in the pessary group. These differences were statistically significant (p < 0.0001). When means at randomisation and at the second measurement were compared, CL had decreased by 3.6 mm in the expectant management group and increased by 2.6 mm in the pessary group; this difference was statistically significant (p < 0.0001). Coefficients of correlation showed that among patients of both groups with the same CL at 20 weeks of gestation, those with a pessary gave birth later. Conclusions: Insertion of an Arabin cervical pessary increased CL in asymptomatic patients with a short cervix, which correlated with shorter gestational age at delivery. The cervical pessary halted the progressive decrease in CL, which correlated with longer gestational age at delivery.

Cervical pessary to reduce preterm birth <34 weeks of gestation after an episode of preterm labor and a short cervix: a randomized controlled trial

BACKGROUND: To date, no intervention has proved effective in reducing the spontaneous preterm birth rate in singleton pregnancies following an episode of threatened preterm labor and short cervix remaining. OBJECTIVE: This study was designed to ascertain whether cervical pessaries could be useful in preventing spontaneous preterm birth in women with singleton pregnancies and a short cervix after a threatened preterm labor episode. STUDY DESIGN: This open randomized controlled trial was conducted in 357 pregnant women (between 240–336 weeks) who had not delivered 48 hours after a threatened preterm labor episode and had a short cervix remaining (≤25 mm at 240–296 weeks; ≤15 mm at 300–336 weeks). Patients were randomly assigned to cervical pessary (179) or routine management (178). The primary outcome was the spontaneous preterm birth rate <34 weeks. Spontaneous preterm birth <28 and 37 weeks and neonatal morbidity and mortality were also evaluated in an intention‐to‐treat analysis. RESULTS: No significant differences between the pessary and routine management groups were observed in the spontaneous preterm birth rate <34 weeks (19/177 [10.7%] in the pessary group vs 24/175 [13.7%] in the control group; relative risk, 0.78; 95% confidence interval, 0.45–1.38). Spontaneous preterm birth <37 weeks occurred less frequently in the pessary group (26/175 [14.7%] vs 44/175 [25.1%]; relative risk, 0.58; 95% confidence interval, 0.38–0.90; P = .01). Preterm premature rupture of membranes rate was significantly lower in pessary carriers (4/177 [2.3%] vs 14/175 [8.0%]; relative risk, 0.28; 95% confidence interval, 0.09–0.84; P = .01). The pessary group less frequently required readmission for new threatened preterm labor episodes (8/177 [4.5%] vs 35/175 [20.0%]; relative risk, 0.23; 95% confidence interval, 0.11–0.47; P < .0001). No serious adverse maternal events occurred; neonatal morbidity and mortality were similar in both groups. CONCLUSION: Pessary use did not significantly lower the spontaneous preterm birth rate <34 weeks in women with a short cervix remaining after a threatened preterm labor episode but did significantly reduce the spontaneous preterm birth rate <37 weeks, threatened preterm labor recurrence, and the preterm premature rupture of membranes rate.

Aneurisma de aorta abdominal en el síndrome de Marfan durante la gestación

We present the case of a 29-year-old pregnant woman with Marfan syndrome who presented an aortic root diameter of <45 mm at the start of gestation with no other abnormalities. She had been diagnosed of Marfan syndrome 2 years previously as a result of a family study. The patient underwent a follow-up cardiologic examination before becoming pregnant. At that time, the aortic root diameter at the sinuses of Valsalva on transesophageal echocardiography was 43 mm (Fig. 1). At week 30 of gestation, a dilatation of the abdominal aorta consistent with a thrombosed aneurysm was visualized on obstetric ultrasound. Magnetic resonance imaging confirmed the abdominal aortic aneurysm, which originated just below the superior mesenteric artery, continued to the aortic bifurcation, and had a maximum diameter of 58 mm and an associated parietal thrombus; there was no evidence of thoracic aorta dissection or dilatation (Fig. 2). On transthoracic echocardiography, the left ventricle showed no dilatation, systolic function was preserved (ejection fraction 55%), the right chambers were normal, and the ascending aorta was dilated at the sinus of Valsalva (45 mm). During pregnancy, the patient received beta-blocker treatment with maximum doses of atenolol (50 mg/day), and blood pressure was well controlled (systolic arterial pressure <120 mmHg). Following assessment by a multidisciplinary team (obstetricians, cardiologists, vascular surgeons, and anesthesiologists) to evaluate the maternal-fetal risk associated with this new finding, it was decided to finalize gestation at fetal maturity. Cesarean section was performed, and a baby boy was delivered (weight 1410 g, Apgar 7 at 1 min and 9 at 5 min, arterial pH 7.4, and venous pH 7.5). The patient was discharged at 7 days following the cesarean, and surgical repair of the abdominal aortic aneurysm was scheduled. One month later, the patient was hospitalized, the abdominal aortic aneurysm was resected, and a 20-mm Dacron graft was placed from the distal thoracic aorta to the aortic bifurcation. During her intensive care unit stay, she required multiple transfusions, parenteral nutrition, and continuous renal replacement therapy due to acute kidney failure. At 17 days, the patient presented retrograde dissection of the thoracic aorta. Because of her critical situation, surgery was rejected as a treatment option in favor of emergency placement of a Cook endoprosthesis in the thoracic aorta. At 3 months posthospitalization, the patient was discharged in acceptable general condition. A large number of cardiac complications have been reported in pregnant women with Marfan syndrome, the most characteristic being thoracic aorta dissection. Nonetheless, development of an abdominal aortic aneurysm during pregnancy in these patients has only been described previously as a finding during the puerperal period. Although most dissections occur in the ascending aorta, the descending thoracic aorta or abdominal aorta also can be affected. Aortic dissection can also occur in the low-risk group; that is, those without aortic dilatation. Although that is rare, these women should be informed that a normal echocardiogram does not indicate an absence of risk. The family history of aortic dissection and rapid growth of the aortic diameter should be included in risk assessment. It is essential to evaluate the entire aorta before and during pregnancy. Biomechanical assessment of aortic distensibility can help to identify patients without aortic dilatation who are at risk of dilatation or dissection. In pregnancies with a fetal gestational age of less than 28 weeks, the recommended treatment is aortic repair or medical treatment without finalizing pregnancy. When fetal gestational age is greater than 32 weeks, the recommended treatment is to finalize pregnancy by cesarian section with posterior aortic repair or medical treatment. In cases of gestational age between 28 and 32 weeks, the decision should be made on an individual basis by consensus between the mother and neonatalogists. Rev Esp Cardiol. 2012;65(3):288–298